natgillin/translations-raw huggingface dataset:
Forekomst af WSD anses for bekræftet, hvis totrins-PCR efterfulgt af sekventering i overensstemmelse med de detaljerede metoder og procedurer i bilag II, del 6, er positiv for WSSV, og hvis der forekommer patognomoniske tegn på WSD i de udvalgte værter.
When targeted surveillance is required to maintain category I health status, as laid down in Article 52 of Directive 2006/88/EC, all farms keeping susceptible species listed in Part II of Annex IV to that Directive within the Member State, zone or compartment concerned shall undergo a health inspection and sampling in accordance with Table 6 B set out in Section II, taking into account the risk level of the farm for the contraction of WSD.
Mistanke om forekomst af WSD kan udelukkes, hvis disse undersøgelser ikke afslører yderligere tegn på forekomst af WSD.
In Member States, zones or compartments where the number of farms is limited and targeted surveillance on those farms does not provide sufficient epidemiological data, the surveillance programmes to maintain disease-free status shall include sampling points selected in accordance with the requirements laid down in point I.1.
Tabel 6.A
The sampling shall be carried out in accordance with Table 6 B set out in Section II.
Overvågningsordning for medlemsstater, zoner og segmenter i den toårige kontrolperiode forud for opnåelse af status som sygdomsfri for så vidt angår WSD, jf. punkt I.2.1
The samples shall be selected, prepared and examined in accordance with the diagnostic and sampling methods set out in Section II and the laboratory examinations must have produced negative results as regards to the agent of WSD.
Antal krebsdyr i prøven
Disease-free status shall only be maintained as long as all samples tested using the diagnostic and sampling methods set out in point II.2 produce negative results for WSD and any suspicion of WSD has been ruled out in accordance with the official investigation and diagnostic methods set out in point II.3.
Tabel 6.B
Requirements for the lifting of the containment measures provided for in Article 39 of Directive 2006/88/EC (the change from Category V to Category III health status) with regard to WSD
Overvågningsordning for medlemsstater, zoner eller segmenter med henblik på at opretholde status som sygdomsfri for så vidt angår WSD, jf. punkt I.3
A Member State, zone or a compartment which has Category V health status with regard to WSD may achieve Category III health status with regard to that listed disease provided that:
Prøverne skal udtages tidligst tre uger efter overførsel af fisk fra ferskvand til saltvand.
In case fallowing is not technically possible, the farms shall be subject to an alternative measure which provides almost similar guarantee for extermination of WSSV from the environment of the farm;
Ovarie- eller sædvæske fra gydebestande indsamles på modningstidspunktet i forbindelse med strygning.
all farms officially declared infected with WSD and all other farms fallowed/been subject to alternative measures in accordance with (a) within the established protection and surveillance zones have been restocked with crustacean sourced from Member States, zones or compartments with a Category I, II or III health status with regard to WSD.
Der skal udtages prøver fra det antal fisk, der sikrer påvisning af VHSV eller IHNV med en konfidens på 95 % ved en udgangsprævalens på 5 %.
the restocking has only taken place when all farms officially declared infected with WSD have been emptied, cleansed, disinfected and fallowed/been subject to alternative measures in accordance with (a);
Der skal udtages prøver fra det antal fisk, der sikrer påvisning af VHSV eller IHNV med en konfidens på 95 % ved en udgangsprævalens på 10 %.
no detection of WSD has occurred during the period of 2 years that follows the completion of the measures set out in paragraphs (a) and (b) and suspicions during this period have been ruled out according to the procedures established in point II.3.
Der skal udtages prøver fra det antal fisk, der sikrer påvisning af VHSV eller IHNV med en konfidens på 95 % ved en udgangsprævalens på 10 %.
Samples of integumental epidermis, either dissected or contained within walking legs, pleopods, mouthparts or gills of the test animal shall be fixed in 95 % ethanol prior to the preparation of samples for two-step PCR.
Hver sundhedsinspektion skal som minimum omfatte én prøve.
Other samples, fixed for histology and transmission electron microscopy may be collected to support diagnostic data arising from PCR.
Der skal udtages prøver fra det antal fisk, der sikrer påvisning af KHV med en konfidens på 95 % ved en udgangsprævalens på 5 %.
Diagnostic methods to obtain or maintain disease-free status with regard to WSD
Gælder ikke for akvakulturbrug, der kun opdrætter regnbueørred (Onchorhynchus mykiss) eller havørred (Salmo trutta) eller begge, og hvor vandforsyningen udelukkende er baseret på ferskvandskilder, der ikke huser atlantisk laks (Salmo salar).
The diagnostic method to be used to obtain or to maintain disease-free status with regard to WSD following the detailed methods and procedures set out in Part 6 of Annex II, shall be two-step PCR.
Prøver skal indsamles og opbevares samt undersøges i løbet af to årlige undersøgelsesperioder af en måneds varighed hver (dvs. forår og efterår), eller når det er hensigtsmæssigt ud fra praktiske overvejelser.
In the case of a positive result of the two-step PCR, the result shall be corroborated by the sequencing of the amplicon before the initial control measures provided for in Article 28 of Directive 2006/88/EC are implemented, if possible under practical conditions by the demonstration of pathognomonic signs of WSD in those susceptible hosts selected, via histology and transmission electron microscopy.
Maksimalt antal fisk pr. samleprøve: 5.
Official investigation and diagnostic methods to rule out the suspicion of or to confirm the presence of infection with WSD
Prøver skal indsamles og undersøges i løbet af to årlige undersøgelsesperioder af en måneds varighed hver (dvs. forår og efterår), eller når det er hensigtsmæssigt ud fra praktiske overvejelser.
When the presence of infection with WSD is required to be confirmed or the suspicion of such infection is required be ruled out in accordance with Article 28 of Directive 2006/88/EC, the following inspection, sampling and testing procedure shall be complied with:
BILAG II
the official investigation shall include at least one health inspection and one sampling of 10 crustaceans when clinical or post-mortem signs consistent with infection with WSD are observed or 150 crustaceans when clinical or post-mortem signs are not observed.
DETALJEREDE DIAGNOSEMETODER OG -PROCEDURER
The samples shall be tested using the diagnostic method set out in point II.2 (two-step PCR);
I dette bilag fastsættes der detaljerede procedurer for de diagnosemetoder, der skal anvendes i forbindelse med laboratorieundersøgelserne i de udryddelses- og overvågningsprogrammer, der er fastsat i bilag I til denne afgørelse, for at bekræfte eller udelukke mistanke om forekomst af følgende ikke-eksotiske sygdomme, der er opført i del II i bilag IV til direktiv 2006/88/EF (»listeopførte sygdomme«), i overensstemmelse med artikel 57, litra b), i samme direktiv:
the presence of WSD shall be considered as confirmed when two-step PCR followed by sequencing, following the detailed methods and procedures set out in this Part 6 of Annex II, is positive for WSSV and, when pathognomonic signs of WSD are present in the selected hosts.
Infektiøs hæmatopoietisk nekrose (IHN)
The suspicion of WSD may be ruled out, if those tests reveal no further evidence of the presence of WSD.
I dette bilag forstås ved »transportmedium«: et cellekulturmedium med 10 % kalveserum og med 200 iu penicillin, 200 μg streptomycin og 200 μg kanamycin pr. ml eller med andre dokumenteret effektive antibiotika.
Table 6 A
DEL 1
Surveillance scheme for Member States, zones and compartments for the 2-year control period which precedes the achievement of WSD disease-free status as referred to in point I.2.1
DETALJEREDE DIAGNOSEMETODER OG -PROCEDURER FOR OVERVÅGNING OG BEKRÆFTELSE AF IHN OG VHS
Number of crustaceans in the sample
I. Diagnosemetoder og -procedurer for overvågning af VHS og IHN
Table 6 B
Hvis der foretages prøveudtagning og laboratorieundersøgelse med henblik på at opnå eller opretholde status som sygdomsfri for så vidt angår IHN eller VHS som fastsat i bilag I, del 1, afsnit I, ved hjælp af diagnosemetoderne i del 1, punkt II.1 og II.2, i samme bilag, anvendes de detaljerede diagnosemetoder og -procedurer i punkt I.1-l I.6 nedenfor.
Surveillance schemes for Member States, zones or compartments to maintain WSD disease-free status as referred to in point I.3
Præparation og forsendelse af fiskeprøver
The samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.
Væv til virologisk undersøgelse i cellekultur
Ovarian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping.
Inden prøverne sendes eller overføres til laboratoriet, fjernes stykker af de organer, som skal undersøges, fra fisken med sterile dissektionsredskaber og overføres til sterile plastrør indeholdende transportmedium.
Samples must be taken from the number of fish that will ensure the detection of VHSV or IHNV with a 95 % confidence if the design prevalence is 5 %.
Den mængde fiskemateriale, der er egnet til virologisk undersøgelse i cellekultur og ved hjælp af RT-qPCR, afhænger af fiskestørrelsen.
Samples must be taken from the number of fish that will ensure detection of VHSV or IHNV with a 95 % confidence if the design prevalence is 10 %.
Det væv, der skal udtages prøver af, er hel fiskeyngel (længde < 4 cm), indvolde inklusive nyre (4 cm < længde < 6 cm) eller, for større fisk, nyre, milt, hjerte og/eller hjerne samt ovarievæske fra gydefisk på gydetidspunktet.
Samples must be taken from the number of fish that will ensure the detection of VHSV or IHNV with a 95 % confidence if the design prevalence is 10 %.
Ovarie- eller sædvæske eller organstykker fra højst 10 fisk kan indsamles i et sterilt rør indeholdende mindst 4 ml transportmedium og udgøre en samleprøve.
There shall be minimum one sample for every health inspection.
Vævet i hver prøve skal veje mindst 0,5 g.
Samples must be taken from the number of fish that will ensure the detection of KHV with a 95 % confidence if the design prevalence is 5 %.
Den virologiske undersøgelse i cellekultur skal påbegyndes hurtigst muligt og senest 48 timer efter prøveudtagningen.
Shall not apply to farms only rearing rainbow trout (Oncorhynchus mykiss) or brown trout (Salmo trutta) or both and where the water supply is exclusively based on fresh water sources not housing Atlantic salmon (Salmo salar).
I undtagelsestilfælde kan den virologiske undersøgelse påbegyndes senest 72 timer efter indsamlingen af materialet, hvis materialet er beskyttet af transportmedium, og kravene til transporttemperaturen kan overholdes.
Samples must be collected and stored and examined during two 1 month test periods per year (namely spring and autumn) or when appropriate in accordance with practical considerations.
Prøver til analyse ved revers transkriptase-polymerasekædereaktion (RT-PCR eller RT-qPCR)
Maximum number of fish per pool: 5.
Prøver udtages fra fisken i overensstemmelse med den procedure, der er beskrevet i punkt I.1.1, med et sterilt instrument og overføres til et sterilt plastrør indeholdende transportmedium.
Samples must be collected and examined during two 1 month test periods per year (namely spring and autumn) or when appropriate in accordance with practical considerations.
Væv fra 10 fisk kan samles i ét rør og udgøre en samleprøve.
ANNEX II
Hvis mængden af inokulum er lille, kan væv fra op til fem fisk dog anvendes.
DETAILED DIAGNOSTIC METHODS AND PROCEDURES
Alternativt kan prøver samles i RNA-stabiliseringsreagens, f.eks. 0,2 g væv/ml reagens i henhold til fabrikanternes anbefaling, idet hver fisk dog skal behandles særskilt og ikke må samles med andre fisk i prøverne på grund af den lille mængde materiale, der skal anvendes til ekstraktion.
This Annex sets out the detailed procedures for the diagnostic methods to be used for the laboratory examination in the eradication and surveillance programmes set out in Annex I to this Decision, and in order to confirm or rule out the suspected presence of the following non-exotic diseases listed in Part II to Annex IV to Directive 2006/88/EC (‘the listed diseases’) in accordance with Article 57 (b) to that Directive:
Der kan også sendes hele fisk til laboratoriet.
Infectious hematopoietic necrosis (IHN)
Forsendelse af fiskeprøver
For the purpose of this Annex, ‘transport medium’ means a cell culture medium with 10 % calf serum and with 200 iu penicillin, 200 μg streptomycin, and 200 μg kanamycin per millilitre or with other antibiotics of proven efficacy.
Rør med fiskevæv i transportmedium til celledyrkning eller RT-PCR/RT-qPCR-analyse skal placeres i isolerede beholdere, f.eks. tykvæggede polystyren-kasser, sammen med tilstrækkeligt med is eller et alternativt kølemiddel med tilsvarende køleeffekt, så det sikres, at prøverne opbevares køligt under transporten til laboratoriet.
PART 1
Dog bør nedfrysning af prøverne undgås.
DETAILED DIAGNOSTIC METHODS AND PROCEDURES FOR THE SURVEILLANCE AND CONFIRMATION OF IHN AND VHS
En prøves temperatur under forsendelsen bør aldrig overstige 10 °C, og der skal stadig være is tilbage i transportkassen, eller en eller flere af fryseblokkene skal fortsat være delvis eller helt frosset, ved kassens ankomst.
I. Diagnostic methods and procedures for the surveillance of VHS and IHN
Der kan sendes hele fisk til laboratoriet, hvis kravene til transporttemperaturen, jf. første afsnit, kan overholdes.
When sampling and laboratory examination for the purpose of obtaining or maintaining disease-free health status with regard to IHN or VHS as set out in Section I of Part 1 of Annex I are carried out, using the diagnostic methods set out in points II.1 and II.2 of Part 1 of that Annex, the detailed diagnostic methods and procedures set out in following points I.1 to I.6 shall apply.
Hele fisk skal indpakkes i absorberende papir og skal derefter forsendes i en plastpose.
Preparation and shipment of samples from fish
Der kan også forsendes levende fisk.
Tissues for virological examination on cell culture
Indsamling af supplerende diagnostisk materiale
Before shipment or transfer to the laboratory, pieces of the organs to be examined shall be removed from the fish with sterile dissection tools and transferred to sterile plastic tubes containing transport medium.
Med det diagnostiske laboratoriums godkendelse kan også andet fiskevæv indsamles og præpareres til supplerende undersøgelser.
The quantity of fish material suitable for virological examination on cell culture and by RT-qPCR is dependent on fish size.
Præparation af prøver til cellekulturundersøgelse og RT-qPCR
Thus, whole alevin (body length < 4 cm), viscera including kidney (4 cm < body length < 6 cm) or, for larger size fish, kidney, spleen, heart and/or encephalon, and ovarian fluid from brood fish at the time of spawning shall be the tissues to be sampled.
Frysning i undtagelsestilfælde
Ovarian or seminal fluid or organ pieces from a maximum of 10 fish may be collected in one sterile tube containing at least 4 ml transport medium and represent one pooled sample.
Hvis der opstår praktiske vanskeligheder, som gør det umuligt at behandle prøverne senest 48 timer efter indsamlingen af fiskevævet, kan vævsprøverne nedfryses til – 20 °C eller lavere temperatur i et transportmedium, og den virologiske undersøgelse foretages inden for 14 dage.
The tissue in each sample shall weigh a minimum of 0,5 gram (g).
Fiskevævet må dog kun fryses og optøs én gang, inden det undersøges.
The virological examination on cell culture shall be started as soon as possible and no later than 48 hours after the collection of the samples.
Der skal føres et register med nærmere oplysninger om grunden til hver enkelt nedfrysning af vævsprøver.
In exceptional cases, the virological examination may be started at the latest within 72 hours after the collection of the material, provided that the material to be examined is protected by a transport medium and that the temperature requirements during transportation can be fulfilled.
Homogenisering af organer
Samples for reversed transcriptase polymerase chain reaction (RT-PCR or RT-qPCR) analysis
På laboratoriet skal fiskevævet i rørene homogeniseres fuldstændigt, enten med stomacher, blender eller morter og pistil med sterilt sand, og derefter opslæmmes i det oprindelige transportmedium.
Samples shall be taken from the fish in accordance with the procedure described in point I.1.1 using a sterile instrument and transferred to a sterile plastic tube containing transport medium.
Hvis prøven består af en hel fisk på under 4 cm, findeles den ved hjælp af en steril saks eller skalpel efter fjernelse af kroppen bag gatåbningen.
Tissue from 10 fish may be collected in one tube and shall represent one pooled sample.
Hvis prøven består af en hel fisk på 4-6 cm, indsamles indvoldene, herunder nyre.
However, in case the amount of inoculum is small, tissue from up to five fish may be used.
Hvis prøven består af en hel fisk på over 6 cm, indsamles vævsprøverne som beskrevet i punkt I.1.
Alternatively, samples may be pooled in RNA stabilization reagents, such as 0,2 g tissue/ml reagent according to the recommendation from the manufacturers, although each fish shall be processed individually and shall not be pooled in the samples because of the small amount of material to be used for extraction.
Vævsprøverne findeles ved hjælp af en steril saks eller skalpel, homogeniseres som beskrevet i første afsnit og opslæmmes i transportmedium.
Whole fish may also be sent to the laboratory.
Det endelige forhold mellem vævsmateriale og transportmedium skal på laboratoriet justeres til 1:10.
Shipment of samples for fish
Centrifugering af homogenatet
Tubes containing fish tissues in transport medium for cell cultivation or RT-PCR/RT-qPCR analysis shall be placed in insulated containers, such as thick-walled polystyrene boxes, together with sufficient ice or an alternative cooling medium with the similar cooling effect to ensure chilling of the samples during transportation to the laboratory.
Homogenatet centrifugeres i en kølecentrifuge ved 2-5 °C og 2000-4000 × g i 15 minutter, hvorefter supernatanten opsamles og kan behandles enten i 4 timer ved 15 °C eller natten over ved 4-8 °C med antibiotika.
However, freezing of the samples shall be avoided.
Hvis prøven er blevet sendt i et transportmedium, kan behandling af supernatanten med antibiotika udelades.
The temperature of a sample during transit must never exceed 10 °C and ice must still be present in the transport box at receipt or one or more freeze blocks must still be partly or completely frozen.
Hvis der opstår praktiske vanskeligheder, f.eks. at varmeskabet går i stykker, eller at der opstår problemer med cellekulturer, som gør det umuligt at pode celler senest 48 timer efter indsamlingen af fiskevævsprøverne, kan supernatanten fryses ved – 80 °C, og den virologiske undersøgelse foretages inden for 14 dage.
Whole fish may be sent to the laboratory if the temperature requirements referred to in the first paragraph during transportation can be fulfilled.
Hvis den opsamlede supernatant opbevares ved en temperatur på – 80 °C senest 48 timer efter prøveudtagningen, kan den, dog kun én gang, genanvendes til virologisk undersøgelse.
Whole fish shall be wrapped up in paper with absorptive capacity and shall finally be shipped in a plastic bag.
Inden supernatanten podes på cellerne, blandes den med en tilsvarende mængde passende fortyndet pool af antisera mod de indigene serotyper af infektiøs pankreasnekrose-virus (IPN-virus) og inkuberes hermed i mindst 1 time ved 15 °C eller i højst 18 timer ved 4 °C.
Live fish may also be shipped.
Antiserumtiteren skal være mindst 1/2000 i en 50 % pladeneutraliseringsprøve.
Collection of supplementary diagnostic material
Formålet med at behandle alle inokula med antiserum mod IPN-virus er at hindre, at der udvikles cytopatisk effekt (CPE) som følge af IPN-virus i podede cellekulturer.
When approved by the diagnostic laboratory, other fish tissues may be collected as well and prepared for supplementary examinations.
Det vil nedsætte de virologiske undersøgelsers varighed og antallet af tilfælde, hvor forekomst af CPE ellers måtte opfattes som en potentiel indikation af VHSV eller IHNV.
Preparation of samples for cell culture examination and RT-qPCR
Når prøverne kommer fra produktionsenheder, der anses for at være frie for IPN, kan behandling af inokula med antiserum mod IPN-virus undlades.
Freezing in exceptional cases
Præparation af prøver til overvågningsprogrammer på basis af RT-PCR og RT-qPCR
Where practical difficulties arise, which make it impossible to process the samples within 48 hours after the collection of the fish tissues, it may be acceptable to freeze the tissue specimens in transport medium at – 20 °C or below and to carry out virological examination within 14 days.
Hvis prøverne blev opsamlet i et transportmedium, gennemføres proceduren i punkt I.4.2 og I.4.3.
However, the fish tissue shall only be frozen and thawed once before examination.
Efter centrifugering opsamles supernatanten, og RNA ekstraheres.
Records shall be kept with details on the reason for each freezing of fish tissue samples.
Hvis der ikke skal foretages yderligere undersøgelser direkte efter centrifugering, fryses prøverne straks ved – 20 °C eller derunder.
Homogenisation of organs
Til analyse af fiskevævsprøver, der er konserveret i RNA-stabiliseringsreagens, skal det efterfølgende arbejde foretages inden for følgende tidsfrister for prøver opbevaret ved forskellige temperaturer:
In the laboratory, the fish tissue in the tubes shall be completely homogenised, either by stomacher, blender or mortar and pestle with sterile sand, and subsequently suspended in the original transport medium.
prøver opbevaret ved 37 °C: en dag
If a sample consists of a whole fish less than 4 cm long, it shall be minced with sterile scissors or scalpel after removal of the body behind the gut opening.
prøver opbevaret ved 25 °C: en uge
If a sample consists of a whole fish with body length between 4 cm and 6 cm, the viscera including kidney shall be collected.
prøver opbevaret ved 4 °C: en måned
If a sample consists of a whole fish more than 6 cm long, the tissue specimens shall be collected as described in point I.1.
prøver opbevaret ved – 20 °C: tidsubegrænset.
The tissue specimens shall be minced with sterile scissors or scalpel and homogenised as described in the first paragraph of this point and suspended in transport medium.
Samleprøver i RNA-stabiliseringsreagens behandles som enkeltprøver i RNA-stabiliseringsreagens.
The final ratio between tissue material and transport medium shall be adjusted in the laboratory to 1:10.
For prøver, der samles i RNA-stabiliseringsreagens, må prøvemængden ikke overstige den af fabrikanten anbefalede for ekstraktion med RNA-kit som f.eks. RNeasy Mini kit (Qiagen) eller tilsvarende.
Centrifugation of homogenate
Hvis større prøver samles, skal ekstraktionskittene eller -metoderne afspejle denne samling.
The homogenate shall be centrifuged in a refrigerated centrifuge at 2 °C to 5 °C at 2000 to 4000 × g for 15 minutes and the supernatant collected and may be treated for either four hours at 15 °C or overnight at 4 to 8 °C with antibiotics.
Prøver, der opsamles i RNA-stabiliseringsreagens, må ikke anvendes til celledyrkning.
If the sample has been shipped in a transport medium, the treatment of the supernatant with antibiotics may be omitted.
Samling af prøver til RT-qPCR
Where practical difficulties arise, such as incubator breakdown or problems with cell cultures, which make it impossible to inoculate cells within 48 hours after the collection of the fish tissue samples, the supernatant may be frozen at – 80 °C and virological examination may be carried out within 14 days.