natgillin/translations-raw huggingface dataset:
In terms of type of technology, two categories of commercial CE-marked tests can be distinguished: tests automated for use on analyser machines, and rapid tests, defined as qualitative or semi-quantitative devices, used singly or in a small series, which involve non-automated procedures and have been designed to give a fast result (6) .
Kar zadeva vrsto tehnologije, je mogoče razlikovati med dvema kategorijama komercialnih testov z oznako CE: testi, ki so avtomatizirani za uporabo na analizatorjih, in hitri testi, ki so opredeljeni kot kvalitativni ali semikvantitativni medicinski pripomočki, ki se uporabljajo posamično ali v majhnih serijah, uporabljajo neavtomatizirane postopke in so načrtovani tako, da dajejo hitre rezultate (6) .
The ECDC (4) and the WHO (17) are already in process of organising an external quality assessment scheme for RT-PCR tests.
ECDC (4) in SZO (17) že organizirata zunanji sistem ocenjevanja kakovosti za teste RT-PCR.
Nevertheless, antibody tests could prove essential for performing large-scale sero-epidemiological population surveys for assessing e.g. the immune status of workers and as one of the elements for guiding de-escalation strategies when the pandemic is under control.
Kljub temu bi se lahko izkazalo, da so testi na protitelesa bistvenega pomena za izvedbo obsežnih seroepidemioloških raziskav med prebivalstvom za oceno na primer imunskega statusa delavcev in, kot eden od elementov, za usmerjanje strategij za postopno opuščanje ukrepov, ko je pandemija pod nadzorom.
National strategies should take account of the intended purpose of each type of test and the importance of the use of the device in a specific context, in particular the specific population groups and the phase of the disease in which the test is supposed to be used.
nacionalne strategije bi morale upoštevati predvideni namen vsake vrste testa in pomen uporabe pripomočka v določenih okoliščinah, zlasti specifično skupino prebivalstva in fazo bolezni, v kateri naj bi se test uporabljal.
External quality assessment schemes could be one way to generate such data.
Eden od načinov pridobivanja takšnih podatkov bi lahko bili zunanji sistemi ocenjevanja kakovosti.
As another example a low limit of detection may result in a lower reproducibility of the test result.
Kot dodaten primer lahko nizka meja zaznavnosti privede do težje obnovljivih testnih rezultatov.
Tests detecting exposure are typically those that detect antibodies in the blood which are produced by the patient's body in response to the infection with the virus.
Testi za ugotavljanje izpostavljenosti so običajno testi, s katerimi se v krvi zaznajo protitelesa, ki jih je proizvedlo bolnikovo telo v odziv na okužbo z virusom.
The technical documentation of the device must contain adequate performance evaluation data showing the performances claimed by the manufacturer and supported by a reference measurement system (when available), with information on the reference methods, the reference materials, the known reference values, the accuracy and measurement units used.
Tehnična dokumentacija pripomočka mora vsebovati ustrezne podatke o oceni učinkovitosti, ki dokazujejo učinkovitost, ki jo zagotavlja proizvajalec, podpira pa jo referenčni merilni sistem (kadar je na voljo), z informacijami o referenčnih metodah, referenčnih materialih, znanih referenčnih vrednostih, točnosti in uporabljenih merskih enotah.
The effectiveness of antibody tests in early COVID-19 diagnosis is very limited because antibodies become detectable in the patient's blood only several days after infection.
Učinkovitost testov na protitelesa pri zgodnjem diagnosticiranju COVID-19 je zelo omejena, saj se protitelesa v bolnikovi krvi zaznajo šele nekaj dni po okužbi.
The national processes for adopting these derogations vary across Member States.
Države članice imajo različne nacionalne postopke za sprejemanje teh odstopanj.
To note, automated tests can also be fast and designed in portable equipment form, but they do not fall under the above definition of rapid tests.
Opozoriti je treba, da so avtomatizirani testi lahko tudi hitri in načrtovani kot prenosna oprema, vendar ne spadajo v zgornjo opredelitev hitrih testov.
Production of a working document containing a literature review on device performance and initial guidance on performance criteria for COVID-19 devices, including RT-PCR tests, antigen and antibody tests, in the context of a project group including the Commission, the ECDC and representatives of experts from in vitro diagnostics competent authorities and health technology assessment bodies.
priprava delovnega dokumenta s pregledom literature o učinkovitosti pripomočkov in priprava prvotnih smernic glede meril za učinkovitost pripomočkov pri COVID-19, vključno s testi RT-PCR, antigenskimi testi in testi na protitelesa, v okviru projektne skupine, ki vključuje Komisijo, ECDC ter predstavnike strokovnjakov iz organov, pristojnih za in vitro diagnostiko, in organov za vrednotenje zdravstvenih tehnologij;
The Commission will discuss with industry and competent authorities what further guidance on conformity assessment is needed.
Z industrijo in pristojnimi organi bo razpravljala o nadaljnjih smernicah glede ugotavljanja skladnosti, ki bi jih bilo treba pripraviti.
Correct understanding of the interplay of the related definitions is essential for appropriate use of the devices.
Za ustrezno uporabo pripomočkov je bistvenega pomena pravilno razumevanje interakcije med povezanimi opredelitvami.
The manufacturer must confirm that the device has been manufactured taking into account the "state of the art" in terms of the performance parameters listed in the first paragraph of this section.
Proizvajalec mora potrditi, da je bil pripomoček proizveden ob upoštevanju najsodobnejših parametrov učinkovitosti iz prvega odstavka tega oddelka.
The EU regulatory context of COVID-19 test devices
Regulativni okvir EU za pripomočke za testiranje COVID-19
Therefore, it is highly recommended to carry out additional validation of the clinical performance of tests for COVID-19 by comparison with a reference method in a sufficiently large number of target population subjects before introducing the devices into the clinical routine.
Zato je zelo priporočljivo izvesti dodatno validacijo klinične učinkovitosti testov na COVID-19 s primerjavo z referenčno metodo pri dovolj visokem številu oseb iz ciljne populacije, preden se pripomočki uvedejo v klinično prakso.
Further work will be carried out to collect and analyse evidence on the context(s) in which these tests are used to provide valuable information to inform Member States' decisions on testing strategy.
Nadaljevalo se bo delo za zbiranje in analizo dokazov o okoliščinah, v katerih se ti testi uporabljajo, da bi se zagotovile dragocene informacije, na podlagi katerih bodo države članice odločale o strategiji testiranja;
They must achieve the relevant performance, in particular in terms of analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including control of known relevant interference, and limits of detection, stated by the manufacturer (9) .
Dosegati morajo ustrezno učinkovitost, zlasti glede analitične občutljivosti, diagnostične občutljivosti, analitične specifičnosti, diagnostične specifičnosti, točnosti, ponovljivosti, obnovljivosti, vključno z nadzorom znanih pomembnih motenj, in mej zaznavnosti, ki jih je navedel proizvajalec (9) .
A reason for this is the possible difficulty for the untrained lay user to make the correct interpretation of the result and its implications (e.g. that the result could be a false positive or false negative which a health professional could identify by taking into account the clinical context of the patient).
Razlog za to so možne težave, ki bi jih lahko neusposobljeni nestrokovni uporabniki imeli pri pravilni razlagi rezultata in njegovih posledicah (npr. da bi rezultat lahko bil lažno pozitiven ali lažno negativen, kar bi zdravstveni delavec lahko opredelil ob upoštevanju kliničnega ozadja pacienta).
It should be noted that making devices destined for professional use available to lay users, e.g. via pharmacies or on the web, is not legally permitted.
Opozoriti je treba, da pripomočkov, namenjenih za poklicno uporabo, zakonsko ni dovoljeno dati na voljo nestrokovnim uporabnikom, npr. v lekarnah ali na spletu.
For example, for RT-PCR tests, this could be the identification of stable target sequences (i.e. genetic fragments characteristic of SARS-CoV-2 virus to be detected).
Pri testih RT-PCR gre lahko na primer za opredelitev stabilnih ciljnih zaporedij (tj. genskih fragmentov, značilnih za virus SARS-CoV-2, ki jih je treba zaznati).
It should be noted that, to inform national strategies, it is especially important to contextualise each type of test for its intended purpose, for example diagnosis or screening.
Opozoriti je treba, da je za obveščanje o nacionalnih strategijah še posebej pomembno, da se vsaka vrsta testa umesti v kontekst glede na predvideni namen, na primer diagnosticiranje ali presejalni test.
The Commission, Member States and stakeholders should consider what are the critical aspects of device performance specific to COVID-19 on which a common approach should be taken.
Komisija, države članice in zainteresirane strani bi morale upoštevati ključne vidike učinkovitosti pripomočka, ki so značilne za COVID-19 in o katerih bi bilo treba sprejeti skupni pristop.
Various choices of parameter combinations can be justified, subject to the purpose of the device: fast-track screening, diagnosis, confirmation etc. For example, when a person is examined for the first time, this should be done with a test that is very precise and that has a low level of false positives, and certainly a very low level of false negatives.
Različne možnosti kombinacij parametrov so lahko utemeljene, odvisno od namena pripomočka: hitri presejalni testi, diagnosticiranje, potrditev itd. Na primer, pri prvem pregledu je treba uporabiti test, ki je zelo natančen in z nizko stopnjo lažno pozitivnih rezultatov, zlasti pa z zelo nizko stopnjo lažno negativnih rezultatov.
This includes considering the specific target population (e.g. health professionals, general public), the phase of the disease they are meant to be used for (e.g. asymptomatic/healthy subjects, confirmed cases, discharge after hospital admissions etc.) and the clinical decision taken based on the test's results.
To vključuje upoštevanje specifične ciljne populacije (npr. zdravstveni delavci, širša javnost), faze bolezni, za katero naj bi se uporabljale (npr. osebe brez simptomov/zdrave osebe, potrjeni primeri, odpust po hospitalizaciji itd.) in kliničnih odločitev na podlagi rezultatov testa.
Antibody tests exist both as automated and as rapid tests.
Testi na protitelesa so lahko avtomatizirani ali hitri testi.
Both the WHO and FIND are currently working on validation studies of different devices.
SZO in FIND trenutno pripravljata študije za validacijo različnih pripomočkov.
Scientific peer-reviewed results for the clinical validation of commercial COVID-19 tests are highly recommended before they can be safely and reliably used for medical or public health decision making.
Zelo priporočljivo je pridobiti strokovno pregledane znanstvene rezultate za klinično validacijo komercialnih testov na COVID-19, preden jih je mogoče varno in zanesljivo uporabiti za sprejemanje zdravstvenih odločitev ali odločitev v zvezi z javnim zdravjem.
This includes regulatory exchanges on device conformity, availability and reliability, maintaining an inventory of devices and sharing information on national actions, covering also national derogations issued by Member States and justifications for them.
To vključuje izmenjavo informacij regulativnih organov o skladnosti, razpoložljivosti in zanesljivosti pripomočkov, vzdrževanje seznama pripomočkov in izmenjavo informacij o nacionalnih ukrepih, vključno z nacionalnimi odstopanji, ki jih izdajo države članice, in utemeljitvami zanje;
Publication of guidance on medical device conformity assessment (19) and an overview of international recognition of standards (20) , which also include standards relevant to in vitro diagnostic devices.
objava smernic za ugotavljanje skladnosti medicinskih pripomočkov (19) in pregled mednarodno priznanih standardov (20) , ki vključujejo tudi standarde, relevantne za in vitro medicinske pripomočke;
There can be trade-offs between parameters, for example between the sensitivity of the test (detecting the maximum number of positive individuals) and its specificity (ability to distinguish between true and false positives).
Mogoči so kompromisi med parametri, na primer med občutljivostjo testa (ugotavljanje največjega števila pozitivnih oseb) in njegovo specifičnostjo (zmožnost razlikovanja med pozitivnimi in lažno pozitivnimi rezultati).
In order to make sure that tests are used appropriately, that device performance is of highest reasonably possible level, and that approaches to evaluation and validation of device performance are further aligned across the Union, the following actions should be taken:
Za zagotovitev ustrezne uporabe testov, največje učinkovitosti pripomočkov, ki se lahko razumno pričakuje, ter nadaljnjega usklajevanja pristopov k oceni in validaciji učinkovitosti pripomočkov po vsej Uniji je treba sprejeti naslednje ukrepe:
The Commission will assist Member States in their market surveillance activities by putting in place arrangements to share and access information efficiently.
Državam članicam bo pomagala pri njihovih dejavnostih nadzora trga, tako da bo vzpostavila mehanizme za učinkovito izmenjavo informacij in dostop do njih;
In terms of the scientific rationale, the COVID-19 tests available today fall broadly into two categories: those detecting the SARS-CoV-2 virus and those detecting past exposure to the virus (more specifically the immune response of the human body to the infection).
Kar zadeva znanstveno utemeljitev, so danes razpoložljivi testi na COVID-19 v splošnem razvrščeni v dve kategoriji: testi za zaznavanje virusa SARS-CoV-2 in testi za ugotavljanje pretekle izpostavljenosti virusu (konkretneje, imunskega odziva človeškega telesa na okužbo).
The term near-patient test is not used for devices intended for lay users, which must be classified as self-tests.
Izraz „test ob pacientu" se ne uporablja za pripomočke, namenjene nestrokovnim uporabnikom; ti pripomočki morajo biti razvrščeni v kategorijo samotestov.
In contrast, in the de-escalation stage, sensitivity (detecting all remaining infected individuals) could be more important than specificity to make sure the disease is indeed contained.
Nasprotno bi lahko bila občutljivost (odkrivanje vseh preostalih okuženih oseb) v fazi postopnega opuščanja ukrepov pomembnejša od specifičnosti, da se zagotovi, da je bolezen dejansko zajezena.
The Commission, Member States, and stakeholders, with consultation of the ECDC, will discuss best practices for performance evaluation of different types of COVID-19 test in the context of conformity assessment in the coming month and review this topic on a regular basis.
Komisija, države članice in zainteresirane strani bodo v posvetovanju z ECDC v okviru ugotavljanja skladnosti v prihodnjem mesecu razpravljale o najboljših praksah za oceno učinkovitosti različnih vrst testov na COVID-19 ter to temo redno pregledovale.
Manufacturers are obliged to explain their choices of performance levels in the instructions for use and to determine the specific purpose in accordance with the choices made.
Proizvajalci morajo v navodilih za uporabo pojasniti svoje odločitve glede ravni učinkovitosti in v skladu z odločitvami določiti posebni namen.
Finally, in terms of location of testing, devices can be either laboratory-based or near-patient, also termed point-of-care, i.e. performed near a patient and outside of laboratory testing facilities (8) .
Kar pa zadeva lokacijo testiranja, so pripomočki namenjeni uporabi bodisi v laboratoriju bodisi ob pacientu (na mestu oskrbe), kar pomeni, da se testi izvajajo ob pacientu in zunaj laboratorijev (8) .
Taking stock of the state of the art on a regular basis will support Member States' informed decisions on national testing strategies, as well as support the continuous development of devices by manufacturers.
Redni pregled najsodobnejšega tehničnega razvoja bo v podporo državam članicam pri sprejemanju informiranih odločitev o nacionalni strategiji testiranja, proizvajalcem pa pri stalnem razvoju pripomočkov.
If the person tests positive and is examined a few days later, the test may have some tolerance for false positives (since the individual is most likely still positive), but not for false negatives (as this would lead to wrong conclusions).
Če je oseba s pozitivnim testom pregledana nekaj dni pozneje, lahko test nekoliko odstopa glede lažno pozitivnih rezultatov (saj je oseba verjetno še vedno pozitivna), ne pa glede lažno negativnih rezultatov (saj bi to vodilo v napačne ugotovitve).
Validation of test performance
Validacija učinkovitosti testov
For effective management of the different stages of the pandemic it is vital to understand first what information different tests can deliver, i.e. what is the intended purpose of a given test, and second the level of a test's performance, i.e. how well it is able to achieve that purpose.
Za učinkovito obvladovanje različnih faz pandemije je ključnega pomena zavedanje o tem, katere informacije lahko z različnimi testi pridobimo, tj. kakšen je predvideni namen določenega testa, in kakšna je njihova učinkovitost, tj. v kolikšni meri je dosežen navedeni namen testa.
As explained above, the manufacturer evaluates the performance of the device in accordance with the intended purpose before placing the device on the market.
Kot je pojasnjeno zgoraj, proizvajalec pred dajanjem pripomočka na trg oceni njegovo učinkovitost v skladu z njegovim predvidenim namenom.
It outlines the regulatory context of COVID-19-related in vitro diagnostic testing devices in the EU and gives an overview of different types of tests and their purposes.
V njem je opisan regulativni okvir za in vitro diagnostične medicinske pripomočke za testiranje COVID-19 v EU ter so pregledane različne vrste testov in njihov namen.
They do not give a definite answer on the presence or absence of the SARS-CoV-2 virus and thus they are not suitable to assess if the tested individual may be contagious for others.
S testi na protitelesa ni mogoče zagotovo potrditi prisotnosti ali odsotnosti virusa SARS-CoV-2, zato niso primerni za oceno, ali je testirana oseba kužna.
For the first category, there are two subtypes: on the one hand those detecting the virus genetic material (by reverse transcription polymerase chain reaction, or RT-PCR), and on the other hand those detecting components of the virus such as proteins on its surface (antigen tests).
V prvi kategoriji sta dve podvrsti testov: testi za zaznavanje virusnega genskega materiala (s polimerazno verižno reakcijo z reverzno transkriptazo ali RT-PCR) in testi za zaznavanje virusnih komponent, kot so beljakovine na površini virusa (antigenski testi).
Guidelines on COVID-19 in vitro diagnostic tests and their performance
Smernice glede in vitro diagnostičnih testov na COVID-19 in njihove učinkovitosti
These tests are typically performed on nasal or throat secretions (i.e. swabs or washes).
Pri teh testih se običajno testirajo izločki nosu ali žrela (tj. brisi ali izpirki).
Regarding performance of tests in the context of population testing, there are drawbacks both from insufficient diagnostic sensitivity (e.g. leading to missing infected individuals) and insufficient diagnostic specificity (e.g. imposing confinement measures on individuals who are not true positives).
Kar zadeva učinkovitost testov pri testiranju prebivalstva, obstajajo pomanjkljivosti zaradi nezadostne diagnostične občutljivosti (kar povzroči neodkritje okuženih oseb) in nezadostne diagnostične specifičnosti (kar na primer povzroči uvedbo ukrepov za omejevanje izhoda osebam, ki dejansko niso pozitivne).
A test that is very sensitive at detecting the target of interest is more likely to also detect related but distinct targets that are not of interest, i.e. it may be less specific.
Pri testu, ki je zelo občutljiv na zaznavanje ciljnega parametra, je bolj verjetno, da bodo zaznani tudi povezani parametri, ki pa niso ciljni, kar pomeni, da je test morda manj specifičen.
As explained in point 3 of these guidelines, tests can be intended by the manufacturer for use by health professionals or by lay users (self-tests).
Kot je pojasnjeno v točki 3 teh smernic, proizvajalec teste lahko predvidi za uporabo s strani zdravstvenih delavcev ali nestrokovnih uporabnikov (samoteste).
Critical performance parameters such as the diagnostic sensitivity, diagnostic specificity and the limit of detection of the device for the given context and purpose should be considered.
Upoštevati bi bilo treba ključne parametre učinkovitosti, kot so diagnostična občutljivost, diagnostična specifičnost in meja zaznavnosti pripomočka glede na dane okoliščine in namen;
This needs to be taken into account along with the stage of the pandemic in a particular population.
Poleg stopnje pandemije v določeni populaciji je treba tako upoštevati tudi te ugotovitve.
The Commission, together with Member States, will put efforts into the development of tools to enable evaluation of device performance and align approaches across the Union, such as reference materials and methods for standardised comparison.
Komisija si bo skupaj z državami članicami prizadevala za pripravo orodij, kot so referenčni materiali in metode za standardizirano primerjavo, s katerimi bo mogoče oceniti učinkovitost pripomočkov in uskladiti pristope po vsej Uniji.
Commercial RT-PCR tests are generally non-rapid automated tests, with some portable devices becoming available.
Komercialni testi RT-PCR so načeloma avtomatizirani testi, ki ne spadajo v kategorijo hitrih testov, na trgu pa se pojavljajo nekateri prenosni pripomočki.
Fast-track clinical validation studies of rapid diagnostic tests for COVID-19 by hospital laboratories are ongoing in several EU Member States.
V več državah članicah EU se v bolnišničnih laboratorijih izvajajo pospešene klinične študije za validacijo hitrih diagnostičnih testov na COVID-19.
Directive 98/79/EC on in vitro diagnostic medical devices (IVD) (1) currently applies to COVID-19 tests.
Za teste na COVID-19 se trenutno uporablja Direktiva 98/79/ES o in vitro diagnostičnih medicinskih pripomočkih (IVD) (1) .
In terms of the intended user, tests can be designed by the manufacturer to be used by health professionals or by lay users (self-tests).
Kar zadeva predvidenega uporabnika, proizvajalec teste lahko načrtuje za uporabo s strani zdravstvenih delavcev ali nestrokovnih uporabnikov (samoteste).
Considerations on test performance
Učinkovitost testov
RT-PCR tests are those currently recommended by the World Health Organisation (WHO) (3) and the European Centre for Disease Prevention and Control (ECDC) (4) for diagnosis of COVID-19.
Svetovna zdravstvena organizacija (v nadaljnjem besedilu: SZO) (3) ter Evropski center za preprečevanje in obvladovanje bolezni (v nadaljnjem besedilu: ECDC) (4) trenutno za diagnosticiranje COVID-19 priporočata teste RT-PCR.
It includes considerations on device performance and validating that performance.
Vključuje učinkovitost pripomočkov in validacijo navedene učinkovitosti.
Anti-SARS-CoV-2 virus antibody tests are abundant on the market.
Na trgu so na voljo številni testi na protitelesa proti virusu SARS-CoV-2.
This can take several months.
To lahko traja več mesecev.
Accompanying measures
Spremljevalni ukrepi
Source: Commission services.
Vir: službe Komisije.
More than half of the EU's Member States have proclaimed a state of emergency.
Več kot polovica držav članic EU je razglasila izredne razmere.
Yet, this demand is not always matched with sufficient supply.
Vendar se to povpraševanje ne ujema vedno z zadostno ponudbo.
Constant dialogue with social partners will also be key.
Ključnega pomena bo tudi stalen dialog s socialnimi partnerji.
All Member States are affected, albeit to different degrees.
Prizadete so vse države članice, čeprav v različnem obsegu.