Gebrauchshinweis
SARSTEDT Salivette® VD

2-4
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DE Gebrauchshinweis – SARSTEDT Salivette® VD
EN Instructions for use – SARSTEDT Salivette® VD
BG ȤɉɍɎɌɏɆɒɄɄɃȼɏɋɊɎɌɁȽȼş6$567('76DOLYHWWH® VD
CS Návod k obsluze – SARSTEDT Salivette® VD
DA Brugsanvisning – SARSTEDT Salivette® VD
EL 2ǳǶǲǮǴǿȄǾǭȀǴȆǿş6$567('76DOLYHWWH® VD
ES Instrucciones de uso – SARSTEDT Salivette® VD
ET Kasutusjuhend – SARSTEDT Salivette® VD
FR Mode d’emploi – SARSTEDT Salivette® VD
HR Uputa za upotrebu – SARSTEDT Salivette® VD
HU Használati utasítás – SARSTEDT Salivette® VD
Istruzioni d’uso – SARSTEDT Salivette® VDIT
KO ㌂㣿G㍺ⳛ㍲ – SARSTEDT Salivette® VD
LT Naudojimo instrukcijos – SARSTEDT Salivette® VD
LV /LHWRđDQDVQRUÌGHVş6$567('76DOLYHWWH® VD
NL Gebruiksaanwijzing – SARSTEDT Salivette® VD
NO Bruksanvisning – SARSTEDT Salivette® VD
PL ,QVWUXNFMDREVúXJLş6$567('76DOLYHWWH® VD
PT Instruções de utilização – SARSTEDT Salivette® VD
RO ,QVWUXFėLXQLGHXWLOL]DUHş6$567('76DOLYHWWH® VD
RU ȤɉɍɎɌɏɆɒɄɛɋɊɋɌɄɈɁɉɁɉɄɚş6$567('76DOLYHWWH® VD
SK 1ÈYRGQD3RXĭLWLHş6$567('76DOLYHWWH® VD
SL Navodila za uporabo – SARSTEDT Salivette® VD
SV Bruksanvisning – SARSTEDT Salivette® VD
TH คําแนะนําในการใช้งาน – SARSTEDT Salivette® VD
TR .XOODQêPL×LQWDOLPDWODUş6$567('76DOLYHWWH® VD
ZH ἗䓀完㖦 – SARSTEDT Salivette® VD

1Gebrauchshinweis – SARSTEDT Salivette® VD

DEVerwendungszweck
Die Salivette® VD ist ein Probengefäß für Speichelproben und dient der Entnahme, dem Transport, der Verarbeitung und der Lagerung von Speichel für das Screening auf Virusmaterial, z.B. Nukleinsäuren von SARSCoV-2, in in-vitro diagnostischen Bestimmungen. Das Produkt ist für den Einsatz im professionellen Umfeld und die Anwendung durch medizinisches Fachpersonal und Laborpersonal bestimmt.

Produktbeschreibung
Die Salivette® VD besteht aus einem transparenten Kunststoffgefäß mit Spitzboden, einem Einhängegefäß, einer Saugrolle aus Watte und einem hellblauen Stopfen.
Bei der Saugrolle aus Watte handelt es sich um ein Naturprodukt. Verfärbungen und dunklere Einschlüsse oder Stellen sind naturgemäß und unvermeidbar.

51.1534.100=

Kunststoffgefäß+

Einhängegefäß+

Saugrolle+

hellblauer Stopfen

Sicherheits- und Warnhinweise1.

Das Produkt darf nicht bei Kindern unter 3 Jahren sowie bei Patienten mit erhöhter Verschluckungsgefahr angewendet werden.

2.

Allgemeine Vorsichtsmaßnahmen: Verwenden Sie Handschuhe und andere allgemeine persönliche Schutzausrüstung, um sich vor einer möglichen Exposition gegenüber potentiell infektiösem Probenmaterial zu
schützen. Die Sicherheitsrichtlinien und -verfahren Ihrer Einrichtung müssen befolgt werden.

3.

Der mit der Salivette® VD gewonnene und verarbeitete Speichel ist nicht zur Rückführung in den menschlichen Körper bestimmt.

4.

Eine Salivette® VD nach dem Haltbarkeitsdatum nicht mehr verwenden. Die Haltbarkeit einer Salivette® VD endet am letzten Tag des angegebenen Monats und Jahres.

Lagerung
Die Salivette® VD ist vor Verwendung bei Raumtemperatur zu lagern.

Transport
Das Produkt kann manuell innerbetrieblich oder zusammen mit einem ADR (Verpackungsanweisung P650) konformen Sekundärgefäß transportiert werden. Für den Probentransport der Salivette® VD wird das ADR(Verpackungsanweisung P650) konforme Versandgefäß Art.-Nr. 78.898 mit Saugeinlage plus Schraubverschluss Art.-Nr. 65.679 sowie eine Versandbox /-tasche empfohlen.
Für Patient:
Folgen Sie zur Rückgabe der Speichelprobe in der fest verschlossenen Salivette® VD den Anweisungen des Arztes und verwenden Sie das vom Arzt bereitgestellte Sekundärgefäß und die Versandbox /-tüte. Falls die
Rückgabe nicht direkt erfolgt, lagern Sie diese Salivette® VD im Kühlschrank.

Einschränkungen
Die Speichelentnahme soll frühestens 60 Minuten nach einer Mahlzeit (flüssige/feste Nahrungsaufnahme), Zähneputzen oder oralen Einnahme von Medikamenten erfolgen, um eine Kontamination des Speichels durch
störende Substanzen zu vermeiden.
Lagerungsdauer und -temperatur sind abhängig von der Haltbarkeit der zu untersuchenden Parameter. Daher und auf Grund des schon bei Raumtemperatur nach einigen Stunden einsetzenden Bakterienwachstums im
Speichel wird empfohlen, die Salivette® VD nach Probennahme fest verschlossen entweder innerhalb von 4h zu zentrifugieren und zu analysieren oder direkt im Kühlschrank bis zur weiteren Prozessierung zu lagern.

Probennahme und Handhabung
LESEN SIE DIESES DOKUMENT VOLLSTÄNDIG DURCH, BEVOR SIE MIT DER SPEICHELGEWINNUNG BEGINNEN.
Für die Probennahme benötigtes Arbeitsmaterial:
1.

Handschuhe, Kittel, Augenschutz oder andere geeignete Schutzkleidung zum Schutz vor durch Speichel übertragene Pathogene oder potenziell infektiösen Materialien.

2.

Anzahl Salivette® VD gemäß Anforderung vom Arzt.

3.

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2

DEProbennahme

2 min ohne
KaubewegungƊPLQ

1 min
500 x gProbe

Rückstände

Die Speichelentnahme soll frühestens 60 Minuten nach einer Mahlzeit (flüssige/feste Nahrungsaufnahme), Zähneputzen, Rauchen oder oralen Einnahme von Medikamenten erfolgen, um eine Kontamination desSpeichels durch störende Substanzen zu vermeiden.
Unmittelbar vor der Speichelentnahme Hände waschen und abtrocknen.
Die Saugrolle am hinteren Ende mit zwei Fingern aus der geöffneten Salivette® VD entnehmen und
in den Mund legen.
Die Saugrolle soll für 2 Minuten ohne Kaubewegungen im Mund (z.B. Wangentasche) verweilen. Die zu gewinnende Mindestspeichelmenge soll 500μl betragen. Bei extrem geringer Speichelbildung lässt man die
Saugrolle länger im Mund ruhen.
Die Saugrolle am hinteren Ende mit zwei Fingern aus dem Mund nehmen undunmittelbar in die Salivette® VD stecken und mit dem hellblauen Stopfen verschließen.
Für Patient: Folgen Sie zur Rückgabe der Speichelprobe in der fest verschlossenen Salivette® VD den Anweisungen des Arztes und verwenden Sie das vom Arzt bereitgestellte Sekundärgefäß und die Versandbox/-tüte. Falls die Rückgabe nicht direkt erfolgt, lagern Sie diese Salivette® VD im Kühlschrank.
Für Arzt und Labor:
Auf Grund des schon bei RT nach einigen Stunden einsetzenden Bakterienwachstums im Speichel wird empfohlen, die Salivette® VD nach Probennahme fest verschlossen entweder innerhalb von 4h bei 500 x g
für 1 Minute zu zentrifugieren und zu analysieren oder direkt im Kühlschrank bis zur weiteren Prozessierung zu lagern.
Nach Zentrifugation das Einhängegefäß inklusive Stopfen aus dem Kunststoffgefäß mit Spitzboden herausnehmen.
Im Spitzboden des Kunststoffgefäßes befindet sich der reine Speichel für die weitere Analyse über den Rückständen, die sich im Reservoir des Spitzbodens befinden.
Nach Analyse das Kunststoffgefäß mit Spitzboden und das Einhängegefäß in einem Entsorgungsbehälter entsorgen.

Entsorgung – gilt für Arzt und Labor
1.

Es sind die allgemeinen Hygienerichtlinien sowie die gesetzlichen Bestimmungen für die ordnungsgemäße Entsorgung von infektiösem Material zu beachten und einzuhalten.

2.

Einmalhandschuhe verhindern dabei das Risiko einer Infektion.

3.

Kontaminierte oder befüllte Salivette®9'PXVVLQJHHLJQHWHP(QWVRUJXQJVEHKËOWHUIĞUELRORJLVFKH*HIDKUVWRĳHHQWVRUJWZHUGHQGHUDQVFKOLHĔHQGDXWRNODYLHUWXQGYHUEUDQQWZHUGHQNDQQ

4.

Die Entsorgung muss in einer geeigneten Verbrennungsanlage oder mittels Autoklavieren (Dampfsterilisation) erfolgen.

3

DE
Literatur
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

Symbol- und Kennzeichnungsschlüssel:

Artikelnummer

Chargenbezeichnung

Verwendbar bis

CE-Zeichen

In-vitro-Diagnostikum

Gebrauchsanleitung beachten

Bei Wiederverwendung: Kontaminationsgefahr

Vor Sonnenlicht geschützt aufbewahren

Trocken lagern

Hersteller

Land der Herstellung

Technische Änderungen vorbehalten.
Alle in Zusammenhang mit dem Produkt aufgetretenen schwerwiegenden Vorfälle sind dem Hersteller und der zuständigen nationalen Behörde zu melden.

4Instructions for use – SARSTEDT Salivette® VD

ENIntended use
The Salivette® VD is a specimen tube for saliva samples and is used for the collection, transport, processing and storage of saliva for screening of virus material, e.g. SARS-CoV-2 nucleic acids, in in vitro diagnostic
tests. The product is intended for use in a professional environment by qualified medical and laboratory personnel.

Product description
The Salivette® VD consists of a transparent conical bottom plastic tube, an insert, an absorbent cotton roll and a light blue cap.
The absorbent cotton roll is a natural product. Discolouration and darker inclusions or areas are natural and unavoidable.

51.1534.100=

Plastic tube+

Insert+Absorbent roll+Light blue cap

Safety information and warnings
1.

The product must not be used in children under 3 years of age or in patients at increased risk of choking.

2.

General precautions: Use gloves and other general personal protective equipment to protect yourself against possible exposure to potentially infectious sample material. Always follow the safety guidelines andprocedures of your facility.

3.

The saliva collected and processed with the Salivette® VD is not intended to be returned to the human body.

4.

Do not use Salivette® VD after the expiry date. The expiry date of Salivette® VD is the last day of the month and year as indicated.

Storage
Store Salivette® VD at room temperature before use.

Transport
The product can be transported manually in-house or with an ADR-compliant (packaging instruction P650) secondary container. The ADR-compliant (packaging instruction P650) shipping container, Art. no. 78.898,
with absorbent insert plus screw cap, Art. no. 65.679, and shipping box /bag is recommended for Salivette® VD specimen transport.
For the patient:
To return the saliva sample in the tightly closed Salivette® VD, follow the doctor's instructions and use the secondary container provided by the doctor and the shipping box/bag. If it is not returned immediately, store thisSalivette® VD in the refrigerator.

Limitations
The saliva sample should be taken at least 60 minutes after a meal (liquid/solid food intake), brushing teeth or taking oral medication, in order to avoid the saliva being contaminated with interfering substances.
The storage duration and temperature depend on the shelf life for the parameters to be tested. Therefore, and since the onset of bacterial growth in saliva can be expected after just a few hours at room temperature, it isrecommended that the Salivette® VD be sealed tightly after sampling and either centrifuged and analysed within 4 hours or placed immediately in a refrigerator until further processing.

Specimen collection and handling
READ ALL OF THIS DOCUMENT BEFORE STARTING TO COLLECT SALIVA.
Material required to collect a specimen:
1.

Gloves, gown, goggles or other suitable protective gear to protect against pathogens transmitted via saliva or potentially infectious materials.

2.

Number of Salivette® VD tubes as requested by the doctor.

3.

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5

EN
Sample collection

2 min without making
any chewing motionsƊPLQ

1 min
500 x gSpecimen

Residues

The saliva sample should be taken at least 60 minutes after a meal (liquid/solid food intake), brushing teeth, smoking or taking oral medication, in order to avoid the saliva being contaminated with interfering
substances.
Immediately before collecting the saliva, wash and dry hands.
With two fingers, remove the absorbent roll at the far end from the opened Salivette® VD andplace it in the mouth.
7KHDEVRUEHQWUROOVKRXOGEHNHSWLQWKHPRXWK HJLQWKHFKHHN IRUPLQXWHVZLWKRXWFKHZLQJ7KHDPRXQWRIVDOLYDFROOHFWHGVKRXOGEHDWOHDVWbƐO,IDQH[WUHPHO\VPDOODPRXQWRIVDOLYDLVSURGXFHGOHDYH
the absorbent roll in the mouth longer.
With two fingers, take the absorbent roll out of the mouth by the far end andplace it immediately in the Salivette® VD and seal with the light blue cap.
For the patient: To return the saliva sample in the tightly closed Salivette® VD, follow the doctor's instructions and use the secondary container provided by the doctor and the shipping box/bag. If it is not returned
immediately, store this Salivette® VD in the refrigerator.
For doctors and laboratories:
Because of the onset of bacterial growth in saliva after a few hours at room temperature, it is recommended to either centrifuge the firmly closed Salivette® VD within 4 hours after specimen collection at 500 x g
for 1 minute and analyse it or to store it immediately in the refrigerator until further processing.
After centrifugation, take the insert including cap out of the conical bottom plastic tube.
The pure saliva for further analysis is found in the conical bottom of the plastic tube above the residues that are located in the reservoir of the conical bottom.
After analysis, dispose of the conical bottom plastic tube and the insert in a disposal container.

Disposal – for doctors and laboratories
1.

The general hygiene guidelines and regulations for the proper disposal of infectious material must be observed and complied with.

2.

Disposable gloves prevent the risk of infection.

3.

&RQWDPLQDWHGRUıOOHG6DOLYHWWH® VD tubes must be disposed of in suitable containers for hazardous biological waste that can be subsequently autoclaved and incinerated.

4.

They must be disposed of in a suitable incinerator or by autoclaving (steam sterilisation).

6

EN
Literature
Hoch et al. Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al. NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

Key for symbols and labels:

Article number

Batch number

Use byCE marking

In vitro diagnostic device

Follow the instructions for use

If reused: Risk of contamination

Store away from sunlight

Store in a dry place

Manufacturer

Country of manufacture

Technical modifications reserved.
All serious incidents relating to the product must be reported to the manufacturer and the competent national authority.

7ȤɉɍɎɌɏɆɒɄɄɃȼɏɋɊɎɌɁȽȼş6$567('76DOLYHWWH® VD

BG

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ȪɋɄɍȼɉɄɁɉȼɋɌɊɀɏɆɎȼ
Salivette®9'ɍɁɍɖɍɎɊɄɊɎɋɌɊɃɌȼɓɉȼɋɇȼɍɎɈȼɍɊȾȼɁɋɌɏȾɁɎɆȼɍɊɍɎɌɊɀɖɉɊȾɄɍɛɕɍɖɀɋȼɈɏɓɁɉɎȼɈɋɊɉɄɍȾɁɎɇɊɍɄɉɛɃȼɋɏɔȼɇɆȼ
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ȤɉɍɎɌɏɆɒɄɄɃȼȽɁɃɊɋȼɍɉɊɍɎ
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ȪȽɕɄɋɌɁɀɋȼɃɉɄɈɁɌɆɄȤɃɋɊɇɃȾȼɅɎɁɌɖɆȼȾɄɒɄɄɀɌɏȿɄɊȽɕɄɇɄɓɉɄɋɌɁɀɋȼɃɉɄɍɌɁɀɍɎȾȼɃȼɀȼɍɁɋɌɁɀɋȼɃɄɎɁɊɎɁȾɁɉɎɏȼɇɉɊɄɃɇȼȿȼɉɁɉȼɋɊɎɁɉɒɄȼɇɉɊɄɉɐɁɆɒɄɊɃɁɉɋɌɊȽɁɉɈȼɎɁɌɄȼɇȭɋȼɃȾȼɅɎɁ
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Salivette®9'ɎɌɛȽȾȼɀȼɍɁɍɖɑɌȼɉɛȾȼɋɌɄɍɎȼɅɉȼɎɁɈɋɁɌȼɎɏɌȼɋɌɁɀɄɏɋɊɎɌɁȽȼ

ȮɌȼɉɍɋɊɌɎ
ȫɌɊɀɏɆɎɖɎɈɊɂɁɀȼȽɖɀɁɎɌȼɉɍɋɊɌɎɄɌȼɉɇɊɆȼɇɉɊɉȼɌɖɆȼɄɇɄɍȾɎɊɌɄɓɁɉɍɖɀɊɎȿɊȾȼɌɛɕɉȼ$'5 ȤɉɍɎɌɏɆɒɄɄɎɁɃȼɊɋȼɆɊȾȼɉɁ3 ȣȼɎɌȼɉɍɋɊɌɎȼɉȼɋɌɊȽɄȾ6DOLYHWWH®9'ɍɁɋɌɁɋɊɌɖɓȾȼȾɎɊɌɄɓɁɉɍɖɀ
ɊɎȿɊȾȼɌɛɕɉȼ$'5 ȤɉɍɎɌɏɆɒɄɄɎɁɃȼɊɋȼɆɊȾȼɉɁ3 ɍɋɌɊɀɏɆɎɊȾǂɍɋɊɋɄȾȼɕȼȾɇɊɂɆȼɄɆȼɋȼɓɆȼɉȼȾɄɉɎɋɌɊɀɏɆɎɊȾǂɆȼɆɎɊɄɆɏɎɄɛɎɊɌȽɄɓɆȼɃȼɎɌȼɉɍɋɊɌɎ
ȣȼɋȼɒɄɁɉɎȼ
ȭɇɁɀȾȼɅɎɁɉȼɍɊɆɄɎɁɉȼɇɁɆȼɌɛɋɌɄɋɌɁɀȼȾȼɉɁɉȼɍɇɚɉɓɁɉȼɎȼɋɌɊȽȼȾɃɀɌȼȾɊɃȼɎȾɊɌɁɉȼɎȼ6DOLYHWWH®9'ɄɄɃɋɊɇɃȾȼɅɎɁɋɌɁɀɊɍɎȼȾɁɉɄɎɁɊɎɇɁɆȼɌɛȾɎɊɌɄɓɁɉɍɖɀɄɆɏɎɄɛɎɊɌȽɄɓɆȼɃȼɎɌȼɉɍɋɊɌɎȞɍɇɏɓȼɅɓɁ
ɉɁɁȾɖɃɈɊɂɉɊɉɁɃȼȽȼȾɉɊɋɌɁɀȼȾȼɉɁɉȼɋɌɊȽȼɎȼɍɖɑɌȼɉɛȾȼɅɎɁ6DOLYHWWH®9'ȾɑɇȼɀɄɇɉɄɆ

ȪȿɌȼɉɄɓɁɉɄɛ
ȞɃɁɈȼɉɁɎɊɉȼɍɇɚɉɓɁɉȼɋɌɊȽȼɎɌɛȽȾȼɀȼɍɁɄɃȾɖɌɔɄɉȼɅɌȼɉɊɈɄɉɏɎɄɍɇɁɀɑɌȼɉɁɉɁ ɎɁɓɉɊɍɎɄɎȾɖɌɀɄɑɌȼɉɄ ɈɄɁɉɁɉȼɃɖȽɄɄɇɄɊɌȼɇɁɉɋɌɄɁɈɉȼɇɁɆȼɌɍɎȾȼɃȼɀȼɍɁɄɃȽɁȿɉɁɃȼɈɖɌɍɛȾȼɉɁɉȼɍɇɚɉɆȼɎȼ
ɍɖɍɍɎɌȼɉɄɓɉɄȾɁɕɁɍɎȾȼ
ȞɌɁɈɁɎɊɄɎɁɈɋɁɌȼɎɏɌȼɎȼɉȼɍɖɑɌȼɉɁɉɄɁɃȼȾɄɍɛɎɊɎɎɌȼɅɉɊɍɎɎȼɃȼɄɃɍɇɁɀȾȼɉɄɎɁɋȼɌȼɈɁɎɌɄȫɊɎȼɃɄɋɌɄɓɄɉȼɄɋɊɌȼɀɄȽȼɆɎɁɌɄȼɇɉɄɛɌȼɍɎɁɂȾɍɇɚɉɆȼɎȼɆɊɅɎɊɃȼɋɊɓȾȼɍɇɁɀɉɛɆɊɇɆɊɓȼɍȼɉȼɍɎȼɅɉȼ
ɎɁɈɋɁɌȼɎɏɌȼɍɁɋɌɁɋɊɌɖɓȾȼ6DOLYHWWH®9'ɀȼɍɁɒɁɉɎɌɊɐɏȿɄɌȼȾɌȼɈɆɄɎɁɉȼɓȼɍȼɋɇɖɎɉɊɃȼɎȾɊɌɁɉȼɄɀȼɍɁȼɉȼɇɄɃɄɌȼɄɇɄɉȼɋɌȼȾɊɀȼɍɁɍɖɑɌȼɉɄȾɑɇȼɀɄɇɉɄɆɀɊɋɊɉȼɎȼɎɖɔɉȼɎȼɊȽɌȼȽɊɎɆȼ

ȞɃɁɈȼɉɁɉȼɋɌɊȽɄɄɏɋɊɎɌɁȽȼ
ȫȬȪȳȡȮȡȮȡȮȪȣȤȠȪȦȯȨȡȩȮȤȣȲȻȧȪȫȬȡȠȤȠȜȣȜȫȪȳȩȡȮȡȭȞȣȡȨȜȩȡȮȪȩȜȭȧȺȩȳȡȩȜȫȬȪȝȜȬȼȽɊɎɉɄɈȼɎɁɌɄȼɇɄɉɁɊȽɑɊɀɄɈɄɃȼȾɃɁɈȼɉɁɎɊɉȼɋɌɊȽɄ
1.

ȬɖɆȼȾɄɒɄɋɌɁɍɎɄɇɆȼɊɓɄɇȼɄɇɄɀɌɏȿɊɋɊɀɑɊɀɛɕɊɃȼɕɄɎɉɊɊȽɇɁɆɇɊɃȼɃȼɕɄɎȼɊɎɋȼɎɊȿɁɉɄɋɌɁɉɊɍɄɈɄɍɖɍɍɇɚɉɆȼɎȼɄɇɄɀɌɏȿɄɋɊɎɁɉɒɄȼɇɉɊɄɉɐɁɆɒɄɊɃɉɄɈȼɎɁɌɄȼɇɄ

2.

ȝɌɊɅ6DOLYHWWH®9'ɍɖȿɇȼɍɉɊɏɆȼɃȼɉɄɛɎȼɉȼɇɁɆȼɌɛ

3.

ȫɊɋɖɇɉɁɎɁɄɉɐɊɌɈȼɒɄɛɎȼɃȼɄɀɁɉɎɄɐɄɆȼɒɄɛɉȼɋɌɊȽȼɎȼ ȾɖɌɑɏɁɎɄɆɁɎȼ 

8BGȞɃɁɈȼɉɁɉȼɋɌɊȽȼ

ɈɄɉɏɎɄȽɁɃɀȼ
ɀɖȾɓɁɎɁ

ƊPLQ

1 min
500 x gȫɌɊȽȼȪɍɎȼɎɖɒɄ

ȞɃɁɈȼɉɁɎɊɉȼɍɇɚɉɓɁɉȼɋɌɊȽȼɎɌɛȽȾȼɀȼɍɁɄɃȾɖɌɔɄɉȼɅɌȼɉɊɈɄɉɏɎɄɍɇɁɀɑɌȼɉɁɉɁ ɎɁɓɉɊɍɎɄɎȾɖɌɀɄɑɌȼɉɄ ɈɄɁɉɁɉȼɃɖȽɄɋɏɔɁɉɁɄɇɄɊɌȼɇɁɉɋɌɄɁɈɉȼɇɁɆȼɌɍɎȾȼɃȼɀȼɍɁɄɃȽɁȿɉɁ
ɃȼɈɖɌɍɛȾȼɉɁɉȼɍɇɚɉɆȼɎȼɍɖɍɍɎɌȼɉɄɓɉɄȾɁɕɁɍɎȾȼ
ȤɃɈɄɅɎɁɄɄɃɍɏɔɁɎɁɌɖɒɁɎɁɍɄɉɁɋɊɍɌɁɀɍɎȾɁɉɊɋɌɁɀɄȾɃɁɈȼɉɁɎɊɉȼɍɇɚɉɓɁɉȼɎȼɋɌɊȽȼ
ȱȾȼɉɁɎɁɋȼɈɏɓɉɄɛɎȼɈɋɊɉɃȼɃȼɀɉɄɛɆɌȼɅɍɀȾȼɋɌɖɍɎȼɄɃȾȼɀɁɎɁȿɊɊɎɊɎȾɊɌɁɉȼɎȼ6DOLYHWWH® VDɄȿɊɋɊɍɎȼȾɁɎɁȾɏɍɎȼɎȼ
ȪɍɎȼȾɁɎɁɋȼɈɏɓɉɄɛɎȼɈɋɊɉȾɏɍɎȼɎȼɃȼɈɄɉɏɎɄȽɁɃɀȼȿɊɀɖȾɓɁɎɁ ɉȼɋɌɄɈɁɌȾɆɏɑɄɉȼɎȼɉȼȽɏɃȼɎȼ ȨɄɉɄɈȼɇɉɊɎɊɆɊɇɄɓɁɍɎȾɊɋɊɁɎȼɍɇɚɉɆȼɎɌɛȽȾȼɀȼɁƐOȫɌɄɈɉɊȿɊɍɇȼȽɊɍɇɚɉɆɊɊɎɀɁɇɛɉɁ
ɊɍɎȼȾɁɎɁɋȼɈɏɓɉɄɛɎȼɈɋɊɉɋɊɀɖɇȿɊȾɏɍɎȼɎȼ
ȱȾȼɉɁɎɁɋȼɈɏɓɉɄɛɎȼɈɋɊɉɃȼɃȼɀɉɄɛɆɌȼɅɍɀȾȼɋɌɖɍɎȼɄɃȾȼɀɁɎɁȿɊɊɎɏɍɎȼɎȼɄ
ɉɁɃȼȽȼȾɉɊɛɋɊɍɎȼȾɁɎɁȾ6DOLYHWWH®9'ȭɇɁɀɎɊȾȼɃȼɎȾɊɌɁɎɁɍȽɛɇȼɎȼɃȼɋɏɔȼɇɆȼ
ȣȼɋȼɒɄɁɉɎȼȭɇɁɀȾȼɅɎɁɉȼɍɊɆɄɎɁɉȼɇɁɆȼɌɛɋɌɄɋɌɁɀȼȾȼɉɁɉȼɍɇɚɉɓɁɉȼɎȼɋɌɊȽȼȾɃɀɌȼȾɊɃȼɎȾɊɌɁɉȼɎȼ6DOLYHWWH®9'ɄɄɃɋɊɇɃȾȼɅɎɁɋɌɁɀɊɍɎȼȾɁɉɄɎɁɊɎɇɁɆȼɌɛȾɎɊɌɄɓɁɉɍɖɀɄɆɏɎɄɛɎɊɌȽɄɓɆȼɃȼ
ɎɌȼɉɍɋɊɌɎȞɍɇɏɓȼɅɓɁɉɁɁȾɖɃɈɊɂɉɊɉɁɃȼȽȼȾɉɊɋɌɁɀȼȾȼɉɁɉȼɋɌɊȽȼɎȼɍɖɑɌȼɉɛȾȼɅɎɁ6DOLYHWWH®9'ȾɑɇȼɀɄɇɉɄɆ
ȣȼɇɁɆȼɌɛɄɇȼȽɊɌȼɎɊɌɄɛɎȼ
ȫɊɎȼɃɄɋɌɄɓɄɉȼɄɋɊɌȼɀɄȽȼɆɎɁɌɄȼɇɉɄɛɌȼɍɎɁɂȾɍɇɚɉɆȼɎȼɆɊɅɎɊɃȼɋɊɓȾȼɍɇɁɀɉɛɆɊɇɆɊɓȼɍȼɉȼɍɎȼɅɉȼɎɁɈɋɁɌȼɎɏɌȼɍɁɋɌɁɋɊɌɖɓȾȼɍɇɁɀȾɃɁɈȼɉɁɎɊɉȼɋɌɊȽȼɎȼ6DOLYHWWH®9'ɄɇɄɀȼɍɁ
ɒɁɉɎɌɊɐɏȿɄɌȼȾɌȼɈɆɄɎɁɉȼɓȼɍȼɋɌɄ[JɃȼɈɄɉɏɎȼɄɇɄɉɁɃȼȽȼȾɉɊɀȼɍɁɋɊɍɎȼȾɄɄɍɖɑɌȼɉɛȾȼȾɑɇȼɀɄɇɉɄɆɀɊɋɊɉȼɎȼɎɖɔɉȼɎȼɊȽɌȼȽɊɎɆȼ
ȭɇɁɀɒɁɉɎɌɊɐɏȿɄɌȼɉɁɎɊɄɃȾȼɀɁɎɁȾɄɍɛɕɄɛɍɖɀɃȼɁɀɉɊɍɖɍɃȼɋɏɔȼɇɆȼɎȼɊɎɋɇȼɍɎɈȼɍɊȾȼɎȼɁɋɌɏȾɁɎɆȼɍɊɍɎɌɊɀɖɉɊ
ȳɄɍɎȼɎȼɍɇɚɉɆȼɃȼɋɊɉȼɎȼɎɖɔɁɉȼɉȼɇɄɃɊɍɎȼȾȼɉȼɀɖɉɊɎɊɉȼɋɇȼɍɎɈȼɍɊȾȼɎȼɁɋɌɏȾɁɎɆȼɉȼɀɊɍɎȼɎɖɒɄɎɁɆɊɄɎɊɍɁɉȼɈɄɌȼɎȾɌɁɃɁɌȾɊȼɌȼɉȼɊɍɎɌɊɎɊɀɖɉɊ
ȭɇɁɀȼɉȼɇɄɃȼɄɃɑȾɖɌɇɁɎɁɋɇȼɍɎɈȼɍɊȾȼɎȼɁɋɌɏȾɁɎɆȼɍɊɍɎɌɊɀɖɉɊɄȾɄɍɛɕɄɛɍɖɀȾɋɊɀɑɊɀɛɕɆɊɉɎɁɅɉɁɌɃȼɊɎɋȼɀɖɒɄ

ȤɃɑȾɖɌɇɛɉɁşȾȼɂɄɃȼɇɁɆȼɌɛɄɇȼȽɊɌȼɎɊɌɄɛɎȼ
1.

ȭɋȼɃȾȼɅɎɁɊȽɕɄɎɁɑɄȿɄɁɉɉɄɉȼɍɊɆɄɄɃȼɆɊɉɊȾɄɉȼɌɁɀȽɄɃȼɋɌȼȾɄɇɉɊɎɊɄɃɑȾɖɌɇɛɉɁɉȼɄɉɐɁɆɒɄɊɃɉɄɈȼɎɁɌɄȼɇɄ

2.

ȬɖɆȼȾɄɒɄɎɁɃȼɁɀɉɊɆɌȼɎɉȼɏɋɊɎɌɁȽȼɋɌɁɀɊɎȾɌȼɎɛȾȼɎɌɄɍɆȼɊɎɄɉɐɁɆɒɄɄ

3.

ȣȼɈɖɌɍɁɉɄɎɁɄɇɄɋɖɇɉɄ6DOLYHWWH®9'ɎɌɛȽȾȼɀȼɍɁɄɃɑȾɖɌɇɛɎȾɋɊɀɑɊɀɛɕɄɆɊɉɎɁɅɉɁɌɄɃȼɊɋȼɍɉɄȽɄɊɇɊȿɄɓɉɄɊɎɋȼɀɖɒɄɍɇɁɀɆɊɁɎɊɈɊȿȼɎɀȼȽɖɀȼɎȼȾɎɊɆɇȼȾɄɌȼɉɄɄɄɃȿɊɌɁɉɄ

4.

ȪɎɋȼɀɖɓɉɄɎɁɋɌɊɀɏɆɎɄɎɌɛȽȾȼɀȼɈɄɉȼɎɋɌɁɃɋɊɀɑɊɀɛɕɄɉɍɄɉɁɌȼɎɊɌɄɇɄɋɌɊɒɁɍɉȼȼȾɎɊɆɇȼȾɄɌȼɉɁ ɍɎɁɌɄɇɄɃȼɒɄɛɍɋȼɌȼ 

9BGȧɄɎɁɌȼɎɏɌȼ
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

ȦɊɀɉȼɍɄɈȾɊɇɄɄɄɀɁɉɎɄɐɄɆȼɒɄɄ

ȩɊɈɁɌɉȼȼɌɎɄɆɏɇ

ȫȼɌɎɄɀȼ

ȟɊɀɁɉɀɊ

ȭȡɈȼɌɆɄɌɊȾɆȼ

ȤɉȾɄɎɌɊɀɄȼȿɉɊɍɎɄɆȼ

ȭɋȼɃȾȼɅɎɁɌɖɆɊȾɊɀɍɎȾɊɎɊɃȼɏɋɊɎɌɁȽȼ

ȫɌɄɋɊȾɎɊɌɉȼɏɋɊɎɌɁȽȼȪɋȼɍɉɊɍɎɊɎɆɊɉɎȼɈɄɉȼɒɄɛ

ȫȼɃɁɎɁɊɎɍɇɖɉɓɁȾȼɍȾɁɎɇɄɉȼ

ȭɖɑɌȼɉɛȾȼɅɎɁɉȼɍɏɑɊ

ȫɌɊɄɃȾɊɀɄɎɁɇ

ȠɖɌɂȼȾȼɉȼɋɌɊɄɃȾɊɀɍɎȾɊ

ȣȼɋȼɃȾȼɍɁɋɌȼȾɊɎɊɃȼɄɃȾɖɌɔȾȼɉɁɉȼɎɁɑɉɄɓɁɍɆɄɋɌɊɈɁɉɄ
ȞɍɄɓɆɄɍɁɌɄɊɃɉɄɄɉɒɄɀɁɉɎɄɍȾɖɌɃȼɉɄɍɋɌɊɀɏɆɎȼɎɌɛȽȾȼɀȼɍɁɍɖɊȽɕȼȾȼɎɉȼɋɌɊɄɃȾɊɀɄɎɁɇɛɄɉȼɆɊɈɋɁɎɁɉɎɉɄɛɉȼɒɄɊɉȼɇɁɉɊɌȿȼɉ

10

Návod k obsluze – SARSTEDT Salivette® VD

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12

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Literatura
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359.OìÕSURV\PERO\DbR]QDÕHQìqìVORYĨURENX

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Brugsanvisning – SARSTEDT Salivette® VD

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Salivette® VD er et prøverørtil spytprøver, der bruges til opsamling, transport, behandling og opbevaring af spyt til screening for virusmateriale, f.eks. nukleinsyrer fra SARS-CoV-2, gennem in vitro diagnostisk
bestemmelse. Produktet er beregnet til brug i et professionelt miljø og til anvendelse af medicinsk fag- og laboratoriepersonale.

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Salivette® VD består af et gennemsigtigt plastikrør med spids bund, et indlæg, en sugerulle af vat og en lyseblå prop.
Sugerullen af vat er et naturprodukt. Misfarvning og mørkere områder eller steder er naturlige og uundgåelige.

51.1534.100=

Plastikbeholder+Indlæg+Sugerulle+

Lyseblå prop

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1.

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2.

Generelle forholdsregler: Brug handsker og andet generelt personligt beskyttelsesudstyr for at beskytte dig mod mulig eksponering for potentielt infektiøse prøver. Din institutions sikkerhedsretningslinjer og-procedurer skal følges.

3.

Det spyt, der er opsamlet og behandlet med Salivette® VD, er ikke beregnet til tilbageførsel i den menneskelige organisme.

4.

Brug ikke Salivette® VD efter holdbarhedsdatoen. Holdbarheden af Salivette® VD slutter på sidste dag af den angivne måned og det angivne år.

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Salivette® VD skal opbevares ved rumtemperatur før brug.

Transport
Produktet kan transporteres manuelt internt på faciliteten sammen med en sekundærbeholder, som er i overensstemmelse med ADR (pakningsinstruktion P650). Til prøvetransporten af Salivette® VD anbefales en
forsendelsesbeholder med varenr. 78.898, som er i overensstemmelse med ADR (pakningsinstruktion P650), med sugeindlæg plus skruelukning med varenr. 65.679 samt en forsendelsesboks/-pose.
Til patient:
Ved returnering af spytprøven i det fastlukkede Salivette® VD rør skal du følge lægens anvisninger, og bruge den sekundære beholder og forsendelsesboksen/-posen, som lægen har stillet til rådighed. Hvis returneringenikke sker direkte, skal Salivette® VD røret opbevares i køleskab.

Begrænsninger
Spytprøveindsamlingen skal tidligst ske 60 minutter efter et måltid (optagelse af flydende/fast ernæring), tandbørstning eller oral indtagelse af lægemidler for at undgå kontamination af spyttet med forstyrrende
substanser.
Opbevaringstid og temperatur afhænger af holdbarheden af de parametre, der skal undersøges. Derfor og på grund af bakterievæksten i spyttet, der ved stuetemperatur allerede starter efter et par timer, anbefales, at
Salivette® VD røret lukkes tæt umiddelbart efter prøvetagningen og enten centrifugeres og analyseres inden for fire timer eller opbevares i køleskabet indtil videre bearbejdning.

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Materiale, der kræves til prøveudtagning:
1.

Handsker, kittel, øjenværn eller anden passende beskyttelsesbeklædning til beskyttelse mod spytbårne sygdomsfremkaldende organismer eller potentielt smitsomme materialer.

2.

Antal Salivette® VD rør i henhold til lægens ordinering.

3.

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14

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Prøvetagning

2 min. uden
tyggebevægelserƊPLQ

1 min.
500 x g

Prøve

ResterSpytprøveindsamlingen skal tidligst ske 60 minutter efter et måltid (optagelse af flydende/fast ernæring), tandbørstning, rygning eller oral indtagelse af lægemidler for at undgå kontamination af spyttet med
forstyrrende substanser.
Vask, og tør hænderne umiddelbart før spytprøveindsamlingen.
Tag sugerullen med to fingre fra den bageste del ud af det åbnede Salivette® VD rør, ogSODFÜUGHQLPXQGHQ
Sugerullen skal blive i munden (f.eks. i kinden) i 2 minutter uden at foretage tyggebevægelser. Den mindste mængde af spyt, der skal opsamles, er 500 μl. Lad sugerullen ligge længere i munden ved ekstrem lav
spytdannelse.
Tag sugerullen ud af munden ved med to fingre at tage fat i den bageste del, og
stik den direkte ind i Salivette® VD røret, og luk det med den lyseblå prop.
Til patient: Ved returnering af spytprøven i det fastlukkede Salivette® VD rør skal du følge lægens anvisninger, og bruge den sekundære beholder og forsendelsesboksen/-posen, som lægen har stillet til rådighed.
Hvis returneringen ikke sker direkte, skal Salivette® VD røret opbevares i køleskab.
Til læge og laboratorium:På grund af bakterievæksten i spyttet, der allerede starter efter et par timer, anbefales, at Salivette® VD røret lukkes tæt umiddelbart efter prøvetagningen, og enten centrifugeres ved 500 x g i 1 minut, og
analyseres inden for fire timer, eller opbevares i køleskabet indtil videre bearbejdning.
Efter centrifugering tages indlægget inklusive propper ud af plastikrøret med den spidse bund.
I plastikrørets spidse bund er det rene spyt, der kan bruges til yderligere analyse vha de rester, der befinder sig i reservoiret i den spidse bund.
Efter analysen skal plastikrøret med den spidse bund og indlægget bortskaffes i en bortskaffelsesbeholder.

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1.

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Engangshandsker formindsker derved risikoen for infektion.

3.

Kontaminerede eller fyldte Salivette®9'UĉUVNDOERUWVNDĳHVLHQHJQHWERUWVNDĳHOVHVEHKROGHUWLOELRORJLVNIDUOLJHVWRĳHUVRPHIWHUIĉOJHQGHNDQDXWRNODYHUHVRJEUÑQGHV4.

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15

DA
Litteratur
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

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Varenummer

Batchnummer

Mindst holdbar til

CE-mærke

In-vitro-diagnostik

Følg brugervejledningen

Ved genanvendelse: Fare for kontaminering

Opbevares beskyttet mod sollys

Opbevares tørt

ProducentFremstillingsland

Der tages forbehold for tekniske ændringer.
Alle alvorlige hændelser, der er opstået i forbindelse med dette produkt, skal meddeles producenten og den kompetente ansvarlige myndighed.

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Ǥǽ6DOLYHWWH®9'ǴǮǻǰǸǬǻǰȃǸǰǺǮǳǸǽǳǴǸǲƑǫȁȆǻǲǸǰǳǴǮǲƑǰȁǰȀǸǬǺǽȂǹǰǸȄǾǶȀǸƑǽƒǽǸǴǮȁǰǸǲǸǰȁǶǺǭȅǶȁǶƑǴȁǰȃǽǾǫȁǶǻǴƒǴǼǴǾǲǰȀǮǰǹǰǸȁǶǻǰƒǽǷǭǹǴȂȀǶȀǮǴǺǽȂǲǸǰȁǽǻǬǺǴǲȄǽǸǸǹǽȊȂǺǸǹǽȊǻǽȂǹǺǴȇǹȋǻǽǼǬȆǻ
6$56&R9ȀǴin-vitroǳǸǰǲǻȆȀȁǸǹǽȊǿƒǾǽȀǳǸǽǾǸȀƑǽȊǿǤǽƒǾǽȇȉǻƒǾǽǽǾǮǵǴȁǰǸǲǸǰȁǶǻǴȃǰǾƑǽǲǭȀǴǴƒǰǲǲǴǺƑǰȁǸǹȉƒǴǾǸǱǫǺǺǽǻǹǰǸǲǸǰȄǾǭȀǶǰƒȉǹǰȁǰǾȁǸȀƑǬǻǽǸǰȁǾǸǹȉǹǰǸǴǾǲǰȀȁǶǾǸǰǹȉƒǾǽȀȆƒǸǹȉǡǴǾǸǲǾǰȃǭƒǾǽȇȉǻȁǽǿ
Ǥǽ6DOLYHWWH®9'ǰƒǽȁǴǺǴǮȁǰǸǰƒȉǬǻǰǳǸǰȃǰǻǬǿƒǺǰȀȁǸǹȉȀȆǺǶǻǫǾǸǽƑǴǹȆǻǸǹȉƒȂǷƑǬǻǰǬǻǰǬǻǷǴȁǽǬǻǰǾǽǺȉǰƒǽǾǾȉȃǶȀǶǿǰƒȉǱǰƑǱǫǹǸǹǰǸǬǻǰǲǰǺǫǵǸǽƒȋƑǰǤǽǾǽǺȉǰƒǽǾǾȉȃǶȀǶǿǰƒȉǱǰƑǱǫǹǸǴǮǻǰǸǬǻǰȃȂȀǸǹȉƒǾǽȇȉǻǠǰƒǽȄǾȆƑǰȁǸȀƑȉǿǹǰǸȁǰƒǸǽȀǹǽȊǾǰǴǲǹǺǴǮȀƑǰȁǰǭǹǶǺǮǳǴǿǴǮǻǰǸȃȂȀǸǹǫǹǰǸǰǻǰƒȉȃǴȂǹȁǰ51.1534.100=

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+ǢǽǺȉǰƒǽǾǾȉȃǶȀǶǿ

+ǲǰǺǫǵǸǽƒȋƑǰǠǳǶǲǮǴǿǰȀȃǰǺǴǮǰǿǹǰǸƒǾǽǴǸǳǽƒǽǸǭȀǴǸǿ
1.

ǤǽƒǾǽȇȉǻǳǴǻƒǾǬƒǴǸǻǰȄǾǶȀǸƑǽƒǽǸǴǮȁǰǸȀǴƒǰǸǳǸǫǹǫȁȆȁȆǻǴȁȋǻǭȀǴǫȁǽƑǰƑǴǰȂǼǶƑǬǻǽǹǮǻǳȂǻǽǹǰȁǫƒǽȀǶǿ

2.

ǕǴǻǸǹǬǿƒǾǽȃȂǺǫǼǴǸǿǧǾǶȀǸƑǽƒǽǸǴǮȁǴǲǫǻȁǸǰǹǰǸǫǺǺǽǲǴǻǸǹȉǰȁǽƑǸǹȉƒǾǽȀȁǰȁǴȂȁǸǹȉǴǼǽƒǺǸȀƑȉǲǸǰȁǶǻƒǾǽȀȁǰȀǮǰȀǰǿǰƒȉȁǶǻƒǸǷǰǻǭǬǹǷǴȀǶȀǴǺǽǸƑȋǳǶȂǺǸǹǫǳǴǮǲƑǰȁǽǿǠǸƒǽǺǸȁǸǹǬǿǹǰǸǽǸǳǸǰǳǸǹǰȀǮǴǿǰȀȃǰǺǴǮǰǿȁǽȂǸǳǾȊƑǰȁȉǿȀǰǿƒǾǬƒǴǸǻǰȁǶǾǽȊǻȁǰǸ3.

ǠȀǮǴǺǽǿƒǽȂȀȂǺǺǬǲǴȁǰǸǹǰǸȂƒǽǱǫǺǺǴȁǰǸȀǴǴƒǴǼǴǾǲǰȀǮǰƑǴȁǽ6DOLYHWWH®9'ǳǴǻƒǾǽǽǾǮǵǴȁǰǸǲǸǰǴƒǰǻǬǲȄȂȀǶȀȁǽǰǻǷǾȋƒǸǻǽȀȋƑǰ4.

ǝǶǻȄǾǶȀǸƑǽƒǽǸǴǮȁǴȁǽ6DOLYHWWH®9'ƑǴȁǫȁǽƒǬǾǰǿȁǶǿǶƑǴǾǽƑǶǻǮǰǿǺǭǼǶǿǘǳǸǰȁǶǾǶȀǸƑȉȁǶȁǰǴǻȉǿ6DOLYHWWH®9'ǺǭǲǴǸȁǶǻȁǴǺǴȂȁǰǮǰǶƑǬǾǰȁǽȂǰǻǰǲǾǰȃȉƑǴǻǽȂƑǭǻǰǹǰǸǬȁǽȂǿǦȊǺǰǼǶ
Ǥǽ6DOLYHWWH®9'ƒǾǬƒǴǸǻǰȃȂǺǫȀȀǴȁǰǸȀǴǷǴǾƑǽǹǾǰȀǮǰǳȆƑǰȁǮǽȂƒǾǸǻǰƒȉȁǶȄǾǭȀǶǝǴȁǰȃǽǾǫ
ǤǽƒǾǽȇȉǻƑƒǽǾǴǮǻǰƑǴȁǰȃǴǾǷǴǮȄǴǸǾǽǹǮǻǶȁǰǴǻȁȉǿȁȆǻǴǲǹǰȁǰȀȁǫȀǴȆǻǭȀǴǬǻǰǳǴȂȁǴǾǴȊǽǻȃǸǰǺǮǳǸǽȀȂƑǱǰȁȉƑǴ$'5 ǽǳǶǲǮǰȀȂȀǹǴȂǰȀǮǰǿ3 ǕǸǰȁǶƑǴȁǰȃǽǾǫǳǴǸǲƑǫȁȆǻȁǽȂ6DOLYHWWH®9'ȀȂǻǮȀȁǰȁǰǸǶȄǾǭȀǶȁǽȂȀȂƑǱǰȁǽȊƑǴ$'5ǳǽȄǴǮǽȂǰƒǽȀȁǽǺǭǿ ǽǳǶǲǮǰȀȂȀǹǴȂǰȀǮǰǿ3 ƑǴǹȆǳƒǾƑǴǰƒǽǾǾǽȃǶȁǸǹȉȂǺǸǹȉǹǰǸȁǽǱǸǳȆȁȉƒȋƑǰƑǴǹȆǳƒǾǹǰǷȋǿǴƒǮȀǶǿǹǰǸǶȄǾǭȀǶǴǻȉǿǹǽȂȁǸǽȊȀǰǹǽȊǺǰǿǰƒǽȀȁǽǺǭǿǕǸǰȁǽǻǰȀǷǴǻǭǕǸǰǻǰǴƒǸȀȁǾǬȅǴȁǴȁǽǳǴǮǲƑǰȀǮǴǺǽȂȀȁǽǴǾƑǶȁǸǹǫǹǺǴǸȀȁȉ6DOLYHWWH®9'ǰǹǽǺǽȂǷǭȀȁǴȁǸǿǽǳǶǲǮǴǿȁǽȂǸǰȁǾǽȊǹǰǸȄǾǶȀǸƑǽƒǽǸǭȀȁǴȁǽǳǴȂȁǴǾǴȊǽǻǳǽȄǴǮǽƒǽȂƒǰǾǬȄǴȁǰǸǰƒȉȁǽǻǸǰȁǾȉǹǰǸȁǽǹǽȂȁǮȀǫǹǽǰƒǽȀȁǽǺǭǿǖǫǻǳǴǻǴƒǸȀȁǾǰȃǴǮǰƒǴȂǷǴǮǰǿǰƒǽǷǶǹǴȊȀȁǴǰȂȁȉȁǽ6DOLYHWWH®9'ȀȁǽȅȂǲǴǮǽǡǴǾǸǽǾǸȀƑǽǮ
ǘǺǭȅǶȁǽȂȀǮǴǺǽȂƒǾǬƒǴǸǻǰǴǹȁǴǺǴǮȁǰǸȁǽȂǺǫȄǸȀȁǽǻǺǴƒȁǫƑǴȁǫǰƒȉǬǻǰǲǴȊƑǰ ǺǭȅǶȂǲǾǭǿȀȁǴǾǴǫǿȁǾǽȃǭǿ ǱǽȊǾȁȀǸȀƑǰȁȆǻǳǽǻȁǸȋǻǭǺǭȅǶȃǰǾƑǰǹǴȂȁǸǹǭǿǰǲȆǲǭǿǰƒȉȁǽȂȀȁȉƑǰȁǽǿƒǾǽǹǴǸƑǬǻǽȂǻǰǰƒǽȃǴȊǲǴȁǰǸǶƑȉǺȂǻȀǶȁǽȂȀǮǴǺǽȂǰƒȉǽȂȀǮǴǿƑǴǳǸǰȀƒǰȀȁǸǹǭǴƒǮǳǾǰȀǶǘǳǸǫǾǹǴǸǰȃȊǺǰǼǶǿǹǰǸǶǷǴǾƑǽǹǾǰȀǮǰǴǼǰǾȁȋǻȁǰǸǰƒȉȁǶǳǸǰȁǶǾǶȀǸƑȉȁǶȁǰȁȆǻƒǰǾǰƑǬȁǾȆǻƒǽȂƒǾǬƒǴǸǻǰǴǼǴȁǰȀȁǽȊǻǕǸǰȁǽǻǺȉǲǽǰȂȁȉǹǰǸǺȉǲȆȁǶǿǱǰǹȁǶǾǸǰǹǭǿǰǻǫƒȁȂǼǶǿȀȁǽǻȀǮǴǺǽƒǽȂǼǴǹǸǻǫƑǴȁǫǰƒȉƑǴǾǸǹǬǿȋǾǴǿȀǴǷǴǾƑǽǹǾǰȀǮǰǳȆƑǰȁǮǽȂȀȂǻǸȀȁǫȁǰǸǶȃȂǲǽǹǬǻȁǾǶȀǶǹǰǸǶǰǻǫǺȂȀǶȁǽȂǴǾƑǶȁǸǹǫǹǺǴǸȀƑǬǻǽȂ6DOLYHWWH®9'ǴǮȁǴǴǻȁȉǿȆǾȋǻƑǴȁǫȁǶǳǴǸǲƑǰȁǽǺǶȅǮǰǴǮȁǴǶǰƒǴȂǷǴǮǰǿȃȊǺǰǼǭȁǽȂȀȁǽȅȂǲǴǮǽǬȆǿȁǶǻƒǴǾǰǸȁǬǾȆǴƒǴǼǴǾǲǰȀǮǰǣȂǺǺǽǲǭǳǴǸǲƑǫȁȆǻǹǰǸȄǴǸǾǸȀƑȉǿƍǚǓǔǓǣǤǖǡǜǘǢƏǣǤǠǡǓǢǠǞǖǕǕǢǓǦǠǡǢǠǤǠǥǟǖǛǚǞǘǣǖǤǖǤǘǜǘǨǘǣǚǖǜǠǥǓƒǰǸȁǽȊƑǴǻǽǿǱǽǶǷǶȁǸǹȉǿǴǼǽƒǺǸȀƑȉǿǲǸǰȁǶȀȂǺǺǽǲǭǳǴǸǲƑǫȁȆǻ1.

ǕǫǻȁǸǰǾȉƑƒǰƒǾǽȀȁǰȁǴȂȁǸǹǫǲȂǰǺǸǫǭǫǺǺǶǹǰȁǫǺǺǶǺǶƒǾǽȀȁǰȁǴȂȁǸǹǭǴǻǳȂƑǰȀǮǰǲǸǰȁǶǻƒǾǽȀȁǰȀǮǰȀǰǿǰƒȉƒǰǷǽǲȉǻǽȂǿǽǾǲǰǻǸȀƑǽȊǿƒǽȂƑǴȁǰǳǮǳǽǻȁǰǸƑǬȀȆȁǽȂȀǮǴǺǽȂǭȁȂȄȉǻƑǽǺȂȀƑǰȁǸǹȋǻȂǺǸǹȋǻ

2.

ǡǽȀȉȁǶȁǰȀȆǺǶǻǰǾǮȆǻ6DOLYHWWH®9'ȀȊƑȃȆǻǰƑǴȁǽǰǮȁǶƑǰȁǽȂǸǰȁǾǽȊ

3.

ǣȂƑƒǺǭǾȆȀǶȁȆǻȀȁǽǸȄǴǮȆǻǲǸǰȁǶǻȁǰȂȁǽƒǽǮǶȀǶǳǴǸǲƑǫȁȆǻ ȀȁǶǻǴȁǸǹǬȁǰ 

17

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500 x gƍǴǮǲƑǰ

ǥƒǽǺǴǮƑƑǰȁǰ

ǘǺǭȅǶȁǽȂȀǮǴǺǽȂƒǾǬƒǴǸǻǰǴǹȁǴǺǴǮȁǰǸȁǽȂǺǫȄǸȀȁǽǻǺǴƒȁǫƑǴȁǫǰƒȉǬǻǰǲǴȊƑǰ ǺǭȅǶȂǲǾǭǿȀȁǴǾǴǫǿȁǾǽȃǭǿ ǱǽȊǾȁȀǸȀƑǰȁȆǻǳǽǻȁǸȋǻǹǫƒǻǸȀƑǰǭǺǭȅǶȃǰǾƑǰǹǴȂȁǸǹǭǿǰǲȆǲǭǿǰƒȉȁǽȂȀȁȉƑǰȁǽǿƒǾǽǹǴǸƑǬǻǽȂǻǰǰƒǽȃǴȊǲǴȁǰǸǶƑȉǺȂǻȀǶȁǽȂȀǮǴǺǽȂǰƒȉǽȂȀǮǴǿƑǴǳǸǰȀƒǰȀȁǸǹǭǴƒǮǳǾǰȀǶǡǺȊǻǴȁǴǹǰǸȀǹǽȂƒǮȀȁǴȁǰȄǬǾǸǰȀǰǿƒǾǸǻǰƒȉȁǶǺǭȅǶȁǽȂȀǮǴǺǽȂǓȃǰǸǾǬȀȁǴȁǽǾǽǺȉǰƒǽǾǾȉȃǶȀǶǿǰƒȉȁǽƒǮȀȆǫǹǾǽƑǴǳȊǽǳǫǹȁȂǺǰǰƒȉȁǽǰǻǽǸǹȁȉ6DOLYHWWH®9'ǹǰǸȁǽƒǽǷǴȁǭȀȁǴȁǽȀȁǽȀȁȉƑǰǤǽǾǽǺȉǰƒǽǾǾȉȃǶȀǶǿǷǰƒǾǬƒǴǸǻǰƒǰǾǰƑǴǮǻǴǸǲǸǰǺǴƒȁǫȀȁǽȀȁȉƑǰ ƒȄȀȁǶǻƒǰǾǴǸǰǹǭǹǽǸǺȉȁǶȁǰ ȄȆǾǮǿǹǸǻǭȀǴǸǿƑǫȀǶȀǶǿǘƒǽȀȉȁǶȁǰȀǮǴǺǽȂƒǽȂǺǰƑǱǫǻǴȁǰǸǷǰƒǾǬƒǴǸǻǰǴǮǻǰǸȁǽȂǺǫȄǸȀȁǽǻƑOǖǫǻǽȀȄǶƑǰȁǸȀƑȉǿȀǮǴǺǽȂǴǮǻǰǸǴǼǰǸǾǴȁǸǹǫȄǰƑǶǺȉǿǰȃǭȀȁǴȁǽǾǽǺȉǰƒǽǾǾȉȃǶȀǶǿǲǸǰƑǴǲǰǺȊȁǴǾǽǳǸǫȀȁǶƑǰƑǬȀǰȀȁǽȀȁȉƑǰǤǾǰǱǭǼȁǴȁǽǾǽǺȉǰƒǽǾǾȉȃǶȀǶǿǰƒȉȁǽƒǮȀȆǫǹǾǽƑǴǳȊǽǳǫǹȁȂǺǰǰƒȉȁǽȀȁȉƑǰǹǰǸȁǽƒǽǷǴȁǭȀȁǴȁǽǰƑǬȀȆǿƑǬȀǰȀȁǽ6DOLYHWWH®9'ǹǰǸȀȃǾǰǲǮȀȁǴȁǽƑǴȁǽǲǰǺǫǵǸǽƒȋƑǰǕǸǰȁǽǻǰȀǷǴǻǭǕǸǰǻǰǴƒǸȀȁǾǬȅǴȁǴȁǽǳǴǮǲƑǰȀǮǴǺǽȂȀȁǽǴǾƑǶȁǸǹǫǹǺǴǸȀȁȉ6DOLYHWWH®9'ǰǹǽǺǽȂǷǭȀȁǴȁǸǿǽǳǶǲǮǴǿȁǽȂǸǰȁǾǽȊǹǰǸȄǾǶȀǸƑǽƒǽǸǭȀȁǴȁǽǳǴȂȁǴǾǴȊǽǻǳǽȄǴǮǽƒǽȂƒǰǾǬȄǴȁǰǸǰƒȉȁǽǻǸǰȁǾȉǹǰǸȁǽǹǽȂȁǮȀǫǹǽǰƒǽȀȁǽǺǭǿǖǫǻǳǴǻǴƒǸȀȁǾǰȃǴǮǰƒǴȂǷǴǮǰǿǰƒǽǷǶǹǴȊȀȁǴǰȂȁȉȁǽ6DOLYHWWH®9'ȀȁǽȅȂǲǴǮǽǕǸǰȁǽǻǸǰȁǾȉǹǰǸȁǽǴǾǲǰȀȁǭǾǸǽǜȉǲȆȁǶǿǱǰǹȁǶǾǸǰǹǭǿǰǻǫƒȁȂǼǶǿȀȁǽǻȀǮǴǺǽƒǽȂǼǴǹǸǻǫƑǴȁǫǰƒȉƑǴǾǸǹǬǿȋǾǴǿȀǴǷǴǾƑǽǹǾǰȀǮǰǳȆƑǰȁǮǽȂȀȂǻǸȀȁǫȁǰǸǶȃȂǲǽǹǬǻȁǾǶȀǶǹǰǸǶǰǻǫǺȂȀǶȁǽȂǴǾƑǶȁǸǹǫǹǺǴǸȀƑǬǻǽȂ6DOLYHWWH®9'ǴǮȁǴǴǻȁȉǿȆǾȋǻȀǴ[JǲǸǰǺǴƒȁȉƑǴȁǫȁǶǳǴǸǲƑǰȁǽǺǶȅǮǰǴǮȁǴǶǰƒǴȂǷǴǮǰǿȃȊǺǰǼǭȁǽȂȀȁǽȅȂǲǴǮǽǬȆǿȁǶǻƒǴǾǰǸȁǬǾȆǴƒǴǼǴǾǲǰȀǮǰǝǴȁǫȁǶȃȂǲǽǹǬǻȁǾǶȀǶǰȃǰǸǾǬȀȁǴȁǽǬǻǷǴȁǽƑǰǵǮƑǴȁǽƒȋƑǰǰƒȉȁǽƒǺǰȀȁǸǹȉȀȆǺǶǻǫǾǸǽƑǴȁǽǻǹȆǻǸǹȉƒȂǷƑǬǻǰǣȁǽǻǹȆǻǸǹȉƒȂǷƑǬǻǰȁǽȂƒǺǰȀȁǸǹǽȊȀȆǺǶǻǰǾǮǽȂǱǾǮȀǹǴȁǰǸǽǹǰǷǰǾȉǿȀǮǴǺǽǿǲǸǰƒǴǾǰǸȁǬǾȆǰǻǫǺȂȀǶƒǫǻȆǰƒȉȁǰȂƒǽǺǴǮƑƑǰȁǰƒǽȂǱǾǮȀǹǽǻȁǰǸȀȁǽǻȁǰƑǸǴȂȁǭǾǰȁǽȂǹȆǻǸǹǽȊƒȂǷƑǬǻǰǝǴȁǫȁǶǻǰǻǫǺȂȀǶǰƒǽǾǾǮȅȁǴȁǽƒǺǰȀȁǸǹȉȀȆǺǶǻǫǾǸǽƑǴȁǽǻǹȆǻǸǹȉƒȂǷƑǬǻǰǹǰǸȁǽǬǻǷǴȁǽȀǴǬǻǰǳǽȄǴǮǽǰƒȉǾǾǸȅǶǿǓƒȉǾǾǸȅǶşǸȀȄȊǴǸǲǸǰȁǽǻǸǰȁǾȉǹǰǸȁǽǴǾǲǰȀȁǭǾǸǽ
1.

ǡǾǬƒǴǸǻǰǺǰƑǱǫǻǽǻȁǰǸȂƒȉȅǶǹǰǸǻǰȁǶǾǽȊǻȁǰǸǽǸǲǴǻǸǹǬǿǽǳǶǲǮǴǿȂǲǸǴǸǻǭǿǹǰǷȋǿǹǰǸǽǸǻǽƑǸǹǬǿǳǸǰȁǫǼǴǸǿǲǸǰȁǶǻǽǾǷǭǰƒȉǾǾǸȅǶƑǽǺȂȀƑǰȁǸǹȋǻȂǺǸǹȋǻ2.

ǤǰǲǫǻȁǸǰƑǮǰǿȄǾǭȀǶǿǰƒǽȁǾǬƒǽȂǻȀȁǶǻƒǴǾǮƒȁȆȀǶǰȂȁǭȁǽǻǹǮǻǳȂǻǽƑȉǺȂǻȀǶǿ3.

ǤǽƑǽǺȂȀƑǬǻǽǭǲǴƑǫȁǽ6DOLYHWWH®9'ƒǾǬƒǴǸǻǰǰƒǽǾǾǮƒȁǴȁǰǸȀǴǹǰȁǫǺǺǶǺǽǳǽȄǴǮǽǰƒȉǾǾǸȅǶǿǴƒǸǹǮǻǳȂǻȆǻǱǸǽǺǽǲǸǹȋǻȂǺǸǹȋǻȁǽǽƒǽǮǽƑƒǽǾǴǮȀȁǶȀȂǻǬȄǴǸǰǻǰȂƒǽǱǺǶǷǴǮȀǴǴƒǴǼǴǾǲǰȀǮǰȀǴǰȂȁȉǹǰȂȀȁǽǭǻǰǰƒǽȁǴȃǾȆǷǴǮ4.

ǘǰƒȉǾǾǸȅǶƒǾǬƒǴǸǻǰƒǾǰǲƑǰȁǽƒǽǸǴǮȁǰǸȀǴǹǰȁǫǺǺǶǺǶƑǽǻǫǳǰǰƒǽȁǬȃǾȆȀǶǿǭƑǬȀȆǴƒǴǼǴǾǲǰȀǮǰǿȀǴǰȂȁȉǹǰȂȀȁǽ ǰƒǽȀȁǴǮǾȆȀǶƑǴǰȁƑȉ 18

ELǔǸǱǺǸǽǲǾǰȃǮǰ
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

ǥƒȉƑǻǶƑǰȀȂƑǱȉǺȆǻǹǰǸǴƒǸȀǶƑǫǻȀǴȆǻǓǾǸǷƑȉǿƒǾǽȇȉǻȁǽǿ

ǓǾǸǷƑȉǿƒǰǾȁǮǳǰǿ

ǧǾǭȀǶǬȆǿǣȊƑǱǽǺǽ&(In-vitroǳǸǰǲǻȆȀȁǸǹȉǸǰȁǾǽȁǴȄǻǽǺǽǲǸǹȉƒǾǽȇȉǻǤǶǾǴǮȁǴȁǸǿǽǳǶǲǮǴǿȄǾǭȀǴȆǿ

ǣǴƒǴǾǮƒȁȆȀǶǴƒǰǻǰȄǾǶȀǸƑǽƒǽǮǶȀǶǿǛǮǻǳȂǻǽǿƑǽǺȊǻȀǴȆǻ

ǦȊǺǰǼǶȀǴȀǶƑǴǮǽƒǽȂǱǾǮȀǹǴȁǰǸƑǰǹǾǸǫǰƒȉȁǶǻǶǺǸǰǹǭǰǹȁǸǻǽǱǽǺǮǰ

ǦȊǺǰǼǶȀǴǼǶǾȉƑǬǾǽǿ

ǛǰȁǰȀǹǴȂǰȀȁǭǿ

ǧȋǾǰǹǰȁǰȀǹǴȂǭǿ

ǥƒȉȁǶǻǴƒǸȃȊǺǰǼǶȁǴȄǻǸǹȋǻȁǾǽƒǽƒǽǸǭȀǴȆǻǏǺǰȁǰȀǽǱǰǾǫƒǴǾǸȀȁǰȁǸǹǫƒǽȂǰȃǽǾǽȊǻȁǽƒǾǽȇȉǻǹǽǸǻǽƒǽǸǽȊǻȁǰǸȀȁǽǻǹǰȁǰȀǹǴȂǰȀȁǭǹǰǸȀȁǶǻǰǾƑȉǳǸǰǴǷǻǸǹǭǰǾȄǭ

19

Instrucciones de uso – SARSTEDT Salivette® VD

ES

8VRSUHYLVWRLa Salivette® VD es un recipiente para muestras de saliva que se utiliza para la extracción, el transporte, el procesamiento y el almacenamiento de saliva para el cribado de material viral, por ejemplo, ácidos nucleicos del
SARS-CoV-2, en diagnósticos analíticos LQbYLWUR. El producto está destinado para la aplicación en el ámbito profesional y el uso por parte de personal sanitario y personal de laboratorio.

Descripción del producto
La Salivette® VD consta de un recipiente de plástico transparente de fondo puntiagudo, un recipiente de suspensión, un rollo absorbente de algodón y un tapón azul claro.
El rollo absorbente de algodón es un producto natural. Los cambios de color y las inclusiones o manchas más oscuras son naturales e inevitables.

51.1534.100=

Recipiente deplástico+

Recipiente desuspensión+

Rollo absorbente+

Tapón azul claro,QGLFDFLRQHVGHVHJXULGDG\DGYHUWHQFLDV
1.

(OSURGXFWRQRGHEHXWLOL]DUVHHQQLþRVPHQRUHVGHbDþRVQLHQSDFLHQWHVFRQPD\RUULHVJRGHDWUDJDQWDPLHQWR

2.

Medidas generales de precaución: Utilice guantes y un equipo de protección personal general para protegerse de una posible exposición a material de muestra potencialmente infeccioso. Observe las directrices y
SURFHGLPLHQWRVGHVHJXULGDGGHVXFHQWURPÜGLFR3.

La saliva recogida y procesada con la Salivette® VD no es apta para su reintroducción en el cuerpo humano.

4.

No utilice la Salivette®9'XQDYH]VXSHUDGDVXIHFKDGHFDGXFLGDG/DYLGDěWLOGHOD6DOLYHWWH®9'WHUPLQDHOěOWLPRGìDGHOPHV\DþRLQGLFDGRV

Almacenamiento
La Salivette® VD debe almacenarse a temperatura ambiente antes de su uso.

Transporte
El producto se puede transportar de forma manual dentro del centro o con un contenedor secundario que cumpla con el ADR (instrucción de embalaje P650). Para transportar muestras con la Salivette® VD, serecomienda utilizar el contenedor de envío conforme a la normativa ADR (instrucción de embalaje P650), n.º de art. 78.898, con plantilla absorbente y tapón de rosca, n.º de art. 65.679, así como una caja o bolsa detransporte.
Para el paciente:
Para entregar la muestra de saliva en la Salivette®9'GHELGDPHQWHFHUUDGDVLJDODVLQVWUXFFLRQHVGHOPÜGLFR\XWLOLFHHOUHFLSLHQWHVHFXQGDULR\ODFDMDREROVDGHHQYìRSURSRUFLRQDGRVSRUHOPÜGLFR6LODPXHVWUDQR
se entrega en el momento, conserve la Salivette® VD en el frigorífico.

Limitaciones/DVDOLYDGHEHUHFRJHUVHDOPHQRVbPLQXWRVGHVSXÜVGHXQDFRPLGD LQJHVWDGHDOLPHQWRVOìTXLGRVRVĂOLGRV GHFHSLOODUVHORVGLHQWHVRGHLQJHULUPHGLFDPHQWRVSRUYìDRUDOSDUDHYLWDUODFRQWDPLQDFLĂQGHODVDOLYD
por sustancias que puedan interferir.
(OWLHPSR\ODWHPSHUDWXUDGHFRQVHUYDFLĂQGHSHQGHQGHODHVWDELOLGDGGHORVSDUÈPHWURVTXHVHYDQDDQDOL]DU3RUORWDQWR\GHELGRDTXHODSUROLIHUDFLĂQEDFWHULDQDHQODVDOLYDFRPLHQ]DGHVSXÜVGHXQDVKRUDVD
temperatura ambiente, se recomienda centrifugar y analizar la Salivette®9'GHELGDPHQWHFHUUDGDGHQWURGHODVbKRUDVVLJXLHQWHVDODUHFRJLGDGHODPXHVWUDRJXDUGDUODGLUHFWDPHQWHHQHOIULJRUìILFRKDVWDVXSRVWHULRU
procesamiento.

Extracción de la muestra y manipulación
LEA COMPLETAMENTE ESTE DOCUMENTO ANTES DE INICIAR LA RECOGIDA DE SALIVA.
Material de trabajo necesario para la extracción de la muestra:
1.

Guantes, bata, protección ocular u otra prenda de protección adecuada para protegerse de los patógenos transmitidos por la saliva o de materiales potencialmente infecciosos.

2.

Cantidad de Salivettes®9'VHJěQODVLQGLFDFLRQHVGHOPÜGLFR3.

&XPSOLPHQWHODLQIRUPDFLĂQGHLGHQWLıFDFLĂQGHODPXHVWUD HQODHWLTXHWD 

20ESExtracción de la muestra

bPLQVLQPRYLPLHQWR
masticatorioƊPLQ

1 min
500 x gMuestraResiduos/DVDOLYDGHEHUHFRJHUVHDOPHQRVbPLQXWRVGHVSXÜVGHXQDFRPLGD LQJHVWDGHDOLPHQWRVOìTXLGRVRVĂOLGRV GHFHSLOODUVHORVGLHQWHVIXPDURGHLQJHULUPHGLFDPHQWRVSRUYìDRUDOSDUDHYLWDUOD
contaminación de la saliva por sustancias que puedan interferir.
/ÈYHVH\VÜTXHVHODVPDQRVLQPHGLDWDPHQWHDQWHVGHODUHFRJLGDGHVDOLYD
Extraiga el rollo absorbente con dos dedos por el extremo posterior de la Salivette® VD abierta ycolóqueselo en la boca.
(OUROORDEVRUEHQWHGHEHSHUPDQHFHUHQODERFD SRUHMHPSORHQHOYHVWìEXOREXFDO GXUDQWHbPLQXWRVVLQPRYLPLHQWRPDVWLFDWRULR/DFDQWLGDGPìQLPDGHVDOLYDTXHGHEHUHFRJHUVHHVGHbƐO6LOD
producción de saliva es muy baja, deje el rollo absorbente en la boca durante más tiempo.
Saque el rollo absorbente de la boca con dos dedos por el extremo posterior,LQVÜUWHORLQPHGLDWDPHQWHHQOD6DOLYHWWH®9'\FLÜUUHORFRQHOWDSĂQD]XOFODURPara el paciente: Para entregar la muestra de saliva en la Salivette®9'GHELGDPHQWHFHUUDGDVLJDODVLQVWUXFFLRQHVGHOPÜGLFR\XWLOLFHHOUHFLSLHQWHVHFXQGDULR\ODFDMDREROVDGHHQYìRSURSRUFLRQDGRVSRUHOPÜGLFR6LODPXHVWUDQRVHHQWUHJDHQHOPRPHQWRFRQVHUYHOD6DOLYHWWH® VD en el frigorífico.
3DUDHOPÜGLFR\HOODERUDWRULR
'HELGRDTXHODSUROLIHUDFLĂQEDFWHULDQDHQODVDOLYDFRPLHQ]DGHVSXÜVGHXQDVKRUDVDWHPSHUDWXUDDPELHQWHVHUHFRPLHQGDFHQWULIXJDU\DQDOL]DUOD6DOLYHWWH®9'GHELGDPHQWHFHUUDGDGHQWURGHODVbKRUDVVLJXLHQWHVDODUHFRJLGDGHODPXHVWUDD[JGXUDQWHbPLQXWRVRJXDUGDUODGLUHFWDPHQWHHQHOIULJRUìILFRKDVWDVXSRVWHULRUSURFHVDPLHQWR'HVSXÜVGHODFHQWULIXJDFLĂQUHWLUHHOUHFLSLHQWHGHVXVSHQVLĂQLQFOXLGRHOWDSĂQGHOUHFLSLHQWHGHSOÈVWLFRGHIRQGRSXQWLDJXGREn el fondo puntiagudo del recipiente de plástico se encuentra la saliva pura para el posterior análisis de los residuos que se encuentran en el depósito del fondo.
'HVSXÜVGHODQÈOLVLVGHVHFKHHOUHFLSLHQWHGHSOÈVWLFRGHIRQGRSXQWLDJXGR\HOUHFLSLHQWHGHVXVSHQVLĂQHQXQFRQWHQHGRUGHHOLPLQDFLĂQ(OLPLQDFLĂQVHDSOLFDDOPÜGLFR\DOODERUDWRULR
1.

Se deben observar y cumplir las directivas sobre higiene general y las disposiciones legales para la eliminación correcta de material infeccioso.

2.

El uso de guantes desechables evita el riesgo de infección.

3.

Las Salivettes® VD usadas o contaminados deben desecharse en contenedores de eliminación adecuados para la eliminación de materiales biológicos peligrosos que admitan un posterior procesamiento en
autoclave e incineración.

4.

/DHOLPLQDFLĂQGHEHOOHYDUVHDFDERHQXQDSODQWDLQFLQHUDGRUDDGHFXDGDRDWUDYÜVGHXQSURFHVRGHDXWRFODYH HVWHULOL]DFLĂQSRUYDSRU 

21

ES
Literatura
Hoch y cols. Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie y cols. NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

Leyendas de símbolos y marcas:

1ěPHURGHDUWìFXOR

Código de loteFecha de caducidad

Marcado CE

DiagnósticoLQbYLWUR&RQVěOWHQVHODVLQVWUXFFLRQHVGHXVR

En caso de reutilización: peligro de contaminación0DQWÜQJDVHDOHMDGRGHODOX]VRODU

0DQWÜQJDVHVHFR

FabricantePaís de fabricación

5HVHUYDGRHOGHUHFKRDUHDOL]DUPRGLILFDFLRQHVWÜFQLFDVCualquier incidente grave relacionado con el producto debe ser notificado al fabricante y a la autoridad nacional competente.

22

Kasutusjuhend – SARSTEDT Salivette® VDET.DVXWXVRWVWDUYHSalivette® VD on süljeproovinõu, mis on mõeldud sülje võtmiseks, transportimiseks, töötlemiseks ja ladustamiseks viirusmaterjali, nt SARS-CoV-2 nukleiinhappe sõelumiseks in vitro diagnostikas. Toode on ette nähtud
professionaalses keskkonnas ja erialasele meditsiini- ja laboripersonalile kasutamiseks.

7RRWHNLUMHOGXVSalivette® koosneb läbipaistvast terava põhjaga plastnõust, sissepandavast nõust, vatirullist ja helesinisest korgist.
Vatirulli puhul on tegemist loodusliku tootega. Värvimuutused ning tumedamad lisandused või kohad on tavapärased ja vältimatud.

51.1534.100=

Plastanum+

Sissepandav nõu+

Vatirull+Helesinine kork

2KXWXVMDKRLDWXVMXKLVHG
1.

7RRGHWHLWRKLNDVXWDGDDOODDDVWDYDQXVWHODVWHMDVXXUHQHQXGDOODQHHODPLVRKXJDSDWVLHQWLGHSXKXO

2.

Üldised ettevaatusabinõud Kasutage kindaid ja teisi üldisi isikukaitsevahendeid, et kaitsta ennast võimaliku kokkupuute eest potentsiaalselt nakkusliku proovimaterjaliga. Järgima peab meditsiiniasutuse
ohutussuuniseid ja -protseduure.

3.

Süsteemiga Salivette® VD saadud ja töödeldud sülg ei ole ette nähtud tagasiviimiseks inimese kehasse.

4.

Ärge kasutage süsteemi Salivette® VD pärast säilivuskuupäeva möödumist. Süsteemi Salivette® VD säilivusaeg lõpeb äratoodud kuu ja aasta viimasel päeval.

Ladustamine
Süsteemi Salivette® VD tuleb enne kasutamist ladustada toatemperatuuril.

Transport
Toodet saab ettevõtte sisesi transportida käsitsi või koos sekundaarse mahutiga, mis on kooskõlas ADRi eeskirjaga (pakendamisjuhisega P650). Süsteemi Salivette® VD proovide transportimiseks soovitatakse ADR
eeskirjaga (pakendamisjuhisega P650) kooskõlas olevat saatmisnõud, artikli nr 78.898, koos imava siseosa ja keermessulguriga, artikli nr 65.679, ning saatmiskarpi/-kotti.
Patsiendile:
Süljeproovi tagastamiseks tihedalt suletud süsteemis Salivette® VD järgige arsti juhiseid ning kasutage arsti antud sekundaarset anumat ja saatmiskarpi/-kotti. Juhul kui ei tagastata kohe, siis hoidke süsteemi Salivette®
VD külmikus.

Piirangud
Süljeproov tuleb võtta kõige varem 60 minutit pärast söömist (vedela/tahke toidu tarbimist), hammaste pesemist või ravimite suukaudset võtmist, et vältida sülje saastumist muude ainetega.
Ladustamiskestus ja -temperatuur olenevad uuritavate parameerite säilivusest. Toatemperatuuril süljes juba mõne tunni pärast algava bakterite kasvu tõttu soovitatakse süsteemi Salivette® VD pärast proovivõtmist
kindlalt suletuna kas 4 h jooksul tsentrifuugida ja analüüsida või kuni edasise töötlemiseni külmikus hoida.

3URRYLYĄWPLQHMDNËLWOHPLQH
ENNE SÜLJEPROOVI VÕTMIST LUGEGE SEE DOKUMENT TÄIELIKULT LÄBI.
Proovivõtmiseks vajalik töömaterjal:
1.

kindad, kittel, silmakaitse või muu sobiv kaitseriietus kaitseks sülje kaudu ülekantavate patogeenide või potentsiaalselt nakkuslike materjalide eest.

2.

Süsteemide Salivette® VD arv arsti nõudel.

3.

7ËLWNHLQIRSURRYLLGHQWLıWVHHULPLVHNV HWLNHWLO 

23ETProovivõtmine

2 min ilma
närimisliigutusetaƊPLQ

1 min
500 × g

Proov

JäägidSüljeproov tuleb võtta kõige varem 60 minutit pärast söömist (vedela/tahke toidu tarbimist), hammaste pesemist, suitsetamist või ravimite suukaudset võtmist, et vältida sülje saastumist muude ainetega.
Vahetult enne süljeproovi võtmist peske ja kuivatage käed.
Võtke vatirull avatud süsteemist Salivette® VD kahe sõrmega tagumisest otsast hoides välja japange suhu.
Vatirull peaks jääma suhu (nt põsetaskusse) 2 minutiks ilma närimisliigutusteta. Minimaalne võetav süljekogus peaks olema 500 μl. Äärmiselt vähese süljeerituse korral jäetakse Vatirull pikemaks ajaks suhu.
Võtke vatirull kahe sõrmega tagumisest otsast hoides suust välja ning
pange vahetult süsteemi Salivette® VD ja sulgege helesinise korgiga.
Patsiendile: Süljeproovi tagastamiseks tihedalt suletud süsteemis Salivette® VD järgige arsti juhiseid ning kasutage arsti antud sekundaarset mahutit ja saatmiskarpi/-kotti. Juhul kui ei tagastata kohe, siis hoidke
süsteemi Salivette® VD külmikus.
Arstile ja laborile
Toatemperatuuril süljes juba mõne tunni pärast algava bakterite kasvu tõttu soovitatakse süsteemi Salivette®9'SËUDVWSURRYLYĄWPLVWNLQGODOWVXOHWXQDNDVKMRRNVXOƅJMXXUHVPLQXWLNVWVHQWULIXXJLGDMD
analüüsida või kuni edasise töötlemiseni külmikus hoida.
Pärast tsentrifuugimist võtke sissepandav nõu, kaasa arvatud kork, läbipaistvast terava põhjaga plastnõust välja.
Plastnõu tipu õnaruses olevate jääkide kohal on edasiseks analüüsiks puhas sülg.
Pärast analüüsi visake terava põhjaga plastnõu ja sissepandav nõu kogumismahutisse.

-ËËWPHNËLWOXVşNHKWLEDUVWLMDODERULNRKWD
1.

Järgida tuleb üldisi hügieenisuuniseid ning õigusaktide sätteid nakkusliku materjali nõuetekohase jäätmekäitluse kohta ja neist tuleb kinni pidada.

2.

Ühekordselt kasutatavad kindad takistavad seejuures nakatumise riski.

3.

Saastunud või täidetud süsteemid Salivette® VD tuleb visata ohtlike bioloogiliste materjalide jaoks mõeldud sobivasse kogumismahutisse, mida saab seejärel autoklaavida ja ära põletada.

4.

Jäätmekäitlus peab toimuma sobivas põletusrajatises või autoklaavimise (aursteriliseerimise) teel.

24

ET
Kirjandus
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

Sümbolite ja märgistuste võtiArtikli number

Partii numberKõlblik kuni

CE-märgis

In vitro diagnostikavahend

Järgige kasutusjuhendit

Taaskasutamise korral: saastumisoht

Hoidke päikesevalguse eest kaitstult

Ladustage kuivas kohas

TootjaTootjariik

Tehnilised muudatused on võimalikud.
Kõigist tootega seotud ohujuhtumitest tuleb teavitada tootjat ja pädevat riiklikku asutust.

25

Mode d’emploi – SARSTEDT Salivette® VD

FR(PSORLSUÜYX
La Salivette®9'HVWXQUÜFLSLHQWSRXUÜFKDQWLOORQVGHVDOLYH(OOHHVWGHVWLQÜHDXUHFXHLODXWUDQVSRUWDXWUDLWHPHQWHWDXVWRFNDJHGHODVDOLYHHQYXHGXGÜSLVWDJHGHYLUXVFRPPHOHVDFLGHVQXFOÜLTXHVGX
6$56&R9SDUH[HPSOHHQYXHGHUÜDOLVHUGHVGÜWHUPLQDWLRQVGLDJQRVWLTXHVin vitro/HSURGXLWHVWFRQ×XSRXUXQHXWLOLVDWLRQGDQVXQHQYLURQQHPHQWSURIHVVLRQQHOHWOŖDSSOLFDWLRQSDUXQSHUVRQQHOPÜGLFDOTXDOLILÜDescription du produit
La Salivette®9'VHFRPSRVHGŖXQWXEHHQSODVWLTXHWUDQVSDUHQWÇIRQGFRQLTXHGŖXQWXEHVXVSHQGXGŖXQWDPSRQDEVRUEDQWHQRXDWHHWGŖXQERXFKRQEOHXFODLU/HWDPSRQDEVRUEDQWHQRXDWHHVWXQSURGXLWQDWXUHO/ŖDSSDULWLRQGHGÜFRORUDWLRQVHWGŖLQFOXVLRQVRXGH]RQHVSOXVVRPEUHVHVWQDWXUHOOHHWLQÜYLWDEOH

51.1534.100=

Tube en plastique+

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tamponabsorbant+

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1.

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2.

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3.

/DVDOLYHSUÜOHYÜHHWWUDLWÜHDYHFOD6DOLYHWWH®9'QŖHVWSDVGHVWLQÜHÇÝWUHUÜLQWURGXLWHGDQVOHFRUSVKXPDLQ4.

Ne plus utiliser la Salivette®9'VLODGDWHGHSÜUHPSWLRQHVWGÜSDVVÜH/DGXUÜHGHFRQVHUYDWLRQGHOD6DOLYHWWH®9'SUHQGıQOHGHUQLHUMRXUGXPRLVHWGHOŖDQQÜHLQGLTXÜV

Stockage
La Salivette®9'GRLWÝWUHVWRFNÜHÇWHPSÜUDWXUHDPELDQWHDYDQWXWLOLVDWLRQ

Transport/HSURGXLWSHXWÝWUHWUDQVSRUWÜPDQXHOOHPHQWDXVHLQGHOŖÜWDEOLVVHPHQWRXDYHFXQUÜFLSLHQWVHFRQGDLUHFRQIRUPHÇOŖ$'5 LQVWUXFWLRQGŖHPEDOODJH3 3RXUOHWUDQVSRUWGŖÜFKDQWLOORQVGDQVOD6DOLYHWWH® VD, il est
UHFRPPDQGÜGŖXWLOLVHUOHIODFRQGŖH[SÜGLWLRQUÜIbFRQIRUPHÇOŖ$'5 LQVWUXFWLRQGŖHPEDOODJH3 DYHFSDSLHUDEVRUEDQWFRPELQÜDXERXFKRQÇYLVUÜIbHWXQHERîWHXQVDFKHWGŖH[SÜGLWLRQcOŖDWWHQWLRQGXSDWLHQWb
/RUVGHODUHVWLWXWLRQGHOŖÜFKDQWLOORQGHVDOLYHGDQVOD6DOLYHWWH®9'KHUPÜWLTXHPHQWIHUPÜHVXLYH]OHVLQVWUXFWLRQVGHYRWUHPÜGHFLQHWXWLOLVH]OHWXEHVHFRQGDLUHDLQVLTXHODERîWHOHVDFKHWGŖH[SÜGLWLRQTXLYRXVRQW
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WRXWHSULVHPÜGLFDPHQWHXVHSDUYRLHRUDOH
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HVWGRQFUHFRPPDQGÜGHFHQWULIXJHUHWGŖDQDO\VHUOD6DOLYHWWH®9'IHUPÜHKHUPÜWLTXHPHQWGDQVOHVbKHXUHVVXLYDQWOHSUÜOÛYHPHQWRXGHODSODFHUGLUHFWHPHQWDXUÜIULJÜUDWHXUMXVTXŖDXWUDLWHPHQWXOWÜULHXU

3UÜOÛYHPHQWGŖÜFKDQWLOORQHWPDQLSXODWLRQAVANT DE COMMENCER LE RECUEIL DE SALIVE, VEUILLEZ LIRE LE PRÉSENT DOCUMENT DANS SON INTÉGRALITÉ.
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1.

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infectieuses.

2.

Nombre de Salivette®9'HQIRQFWLRQGHODGHPDQGHGXPÜGHFLQ

3.

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26

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Échantillon

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placez-le dans la bouche.
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le tampon absorbant reposer plus longtemps en bouche.
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27

FR5ÜIÜUHQFHVELEOLRJUDSKLTXHVHoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359&OÜVGHV\PEROHHWGŖLGHQWLıFDWLRQb

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35,-(32q(7.$35,.83/-$1-$6/,1(8&,-(/267,352q,7$-7(29$-'2.80(17Materijal potreban za uzimanje uzoraka:
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2.

2GJRYDUDMXÓDNROLÕLQD6$567('76DOLYHWWH®9'SUHPDXSXWLOLMHÕQLND

3.

3RSXQLWHSRGDWNH]DLGHQWLıNDFLMXX]RUND QDQDOMHSQLFL 

29

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Uzimanje uzorka

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1 min
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Za pacijenta:=DSUHGDMXX]RUNDVOLQHXÕYUVWR]DWYRUHQRM6$567('76DOLYHWWH®9'SRVWXSLWHSUHPDXSXWDPDOLMHÕQLNDLXSRWULMHELWHVHNXQGDUQLVSUHPQLNLNXWLMXYUHÓLFX]DVODQMHNRMXYDPMHGDROLMHÕQLN$NRuzorak ne predajete odmah, pohranite SARSTEDT Salivette® VD u hladnjak.
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1.

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2.

Jednokratne rukavice smanjuju rizik od infekcije.

3.

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4.

Zbrinjavanje se mora obaviti u prikladnoj spalionici ili postupkom autoklaviranja (sterilizacije parom).

30

HR
Literatura
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

Objašnjenja simbola i oznaka:

Broj artikla

Broj serije

Upotrijebiti do

Oznaka CE

In vitroGLMDJQRVWLÕNLSURL]YRG

Pogledati upute za uporabu

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Salivette®9'V]ÈPDD]RUYRVNąYHWHOPÜQ\HV]HULQW3.

,QIRUPÈFLĂDPLQWDD]RQRVìWÈV FìPNÜQ NLWąOWÜVÜKH]

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1 perc500 x g

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tegye a szájába.
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szívóhengert hosszabb ideig a szájában.
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dugja közvetlenül a Salivette®9'HJ\VÜJEHPDMGDYLOÈJRVNÜNGXJĂYDO]ÈUMDOH
A beteg számára: A szorosan lezárt Salivette®9'UHQGV]HUEHQWąUWÜQĈQ\ÈOPLQWDDGÈVKR]NąYHVVHD]RUYRVXWDVìWÈVDLWÜVKDV]QÈOMDD]RUYRVÈOWDOUHQGHONH]ÜVUHERFVÈWRWWPÈVRGODJRVHGÜQ\WÜVV]ÈOOìWĂGRER]W]DFVNĂW$PHQQ\LEHQDPLQWDDGÈVQHPNą]YHWOHQĞOWąUWÜQLNWÈUROMDH]WD6DOLYHWWH®9'WHUPÜNHWKĢWĈV]HNUÜQ\EHQ
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2.

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33

HUIrodalom
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

6]LPEĂOXPRNÜVMHOąOÜVHNPDJ\DUÈ]DWD

Cikkszám*\ÈUWÈVLWÜWHOV]ÈP

Lejárat napja:&(MHOąOÜV

In vitro diagnosztikai orvostechnikai eszköz

Olvassa el a használati utasítást!

³MEĂOLIHOKDV]QÈOÈVHVHWÜQ)HUWĈ]ÜVYHV]ÜO\1DSIÜQ\WĈOYÜGYHWÈURODQGĂ

Száraz helyen tartandó

Gyártó

Gyártási ország

A technikai változtatások jogát fenntartjuk.
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34

Istruzioni d'uso - Salivette®VD SARSTEDT

IT

Destinazione d'uso
Salivette®9'ÛXQFRQWHQLWRUHSHUFDPSLRQLGLVDOLYDHVHUYHDUDFFRJOLHUHWUDVSRUWDUHPDQLSRODUHHFRQVHUYDUHODVDOLYDSHUORVFUHHQLQJGLPDWHULDOLYLUDOLDGHVDFLGLQXFOHLFLGL6$56&R9HSHUDQDOLVLGLDJQRVWLFKH
in vitro,OSURGRWWRÛGHVWLQDWRDOO XVRLQXQDPELHQWHSURIHVVLRQDOHGDSDUWHGLSHUVRQDOHPHGLFRHGLODERUDWRULRSUHSDUDWR

Descrizione del prodotto
Il sistema Salivette®9'ÛFRVWLWXLWRGDXQFRQWHQLWRUHLQSODVWLFDWUDVSDUHQWHFRQIRQGRDSXQWDXQLQVHUWRXQWDPSRQHLQRYDWWDHXQWDSSRD]]XUUR,OWDPSRQHLQRYDWWDÛXQSURGRWWRQDWXUDOH&RORUD]LRQLLQVHU]LRQLRSDUWLSLĚVFXUHVRQRQDWXUDOLHLQHYLWDELOL

51.1534.100=

Contenitore inplastica+

Inserto+Tampone+Tappo azzurro,VWUX]LRQLGLVLFXUH]]DHDYYHUWHQ]H
1.

,OSURGRWWRQRQGHYHHVVHUHXWLOL]]DWRSHUEDPELQLGLHWÇLQIHULRUHDWUHDQQLRSHUVRQHFRQULVFKLRGLLQJHVWLRQHHOHYDWR

2.

Precauzioni generali: Indossare guanti e altri dispositivi di protezione individuale generali per proteggersi da una possibile esposizione a materiale potenzialmente infettivo. Attenersi alle direttive e alle procedure di
sicurezza del proprio istituto.

3.

La saliva prelevata e manipolata con Salivette® VD non deve essere nuovamente reintrodotta nell'organismo umano.

4.

Non utilizzare una Salivette® VD dopo la data di scadenza. Il periodo di conservazione di una Salivette® VD termina l'ultimo giorno del mese e dell'anno indicati.

&RQVHUYD]LRQHPrima dell’utilizzo conservare la Salivette® VD a temperatura ambiente.

TrasportowSRVVLELOHWUDVSRUWDUHLQWHUQDPHQWHLOSURGRWWRDPDQRRSSXUHLQVLHPHDXQFRQWHQLWRUHVHFRQGDULRFRQIRUPHDOODUHJRODPHQWD]LRQHb$'5 LVWUX]LRQHGLLPEDOODJJLR3 3HULOWUDVSRUWRGLFDPSLRQLGL6DOLYHWWH® VD si
consiglia il contenitore per spedizioni conforme alla regolamentazione ADR (istruzione di imballaggio P650), n. art. 78.898 con inserto assorbente più tappo a vite n. art. 65.679 e una scatola/borsa da spedizione.
Per il paziente:
Attenersi alle istruzioni del medico relative alla restituzione del campione di saliva nella Salivette® VD ben chiusa e utilizzare il contenitore secondario messo a disposizione dal medico e la scatola/busta per la spedizione.
Se non viene restituita immediatamente, conservare la Salivette® VD in frigorifero.

Limitazioni
Il prelievo di saliva dovrebbe avvenire al più presto 60 minuti dopo un pasto (assunzione di sostanze solide/liquide), la pulizia dei denti o l’assunzione orale di medicinali per evitare la contaminazione della saliva con
sostanze che possono interferire.
/DGXUDWDHODWHPSHUDWXUDGLFRQVHUYD]LRQHGLSHQGRQRGDOSHULRGRGLFRQVHUYD]LRQHGHOSDUDPHWURGDHVDPLQDUH3HUWDQWRDQFKHDIURQWHGHOODFUHVFLWDEDWWHULFDFKHDWHPSHUDWXUDDPELHQWHKDLQL]LRQHOODVDOLYDJLÇ
dopo alcune ore, si consiglia di chiudere saldamente la Salivette® VD dopo il prelievo del campione e di centrifugarla entro 4 h e analizzarla oppure di conservarla direttamente in frigorifero fino all'ulteriore lavorazione.

3UHOLHYRHPDQLSROD]LRQHGHOFDPSLRQH
PRIMA DI PROCEDERE AL PRELIEVO DELLA SALIVA, LEGGERE FINO IN FONDO QUESTO DOCUMENTO.
Materiale di lavoro necessario per il prelievo del campione:1.

Guanti, camici, protezioni per gli occhi o altri indumenti protettivi appropriati per proteggersi da agenti patogeni trasmessi con la saliva o materiali potenzialmente infettivi.

2.

Numero di Salivette® VD secondo le indicazioni del medico.

3.

5LHPSLUHOHLQIRUPD]LRQLVXOOŖLGHQWLıFD]LRQHGHOFDPSLRQH VXOOŖHWLFKHWWD 

35

ITPrelievo del campione

2 min. senza
movimenti masticatoriƊbbPLQ

1 min
500 x gCampione

Residui

Il prelievo di saliva dovrebbe avvenire come minimo 60 minuti dopo un pasto (assunzione di sostanze solide/liquide), la pulizia dei denti, l’aver fumato o l’assunzione orale di medicinali per evitare lacontaminazione della saliva con sostanze che possono interferire.
Pulire la mani e asciugarle subito dopo il prelievo di saliva.
Dalla Salivette®9'DSHUWDSUHQGHUHLOWDPSRQHFRQGXHGLWDVXOOŖHVWUHPLWÇSRVWHULRUHH
metterlo in bocca.
/DVFLDUHLQERFFD DGHVDOOŖLQWHUQRGHOODJXDQFLD LOWDPSRQHSHUPLQXWLVHQ]DPRYLPHQWLPDVWLFDWRUL/DTXDQWLWÇPLQLPDGLVDOLYDSUHOHYDWDGHYHHVVHUHSDULDGDOPHQRbƐO1HOFDVRLQFXLODVDOLYDVLIRUPLLQ
modo molto modesto, lasciare il tampone in bocca più a lungo.
3UHQGHUHLOWDPSRQHGDOODERFFDFRQGXHGLWDVXOOŖHVWUHPLWÇSRVWHULRUHH
inserirlo direttamente nella Salivette® VD chiudendo poi con il tappo azzurro.
Per il paziente: Attenersi alle istruzioni del medico relative alla restituzione del campione di saliva nella Salivette® VD ben chiusa e utilizzare il contenitore secondario messo a disposizione dal medico e la scatola/busta per la spedizione. Se non viene restituita immediatamente, conservare la Salivette® VD in frigorifero.
Per medico e laboratorio:$IURQWHGHOODFUHVFLWDEDWWHULFDFKHDWHPSHUDWXUDDPELHQWHKDLQL]LRQHOODVDOLYDJLÇGRSRDOFXQHRUHVLFRQVLJOLDGLFKLXGHUHVDOGDPHQWHOD6DOLYHWWH® VD dopo il prelievo del campione e di centrifugarla entro 4 h a
500 x g per 1 minuto e analizzarla oppure di conservarla direttamente in frigorifero fino all'ulteriore lavorazione.
Dopo la centrifugazione togliere l’inserto con il tappo dal contenitore in plastica con fondo a punta.
Nel fondo a punta del contenitore in plastica si trova la saliva pura per l’ulteriore analisi dei resti che si trovano nel serbatoio del fondo a punta.
Dopo l’analisi smaltire il contenitore in plastica con fondo a punta e l’inserto in un apposito contenitore per rifiuti.

Smaltimento - per medico e laboratorio:1.

È necessario attenersi alle linee guida generali sull'igiene e alle disposizioni di legge per il corretto smaltimento del materiale infettivo.

2.

I guanti monouso prevengono il rischio di infezione.

3.

La Salivette® VD contaminata o riempita deve essere smaltita in un apposito contenitore per materiali a rischio biologico, che può poi essere sterilizzato in autoclave e incenerito.

4.

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36IT%LEOLRJUDıD
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

Legenda dei simboli e dei contrassegni:

Codice articolo

Designazione della partita

Usare entro

Marchio CE

Diagnostica in vitro

Attenersi alle istruzioni d'uso

In caso di riutilizzo: rischio di contaminazione

Conservare al riparo dalla luce del sole

Conservare in un luogo asciutto

Produttore

Paese di fabbricazione

Con riserva di modifiche tecniche.
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Gaminio aprašymas
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Nenaudokite „Salivette® VD“ pasibaigus galiojimo laikui. „Salivette®9'ŗJDOLRMLPRODLNDVEDLJLDVLSDVNXWLQãQXURG\WRPâQHVLRLUPHWģGLHQÐ

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laikykite „Salivette® VD“ šaldytuve.

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Prieš pat rinkdami seiles, nusiplaukite ir nusausinkite rankas.
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Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

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Partijos pavadinimas

Tinka naudoti iki&(ĭHQNODVIn vitro diagnostikai/DLN\WLVQDXGRMLPRLQVWUXNFLMģ

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Laikyti sausoje vietoje

Gamintojas

Pagaminimo šalis

Galimi techniniai pakeitimai.
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43

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Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

6LPEROXXQDS]ñPàMXPXVNDLGURMXPVArtikula numurs

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Gebruik
De Salivette® VD is een monsterbuisje voor speekselmonsters en wordt gebruikt voor de afname en het transporteren, verwerken en opslaan van speeksel voor het screenen op virusmateriaal, bijv. nucleïnezuren van
SARS-CoV-2, in in-vitro diagnostische doeleinden. Het product is bestemd voor gebruik in een professionele omgeving en door gespecialiseerd medisch personeel en laboratoriumpersoneel.

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De Salivette® VD bestaat uit een transparant kunststof buisje met spitse bodem, een inhangbuisje, een wattenrolletje en een lichtblauwe dop.
Bij het wattenrolletje gaat het om een natuurproduct. Verkleuringen en donkere insluitsels of vlekken zijn natuurlijk en onvermijdbaar.

51.1534.100=

Kunststof buisje+

Inhangbuisje+

Wattenrolletje+

lichtblauwe dop

Veiligheidsinstructies en waarschuwingen
1.

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3.

Speeksel dat met de Salivette®9'JHZRQQHQHQYHUZHUNWLVLVQLHWEHVWHPGRPWHUXJLQKHWPHQVHOİNHOLFKDDPWHZRUGHQJHEUDFKW

4.

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BewarenDe Salivette® VD moet voor gebruik bij kamertemperatuur worden bewaard.

Transport
Het product kan samen met een secundaire recipiënt die voldoet aan de ADR (verpakkingsinstructie P650) worden getransporteerd. Om het monster van de Salivette® VD te transporteren wordt de transportcontainer
art. nr. 78.898, die voldoet aan de ADR (verpakkingsinstructie P650), met absorptie materiaal plus schroefdop art. nr. 65.679 en een transportdoos/zak aanbevolen.
Voor patiënt:Respecteer voor het terugbrengen van het speekselmonster in de vast gesloten Salivette® VD de aanwijzingen van de arts en gebruik de secundaire recipiënt en de verzendbox/-zak die door de arts ter beschikking
worden gesteld. Als het terugbrengen niet direct gebeurt, bewaar de Salivette® VD in de koelkast.

Beperkingen
De speekselafname mag ten vroegste 60 minuten na een maaltijd (vloeibare/vaste voedingsopname), het poetsen van de tanden of orale inname van medicijnen gebeuren, om een contaminatie van het speeksel door
storende substanties te vermijden.
De bewaartijd en -temperatuur zijn afhankelijk van de houdbaarheid van de te onderzoeken parameters. Om deze reden en vanwege de bacteriegroei in speeksel die al na enkele uren bij kamertemperatuur begint, wordt
aanbevolen de Salivette® VD na monstername goed afgesloten ofwel binnen de 4 u te centrifugeren en te analyseren ofwel direct tot verdere verwerking in de koelkast te bewaren.

Monstername en gebruik
LEES DIT DOCUMENT VOLLEDIG VOORDAT U MET DE SPEEKSELWINNING BEGINT.
Benodigdheden voor de monstername:1.

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2.

Aantal Salivette® VD conform vereiste van de arts.

3.

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Monsterafname

2 min zonder
kauwbeweging

ƊPLQ

1 min
500 x gMonster

Residuen

De speekselafname mag pas 60 minuten na een maaltijd (vloeibare/vaste voedingsopname), het poetsen van de tanden, roken of orale inname van medicijnen gebeuren om een contaminatie van het speekseldoor storende substanties te vermijden.
Was onmiddellijk voor de speekselafname uw handen en droog ze af.
Neem het wattenrolletje aan het achterste uiteinde met twee vingers uit de geopende Salivette® VD enplaats het in de mond.
Het wattenrolletje moet gedurende 2 minuten zonder kauwbewegingen in de mond (bijv. wang) blijven zitten. De hoeveelheid te winnen speeksel moet 500 μl bedragen. Bij extreem lage speekselvorming kan men
het wattenrolletje langer in de mond laten rusten.
Neem het wattenrolletje aan het achterste uiteinde met twee vingers uit de mond en
steek het onmiddellijk in de Salivette® VD en sluit deze met de lichtblauwe dop.
Voor patiënt: Respecteer voor het terugbrengen van het speekselmonster in de vast gesloten Salivette® VD de aanwijzingen van de arts en gebruik de secundaire recipiënt en de verzendbox/-zak die door de arts
ter beschikking worden gesteld. Als het terugbrengen niet direct gebeurt, bewaar de Salivette® VD in de koelkast.
Voor arts en laboratorium:
Vanwege de bacteriegroei in speeksel die al na enkele uren bij kamertemperatuur begint, wordt aanbevolen de Salivette® VD na monstername goed afgesloten ofwel binnen de 4 u bij 500 x g gedurende 1 minuut
te centrifugeren en te analyseren ofwel direct tot verdere verwerking in de koelkast te bewaren.
Neem na centrifugatie het inhangbuisje inclusief dop uit het kunststof buisje met spitse bodem:
In de spitse bodem van het kunststof buis bevindt zich het zuivere speeksel voor verdere analyse boven de residuen die zich in het reservoir van de spitse bodem bevinden.
Gooi na analyse het kunststof buisje met spitse bodem en het inhangbuisje in een afvalcontainer.

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2.

:HJZHUSKDQGVFKRHQHQYRRUNRPHQGDDUEİKHWULVLFRRSLQIHFWLH

3.

Gecontamineerde of gevulde Salivette®9'PRHWZRUGHQYHUZİGHUGLQJHVFKLNWHFRQWDLQHUVYRRUJHYDDUOİNHELRORJLVFKHVWRĳHQGLHYHUYROJHQVJHDXWRFODYHHUGHQYHUEUDQGNXQQHQZRUGHQ4.

'HYHUZİGHULQJGLHQWSODDWVWHYLQGHQLQHHQJHVFKLNWHYHUEUDQGLQJVRYHQRIGRRUPLGGHOYDQDXWRFODYHUHQ VWRRPVWHULOLVDWLH 

48

NL
Literatuur
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

Informatie over symbolen en markeringen:

Artikelnummer

Lotnummer

EXP

CE-markering

In-vitro diagnosticum

Gebruikershandleiding opvolgen%İKHUJHEUXLN5LVLFRRSEHVPHWWLQJ

Niet blootstellen aan zonlicht

Droog bewaren

FabrikantLand van productie

Technische wijzigingen voorbehouden.
Alle ernstige incidenten met betrekking tot het product moeten worden gemeld aan de fabrikant en de bevoegde nationale instantie.

49

Bruksanvisning – SARSTEDT Salivette®® VD

NO

Bruksformål
Salivette® VD er en prøvebeholder for spyttprøver og brukes til å innhente, transportere, bearbeide og oppbevare spytt for screening av virusmateriale, f.eks. nukleinsyrer fra SARS-CoV-2, i in vitro-diagnostiske
bestemmelser. Produktet er ment til bruk i profesjonelt miljø av medisinsk fagpersonell og laboratoriepersonell.

3URGXNWEHVNULYHOVH
Salivette® VD består av en transparent plastbeholder med spiss bunn, en hengebeholder, en vattampong til oppsuging og en lyseblå propp.
Vattampongen er et naturprodukt. Misfarginger og mørkere flekker eller steder er naturlig og ikke til å unngå.

51.1534.100=

plastbeholder+

hengebeholder+

tampong til
oppsuging+lyseblå propp

6LNNHUKHWVPHUNQDGHURJDGYDUVOHU
1.

3URGXNWHWPÎLNNHEUXNHVWLOEDUQXQGHUbÎUHOOHUDYSHUVRQHUPHGIRUKĉ\HWIDUHIRUNYHOQLQJ

2.

Generelle forsiktighetstiltak: Bruk hansker og annet generelt personlig verneutstyr for å beskytte deg mot en mulig eksponering overfor potensielt smittsomt prøvemateriale. Sikkerhetsretningslinjene og -prosessene
til helseinstitusjonen der du jobber skal følges.

3.

Spyttet som er oppsamlet og bearbeidet med Salivette® VD er ikke ment for tilbakeføring til menneskekroppen.

4.

En Salivette® VD skal ikke brukes etter at holdbarhetsdatoen er utløpt. Holdbarheten til en Salivette® VD løper ut den siste dagen i den angitte måneden og det angitte året.

2SSEHYDULQJ
Salivette® VD skal oppbevares ved romtemperatur.

Transport
Produktet kan transporteres manuelt eller sammen med en ADR-samsvarende (pakningsanvisning P650) sekundærbeholder. Til prøvetransport av Salivette® VD anbefales den ADR-samsvarende (pakningsanvisningP650) forsendelsesbeholderen med art.nr. 78.898 med sugeinnlegg pluss skrukork med art.nr. 65.679 samt en forsendelsesboks/-pose.
For pasient:
Følg instruksene fra legen for retur av spyttprøven i den forsvarlig lukkede Salivette® VD, og bruk sekundærbeholderen som legen har stilt til disposisjon samt forsendelsesboksen/-posen. Dersom analysen ikke finnersted med en gang, skal Salivette® VD oppbevares i kjøleskapet.

Begrensninger
6S\WWSUĉYHQVNDOWLGOLJVWWDVbPLQXWWHUHWWHUHWPÎOWLG IO\WHQGHIDVWQÑULQJVRSSWDN WDQQSXVVHOOHURUDOWLQQWDNDYPHGLNDPHQWHUGHWWHIRUÎIRUKLQGUHHQNRQWDPLQHULQJDYVS\WWHW
Oppbevaringsvarigheten og -temperaturen avhenger av holdbarheten til parameterne som skal undersøkes. Derfor og på grunn av bakterieveksten i spyttet, som ved romtemperatur oppstår allerede etter noen timer,
anbefales det at Salivette®9'OXNNHVJRGWHWWHUSUĉYHWDNLQJHQRJHQWHQVHQWULIXJHUHVRJDQDO\VHUHVLQQHQbWLPHUHOOHUVHWWHVGLUHNWHLNMĉOHVNDSHWIUHPWLOYLGHUHEHKDQGOLQJ

3UĉYHWDNLQJRJKÎQGWHULQJLES GJENNOM HELE DETTE DOKUMENTET FØR DU STARTER SPYTTOPPSAMLINGEN.
Arbeidsmateriale som behøves til prøvetaking:1.

Hansker, kittel, øyevern eller andre egnede verneklær som beskytter mot spyttoverførte patogener eller potensielt infeksiøst materiale.

2.

Antall Salivette® VD i henhold til kravet fra legen.

3.

)\OOXWLQIRUPDVMRQVRPJMHOGHUSUĉYHLGHQWLıVHULQJHQ SÎHWLNHWW 

50

NO
Prøvetaking

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tyggebevegelseƊbPLQ

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500 x g

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Rester

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Umiddelbart før prøven tas, skal hendene vaskes og tørkes.
Bruk to fingre, grip oppsugingstampongen i den bakre enden og ta den ut ut av den åpnede Salivette® VD, og
legg den i munnen.
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ligge lengre i munnen.
Ta tampongen ut av munnen ved gripe i den bakre enden med to fingre,
stikk den øyeblikkelig inn i Salivette® VD og lukk med den hvite proppen.
For pasient: Følg instruksene fra legen for retur av spyttprøven i den forsvarlig lukkede Salivette® VD, og bruk sekundærbeholderen som legen har stilt til disposisjon samt forsendelsesboksen/-posen. Dersom
overgivelsen ikke finner sted med en gang, skal Salivette® VD oppbevares i kjøleskapet.
For lege og laboratorium:På grunn av bakterieveksten i spyttet, som ved romtemperatur oppstår allerede etter noen timer, anbefales det at Salivette®9'OXNNHVJRGWHWWHUSUĉYHWDNLQJHQRJHQWHQVHQWULIXJHUHVLQQHQbWLPHUYHG[JLbPLQXWWRJVÎDQDO\VHUHVHOOHUVHWWHVGLUHNWHLNMĉOHVNDSHWIUHPWLOYLGHUHEHKDQGOLQJ
Etter sentrifugeringen skal hengebeholderen og proppen tas ut av plastbeholderen med den spisse bunnen.
I den spisse bunnen av plastbeholderen finnes det rene spyttet til videre analyse.
Etter analysen skal plastbeholderen med den spisse bunnen og hengebeholderen kasseres i en avfallsbeholder.

$YIDOOVKÎQGWHULQJşJMHOGHUIRUOHJHRJODERUDWRULXP
1.

De generelle retningslinjene for hygiene samt de lovfestede bestemmelsene for forskriftsmessig destruksjon av infeksiøst materiale skal tas hensyn til og overholdes.

2.

Engangshansker forhindrer faren for infeksjon.

3.

Kontaminerte eller fylte Salivette®9'PÎGHVWUXHUHVLHJQHGHDYIDOOVEHKROGHUHIRUELRORJLVNHIDUHVWRĳHUVRPGHUHWWHUNDQDXWRNODYHUHVRJIRUEUHQQHV4.

'HVWUXHULQJPÎıQQHVWHGLHWHJQHWIRUEUHQQLQJVDQOHJJHOOHUYKDDXWRNODYHULQJ GDPSVWHULOLVHULQJ 

51

NO
Litteratur
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

Forklaring av symboler og kjennetegn:

Artikkelnummer

Produksjonsnummer

Brukes før

CE-merke

In vitro-diagnostisk middel

Overhold bruksanvisningen

Ved gjenbruk: kontaminasjonsfare

Oppbevares beskyttet mot sollys

Lagres tørt

Produsent

Produksjonsland

Med forbehold om tekniske endringer.
Alle alvorlige hendelser knyttet til produktet skal meldes fra om til produsenten og til ansvarlige nasjonale myndigheter.

52

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Przeznaczenie
Probówka Salivette®9'MHVWQDF]\QLHPQDSUĂENãďOLQ\LVúXĮ\GRSRELHUDQLDWUDQVSRUWXSU]HWZDU]DQLDLSU]HFKRZ\ZDQLDďOLQ\GREDGDüSU]HVLHZRZ\FKSRGNÐWHPZ\VWãSRZDQLDPDWHULDúXZLUXVRZHJRQSNZDVĂZ
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2.

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1.

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Liczba probówek Salivette® VD wymagana przez lekarza.

3.

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53

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PL3LďPLHQQLFWZRHoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

2EMDďQLHQLHV\PEROLLR]QDF]Hü

1XPHUDUW\NXúX

Oznaczenie partii=XĮ\ÓGR

Znak CE

Wyrób medyczny do diagnostyki in-vitro

3U]HVWU]HJDÓLQVWUXNFMLXĮ\FLD:SU]\SDGNXSRQRZQHJRXĮ\FLD5\]\NRVNDĮHQLD

3U]HFKRZ\ZDÓ]GDODRGďZLDWúDVúRQHF]QHJR

3U]HFKRZ\ZDÓZVXFK\PPLHMVFX

ProducentKraj produkcji=PLDQ\WHFKQLF]QH]DVWU]HĮRQH:V]HONLHSRZDĮQHLQF\GHQW\]ZLÐ]DQH]SURGXNWHPQDOHĮ\]JúDV]DÓSURGXFHQWRZLLZúDďFLZHPXRUJDQRZLNUDMRZHPX

55

Instruções de utilização - Salivette® VD SARSTEDTPT$SOLFD×ĄHVO Salivette®9'ÜXPUHFLSLHQWHGHDPRVWUDSDUDDPRVWUDVGHVDOLYDHVHUYHSDUDDFROKHLWDWUDQVSRUWHWUDWDPHQWRHDUPD]HQDPHQWRGHVDOLYDSDUDRUDVWUHLRGHYìUXVSRUH[HPSORÈFLGRQXFOHLFRGH6$56&R9QD
determinação de diagnósticos in-vitro2SURGXWRGHVWLQDVHDRXVRHPDPELHQWHSURILVVLRQDOHÇDSOLFD×ÊRSRUSHVVRDOPÜGLFRHWÜFQLFRGHODERUDWĂULRHVSHFLDOL]DGRVDescrição do produto
O Salivette®9'ÜFRPSRVWRSRUXPUHFLSLHQWHGHSOÈVWLFRWUDQVSDUHQWHFRPEDVHSRQWLDJXGDXPUHFLSLHQWHVXVSHQVRXPURORGHDOJRGÊRHXPDWDPSDD]XOFODUD2URORGHDOJRGÊRÜXPSURGXWRQDWXUDO$GHVFRORUD×ÊRHLQFOXVĄHVRXPDQFKDVPDLVHVFXUDVVÊRQDWXUDLVHLQHYLWÈYHLV

51.1534.100=

Recipiente deplástico+

Recipiente
suspenso+

Rolo de algodão

+tampa azul-clara,QVWUX×ĄHVHDYLVRVGHVHJXUDQ×D
1.

2SURGXWRQÊRSRGHVHUXWLOL]DGRSRUFULDQ×DVFRPPHQRVGHDQRVEHPFRPRSRUSDFLHQWHVTXHDSUHVHQWHPULVFRHOHYDGRGHLQJHVWÊR

2.

Precauções gerais: Utilize luvas e outros equipamentos de proteção individual gerais para se proteger de uma possível exposição a material de amostra potencialmente infecioso. As diretrizes e os procedimentos
de segurança da sua instituição devem ser seguidos.

3.

A saliva colhida e processada com o Salivette® VD não se destina a reintegração no corpo humano.

4.

Não reutilizar um Salivette® VD após o prazo de validade. O prazo de validade de um Salivette®9'WHUPLQDQRěOWLPRGLDGRPÝVHDQRHVSHFLıFDGRVArmazenamento
O Salivette®9'GHYHVHUDUPD]HQDGRÇWHPSHUDWXUDDPELHQWHDQWHVGDVXDXWLOL]D×ÊRTransporte
O produto pode ser transportado manualmente no espaço interior ou juntamente com um recipiente secundário compatível com ADR (instrução de embalagem P650). Para o transporte de amostras do Salivette® VD,
ÜUHFRPHQGDGRRUHFLSLHQWHGHWUDQVSRUWHQųDUWFRPFDPDGDDEVRUYHQWHHWDPSDURVFDGDQųDUWHPFRQIRUPLGDGHFRPD$'5 LQVWUX×ÊRGHHPEDODJHP3 EHPFRPRXPDFDL[DXPVDFRGH
transporte.
Para o paciente:
Para a devolução da amostra de saliva no Salivette®9'EHPIHFKDGRVLJDDVLQVWUX×ĄHVGRPÜGLFRHXWLOL]HRUHFLSLHQWHVHFXQGÈULRHDFDL[DRVDFRGHWUDQVSRUWHIRUQHFLGRVSHORPÜGLFR&DVRDGHYROX×ÊRQÊRVHMD
feita diretamente, armazene este Salivette® VD no frigorífico.

/LPLWD×ĄHV
A colheita de saliva deverá ser feita, pelo menos, 60 minutos após uma refeição (ingestão de alimentos líquidos/sólidos), a lavagem dos dentes ou a toma de medicamentos, para evitar uma contaminação da saliva por
substâncias interferentes.
O período e a temperatura de armazenamento dependem do prazo de validade dos parâmetros a serem examinados. Por esta razão e devido ao crescimento bacteriano na saliva, que se inicia logo após algumas
KRUDVÇWHPSHUDWXUDDPELHQWHUHFRPHQGDVHFHQWULIXJDUHDQDOLVDUR6DOLYHWWH®9'DSĂVDFROKHLWDGDDPRVWUDEHPIHFKDGDQRHVSD×RGHKRUDVRXDUPD]HQÈORQRIULJRUìILFRDWÜRSURFHVVDPHQWRSRVWHULRU

Amostragem e manuseamento
LEIA ESTE DOCUMENTO INTEGRALMENTE ANTES DE COMEÇAR A COLHEITA DE SALIVA.
Material de trabalho necessário para a colheita da amostra:
1.

/XYDVEDWDSURWH×ÊRRFXODURXRXWUDVURXSDVGHSURWH×ÊRDGHTXDGDVSDUDSURWH×ÊRFRQWUDDJHQWHVSDWRJÜQLFRVWUDQVPLWLGRVSHODVDOLYDRXPDWHULDLVSRWHQFLDOPHQWHLQIHFLRVRV

2.

Quantidade de Salivette®9'GHDFRUGRFRPDUHTXLVL×ÊRGRPÜGLFR

3.

3UHHQFKHUDLGHQWLıFD×ÊRGDDPRVWUD QDHWLTXHWD 

56

PTColheita de amostra

2 minutos sem
movimento demastigação

ƊPLQ

1 minutos
500 x gAmostraResíduos

A colheita de saliva deverá ser feita, pelo menos, 60 minutos após uma refeição (ingestão de alimentos líquidos/sólidos), a lavagem dos dentes, fumar ou a toma oral de medicamentos, para evitar uma
contaminação da saliva por substâncias interferentes.
Lavar e secar as mãos imediatamente antes da colheita de saliva.
Remover com dois dedos o rolo de algodão na extremidade traseira do Salivette® VD aberto
e colocar na boca.
O rolo de algodão deve permanecer na boca durante 2 minutos sem movimentos de mastigação (por exemplo, bochecha). A quantidade mínima de saliva a ser colhida deverá ser de 500μl. Em caso de pouca
produção de saliva, o rolo de algodão deverá permanecer na boca por mais tempo.
Remover com dois dedos o rolo de algodão da boca einseri-lo imediatamente no Salivette® VD e fechá-lo com a tampa azul-clara.
Para o paciente: Para a devolução da amostra de saliva no Salivette®9'EHPIHFKDGRVLJDDVLQVWUX×ĄHVGRPÜGLFRHXWLOL]HRUHFLSLHQWHVHFXQGÈULRHDFDL[DRVDFRGHWUDQVSRUWHIRUQHFLGRVSHORPÜGLFR&DVR
a devolução não seja feita diretamente, armazene este Salivette® VD no frigorífico.
3DUDRPÜGLFRHRODERUDWĂULR'HYLGRDRFUHVFLPHQWREDFWHULDQRQDVDOLYDTXHVHLQLFLDORJRDSĂVDOJXPDVKRUDVÇWHPSHUDWXUDDPELHQWHUHFRPHQGDVHFHQWULIXJDUHDQDOLVDUR6DOLYHWWH® VD após a colheita da amostra, bem fechada, no
HVSD×RGHKRUDVQRFDVRGH[SRUPLQXWRRXDUPD]HQÈORQRIULJRUìILFRDWÜRSURFHVVDPHQWRSRVWHULRU
Após a centrifugação, remova o recipiente suspenso com a tampa incluída do recipiente de plástico com fundo pontiagudo.
No fundo pontiagudo do recipiente de plástico, encontra-se a saliva pura para a análise mais aprofundada sobre os resíduos que se encontram no reservatório do fundo pontiagudo.
Após a análise, elimine o recipiente de plástico com fundo pontiagudo e o recipiente suspenso num recipiente de eliminação.

(OLPLQD×ÊRşYÈOLGRSDUDRPÜGLFRHODERUDWĂULR
1.

As diretivas gerais de higiene e as normas legais para a eliminação adequada dos materiais infeciosos devem ser observadas e cumpridas.

2.

Luvas descartáveis impedem o risco de infeção.

3.

O Salivette® VD contaminado ou cheio deve ser eliminado em recipientes de eliminação adequados para substâncias biológicas perigosas, que pode então ser autoclavado e incinerado em seguida.

4.

A eliminação deve ocorrer numa instalação de incineração adequada ou por meio de uma autoclave (esterilização a vapor).

57

PT%LEOLRJUDıD
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

Lista de símbolos e sinais:

1ěPHURGRDUWLJR

1ěPHURGRORWH

Prazo de validade

Marcação CE

Diagnóstico in vitro

Observar as instruções de utilização

Em caso de reutilização: Risco de contaminaçãoArmazenar protegido da luz do sol

Armazenar em local seco

FabricantePaís de fabrico

5HVHUYDGRRGLUHLWRDDOWHUD×ĄHVWÜFQLFDV
7RGRVRVLQFLGHQWHVJUDYHVRFRUULGRVHPFRQWH[WRUHODFLRQDGRFRPSURGXWRGHYHPVHUFRPXQLFDGRVDRIDEULFDQWHHÇVDXWRULGDGHVQDFLRQDLVFRPSHWHQWHV58

,QVWUXFėLXQLGHXWLOL]DUHş6DOLYHWWH® VD SARSTEDTRO

6FRSXOXWLOL]ÍULL
Salivette®9'HVWHXQWXESHQWUXSUREHGHVDOLYÍēLHVWHXWLOL]DWSHQWUXFROHFWDUHDWUDQVSRUWXOSUHOXFUDUHDēLGHSR]LWDUHDVDOLYHLSHQWUXVFUHHQLQJXOPDWHULDOXOXLYLURWLFGHH[DODFL]LORUQXFOHLFLGH6$56&R9SHQWUX
stabilirea diagnosticelor in-vitro3URGXVXOHVWHGHVWLQDWXWLOL]ÍULLîQWUXQPHGLXSURIHVLRQDOGHFÍWUHSHUVRQDOPHGLFDOLQVWUXLWîQDFHVWVFRSēLGHFÍWUHSHUVRQDOGHODERUDWRU

Descrierea produsului
Salivette®9'FRQVWÍGLQWUXQWXEGLQSODVWLFWUDQVSDUHQWFXIXQGDVFXėLWXQWXEVXVSHQGDWRUROÍDEVRUEDQWÍGLQYDWÍēLXQGRSDOEDVWUXGHVFKLV
5RODDEVRUEDQWÍGLQEXPEDFHVWHXQSURGXVQDWXUDO'HFRORUDUHDēLLQWDUVLLOHVDXSHWHOHPDLîQFKLVHVXQWQDWXUDOHēLLQHYLWDELOH

51.1534.100=

Tub din plastic+

Recipient desuspensie+

5ROÍDEVRUEDQWÍ

+Dop albastrudeschis,QGLFDėLLSULYLQGVLJXUDQėDēLDWHQėLRQÍUL
1.

3URGXVXOHVWHFRQWUDLQGLFDWFRSLLLORUFXYÉUVWDVXEDQLVDXSDFLHQėLORUFDUHVXQWPDLSUHGLVSXēLODîQJKLėLUHDDFHVWXLD

2.

3UHFDXėLLJHQHUDOH8WLOL]DėLPÍQXēLēLDOWHFKLSDPHQWLQGLYLGXDOJHQHUDOGHSURWHFėLHSHQWUXDYÍSURWHMDîPSRWULYDXQHLSRWHQėLDOHH[SXQHULODRSUREÍSRWHQėLDOLQIHFėLRDVÍ(VWHREOLJDWRULXVÍUHVSHFWDėLGLUHFWLYHOHēL
SURFHGXULOHSULYLQGVLJXUDQėDYDODELOHîQLQVWLWXėLDGYV

3.

6DOLYDSUHOHYDWÍēLSURFHVDWÍFX6DOLYHWWH®9'QXHVWHGHVWLQDWÍSHQWUXUHLQWURGXFHUHDîQFRUSXOXPDQ4.

1XHVWHSHUPLVÍXWLOL]DUHDXQXLWXE6DOLYHWWH®9'GXSÍH[SLUDUHDWHUPHQXOXLGHYDODELOLWDWH3HULRDGDGHYDODELOLWDWHDXQXLWXE6DOLYHWWH®9'VHîQFKHLHîQXOWLPD]LDOXQLLēLDDQXOXLVSHFLıFDWDepozitare
Salivette®9'VHGHSR]LWHD]ÍODWHPSHUDWXUDFDPHUHL

Transport
3URGXVHOHSRWILWUDQVSRUWDWHPDQXDOîQLQWHULRUXOXQLWÍėLLîPSUHXQÍFXXQWXEVHFXQGDUFRQIRUP$'5 LQVWUXFėLXQLGHDPEDODUH3 3HQWUXWUDQVSRUWXOSUREHORU6DOLYHWWH®9'VHUHFRPDQGÍFRQWDLQHUXOGHWUDQVSRUWFRQIRUP$'5 LQVWUXFėLXQLGHDPEDODUH3 QUDUWFXLQVHUėLHDEVRUEDQWÍSOXVFDSDFILOHWDWQUDUWēLRFXWLHSXQJÍGHWUDQVSRUWPentru pacient:
3HQWUXDUHWXUQDSUREDGHVDOLYÍîQWXEXO6DOLYHWWH®9'îQFKLVHWDQēXUPDėLLQVWUXFėLXQLOHPHGLFXOXLēLXWLOL]DėLWXEXOVHFXQGDUēLFXWLDSXQJDGHWUDQVSRUWIXUQL]DWHGHPHGLF'DFÍUHWXUQDUHDQXHVWHLPHGLDWÍSÍVWUDėLDFHVW
tub Salivette®9'îQIULJLGHU

5HVWULFėLL
6DOLYDWUHEXLHSUHOHYDWÍQXPDLGHYUHPHGHGHPLQXWHGXSÍPDVÍ DSRUWGHDOLPHQWHOLFKLGHVROLGH GXSÍVSÍODUHDGLQėLORUVDXDGPLQLVWUDUHDGHPHGLFDPHQWHSHFDOHRUDOÍSHQWUXDHYLWDFRQWDPLQDUHDVDOLYHLFXVXEVWDQėHSHUWXUEDWRDUH
7LPSXOGHGHSR]LWDUHēLWHPSHUDWXUDGHSLQGGHGXUDELOLWDWHDSDUDPHWULORUFDUHWUHEXLHH[DPLQDėL'LQDFHVWPRWLYēLGLQFDX]DFUHēWHULLEDFWHULHQHîQVDOLYÍFDUHîQFHSHGHMDGXSÍFÉWHYDRUHODWHPSHUDWXUDFDPHUHLVH
UHFRPDQGÍFDWXEXO6DOLYHWWH®9'VÍILHîQFKLVHUPHWLFLPHGLDWēLILHVÍVHFHQWULIXJKH]HēLVÍVHDQDOL]H]HîQGHFXUVGHbRUHILHVÍVHGHSR]LWH]HGLUHFWîQIULJLGHUSÉQÍODSUHOXFUDUHDXOWHULRDUÍ

3UHOHYDUHDēLPDQLSXODUHDSUREHORU
&,7,¯,$&(67'2&80(171175(*,0(1$,17('($1&(3(5(&2/7$5($6$/,9(,Material de lucru necesar pentru prelevarea probelor:1.

0ÍQXēLKDODWHHFKLSDPHQWGHSURWHFėLHDRFKLORUVDXDOWHHFKLSDPHQWHGHSURWHFėLHDGHFYDWHSHQWUXSURWHFėLDîPSRWULYDDJHQėLORUSDWRJHQLVDOLYDULVDXDPDWHULDOHORUSRWHQėLDOLQIHFėLRDVH

2.

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&RPSOHWDėL SHHWLFKHWÍ LQIRUPDėLLOHGHLGHQWLıFDUHDSUREHL

59

RO
Prelevare de probe

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de mestecareƊPLQ

1 min
500 x g3UREÍReziduuri

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LPHGLDWÍSÍVWUDėLDFHVWWXE6DOLYHWWH®9'îQIULJLGHU
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1.

7UHEXLHUHVSHFWDWHēLXUPDWHGLUHFWLYHOHJHQHUDOHGHLJLHQÍēLGLVSR]LėLLOHOHJDOHSULYLQGHOLPLQDUHDFRUHFWÍFDGHēHXULDPDWHULDOHORULQIHFėLRDVH

2.

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RUȩȼɃɉȼɓɁɉɄɁ
Salivette®9'ɋɌɁɀɍɎȼȾɇɛɁɎɍɊȽɊɅɋɌɊȽɄɌɆɏɀɇɛɊȽɌȼɃɒɊȾɍɇɚɉɗɄɍɇɏɂɄɎɀɇɛɍȽɊɌȼɎɌȼɉɍɋɊɌɎɄɌɊȾɆɄɊȽɌȼȽɊɎɆɄɄɑɌȼɉɁɉɄɛɍɇɚɉɗɀɇɛɍɆɌɄɉɄɉȿȼɉȼȾɄɌɏɍɉɗɁɈȼɎɁɌɄȼɇɗ ɉȼɋɌɄɈɁɌɉɏɆɇɁɄɉɊȾɗɁ
ɆɄɍɇɊɎɗ6$56&R9 ɀɇɛLQYLWURɀɄȼȿɉɊɍɎɄɆɄȤɃɀɁɇɄɁɋɌɁɀɉȼɃɉȼɓɁɉɊɀɇɛɄɍɋɊɇɘɃɊȾȼɉɄɛȾɋɌɊɐɁɍɍɄɊɉȼɇɘɉɊɅɍɌɁɀɁɆȾȼɇɄɐɄɒɄɌɊȾȼɉɉɗɈɄɍɊɎɌɏɀɉɄɆȼɈɄɈɁɀɄɒɄɉɍɆɄɑɄɇȼȽɊɌȼɎɊɌɉɗɑɏɓɌɁɂɀɁɉɄɅ

ȪɋɄɍȼɉɄɁɋɌɊɀɏɆɎȼ
Salivette®9'ɍɊɍɎɊɄɎɄɃɋɌɊɃɌȼɓɉɊɅɋɇȼɍɎɄɆɊȾɊɅɋɌɊȽɄɌɆɄɍɆɊɉɄɓɁɍɆɄɈɀɉɊɈɋɊɀȾɁɍɉɊɅɋɌɊȽɄɌɆɄȼȽɍɊɌȽɄɌɏɚɕɁȿɊȾȼɎɉɊȿɊȾȼɇɄɆȼɄȿɊɇɏȽɊɅɋɌɊȽɆɄ
ȜȽɍɊɌȽɄɌɏɚɕɄɅȾȼɎɉɗɅȾȼɇɄɆɋɌɁɀɍɎȼȾɇɛɁɎɍɊȽɊɅɉȼɎɏɌȼɇɘɉɗɅɋɌɊɀɏɆɎȧɊɆȼɇɘɉɊɁɊȽɁɍɒȾɁɓɄȾȼɉɄɁɄɋɊɎɁɈɉɁɉɄɁɛȾɇɛɁɎɍɛɁɍɎɁɍɎȾɁɉɉɗɈɄɉɁɄɃȽɁɂɉɗɈ

51.1534.100=

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ȟɊɇɏȽȼɛɋɌɊȽɆȼ

ȨɁɌɗɋɌɁɀɊɍɎɊɌɊɂɉɊɍɎɄ
1.

ȫɌɊɀɏɆɎɉɁɋɌɁɀɉȼɃɉȼɓɁɉɀɇɛɄɍɋɊɇɘɃɊȾȼɉɄɛɏɀɁɎɁɅɈɇȼɀɔɁɇɁɎɄɋȼɒɄɁɉɎɊȾɍɋɊȾɗɔɁɉɉɗɈɌɄɍɆɊɈɋɌɊȿɇȼɎɗȾȼɉɄɛ

2.

ȪȽɕɄɁɈɁɌɗɋɌɁɀɊɍɎɊɌɊɂɉɊɍɎɄȾɊɄɃȽɁɂȼɉɄɁȾɊɃɈɊɂɉɊȿɊɆɊɉɎȼɆɎȼɍɋɊɎɁɉɒɄȼɇɘɉɊɄɉɐɁɆɒɄɊɉɉɗɈɄɈȼɎɁɌɄȼɇȼɈɄɊȽɌȼɃɒɊȾɄɍɋɊɇɘɃɏɅɎɁɃȼɕɄɎɉɗɁɋɁɌɓȼɎɆɄɄɋɌɊɓɄɁɊȽɕɄɁɍɌɁɀɍɎȾȼ
ɄɉɀɄȾɄɀɏȼɇɘɉɊɅɃȼɕɄɎɗȬɏɆɊȾɊɀɍɎȾɏɅɎɁɍɘɋɌɁɀɋɄɍȼɉɄɛɈɄɀɁɅɍɎȾɏɚɕɄɈɄɀɇɛȞȼɔɁȿɊɏɓɌɁɂɀɁɉɄɛ

3.

ȭɇɚɉȼɍɊȽɌȼɉɉȼɛɄɊȽɌȼȽɊɎȼɉɉȼɛɍɋɊɈɊɕɘɚɍɄɍɎɁɈɗ6DOLYHWWH®9'ɉɁɋɌɁɀɉȼɃɉȼɓɁɉȼɀɇɛɋɊȾɎɊɌɉɊȿɊȾȾɁɀɁɉɄɛȾɊɌȿȼɉɄɃɈɓɁɇɊȾɁɆȼ

4.

ȩɁɄɍɋɊɇɘɃɏɅɎɁ6DOLYHWWH®9'ɋɊɍɇɁɄɍɎɁɓɁɉɄɛɍɌɊɆȼȿɊɀɉɊɍɎɄȭɌɊɆȿɊɀɉɊɍɎɄ6DOLYHWWH®9'ɍɊɊɎȾɁɎɍɎȾɏɁɎɋɊɍɇɁɀɉɁɈɏɀɉɚɏɆȼɃȼɉɉɊȿɊɈɁɍɛɒȼɄȿɊɀȼ

ȱɌȼɉɁɉɄɁ
ȭɄɍɎɁɈɏ6DOLYHWWH®9'ɀɊɁɁɄɍɋɊɇɘɃɊȾȼɉɄɛɍɇɁɀɏɁɎɑɌȼɉɄɎɘɋɌɄɆɊɈɉȼɎɉɊɅɎɁɈɋɁɌȼɎɏɌɁ

ȮɌȼɉɍɋɊɌɎɄɌɊȾɆȼ
ȮɌȼɉɍɋɊɌɎɄɌɊȾɆȼɄɃɀɁɇɄɛɈɊɂɁɎɊɍɏɕɁɍɎȾɇɛɎɘɍɛȾɌɏɓɉɏɚȾɉɏɎɌɄɊɌȿȼɉɄɃȼɒɄɄɄɇɄȾɈɁɍɎɁɍɊȾɎɊɌɄɓɉɗɈɄɋɌɊȽɄɌɆȼɈɄɍɊɊɎȾɁɎɍɎȾɏɚɕɄɈɄɎɌɁȽɊȾȼɉɄɛɈȠȪȫȪȟ ŝȤɉɍɎɌɏɆɒɄɛɋɊɏɋȼɆɊȾɆɁ3Ş ȠɇɛɎɌȼɉɍɋɊɌɎɄɌɊȾɆɄɋɌɊȽ6DOLYHWWH®9'ɌɁɆɊɈɁɉɀɏɁɎɍɛɄɍɋɊɇɘɃɊȾȼɎɘɎɌȼɉɍɋɊɌɎɉɗɅɆɊɉɎɁɅɉɁɌɍɊɊɎȾɁɎɍɎȾɏɚɕɄɅɎɌɁȽɊȾȼɉɄɛɈȠȪȫȪȟ ŝȤɉɍɎɌɏɆɒɄɛɋɊɏɋȼɆɊȾɆɁ3Ş ȦȼɎǂɍȼȽɍɊɌȽɄɌɏɚɕɁɅ
ȾɍɎȼȾɆɊɅɄɌɁɃɘȽɊȾɊɅɆɌɗɔɆɊɅȦȼɎǂȼɎȼɆɂɁɎɌȼɉɍɋɊɌɎɉɊɅɆɊɌɊȽɆɊɅɆɊɉɎɁɅɉɁɌɊɈ
ȠɇɛɋȼɒɄɁɉɎȼ
ȠɇɛɍɀȼɓɄɋɌɊȽɗɍɇɚɉɗȾɋɇɊɎɉɊɃȼɆɌɗɎɊɅɍɄɍɎɁɈɁ6DOLYHWWH®9'ɍɊȽɇɚɀȼɅɎɁɏɆȼɃȼɉɄɛȾɌȼɓȼɄɋɊɇɘɃɏɅɎɁɍɘɋɌɁɀɊɍɎȼȾɇɁɉɉɊɅȾɌȼɓɊɈȾɎɊɌɄɓɉɊɅɋɌɊȽɄɌɆɊɅɄɎɌȼɉɍɋɊɌɎɉɊɅɆɊɌɊȽɆɊɅɆɊɉɎɁɅɉɁɌɊɈȡɍɇɄɋɌɊȽɄɌɆɄɍɊȽɌȼɃɒȼɈɄɊɎɋɌȼȾɇɛɚɎɍɛɉȼɄɍɍɇɁɀɊȾȼɉɄɁɉɁɍɌȼɃɏ6DOLYHWWH®9'ɍɇɁɀɏɁɎɑɌȼɉɄɎɘȾɑɊɇɊɀɄɇɘɉɄɆɁ

ȪȿɌȼɉɄɓɁɉɄɛ
ȭȽɊɌɍɇɚɉɗɍɇɁɀɏɁɎɋɌɊȾɊɀɄɎɘɉɁɌȼɉɁɁɓɁɈɓɁɌɁɃɈɄɉɏɎɋɊɍɇɁɓɄɍɎɆɄɃɏȽɊȾɋɌɄɁɈȼɋɄɕɄ ɂɄɀɆɊɅɎȾɁɌɀɊɅ ɄɇɄɋɁɌɊɌȼɇɘɉɊȿɊɋɌɄɁɈȼɇɁɆȼɌɍɎȾȾɊɄɃȽɁɂȼɉɄɁɃȼȿɌɛɃɉɁɉɄɛɍɇɚɉɗɋɊɍɎɊɌɊɉɉɄɈɄ
ȾɁɕɁɍɎȾȼɈɄ
ȭɌɊɆɄɎɁɈɋɁɌȼɎɏɌȼɑɌȼɉɁɉɄɛɃȼȾɄɍɛɎɊɎɍɌɊɆȼȿɊɀɉɊɍɎɄɋɌɁɀɏɍɈɊɎɌɁɉɉɊȿɊɀɇɛɄɍɍɇɁɀɏɁɈɗɑɋȼɌȼɈɁɎɌɊȾȞɍȾɛɃɄɍəɎɄɈɄɄɃɃȼɎɊȿɊɓɎɊɋɌɄɆɊɈɉȼɎɉɊɅɎɁɈɋɁɌȼɎɏɌɁɌɊɍɎȽȼɆɎɁɌɄɅȾɍɇɚɉɁɉȼɓɄɉȼɁɎɍɛ
ɏɂɁɓɁɌɁɃɉɁɍɆɊɇɘɆɊɓȼɍɊȾɌɁɆɊɈɁɉɀɏɁɎɍɛɋɊɍɇɁɍȽɊɌȼɋɌɊȽɗɋɌɊȾɁɍɎɄɒɁɉɎɌɄɐɏȿɄɌɊȾȼɉɄɁɄȼɉȼɇɄɃ6DOLYHWWH®ȾɎɁɓɁɉɄɁɓȼɍɊȾɄɇɄɑɌȼɉɄɎɘɋɌɊȽɏȾɑɊɇɊɀɄɇɘɉɄɆɁɀɊɋɊɍɇɁɀɏɚɕɁɅɊȽɌȼȽɊɎɆɄ

ȭȽɊɌɄɊȽɌȼȽɊɎɆȼɋɌɊȽ
ȫȪȧȩȪȭȮȸȺȫȬȪȳȤȮȜȥȮȡȩȜȭȮȪȻȵȤȥȠȪȦȯȨȡȩȮȫȡȬȡȠȩȜȳȜȧȪȨȫȬȪȲȡȠȯȬȷȭȝȪȬȜȭȧȺȩȷȬɁɆɊɈɁɉɀɏɁɈɗɁɈȼɎɁɌɄȼɇɗɉɁɊȽɑɊɀɄɈɗɁɀɇɛɍȽɊɌȼɊȽɌȼɃɒɊȾ
1.

ȪɀɉɊɌȼɃɊȾɗɁɋɁɌɓȼɎɆɄɈɁɀɄɒɄɉɍɆɄɅɑȼɇȼɎɃȼɕɄɎɉɗɁɊɓɆɄɄɇɄɀɌɏȿɄɁɋɊɀɑɊɀɛɕɄɁɍɌɁɀɍɎȾȼɄɉɀɄȾɄɀɏȼɇɘɉɊɅɃȼɕɄɎɗɀɇɛɋɌɁɀɊɎȾɌȼɕɁɉɄɛɆɊɉɎȼɆɎȼɍɋȼɎɊȿɁɉȼɈɄɄɇɄɋɊɎɁɉɒɄȼɇɘɉɊɄɉɐɁɆɒɄɊɉɉɗɈɄ
ɈȼɎɁɌɄȼɇȼɈɄɋɁɌɁɉɊɍɄɈɗɈɄɍɊɍɇɚɉɊɅ

2.

ȦɊɇɄɓɁɍɎȾɊ6DOLYHWWH®9'ŠɋɊɎɌɁȽɊȾȼɉɄɚȾɌȼɓȼ

3.

ȣȼɋɊɇɉɄɎɁɄɉɐɊɌɈȼɒɄɚɀɇɛɄɀɁɉɎɄɐɄɆȼɒɄɄɊȽɌȼɃɒɊȾ ɉȼəɎɄɆɁɎɆɁ 

62

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ȪɍȼɀɊɆ

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ɋɊɍɎɊɌɊɉɉɄɈɄȾɁɕɁɍɎȾȼɈɄ
ȩɁɋɊɍɌɁɀɍɎȾɁɉɉɊɋɁɌɁɀɍȽɊɌɊɈɋɌɊȽɗɍɇɁɀɏɁɎȾɗɈɗɎɘɄȾɗɍɏɔɄɎɘɌɏɆɄ
ȤɃȾɇɁɆɄɎɁȼȽɍɊɌȽɄɌɏɚɕɄɅȾȼɇɄɆɀȾɏɈɛɋȼɇɘɒȼɈɄɃȼɃȼɀɉɄɅɆɊɉɁɒɄɃɊɎɆɌɗɎɊɅɍɄɍɎɁɈɗ6DOLYHWWH®9'ɄɋɊɇɊɂɄɎɁɁȿɊȾɌɊɎɋȼɒɄɁɉɎȼ
ȜȽɍɊɌȽɄɌɏɚɕɄɅȾȼɇɄɆɀɊɇɂɁɉɉȼɑɊɀɄɎɘɍɛȾɊɌɎɏɋȼɒɄɁɉɎȼ ɉȼɋɌɄɈɁɌȾɃȼɕɁɓɉɊɈɈɁɔɆɁ ȾɎɁɓɁɉɄɁɈɄɉɏɎȫɊɋɌɊɍɄɎɁɋȼɒɄɁɉɎȼɉɁɍɊȾɁɌɔȼɎɘɂɁȾȼɎɁɇɘɉɗɑɀȾɄɂɁɉɄɅȾəɎɊɎɋɁɌɄɊɀ
ȨɄɉɄɈȼɇɘɉɊɁɆɊɇɄɓɁɍɎȾɊɍɊȽɌȼɉɉɊɅɍɇɚɉɗɀɊɇɂɉɊɍɊɍɎȼȾɇɛɎɘɈɆɇȫɌɄɆɌȼɅɉɁɉɁɃɉȼɓɄɎɁɇɘɉɊɈɍɇɚɉɊɊȽɌȼɃɊȾȼɉɄɄȼȽɍɊɌȽɄɌɏɚɕɄɅȾȼɇɄɆɈɊɂɉɊɊɍɎȼȾɄɎɘȾɊɌɎɏɋȼɒɄɁɉɎȼɉȼȽɊɇɁɁ
ɀɇɄɎɁɇɘɉɊɁȾɌɁɈɛ
ȤɃȾɇɁɆɄɎɁȼȽɍɊɌȽɄɌɏɚɕɄɅȾȼɇɄɆɀȾɏɈɛɋȼɇɘɒȼɈɄɃȼɃȼɀɉɄɅɆɊɉɁɒɄɃɊɌɎȼɋȼɒɄɁɉɎȼ
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ȠɇɛɋȼɒɄɁɉɎȼɀɇɛɍɀȼɓɄɋɌɊȽɗɍɇɚɉɗȾɋɇɊɎɉɊɃȼɆɌɗɎɊɅɍɄɍɎɁɈɁ6DOLYHWWH®9'ɍɊȽɇɚɀȼɅɎɁɏɆȼɃȼɉɄɛȾɌȼɓȼɄɋɊɇɘɃɏɅɎɁɍɘɋɌɁɀɊɍɎȼȾɇɁɉɉɊɅȾɌȼɓɊɈȾɎɊɌɄɓɉɊɅɋɌɊȽɄɌɆɊɅɄɎɌȼɉɍɋɊɌɎɉɊɅɆɊɌɊȽɆɊɅ
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ȠɇɛȾɌȼɓȼɄɇȼȽɊɌȼɎɊɌɄɄ
ȤɃɃȼɎɊȿɊɓɎɊɋɌɄɆɊɈɉȼɎɉɊɅɎɁɈɋɁɌȼɎɏɌɁɌɊɍɎȽȼɆɎɁɌɄɅȾɍɇɚɉɁɉȼɓɄɉȼɁɎɍɛɏɂɁɓɁɌɁɃɉɁɍɆɊɇɘɆɊɓȼɍɊȾɌɁɆɊɈɁɉɀɏɁɎɍɛɋɊɍɇɁɍȽɊɌȼɋɌɊȽɗɋɇɊɎɉɊɃȼɆɌɗɎɘɍɄɍɎɁɈɏ6DOLYHWWH®9'ɄɇɄȽɊɋɌɊȾɁɍɎɄ
ɒɁɉɎɌɄɐɏȿɄɌɊȾȼɉɄɁ [JɈɄɉ ɄȼɉȼɇɄɃ6DOLYHWWH®9'ȾɎɁɓɁɉɄɁɓȼɍɊȾɇɄȽɊɑɌȼɉɄɎɘɋɌɊȽɏȾɑɊɇɊɀɄɇɘɉɄɆɁɀɊɋɊɍɇɁɀɏɚɕɁɅɊȽɌȼȽɊɎɆɄ
ȫɊɍɇɁɒɁɉɎɌɄɐɏȿɄɌɊȾȼɉɄɛɄɃȾɇɁɆɄɎɁɋɊɀȾɁɍɉɏɚɋɌɊȽɄɌɆɏɍɋɌɊȽɆɊɅɄɃɋɇȼɍɎɄɆɊȾɊɅɋɌɊȽɄɌɆɄɍɆɊɉɄɓɁɍɆɄɈɀɉɊɈ
ȞɆɊɉɄɓɁɍɆɊɈɀɉɁɋɇȼɍɎɄɆɊȾɊɅɋɌɊȽɄɌɆɄɉȼɀɊɍȼɀɆɊɈɉȼɑɊɀɛɕɄɈɍɛȾɌɁɃɁɌȾɏȼɌɁɍɊȽɄɌȼɁɎɍɛɓɄɍɎȼɛɍɇɚɉȼɀɇɛɀȼɇɘɉɁɅɔɁȿɊȼɉȼɇɄɃȼ
ȫɊɍɇɁȼɉȼɇɄɃȼɏɎɄɇɄɃɄɌɏɅɎɁɋɇȼɍɎɄɆɊȾɏɚɋɌɊȽɄɌɆɏɍɆɊɉɄɓɁɍɆɄɈɀɉɊɈɄɋɊɀȾɁɍɉɏɚɋɌɊȽɄɌɆɏȾɆɊɉɎɁɅɉɁɌɁɀɇɛɏɎɄɇɄɃȼɒɄɄ

ȯɎɄɇɄɃȼɒɄɛŠɀɇɛȾɌȼɓɁɅɄɇȼȽɊɌȼɎɊɌɄɅ
1.

ȭɊȽɇɚɀȼɅɎɁɍȼɉɄɎȼɌɉɊȿɄȿɄɁɉɄɓɁɍɆɄɁɋɌȼȾɄɇȼɄɋɌɁɀɋɄɍȼɉɄɛɋɊɉȼɀɇɁɂȼɕɁɅɏɎɄɇɄɃȼɒɄɄɄɉɐɁɆɒɄɊɉɉɗɑɈȼɎɁɌɄȼɇɊȾ

2.

ȠɇɛɍɉɄɂɁɉɄɛɌɄɍɆȼɄɉɐɄɒɄɌɊȾȼɉɄɛɄɍɋɊɇɘɃɏɅɎɁɊɀɉɊɌȼɃɊȾɗɁɋɁɌɓȼɎɆɄ

3.

ȣȼȿɌɛɃɉɁɉɉɗɁɄɇɄɃȼɋɊɇɉɁɉɉɗɁɍɄɍɎɁɈɗ6DOLYHWWH®9'ɍɇɁɀɏɁɎɏɎɄɇɄɃɄɌɊȾȼɎɘȾɍɊɊɎȾɁɎɍɎȾɏɚɕɄɑɆɊɉɎɁɅɉɁɌȼɑɀɇɛɏɎɄɇɄɃȼɒɄɄȽɄɊɇɊȿɄɓɁɍɆɄɊɋȼɍɉɗɑɊɎɑɊɀɊȾɍɄɑɋɊɍɇɁɀɏɚɕɁɅɍɎɁɌɄɇɄɃȼɒɄɁɅȾ
ȼȾɎɊɆɇȼȾɁɄɍɂɄȿȼɉɄɁɈ

4.

ȯɎɄɇɄɃȼɒɄɛɀɊɇɂɉȼɊɍɏɕɁɍɎȾɇɛɎɘɍɛȾɍɋɁɒɄȼɇɘɉɊɅɋɁɓɄɀɇɛɍɂɄȿȼɉɄɛɊɎɑɊɀɊȾɄɇɄɍɋɊɈɊɕɘɚȼȾɎɊɆɇȼȾȼ ɍɎɁɌɄɇɄɃȼɒɄɛɋȼɌɊɈ 63

RUȧɄɎɁɌȼɎɏɌȼ
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

ȬȼɍɔɄɐɌɊȾɆȼɍɄɈȾɊɇɊȾɄɊȽɊɃɉȼɓɁɉɄɅ

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ȠɄȼȿɉɊɍɎɄɆȼ In vitroȭɊȽɇɚɀȼɅɎɁɄɉɍɎɌɏɆɒɄɚɋɊəɆɍɋɇɏȼɎȼɒɄɄ

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66

SK
Literatúra
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359/HJHQGDV\PERORYDbR]QDÕHQì.DWDOĂJRYÜÕìVOR

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67

Navodila za uporabo – Salivette® VD SARSTEDTSL

Namen uporabe
Salivette® VD je epruveta za vzorce sline in jo uporabljamo za odvzem, transport, obdelavo in shranjevanje sline za presejalni test virusnega materiala npr. nukleinske kisline SARS-CoV-2 pri diagnosticiranju in-vitro.
Izdelek lahko v profesionalnem okolju uporabljajo strokovni zdravstveni delavci in strokovnjaki v laboratoriju.

Opis izdelka
Epruveta Salivette®9'MHVHVWDYOMHQDL]SUR]RUQHSODVWLÕQHSRVRGLFHVNRQLÕDVWLPGQRPYLVHÕHSRVRGLFHYSRMQHJDWDPSRQDL]YDWHLQVYHWORPRGUHJD]DPDđND
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2.

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in postopke, ki veljajo v vaši ustanovi.

3.

Slina, odvzeta in obdelana z epruveto Salivette®9'QLSULPHUQD]DSRQRYQRYUDÕDQMHYÕORYHđNRWHOR

4.

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Epruveto Salivette® VD hranite pri sobni temperaturi.

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epruveto Salivette® VD v hladilniku.

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vzorca tesno zaprete ali za centrifugiranje ali analiziranje v roku 4 ur ali za neposredno shranjevanje v hladilniku za nadaljnje postopke.

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PRED ODVZEMOM SLINE V CELOTI PREBERITE TA DOKUMENT.
Material, potreben za odvzem vzorca:
1.

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2.

Število epruvet Salivette® VD skladno z zahtevami zdravnika.

3.

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Neposredno pred odvzemom sline umijte roke in jih posušite.
Vpojni tampon z zadnjega konca z dvema prstoma vzemite iz odprte epruvete Salivette® VD in
JDSRORĭLWHYXVWD
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Tampon na zadnjem koncu z dvema prstoma vzemite iz ust in
ga vstavite neposredno v epruveto Salivette® VD, ki jo zaprite z belim zamaškom.
Za bolnika:]DYUDÕLORY]RUFDVOLQHYWHVQR]DSUWLHSUXYHWL6DOLYHWWH®9'XSRđWHYDMWHQDYRGLOD]GUDYQLNDLQXSRUDELWHVHNXQGDUQRSRVRGRLQđNDWORYUHÕNR]DSRđLOMDQMHNDUSULSUDYL]GUDYQLNqHYUDÕLORQLQHSRVUHGQR
hranite to epruveto Salivette® VD v hladilniku.
Za zdravnika in laboratorij:]DUDGLĭHSULVREQLWHPSHUDWXULĭHSRQHNDMXUDKVSURĭHQLUDVWLEDNWHULMYVOLQLMHSULSRURÕOMLYRGDHSUXYHWR6DOLYHWWH®9'SRRGY]HPXY]RUFDWHVQR]DSUHWHYđWLULKXUDKSULb[bJ]DHQRPLQXWRDOL]DFHQWULIXJLUDQMH
ali analiziranje ali za neposredno shranjevanje v hladilniku za nadaljnje postopke.
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2.

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69

SL
Literatura
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

6LPEROLLQR]QDÕHYDOQHNRGHŠtevilka izdelka

Oznaka serije

Uporabno do

Znak CEIn-vitro diagnostika

Upoštevajte navodila za uporabo.

Pri ponovni uporabi: nevarnost kontaminacije+UDQLWH]DđÕLWHQRSUHGVRQÕQRVYHWORER

Hranite na suhem mestu.

Proizvajalec'UĭDYDYNDWHULMHELOL]GHOHNL]GHODQ3ULGUĭXMHPRVLSUDYLFRGRWHKQLÕQLKVSUHPHPEO vseh resnih dogodkih v zvezi s proizvodom je treba obvestiti proizvajalca in pristojni nacionalni organ.

70

Bruksanvisning – SARSTEDT Salivette® VD

SE$QYËQGQLQJ
Salivette® VD är ett provrör för salivprov som används för provtagning, transport, bearbetning och förvaring av saliv för undersökning av virusmaterial, t.ex. nukleinsyra från SARS-CoV-2, i diagnostiska analyser in-vitro.
Produkten är avsedd för professionell användning av medicinskt utbildad personal.

3URGXNWEHVNULYQLQJSalivette® VD består av ett transparent plaströr med konformad botten, ett insatsrör, en svabb i bomull och ett ljusblått lock.
Sugrullen i bomull är en naturprodukt. Missfärgningar och mörka inneslutningar eller områden är naturliga och oundvikliga.

51.1534.100=

Plaströr+

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+

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+

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1.

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2.

Allmänna försiktighetsåtgärder: Använd handskar och annan personlig skyddsutrustning för skydd mot potentiellt smittförande provmaterial. Klinikens säkerhetsriktlinjer och -förfaranden måste följas.

3.

Den med Salivette® VD insamlade och bearbetade saliven är inte avsedd för återinföring i människokroppen.

4.

Använd inte Salivette® VD efter sista förbrukningsdag. Utgångsdatum för en Salivette® VD är den sista dagen i angiven månad och år.

)ąUYDULQJ
Förvara Salivtte® VD vid rumstemperatur före användning.

Transport
Produkten kan transporteras manuellt internt eller i ett sekundärkärl i enlighet med ADR (förpackningsinstruktion P650). För provtransport av Salivette® VD rekommenderas ett sekundärkärl enligt ADR(förpackningsinstruktion P650) art.-nr. 78.898 med absorberande inlägg plus skruvförslutning art.-nr. 65.679 samt en leveranslåda/-påse.
För patienten:
Följ läkarens anvisningar när du returnerar salivprovet i den väl förslutna Salivette® VD och använd sekundärkärlet och leveranslådan/-påsen som läkaren har tillhandahållit. Om provet inte returneras på en gång, förvaras
Salivette® VD i kylskåp.

Förbehåll
För att undvika att salivprovet förorenas ska salivuppsamlingen ske tidigast 60 minuter efter intag av föda (flytande/fast), tandborstning eller oralt intag av läkemedel.
Lagringstid och temperatur beror på hållbarheten för de parametrar som ska undersökas. Eftersom det sker en tillväxt av bakterier i saliven efter ett par timmar i rumstemperatur rekommenderas att Salivette® VD försluts
väl efter provtagning och antingen centrifugeras och analyseras inom 4 timmar eller omedelbart placeras i kylskåp för förvaring inför vidare bearbetning.

3URYWDJQLQJRFKKDQWHULQJLÄS DETTA DOKUMENT I SIN HELHET INNAN DU PÅBÖRJAR SALIVUPPSAMLINGEN.
För provtagning nödvändigt arbetsmaterial:
1.

Handskar, skyddsrock, ögonskydd eller andra lämpliga skyddskläder för skydd mot med saliv överförda patogener eller potentiellt smittförande material.

2.

Antal Salivette® VD enligt läkarens ordination.

3.

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71

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Provtagning

2 min utan
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Bottensats

För att undvika att salivprovet förorenas ska salivuppsamlingen ske tidigast 60 minuter efter intag av föda (flytande/fast), tandborstning, rökning eller oralt intag av läkemedel.
Tvätta händerna och torka dem precis innan provuppsamlingen.
Ta ut sugrullen ur den öppnade Salivette® VD genom att ta i dess bakre ände med två fingrar
Placera svabben i munnen.
Sugrullen ska ligga kvar i 2 minuter i munnen (t.ex. vid kinden) utan tuggrörelser. Mängden saliv som samlas in ska vara minst 500 μl. Vid en väldigt låg salivproduktion, låt svabben ligga kvar längre i munnen.
Ta ut svabben ur munnen genom att ta i dess bakre ände med två fingrar
Placera omedelbart i Salivette® VD och förslut med det ljusblå locket.
För patienten: Följ läkarens anvisningar när du returnerar salivprovet i den väl förslutna Salivette® VD och använd sekundärkärlet och leveranslådan/-påsen som läkaren har tillhandahållit. Om provet inte returneras
på en gång, förvaras Salivette® VD i kylskåp.
För läkare och laboratorium:På grund av den bakterietillväxt i saliven som kan förekomma efter ett par timmar i rumstemperatur rekommenderas att Salivette® VD försluts väl efter provtagning och antingen centrifugeras i 1 minut vid 500 x g
och analyseras inom 4 timmar eller omedelbart placeras i kylskåp för förvaring inför vidare bearbetning.
Efter centrifugeringen ska insatsröret inklusive locket tas ut ur plaströret med konformad botten.
I plastkärlets konformade botten samlas den rena saliven för vidare analys ovanför bottensatsen som samlas i kärlets reservoar.
Efter avslutad analys ska plaströret med konisk botten samt insatsröret kasseras i en avfallsbehållare.

$YIDOOVKDQWHULQJşJËOOHUIąUOËNDUHRFKODERUDWRULXP
1.

Ta hänsyn till och följ allmänna hygieniska riktlinjer och lagbestämmelser gällande korrekt avfallshantering av smittförande material.

2.

Engångshandskar minskar risken för infektion.

3.

Kontaminerade eller fyllda Salivette® VD måste placeras i lämpliga avfallsbehållare för biologiskt riskavfall, som direkt kan autoklaveras och brännas.

4.

Avfallshanteringen måste ske i för ändamålet lämplig förbränningsanläggning eller genom autoklavering (ångsterilisering).

72

SE
Litteratur
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

Förklaring av symboler och märkning:

Artikelnummer

Satsbeteckning

Användbar till och med

CE-märkning

In-vitro-diagnostik

Följ bruksanvisningen

Vid återanvändning: Risk för kontaminering

Förvaras skyddad mot solljus

Förvaras torrt

Tillverkare

Tillverkningsland

Med reservation för tekniska ändringar.
Alla allvarliga händelser i samband med produkten ska rapporteras till tillverkaren och den behöriga nationella myndigheten.

73คําแนะนําในการใช้งาน – หลอดเก็บน้ําลาย Salivette® VD ของ SARSTEDT

THวัตถุประสงค์ในการใช้งาน
หลอดเก็บน้ําลาย Salivette® VD เป็นหลอดเก็บตัวอย่างน้ําลายและใช้สําหรับการเก็บรวบรวม การขนส่ง การดําเนินการ และการเก็บรักษาตัวอย่างน้ําลายสําหรับการตรวจวิเคราะห์เพื่อคัดกรององค์ประกอบของไวรัสอย่างเช่น กรดนิวคลีอิกของไวรัสโคโรนา SARS-CoV-2 ในหลอดทดลอง ผลิตภัณฑ์มีไว้สําหรับการ
ใช้งานในสถานพยาบาลโดยเฉพาะและต้องใช้งานโดยบุคลากรที่ได้รับการฝึกอบรมทางการแพทย์มาแล้วและบุคลากรในห้องปฏิบัติการเท่านั้น

คําอธิบายผลิตภัณฑ์
หลอดเก็บน้ําลาย Salivette® VD ประกอบด้วยหลอดพลาสติกใสที่มีก้นแหลม หลอดแขวนลอย ม้วนดูดน้ําลายที่ทําจากสําลี และฝาปิดสีฟา้
ม้วนดูดน้ําลายที่ทําจากสําลีเป็นผลิตภัณฑ์จากธรรมชาติ การเปลี่ยนสีและส่วนหรือจุดที่มีสีเข้มกว่าปกติถือว่าเป็นเรื่องปกติตามธรรมชาติที่หลีกเลี่ยงไม่ได้

51.1534.100=

หลอดพลาสติก

+หลอดแขวนลอย

+ม้วนดูดน้ําลาย

+ฝาปิดสีฟา้

ข้อแนะนําด้านความปลอดภัยและคําเตือน
1.

ห้ามใช้ผลิตภัณฑ์นี้กับเด็กอายุต่ํากว่า 3 ปีและผู้ป่วยที่มีความเสี่ยงต่อการสําลัก

2.

ข้อควรระวังทั่วไป: สวมถุงมือและอุปกรณ์ป้องกันส่วนบุคคลทั่วไปอื่นๆ เพื่อป้องกันการสัมผัสกับเชื้อโรคที่แพร่กระจายทางวัสดุตัวอย่างที่อาจติดเชื้อ ต้องปฏิบัติตามระเบียบข้อบังคับและขั้นตอนด้านความปลอดภัยในสถานพยาบาลเสมอ

3.

ห้ามนําน้ําลายที่เก็บและจัดเตรียมด้วยหลอดเก็บน้ําลาย Salivette® VD กลับเข้าไปในร่างกายมนุษย์อีกครั้ง

4.

ห้ามใช้หลอดเก็บน้ําลาย Salivette® VD หลังจากวันหมดอายุ หลอดเก็บน้ําลาย Salivette® VD ใช้งานได้ถึงวันสุดท้ายของเดือนและปีที่ระบุ

การเก็บรักษา
เก็บหลอดเก็บน้ําลาย Salivette® VD ไว้ที่อุณหภูมิห้องก่อนการใช้งาน

การขนส่ง
ผลิตภัณฑ์นี้สามารถขนส่งภายในสถานพยาบาลด้วยมือหรือขนส่งโดยใช้หลอดเก็บตัวอย่างอีกหลอดหนึ่งที่ได้มาตรฐาน ADR (คําแนะนําในการบรรจุภัณฑ์ P650) การขนส่งตัวอย่างในหลอดเก็บน้ําลาย Salivette® VD ต้องเป็นไปตามมาตรฐาน ADR (คําแนะนําในการบรรจุภัณฑ์ P650) ขอแนะนําให้ใช้หลอด
สําหรับขนส่ง รหัสสินค้า 78.898 ร่วมกับแผ่นดูดซับและฝาเกลียว รหัสสินค้า 65.679 และกล่อง/ถุงสําหรับขนส่ง
สําหรับผู้ป่วย:การส่งคืนตัวอย่างน้ําลายในหลอดเก็บน้ําลาย Salivette® VD ที่ปิดฝาแน่นดีแล้ว ให้ปฏิบัติตามคําแนะนําของแพทย์และใช้หลอดเก็บตัวอย่างอีกหลอดหนึ่งและกล่อง/ถุงสําหรับขนส่งที่แพทย์ให้มาด้วย หากไม่สามารถส่งคืนตัวอย่างได้โดยตรงทันที ให้เก็บหลอดเก็บน้ําลาย Salivette® VD ไว้ในตู้เย็น

ข้อจํากัด
ควรเก็บตัวอย่างน้ําลายหลังจากการรับประทานอาหาร (ทั้งที่เป็นของเหลว/ของแข็ง) การแปรงฟัน หรือการทานยาผ่านไปแล้วอย่างน้อย 60 นาที เพื่อหลีกเลี่ยงการปนเปื้อนของสารอื่นๆ ที่รบกวนคุณสมบัติของน้ําลาย
ระยะเวลาและอุณหภูมิในการจัดเก็บขึ้นอยู่กับอายุการใช้งานของตัวแปรที่จะตรวจวิเคราะห์ ด้วยเหตุผลนี้ และเนื่องจากการเจริญเติบโตของแบคทีเรียในน้ําลายจะเริ่มขึ้นหลังจากผ่านไปไม่กี่ชั่วโมงที่อุณหภูมิห้อง ขอแนะนําให้ปิดฝาหลอดเก็บน้ําลาย Salivette® VD ให้แน่นหลังจากการเก็บตัวอย่าง แล้วนําไปหมุน
เหวี่ยงและตรวจวิเคราะห์ภายใน 4 ชั่วโมง หรือนําไปเก็บไว้ในตู้เย็นทันทีจนกว่าจะนํามาตรวจวิเคราะห์ต่อไป

การเก็บตัวอย่างและการจัดการ
กรุณาอ่านและทําความเข้าใจเอกสารนี้อย่างละเอียดก่อนเริ่มทําการเก็บตัวอย่างน้ําลาย
สําหรับการเก็บตัวอย่างต้องมีวัสดุใช้งานที่จําเป็น:1.

สวมใส่ถุงมือ ผ้ากันเปื้อน อุปกรณ์ปกป้องดวงตา หรือชุดป้องกันอื่นๆ ที่เหมาะสมสําหรับการป้องกันเชื้อโรคที่แพร่กระจายทางน้ําลายหรือวัสดุที่อาจมีการติดเชื้อ

2.

หลอดเก็บน้ําลาย Salivette® VD ตามจํานวนที่แพทย์สั่ง

3.

ข้อมูลสําหรับการระบุตัวอย่าง (บนสติกเกอร์)74

THการเก็บตัวอย่าง

2 นาทีโดยไม่ต้องเคี้ยว

≥ 60 นาที

1 นาที
500 x gตัวอย่าง

ตะกอนควรเก็บตัวอย่างน้ําลายหลังจากการรับประทานอาหาร (ทั้งที่เป็นของเหลว/ของแข็ง) การแปรงฟัน การสูบบุหรี่ หรือการทานยาผ่านไปแล้วอย่างน้อย 60 นาที เพื่อหลีกเลี่ยงการปนเปื้อนของสารอื่นๆ ที่รบกวนคุณสมบัติของน้ําลาย
ล้างมือและเช็ดให้แห้ง จากนั้นให้ทําการเก็บตัวอย่างน้ําลายทันที
ใช้นิ้วมือสองนิ้วหยิบปลายด้านหลังของม้วนดูดน้ําลายออกจากหลอดเก็บน้ําลาย Salivette® VD ที่เปิดแล้ว และเอาใส่เข้าไปในปาก
อมม้วนดูดน้ําลายไว้ในปาก (เช่น บริเวณกระพุ้งแก้ม) นาน 2 นาทีโดยไม่ต้องเคี้ยว ปริมาณขั้นต่ําของน้ําลายที่ต้องเก็บควรเป็น 500 ไมโครลิตร หากมีน้ําลายน้อยมาก ให้อมม้วนดูดน้ําลายไว้ในปากนานกว่านั้น
ใช้นิ้วมือสองนิ้วหยิบปลายด้านหลังของม้วนดูดน้ําลายออกจากปาก และเสียบเข้าไปในหลอดเก็บน้ําลาย Salivette® VD ทันทีแล้วปิดด้วยฝาสีฟ้าให้แน่น
สําหรับผู้ป่วย: การส่งคืนตัวอย่างน้ําลายในหลอดเก็บน้ําลาย Salivette® VD ที่ปิดฝาแน่นดีแล้ว ให้ปฏิบัติตามคําแนะนําของแพทย์และใช้หลอดเก็บตัวอย่างอีกหลอดหนึ่งและกล่อง/ถุงสําหรับขนส่งที่แพทย์ให้มาด้วย หากไม่สามารถส่งคืนตัวอย่างได้โดยตรงทันที ให้เก็บหลอดเก็บน้ําลาย Salivette® VD ไว้ในตู้เย็น
สําหรับแพทย์และห้องปฏิบัติการ:เนื่องจากการเจริญเติบโตของแบคทีเรียในน้ําลายจะเริ่มขึ้นหลังจากผ่านไปไม่กี่ชั่วโมงที่อุณหภูมิห้อง ขอแนะนําให้ปิดฝาหลอดเก็บน้ําลาย Salivette® VD ให้แน่นหลังจากการเก็บตัวอย่าง แล้วนําไปหมุนเหวี่ยงด้วยแรง 500 x g นาน 1 นาทีและตรวจวิเคราะห์ภายใน 4 ชั่วโมง หรือนําไปเก็บไว้ในตู้เย็น
ทันทีจนกว่าจะนํามาตรวจวิเคราะห์ต่อไป
หลังจากการหมุนเหวี่ยง ให้นําหลอดแขวนลอยพร้อมทั้งฝาปิดออกจากหลอดพลาสติกที่มีก้นแหลม
น้ําลายบริสุทธิ์สําหรับการตรวจวิเคราะห์ต่อไปจะลอยอยู่เหนือเศษตะกอนที่สะสมอยู่ในก้นแหลมของหลอดพลาสติก
หลังจากการตรวจวิเคราะห์ ให้ทิ้งหลอดพลาสติกที่มีก้นแหลมและหลอดแขวนลอยลงในภาชนะสําหรับทิ้ง

การทิ้ง – ใช้สําหรับแพทย์และห้องปฏิบัติการ
1.

ต้องศึกษาและปฏิบัติตามแนวทางปฏิบัติดา้ นสุขอนามัยทั่วไปและข้อกําหนดของกฎหมายสําหรับการทิ้งวัสดุติดเชื้ออย่างถูกต้อง

2.

การสวมถุงมือแบบใช้ครั้งเดียวจะช่วยป้องกันความเสี่ยงในการติดเชื้อ

3.

ต้องทิ้งหลอดเก็บน้ําลาย Salivette® VD ที่มีการปนเปื้อนหรือใส่น้ําลายแล้วลงในภาชนะสําหรับทิ้งสารชีวภาพอันตรายที่เหมาะสมซึ่งสามารถนําไปอบฆ่าเชื้อและเผาทําลายในภายหลังได้

4.

ต้องทิ้งโดยใช้เตาเผาหรือใช้การอบฆ่าเชื้อ (การนึ่งฆ่าเชื้อ) ที่เหมาะสม

75

THเอกสารอ้างอิง
Hoch และคณะ Diagnostics (การวินิจฉัย) 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years (ความน่าจะเป็นและความแม่นยําในการตรวจคัดกรองไวรัสโคโรนา SARS-CoV-2 จากน้ําลายของเด็กอายุ
ต่ํากว่า 12 ปีในสถานศึกษา), DOI: 10.3390/diagnostics11101797
Wyllie และคณะ NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2 (การตรวจหาไวรัสโคโรนา SARS-CoV-2 จากสารตัวอย่างที่ได้จากน้ําลายหรือสารคัดหลั่งหลังโพรงจมูก), DOI: 10.1056/NEJMc2016359

สัญลักษณ์และรหัสระบุ:รหัสสินค้า

หมายเลขรุ่นที่ผลิต

ใช้ได้จนถึง

สัญลักษณ์ CEการตรวจวินิจฉัยในหลอดทดลอง

กรุณาดูคําแนะนําในการใช้งาน

ในกรณีการนํากลับมาใช้ซ้ํา: อันตรายจากการปนเปื้อน

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ผู้ผลิต

ประเทศที่ผลิต

สงวนสิทธิ์ในการดัดแปลงทางเทคนิค
หากพบอุบัติการณ์ร้ายแรงใดๆ ที่เกี่ยวข้องกับผลิตภัณฑ์ จะต้องแจ้งให้ผู้ผลิตและผู้มีหน้าที่กํากับดูแลผลิตภัณฑ์ในประเทศของท่านทราบ

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Depolama
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Hasta için:
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Doktor ve Laboratuvar için:
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Literatür
Hoch et al Diagnostics 11(10):1707 2021, Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years, DOI: 10.3390/diagnostics11101797
Wyllie et al NEJM 383:13 2020, Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2, DOI: 10.1056/NEJMc2016359

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