natgillin/translations-raw huggingface dataset:
Where the result is positive or inconclusive the residual tissues must be subject to confirmatory testing, and be processed subsequently in accordance with the EU reference laboratory guidelines on discriminatory testing and classification — “TSE strain characterisation in small ruminants: A technical handbook for National Reference Laboratories in the EU”.
imunohistokemijska metoda (IHC);
The samples shall be correctly marked as to the identity of the sampled animal.
prikaz značilnih vlaken z elektronsko mikroskopijo;
Laboratories
histopatološka preiskava;
Any laboratory examination for TSE shall be carried out in official diagnostic laboratories designated for that purpose by the competent authority.
kombinacija hitrih testov iz tretjega pododstavka.
Methods and protocols
Kadar rezultat histopatološke preiskave ni dokončen ali je negativen, se tkiva dodatno pregledajo z eno od drugih potrditvenih metod in protokolov.
Laboratory testing for the presence of BSE in bovine animals
Hitri testi se lahko uporabijo za primarno presejanje sumljivih primerov in, če rezultat ni dokončen ali je pozitiven, za nadaljnjo potrditev v skladu s smernicami referenčnega laboratorija EU – ‚Pravila OIE za uradno potrditev BSE pri govedu (na podlagi začetnega reaktivnega rezultata pri odobrenem hitrem testu) z uporabo drugega hitrega testa‘ (OIE rules for the official confirmation of BSE in bovines (based on an initial reactive result in an approved rapid test) by using a second rapid test) ter pod pogojem:
Samples from bovine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual:
da je eden od dveh hitrih testov Western blot;
the immunohistochemical (IHC) method;
da drugi uporabljeni hitri test:
Western blot;
vključuje negativno kontrolo tkiva in vzorec goveda z BSE kot pozitivno kontrolo tkiva,
the demonstration of characteristic fibrils by electron microscopy;
ni istega tipa kot test, ki se je uporabil za primarno presejanje;
histopathological examination;
da se rezultat prvega testa, če je bil uporabljen hitri Western blot, dokumentira, slika blota pa predloži nacionalnemu referenčnemu laboratoriju za TSE;
the combination of rapid tests as laid down in the third subparagraph.
da se vzorec pregleda z eno od drugih potrditvenih metod, kadar se rezultat primarnega presejanja ne potrdi z nadaljnjim hitrim testom;
Rapid tests may be used for both primary screening of suspect cases and, if inconclusive or positive, for subsequent confirmation, according to the guidelines from the EU reference laboratory — “OIE rules for the official confirmation of BSE in bovines (based on an initial reactive result in an approved rapid test) by using a second rapid test”, and provided that:
Če je rezultat ene od potrditvenih preiskav iz točk (i) do (v) prvega pododstavka pozitiven, se žival obravnava kot pozitivni primer BSE.
the confirmation is carried out in a national reference laboratory for TSEs;
Spremljanje BSE
and
Vzorci goveda, poslani v laboratorijsko testiranje v skladu z določbami dela I poglavja A Priloge III, se pregledajo s hitrimi testi.
one of the two rapid tests is a Western blot;
Če rezultat hitrega testa ni dokončen ali je pozitiven, se na vzorcu takoj opravijo potrditvene preiskave z vsaj eno od naslednjih metod in protokolov iz zadnje izdaje Priročnika:
the second rapid test used:
kombinacija hitrih testov iz četrtega pododstavka.
includes a negative tissue control and a bovine BSE sample as positive tissue control,
Kadar rezultat histopatološke preiskave ni dokončen ali je negativen, se tkiva dodatno pregledajo z eno od drugih potrditvenih metod in protokolov.
is of a different type than the test used for the primary screening;
Hitri testi se lahko uporabijo za primarno presejanje in, če rezultat ni dokončen ali je pozitiven, za nadaljnjo potrditev v skladu s smernicami referenčnega laboratorija EU – ‚Pravila OIE za uradno potrditev BSE pri govedu (na podlagi začetnega reaktivnega rezultata pri odobrenem hitrem testu) z uporabo drugega hitrega testa‘ (OIE rules for the official confirmation of BSE in bovines (based on an initial reactive result in an approved rapid test) by using a second rapid test) ter pod pogojem:
if a rapid Western blot is used as the first test, the result of that test must be documented and the blot image submitted to the national reference laboratory for TSEs;
Če rezultat hitrega testa ni dokončen ali je pozitiven in je rezultat vsaj ene od potrditvenih preiskav iz točk (i) do (v) prvega pododstavka pozitiven, se žival obravnava kot pozitiven primer BSE.
where the result of the primary screening is not confirmed by the subsequent rapid test, the sample must be subjected to an examination by one of the other confirmatory methods;
Nadaljnja preiskava pozitivnih primerov BSE
where the histopathological examination is used for that purpose, but proves to be inconclusive or negative, the tissues must be submitted to a further examination by one of the other confirmatory methods and protocols.
Vzorci vseh pozitivnih primerov BSE se pošljejo v laboratorij, ki ga imenuje pristojni organ in ki je uspešno opravil preskus usposobljenosti, ki ga je organiziral referenčni laboratorij EU za razločevalno testiranje potrjenih primerov BSE; tam se izvede nadaljnjo testiranje v skladu z metodami in protokoli, določenimi po metodi referenčnega laboratorija EU za klasifikacijo izolatov TSE pri govedu (dvojna blot metoda za začasno klasifikacijo izolatov TSE pri govedu).
If the result of one of the confirmatory examinations referred to in points (i) to (v) of the first subparagraph is positive, the animal shall be regarded as a positive BSE case.
Laboratorijsko testiranje na prisotnost TSE pri ovcah ali kozah
BSE monitoring
Na vzorcih ovc in koz, poslanih v laboratorijsko testiranje v skladu z določbami člena 12(2), se takoj opravijo potrditvene preiskave z vsaj eno od naslednjih metod in protokolov iz zadnje izdaje Priročnika:
Samples from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part I shall be examined by a rapid test.
histopatološka preiskava.
When the result of the rapid test is inconclusive or positive, the sample shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual:
Kadar rezultat histopatološke preiskave ni dokončen ali je negativen, se tkiva dodatno pregledajo z eno od drugih potrditvenih metod in protokolov.
the combination of rapid tests as laid down in the fourth subparagraph.
Hitri testi se lahko uporabijo za primarno presejanje sumljivih primerov.
Where the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.
Takšni testi se ne smejo uporabiti za nadaljnjo potrditev.
Rapid tests may be used for both primary screening and, if inconclusive or positive, for subsequent confirmation, according to the guidelines from the EU reference laboratory — “OIE rules for the official confirmation of BSE in bovines (based on an initial reactive result in an approved rapid test) by using a second rapid test”, and provided that:
Kadar je rezultat hitrega testa za primarno presejanje sumljivih primerov pozitiven ali ni dokončen, se vzorec pregleda z eno od potrditvenih preiskav iz točk (i) do (iv) prvega pododstavka.
An animal shall be regarded a positive BSE case if the result of the rapid test is inconclusive or positive, and at least one of the confirmatory examinations referred to in points (i) to (v) of the second subparagraph is positive.
Kadar se v navedeni namen uporabi histopatološka preiskava, katere rezultat pa ni dokončen ali je negativen, se tkiva dodatno pregledajo z eno od drugih potrditvenih metod in protokolov.
Further examination of positive BSE cases
Če je rezultat ene od potrditvenih preiskav iz točk (i) do (v) prvega pododstavka pozitiven, se žival obravnava kot pozitivni primer TSE in opravijo se dodatne preiskave iz točke (c).
Samples from all positive BSE cases shall be forwarded to a laboratory, appointed by the competent authority, which has participated successfully in the latest proficiency testing organised by the EU reference laboratory for discriminatory testing of confirmed BSE cases, where they shall be further tested in accordance with the methods and protocols laid down in the EU reference laboratory's method for the classification of bovine TSE isolates (a two-blot method for the provisional classification of bovine TSE isolates).
Spremljanje TSE
Laboratory testing for the presence of TSE in ovine and caprine animals
Vzorci ovc in koz, poslani v laboratorij za testiranje v skladu z določbami iz dela II poglavja A Priloge III (Spremljanje pri ovcah in kozah), se pregledajo s hitrim testom, da se zagotovi odkritje vseh znanih sevov TSE.
Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual:
Če rezultat hitrega testa ni dokončen ali je pozitiven, se vzorčena tkiva nemudoma pošljejo v uradni laboratorij za potrditvene preiskave s histopatološko preiskavo, imunohistokemijsko preiskavo, Western blotom ali prikazom značilnih vlaken z elektronsko mikroskopijo, kakor je navedeno v točki (a).
histopathological examination.
Če je rezultat potrditvene preiskave negativen ali ni dokončen, se tkiva dodatno pregledajo z imunohistokemijsko preiskavo ali Western blotom.
In case the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.
Če je rezultat ene od potrditvenih preiskav pozitiven, se žival obravnava kot pozitivni primer TSE in opravijo se dodatne preiskave iz točke (c).
Rapid tests may be used for primary screening of suspect cases.
Nadaljnja preiskava pozitivnih primerov TSE.
Such tests may not be used for subsequent confirmation.
Primarno molekularno testiranje z razločevalno Western blot metodo
Where the result of the rapid test used for primary screening of suspect cases is positive or inconclusive, the sample shall be subjected to an examination by one of the confirmatory examinations referred to in points (i) to (iv) of the first subparagraph.
Vzorce klinično sumljivih primerov in vzorce živali, testiranih v skladu s točkama 2 in 3 dela II poglavja A Priloge III, ki se na podlagi preiskav iz točk (a) ali (b) obravnavajo kot pozitivni primeri TSE, vendar niso atipični primeri praskavca, ali kažejo značilnosti, ki so po mnenju laboratorija za testiranje razlog za preiskavo, pregleda uradni diagnostični laboratorij, ki ga je imenoval pristojni organ, ki je uspešno opravil zadnji preskus usposobljenosti, ki ga je za uporabe take metode organiziral referenčni laboratorij EU, z uporabo razločevalne Western blot metode iz smernic referenčnega laboratorija EU.
Where the histopathological examination is used for that purpose, but proves to be inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.
Sekundarno molekularno testiranje z dodatnimi metodami molekularnega testiranja
If the result of one of the confirmatory examinations referred to in points (i) to (iv) of the first subparagraph is positive, the animal shall be regarded as a positive TSE case and further examination as referred to in point (c) shall be performed.
Primeri TSE, kjer prisotnosti BSE ni mogoče izključiti v skladu s smernicami, ki jih je za primarno molekularno testiranje iz točke (i) izdal referenčni laboratorij EU, se nemudoma pošljejo referenčnemu laboratoriju EU, skupaj z vsemi razpoložljivimi informacijami.
TSE monitoring
Na vzorcih se opravijo nadaljnje preiskave in potrditev z vsaj eno nadomestno metodo, ki se imunohistokemijsko razlikuje od prvotne primarne molekularne metode glede na količino in narave referenčnega materiala, kot je opisano v smernicah referenčnega laboratorija EU.
Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part II (Monitoring in ovine and caprine animals) shall be examined by a rapid test, in order to ensure the detection of all known strains of TSE.
Ti dodatni testi se opravijo v naslednjih laboratorijih, odobrenih za izvajanje ustrezne metode:
When the result of the rapid test is inconclusive or positive, the sampled tissues shall immediately be sent to an official laboratory for confirmatory examinations by histopathology, immunohistochemistry, Western blotting or demonstration of characteristic fibrils by electron microscopy, as referred to in point (a).
Rezultate analizira referenčni laboratorij EU, ki mu pri tem pomaga skupina izvedencev, imenovana strokovna skupina za tipizacijo sevov (STEG), vključno s predstavnikom ustreznega nacionalnega referenčnega laboratorija.
If the result of the confirmatory examination is negative or inconclusive, the tissues shall be submitted to a further examination by immunohistochemistry or Western blotting.
Rezultat navedene analize se nemudoma sporoči Komisiji.
If the result of one of the confirmatory examinations is positive, the animal shall be regarded as a positive TSE case and further examination as referred to in point (c) shall be performed.
Biološki poskusi na miših
Further examination of positive TSE cases
Vzorci, ki kažejo na BSE ali njihov rezultat za BSE po sekundarnem molekularnem testiranju ni dokončen, se nato za dokončno potrditev analizirajo z biološkimi poskusi na miših.
Primary molecular testing with a discriminatory Western blotting method
Narava ali količina razpoložljivega materiala lahko vpliva na načrt bioloških poskusov, ki ga odobri referenčni laboratorij EU, ki mu za vsak primer posebej pri tem pomaga skupina STEG.
Samples from clinical suspect cases and from animals tested in accordance with Annex III, Chapter A, Part II, points 2 and 3 which are regarded as positive TSE cases but which are not atypical scrapie cases following the examinations referred to in points (a) or (b), or which display characteristics which are deemed by the testing laboratory to merit investigation, shall be examined using a discriminatory Western blotting method listed in the guidelines of the EU reference laboratory by an official diagnostic laboratory designated by the competent authority, which has participated successfully in the latest proficiency testing organised by the EU reference laboratory for the use of such a method.
Biološke poskuse izvede referenčni laboratorij EU ali laboratoriji, ki jih imenuje referenčni laboratorij EU.
Secondary molecular testing with additional molecular testing methods
Rezultate analizira referenčni laboratorij EU, pri tem pa mu pomaga skupina STEG.
TSE cases in which the presence of BSE cannot be excluded according to the guidelines issued by the EU reference laboratory by the primary molecular testing referred to in point (i), shall be referred immediately to the EU reference laboratory, with all the relevant information available.
Laboratorijsko testiranje na prisotnost TSE pri vrstah, razen tistih iz točk 3.1 in 3.2
The samples shall be submitted to further investigation and confirmation by at least one alternative method, differing immunochemically from the original primary molecular method, depending on the volume and nature of the referred material, as described in the guidelines of the EU reference laboratory.
Kadar so metode in protokoli za teste, ki se izvajajo za potrditev sumljive prisotnosti TSE pri vrstah, z izjemo goveda, ovac in koz, uveljavljeni, morajo te metode in protokoli vključevati vsaj histopatološko preiskavo možganskega tkiva.
These additional tests will be carried out in the following laboratories approved for the relevant method:
Pristojni organ lahko zahteva tudi laboratorijske teste, kot so imunohistokemijska preiskava, Western blot, prikaz značilnih vlaken z elektronsko mikroskopijo, ali druge metode za ugotavljanje oblike prionskega proteina, povezane z boleznijo.
The results shall be interpreted by the EU reference laboratory assisted by a panel of experts referred to as the Strain Typing Expert Group (STEG), including a representative of the relevant national reference laboratory.
V vsakem primeru je treba izvesti vsaj še eno drugačno laboratorijsko preiskavo, če je začetna histopatološka preiskava negativna ali njen rezultat ni dokončen.
The Commission shall be informed immediately about the outcome of that interpretation.
Najmanj tri različne preiskave s pozitivnimi rezultati se izvedejo ob prvem pojavu bolezni.
Mouse bioassay
Zlasti kadar obstaja sum na BSE pri vrstah, z izjemo goveda, se primeri pošljejo referenčnemu laboratoriju EU, ki mu za nadaljnjo opredelitev pomaga skupina STEG.
Samples indicative of BSE or inconclusive for BSE, following secondary molecular testing, shall be further analysed by mouse bioassay for final confirmation.
Hitri testi
The nature or quantity of available material may influence the bioassay design, which will be approved by the EU reference laboratory assisted by the STEG on a case by case basis.
Za izvajanje hitrih testov v skladu s členoma 5(3) in 6(1) se kot hitri testi za spremljanje BSE pri govedu uporabljajo le naslednje metode:
Bioassays will be performed by the EU reference laboratory, or by laboratories designated by the EU reference laboratory.
test imunoblot na podlagi postopka Western blot za določanje fragmenta PrPRes, odpornega proti proteinazi K (test Prionics-Check Western),
The results shall be interpreted by the EU reference laboratory assisted by the STEG.
‚sendvič‘ imunološki preskus (sandwich immunoassay) za določanje PrPRes, ki se izvede po denaturaciji in koncentraciji (hitri test Bio-Rad TeSeE SAP),
Laboratory testing for the presence of TSEs in species other than those referred to in points 3.1 and 3.2
imunološki preskus na mikroplošči (ELISA) za določanje PrPRes, odpornega proti proteinazi K, z monoklonskimi protitelesi (test Prionics-Check LIA),
Where methods and protocols are established for tests carried out to confirm the suspected presence of a TSE in a species other than bovine, ovine and caprine, they shall include at least a histopathological examination of brain tissue.
imunološki preskus, ki temelji na selektivni vezavi PrPSc na kemijski polimer ter na detekcijskem monoklonskem protitelesu, usmerjenem proti ohranjenim delom molekule PrP (IDEXX HerdChek BSE Antigen Test Kit, EIA & HerdChek BSE-Scrapie Antigen, (IDEXX Laboratories)),
The competent authority may also require laboratory tests such as immunohistochemistry, Western blotting, demonstration of characteristic fibrils by electron microscopy or other methods designed to detect the disease associated form of the prion protein.
imunološki preskus na podlagi lateralnega vleka, kjer se uporabita dve različni monoklonski protitelesi za določanje frakcij PrP, odpornih proti proteinazi K (Prionics Check PrioSTRIP),
In any case at least one other laboratory examination shall be carried out if the initial histopathological examination is negative or inconclusive.
dvostranski imunološki preskus z uporabo dveh različnih monoklonskih protiteles, usmerjenih proti dvema epitopoma, ki sta prisotna v zelo nerazvejani obliki govejega PrPSc (Roboscreen Beta Prion BSE EIA Test Kit).
At least three different examinations with positive results shall be carried out in the event of the first appearance of the disease.
Za izvajanje hitrih testov v skladu s členoma 5(3) in 6(1) se kot hitri testi za spremljanje TSE pri ovcah in kozah uporabljajo le naslednje metode:
In particular, where BSE is suspected in a species other than bovine animals, the cases shall be referred to the EU reference laboratory assisted by the STEG for further characterisation.
imunološki preskus ‚sendvič‘ za določanje PrPRes s kompletom TeSeE Sheep/Goat Detection kit, ki se izvede po denaturaciji in koncentraciji s kompletom TeSeE Sheep/Goat Purification kit (hitri test Bio-Rad TeSeE),
Rapid tests
imunološki preskus, ki temelji na selektivni vezavi PrPSc na kemijski polimer ter na detekcijskem monoklonskem protitelesu, usmerjenem proti ohranjenim delom molekule PrP (HerdChek BSE-Scrapie Antigen (IDEXX Laboratories)),
For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), only the following methods shall be used as rapid tests for the monitoring of BSE in bovine animals:
imunološki preskus na podlagi lateralnega vleka, kjer se uporabita dve različni monoklonski protitelesi za določanje frakcij PrP, odpornih proti proteinazi K (Prionics Check PrioSTRIP SR, protokol za vizualno odčitavanje).
the immunoblotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test),
Pri vseh hitrih testih mora vzorčno tkivo, ki se uporablja pri testu, ustrezati zahtevam iz proizvajalčevih navodil za uporabo.
the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test),
Proizvajalci hitrih testov morajo imeti vzpostavljen sistem zagotavljanja kakovosti, ki ga je odobril referenčni laboratorij EU in ki zagotavlja, da se učinkovitost testiranja ne spreminja.
the microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),
Proizvajalci morajo referenčnemu laboratoriju EU predložiti testne protokole.
the immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA & HerdChek BSE-Scrapie Antigen (IDEXX Laboratories)),
Spremembe hitrih testov in testnih protokolov se lahko izvedejo le po predhodnem uradnem obvestilu, poslanem referenčnemu laboratoriju EU, in če referenčni laboratorij EU sklene, da sprememba ne zmanjša občutljivosti, specifičnosti ali zanesljivosti hitrega testa.
the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP),
Ugotovitev se sporoči Komisiji in nacionalnim referenčnim laboratorijem.
the two-sided immunoassay using two different monoclonal antibodies directed against two epitopes presented in a highly unfolded state of bovine PrPSc (Roboscreen Beta Prion BSE EIA Test Kit).
Alternativni testi
For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), only the following methods shall be used as rapid tests for the monitoring of TSE in ovine and caprine animals:
(Bo določeno kasneje)“
the sandwich immunoassay for PrPRes detection with the TeSeE Sheep/Goat Detection kit carried out following denaturation and concentration steps with the TeSeE Sheep/Goat Purification kit (Bio-Rad TeSeE Sheep/Goat rapid test),
Referenčni laboratorij Evropske unije za TSE je 2. maja 2013 odobril nova navodila za uporabo kompleta.
the immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (HerdChek BSE-Scrapie Antigen (IDEXX Laboratories)),
Poleg tega je družba Enfer Group 6. decembra 2013 sporočila, da je prenehala proizvajati diagnostični komplet Enfer Version 3 TSE, in zahtevala črtanje tega kompleta s seznama odobrenih hitrih testov na BSE pri govedu.
the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics — Check PrioSTRIP SR, visual reading protocol).
900001–1000000
In all rapid tests, sample tissue on which the test must be applied must comply with the manufacturer's instructions for use.
800001–900000
Producers of rapid tests must have a quality assurance system in place that has been approved by the EU reference laboratory and ensures that the test performance does not change.
700001–800000