natgillin/translations-raw huggingface dataset:
According to those rules, all parts of the body of an animal tested for bovine spongiform encephalopathy (BSE), including the hide, are to be retained under official control until a negative result to the rapid test has been obtained, unless they are disposed of in accordance with two of the means set out in Article 4(2) of Regulation (EC) No 1774/2002.
V skladu z navedenimi pravili se vsi deli telesa živali, ki se testira na govejo spongiformno encefalopatijo (BSE), vključno s kožo, zadržijo pod uradnim nadzorom do prejema negativnega rezultata hitrega testa, razen če se odstranijo na načina, določena v členu 4(2) Uredbe (ES) št. 1774/2002.
Also, all parts of the body of an animal found positive or inconclusive to a rapid test including the hide are to be disposed of in accordance with the same means of disposal.
Tudi vsi deli telesa živali, pri kateri je rezultat hitrega testa pozitiven ali ni dokončen, vključno s kožo, se odstranijo na ista načina odstranjevanja.
Regulation (EC) No 1774/2002 provides for the possibility of additional means of disposal to be approved for Category 1 material, in the light of developments in scientific knowledge.
Uredba (ES) št. 1774/2002 določa, da se glede na znanstvene dosežke lahko za material kategorije 1 odobrijo dodatni načini odstranjevanja.
Such alternative means are approved and laid down in Commission Regulation (EC) No 92/2005 [3].
Takšni nadomestni načini so odobreni in določeni v Uredbi Komisije (ES) št. 92/2005 [3].
In the interest of consistency of Community legislation, points 6.3 and 6.4 of Part I of Chapter A of Annex III to Regulation (EC) No 999/2001 should be amended to cover also those additional means of disposal.
Zaradi doslednosti zakonodaje Skupnosti je treba točki 6.3 in 6.4 dela I poglavja A Priloge III k Uredbi (ES) št. 999/2001 spremeniti, da se vključijo tudi navedeni dodatni načini odstranjevanja.
Chapter C of Annex X to Regulation (EC) No 999/2001 lays down rules for the sampling and laboratory testing for the presence of TSEs.
V poglavju C Priloge X k Uredbi (ES) št. 999/2001 so določena pravila za vzorčenje in laboratorijsko testiranje na prisotnost TSE.
According to those rules, the first diagnostic method to be used for the confirmation of a clinical suspect case of BSE is based on histopathological examination, which is the method recommended in an earlier edition of the Manual for diagnostic tests and vaccines for terrestrial animals of the World Organisation for Animal Health (OIE) (‘the Manual’).
V navedenih pravilih je histopatološka preiskava prva diagnostična metoda, ki se uporabi za potrditev kliničnega suma na BSE in je priporočena tudi v prejšnji izdaji Priročnika diagnostičnih testov in cepiv za kopenske živali Svetovne organizacije za zdravje živali (OIE) („Priročnik“).
In the latest edition of the Manual, adopted in May 2008, histopathological examination is no longer considered as the reference diagnostic method for investigation of animals suspected of being infected by BSE.
V zadnji izdaji Priročnika, sprejeti maja 2008, histopatološka preiskava ni več referenčna diagnostična metoda za preiskovanje živali, pri katerih obstaja sum na okužbo z BSE.
According to the Manual, immunohistochemical and immunochemical methods, including rapid tests, may now be used for that purpose.
V skladu s Priročnikom se lahko za navedeni namen uporabljajo imunohistokemijske in imunokemijske metode, vključno s hitrimi testi.
The Community reference laboratory for TSEs considers that applying the same approach for the investigation of ovine and caprine animals suspected of being infected by a TSE is relevant and scientifically robust.
Referenčni laboratorij Skupnosti za TSE meni, da je uporaba istih metod pri preiskovanju ovc in koz, pri katerih obstaja sum na TSE, ustrezna in znanstveno zanesljiva.
The methods and protocols to be used for the BSE active surveillance in bovine animals should therefore be amended to reflect the recent modification of the Manual.
Metode in protokole, ki se uporabljajo pri aktivnem spremljanju BSE pri govedu, je zato treba spremeniti, da se upoštevajo zadnje spremembe Priročnika.
Point 3.2(c) of Chapter C of Annex X to Regulation (EC) No 999/2001 provides for further examination of positive scrapie cases in ovine and caprine animals in order to investigate the possible presence of BSE.
V točki 3.2(c) poglavja C Priloge X k Uredbi (ES) št. 999/2001 je določena nadaljnja preiskava pozitivnih primerov praskavca pri ovcah in kozah za določanje morebitne prisotnosti BSE.
In its opinion on classification of atypical Transmissible Spongiform Encephalopathy (TSE) cases in small ruminants [4], of 26 October 2005, the European Food Safety Authority states that atypical scrapie cases are clearly distinguishable from BSE.
Evropska agencija za varnost hrane je v svojem mnenju o razvrstitvi primerov atipične transmisivne spongiformne encefalopatije pri drobnici [4] z dne 26. oktobra 2005 navedla, da se primeri atipičnega praskavca jasno ločijo od BSE.
In addition, in its guidelines [5], the Community reference laboratory for TSEs considers that if a TSE is confirmed as an atypical scrapie case, no further testing is required.
Poleg tega referenčni laboratorij Skupnosti za TSE v svojih smernicah [5] navaja, da v primeru potrditve primera TSE kot atipičnega praskavca dodatne preiskave niso potrebne.
Diagnosed atypical scrapie cases should therefore be exempted from the requirement of further examination set out in point 3.2(c) of Chapter C of Annex X to Regulation (EC) No 999/2001.
Diagnosticirane primere atipičnega praskavca je zato treba izvzeti iz zahteve za nadaljnje preiskave iz točke 3.2(c) poglavja C Priloge X k Uredbi (ES) št. 999/2001.
Point 4 of Chapter C of Annex X to Regulation (EC) No 999/2001 sets out a list of rapid tests approved for the monitoring of TSEs in bovine, ovine and caprine animals.
Točka 4 poglavja C Priloge X k Uredbi (ES) št. 999/2001 določa seznam hitrih testov, ki so bili potrjeni za spremljanje TSE pri govedu, ovcah in kozah.
The commercial denomination of some currently approved TSE tests has recently changed.
Komercialne oznake nekaterih odobrenih testov za TSE so se nedavno spremenile.
For the sake of transparency, these changes should be reflected in Point 4 of Chapter C of Annex X.
Zaradi preglednosti je treba te spremembe upoštevati v točki 4 poglavja C Priloge X.
In addition, the companies manufacturing certain rapid tests do not exist anymore.
Poleg tega podjetja, ki so proizvajala nekatere hitre teste, ne poslujejo več.
Other companies producing rapid tests have not submitted the details of their quality system to the Community reference laboratory for review.
Druga podjetja, ki proizvajajo hitre teste, referenčnemu laboratoriju Skupnosti niso predložila v pregled natančnih podatkov o svojih sistemih zagotavljanja kakovosti.
Certain other rapid tests have been withdrawn from the market.
Nekateri drugi hitri testi niso več na trgu.
It is therefore appropriate to amend accordingly the lists of rapid tests approved for the monitoring of BSE and TSEs, set out in point 4 of Chapter C of Annex X to Regulation (EC) No 999/2001.
Zato je primerno ustrezno spremeniti sezname hitrih testov, odobrenih za spremljanje BSE in TSE iz točke 4 poglavja C Priloge X k Uredbi (ES) št. 999/2001.
In the interest of clarity and legal certainty, the wording of the heading of point 3.2(c) of Annex X, Chapter C, should be amended to be consistent with the general scope of paragraph 3.2 of Annex X, Chapter C which is related to laboratory testing for the presence of TSE in ovine and caprine animals.
Zaradi jasnosti in pravne varnosti je treba naslov točke 3.2(c) poglavja C Priloge X spremeniti tako, da je dosledno s splošnim obsegom odstavka 3.2 poglavja C Priloge X, ki se nanaša na laboratorijsko testiranje na prisotnost TSE pri ovcah in kozah.
Annexes III and X to Regulation (EC) No 999/2001 are amended in accordance with the Annex to this Regulation.
Prilogi III in X k Uredbi (ES) št. 999/2001 se spremenita v skladu s Prilogo k tej uredbi.
Annexes III and X to Regulation (EC) No 999/2001 are amended as follows:
Prilogi III in X k Uredbi (ES) št. 999/2001 se spremenita:
in Part I of Chapter A of Annex III, points 6.3 and 6.4 are replaced by the following:
V delu I poglavja A Priloge III se točki 6.3 in 6.4 nadomestita z naslednjim:
All parts of the body of an animal tested for BSE including the hide shall be retained under official control until a negative result to the rapid test has been obtained, unless they are disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002 of the European Parliament and of the Council.
Vsi deli telesa živali, ki se testira na BSE, vključno s kožo, se zadržijo pod uradnim nadzorom do prejema negativnega rezultata hitrega testa, razen če se odstranijo v skladu s členom 4(2)(a), (b) ali (e) Uredbe (ES) št. 1774/2002.
All parts of the body of an animal found positive or inconclusive to the rapid test including the hide shall be disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002, apart from material to be retained in conjunction with the records provided for in Chapter B(III).’;
Vsi deli telesa živali, pri katerih je rezultat hitrega testa pozitiven ali ni dokončen, vključno s kožo, se odstranijo v skladu členom 4(2)(a), (b) ali (e) Uredbe (ES) št. 1774/2002, razen snovi, ki se zadržijo zaradi evidence iz poglavja B(III).“
in Annex X, Chapter C is amended as follows:
Poglavje C Priloge X se spremeni:
In Point 3.1, points (a) and (b) are replaced by the following:
V točki 3.1 se točki (a) in (b) nadomestita z naslednjim:
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:
Na vzorcih govedi, poslanih v laboratorijsko testiranje na podlagi določb člena 12(2), se takoj opravijo potrditvene preiskave z vsaj eno od naslednjih metod in protokolov iz zadnje izdaje Priročnika:
the immunohistochemical (IHC) method;
imunohistokemijska metoda (IHC);
SAF-immunoblot or OIE approved alternative;
SAF-imunoblot ali nadomestna metoda, ki jo je odobrila Svetovna organizacija za zdravje živali;
the demonstration of characteristic fibrils by electron microscopy;
prikaz značilnih vlaken z elektronsko mikroskopijo;
the histopathological examination;
histopatološki pregled;
the combination of rapid tests as laid down in the third subparagraph.
kombinacija hitrih testov iz tretjega pododstavka.
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.
Kadar rezultat histopatološke preiskave ni dokončen ali je negativen, se tkiva dodatno pregledajo z eno od drugih potrditvenih metod in protokolov.
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 Community reference laboratory and provided that:
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 Skupnosti pod pogojem,
the confirmation is carried out in a national reference laboratory for TSEs; and
da se potrditvena preiskava izvaja v nacionalnem referenčnem laboratoriju za TSE in
one of the two rapid tests is a Western blot; and
da je eden od dveh hitrih testov Western blot in
the second rapid test used:
da drugi uporabljeni hitri test:
includes a negative tissue control and a bovine BSE sample as positive tissue control,
vključuje negativno kontrolo tkiva in vzorec goveda z BSE kot pozitivno kontrolo tkiva,
is of a different type than the test used for the primary screening; and
ni istega tipa kot test, ki se je uporabil za primarno presejanje in
if a rapid Western blot is used as the first test, the result of that test must be documented and submitted to the national reference laboratory for TSEs; and
da se rezultat prvega testa, če je bil uporabljen Western blot, dokumentira in predloži nacionalnemu referenčnemu laboratoriju za TSE in
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; in case 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.
da se vzorec pregleda z eno od drugih potrditvenih metod, kadar se rezultat primarnega presejanja ne potrdi z nadaljnjim hitrim testom; kadar se v navedeni namen uporabi histopatološka preiskava, katere rezultat pa ni dokončen ali je negativen, se morajo tkiva dodatno pregledati z eno od drugih potrditvenih metod in protokolov.
If the result of one of the confirmatory examinations referred to in points (i) to (v) of the first subparagraph is positive, the animals shall be regarded a positive BSE cases.
Če je rezultat ene od potrditvenih preiskav iz točk (i) do (v) prvega pododstavka pozitiven, se živali obravnavajo kot pozitivni primeri BSE.
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.
Vzorci govedi, poslani v laboratorijsko testiranje na podlagi določb dela I poglavja A Priloge III, se pregledajo s hitrimi testi.
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:
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 combination of rapid tests as laid down in the fourth subparagraph.
kombinacija hitrih testov iz četrtega pododstavka.
Rapid tests may be used for both primary screening and, if inconclusive or positive, for subsequent confirmation, according to the guidelines from the Community reference laboratory and provided that:
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 Skupnosti pod pogojem,
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 first subparagraph is positive.’;
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.“
in Point 3.2, point (a) is replaced by the following:
V točki 3.2 se odstavek (a) nadomesti z naslednjim:
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:
Na vzorcih ovc in koz, poslanih v laboratorijsko testiranje na podlagi določb člena 12(2), se takoj opravijo potrditvene preiskave z vsaj eno od naslednjih metod in protokolov iz zadnje izdaje Priročnika:
the histopathological examination.
histopatološki pregled.
Rapid tests may be used for primary screening of suspect cases.
Hitri testi se lahko uporabijo za primarno presejanje sumljivih primerov.
Such tests may not be used for subsequent confirmation.
Takšni testi se ne smejo uporabiti za nadaljnjo potrditev.
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.
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.
In case 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.
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.
If the result of one of the confirmatory examinations referred to in point (i) to (iv) of the first subparagraph is positive, the animals shall be regarded positive TSE cases and further examination as referred to in point (c) shall be performed.’;
Če je rezultat ene od potrditvenih preiskav iz točk (i) do (v) prvega pododstavka pozitiven, se živali obravnavajo kot pozitivni primeri TSE in opravijo se dodatne preiskave iz točke (c).“
in point 3.2, the heading of point (c) is replaced by the following:
V točki 3.2 se naslov odstavka (c) nadomesti z naslednjim:
Further examination of positive TSE cases’;
Nadaljnja preiskava pozitivnih primerov TSE“.
in point 3.2, point (c)(i) is replaced by the following:
V točki 3.2 se odstavek (c)(i) nadomesti z naslednjim:
Primary molecular testing with a discriminatory immuno-blotting
Primarno molekularno testiranje z razločevalno imunoblot analizo
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 forwarded for further examination by a primary molecular typing method to:
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, se pošlje v nadaljnjo preiskavo z metodo primarne molekularne tipizacije v:
to a laboratory, appointed by the competent authority, which has participated successfully in proficiency testing organised by the Community reference laboratory for the use of a molecular typing method.’;
laboratorij, ki ga določi pristojni organ in ki je uspešno sodeloval pri preskušanju strokovnosti, ki ga je organiziral referenčni laboratorij Skupnosti za uporabo metode molekularne tipizacije.“
in point 3.2(c)(ii), the word ‘scrapie’ is replaced by ‘TSE’;
V točki 3.2(c)(ii) se beseda „praskavca“ nadomesti z besedo „TSE“.
point 4 is replaced by the following:
Točka 4 se nadomesti z naslednjim:
the immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test),
test imunoblot na podlagi postopka Western blot za določanje fragmenta PrPRes, odpornega proti proteinazi K (test Prionics-Check Western),
the chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test & Enfer TSE Kit version 2.0, automated sample preparation),
kemiluminiscenčni test ELISA, ki vključuje postopek ekstrakcije in tehniko ELISA z uporabo ojačanega kemiluminiscenčnega reagenta (Enfer test & Enfer TSE Kit, različica 2.0, avtomatizirana priprava vzorca),
the microplate-based immunoassay for the detection of PrPSc (Enfer TSE Version 3),
imunološki preskus na mikroplošči za določanje PrPSc (Enfer TSE, različica 3),
the sandwich immunoassay for PrPRes detection with the TeSeE SAP Detection kit carried out following denaturation and concentration steps with the TeSeE Purification kit (Bio-Rad TeSeE rapid test),
imunološki preskus ‚sendvič‘ za določanje PrPRes s kompletom TeSeE SAP Detection kit, ki se izvede po denaturaciji in koncentraciji s kompletom TeSeE Purification kit (hitri test Bio-Rad TeSeE),
the microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),
imunološki preskus na mikroplošči (ELISA) za določanje PrPRes, odpornega proti proteinazi K, z monoklonskimi protitelesi (test Prionics-Check LIA),
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),
imunološki preskus, ki temelji na selektivni vezavi PrPSc na kemijski polimer ter na detekcijskem monoklonskem protitelesu, usmerjenem proti ohranjenim delom molekule PrP (komplet IDEXX HerdChek BSE Antigen Test Kit, EIA),
the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP),
imunološki preskus na podlagi lateralnega vleka, kjer se uporabita dve različni monoklonski protitelesi za določanje frakcij PrP, odpornih proti proteinazi K (Prionics Check PrioSTRIP),
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),
dvostranski imunološki preskus z uporabo dveh različnih monoklonskih protitelesih, usmerjenih proti dvema epitopoma, ki sta prisotna v zelo razviti obliki govejega PrPSc (Roboscreen Beta Prion BSE EIA Test Kit),
the sandwich ELISA for the detection of Proteinase K-resistant PrPSc (Roche Applied Science PrionScreen).
‚sendvič‘ test ELISA za določanje PrPSc, odpornega proti proteinazi K (Roche Applied Science PrionScreen).
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),
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),
the chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer TSE Kit version 2.0),
kemiluminiscenčni test ELISA, ki vključuje postopek ekstrakcije in tehniko ELISA z uporabo ojačanega kemiluminiscenčnega reagenta (Enfer TSE Kit, različica 2.0),
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-Scrapie Antigen Test Kit, EIA),
imunološki preskus, ki temelji na selektivni vezavi PrPSc na kemijski polimer ter na detekcijskem monoklonskem protitelesu, usmerjenem proti ohranjenim delom molekule PrP (komplet IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA),
the immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western Small Ruminant test),
test imunoblot na podlagi postopka Western blot za določanje fragmenta PrPRes, odpornega proti proteinazi K (Prionics-Check Western Small Ruminant test),
the microplate-based chemiluminescent immunoassay for the detection of Proteinase K-resistant PrPSc (Prionics Check LIA Small Ruminants).
imunološki preskus s kemiluminiscenco na mikroplošči za določanje PrPSc, odpornega proti proteinazi K (Prionics Check LIA Small Ruminants).
Producers of rapid tests must have a quality assurance system in place that has been approved by the Community reference laboratory and ensures that the test performance does not change.
Proizvajalci hitrih testov morajo imeti vzpostavljen sistem zagotavljanja kakovosti, ki ga je odobril referenčni laboratorij Skupnosti in ki zagotavlja, da se učinkovitost testiranja ne spreminja.