natgillin/translations-raw huggingface dataset:
one of the two rapid tests is a Western blot;
jedan od dvaju testova je Western blot;
the second rapid test used:
drugi korišteni brzi test:
includes a negative tissue control and a bovine BSE sample as positive tissue control,
obuhvaća negativnu kontrolu tkiva i jedan uzorak goveda s GSE-om kao pozitivnu kontrolu tkiva,
is of a different type than the test used for the primary screening;
je različit tip testa od onog primijenjenoga za primarno ispitivanje;
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;
ako se brzi test Western blot koristi kao prvi test, mora se dokumentirati nalaz toga testa i dostaviti nacionalnom referentnom laboratoriju za TSE-ove;
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;
v. ako nalaz primarnog ispitivanja nije potvrđen naknadnim brzim testom, uzorak se mora podvrgnuti ispitivanju nekom drugom potvrdnom metodom;
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.
ako se u tu svrhu primjenjuje histopatološka pretraga, čiji je nalaz nejasan ili negativan, tkivo se mora podvrgnuti daljnjem ispitivanju nekom drugom potvrdnom metodom i protokolom.
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.
Ako je nalaz jednoga od potvrdnih ispitivanja iz točaka i. do v. prvog podstavka pozitivan, životinja se smatra pozitivnim slučajem GSE-a.
BSE monitoring
Praćenje GSE-a
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.
Uzorci goveda poslani na laboratorijsko testiranje prema odredbama Priloga III. poglavlja A dijela I. moraju se ispitati brzim testom.
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:
Ako je nalaz brzog testa nejasan ili pozitivan, uzorak se odmah podvrgava potvrdnom testiranju primjenom barem jedne od sljedećih metoda i protokola utvrđenih u najnovijem izdanju priručnika:
the combination of rapid tests as laid down in the fourth subparagraph.
v. kombinacija brzih testova utvrđenih u trećem podstavku.
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.
Ako je nalaz histopatološkog pregleda dvojben ili negativan, tkiva se podvrgavaju daljnjem pregledu primjenom jedne od ostalih potvrdnih metoda i protokola.
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:
Brzi se testovi mogu primjenjivati kako za primarna ispitivanja sumnjivih slučajeva tako i, u slučaju nejasnog ili negativnog nalaza, za naknadnu potvrdu, prema smjernicama referentnog laboratorija EU – ‚Pravila OIE-a za službenu potvrdu GSE-a kod goveda (na temelju početnog reaktivnog nalaza odobrenoga brzog testa) uporabom drugoga brzog testa’, i pod uvjetom da:
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.
Životinja se smatra pozitivnim slučajem GSE-a ako je rezultat brzog testa dvojben ili pozitivan i barem je jedno od potvrdnih ispitivanja iz točaka i. do v. drugog podstavka pozitivno.
Further examination of positive BSE cases
Daljnje ispitivanje pozitivnih slučajeva GSE-a
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).
Uzorci svih pozitivnih slučajeva GSE-a prosljeđuju se laboratoriju koji je imenovalo nadležno tijelo i koji je uspješno sudjelovao u posljednjoj provjeri stručne osposobljenosti koju organizira referentni laboratorij EU-a za diskriminatorno ispitivanje potvrđenih slučajeva GSE-a, gdje će se dalje testirati u skladu s metodama i protokolima propisanima u metodi referentnog laboratorija EU-a za klasifikaciju TSE izolata kod goveda (metoda dvaju koraka testa Western blot za privremenu klasifikaciju TSE izolata kod goveda).
Laboratory testing for the presence of TSE in ovine and caprine animals
Laboratorijsko ispitivanje na prisutnost TSE-a u ovaca i koza
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:
Uzorci ovaca i koza poslani na laboratorijsko testiranje prema odredbama članka 12. stavka 2. bez odlaganja moraju se podvrgnuti potvrdnom testiranju uz primjenu barem jedne od sljedećih metoda i protokola utvrđenih u najnovijem izdanju priručnika:
histopathological examination.
histopatološki pregled;
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.
Ako je nalaz histopatološkog pregleda dvojben ili negativan, tkiva se podvrgavaju daljnjem pregledu primjenom jedne od ostalih potvrdnih metoda i protokola.
Rapid tests may be used for primary screening of suspect cases.
Brzi se testovi mogu primjenjivati za primarna ispitivanja sumnjivih slučajeva.
Such tests may not be used for subsequent confirmation.
Takvi se testovi ne smiju primjenjivati za naknadnu potvrdu.
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.
Ako je nalaz brzog testa koji je primijenjen za primarno ispitivanje sumnjivih slučajeva pozitivan ili nejasan, uzorak se mora podvrgnuti ispitivanju jednim od potvrdnih testova iz podtočaka od i. do iv. prvog podstavka.
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.
Ako se u tu svrhu koristi histopatološki pregled, a nalaz je dvojben ili negativan, tkiva se podvrgavaju daljnjem pregledu primjenom jedne od ostalih potvrdnih metoda i protokola.
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.
Ako je nalaz jednoga od potvrdnih ispitivanja iz podtočaka i. do iv. prvog podstavka pozitivan, životinja se smatra pozitivnim slučajem TSE-a i provodi se daljnje ispitivanje kako je navedeno u točki (c).
TSE monitoring
Praćenje TSE-a
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.
Uzorci ovaca i koza koji su poslani na laboratorijske pretrage u skladu s odredbama Priloga III. poglavlja A dijela II. (Praćenje u ovaca i koza) ispituju se brzim testom kako bi se osiguralo otkrivanje svih poznatih sojeva TSE-a.
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).
Ako je rezultat brzog testa dvojben ili pozitivan, uzorci tkiva odmah se dostavljaju službenom laboratoriju na potvrdna ispitivanja histopatološkim pregledom, imunohistokemijskim ispitivanjem, pretragom Western blot ili prikazom karakterističnih vlakanaca pomoću elektronske mikroskopije, kako je navedeno u točki (a).
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.
Ako je rezultat potvrdne pretrage nejasan ili negativan, tkiva se podvrgavaju daljnjem pregledu imunohistokemijskim ispitivanjem ili pretragom Western blot.
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.
Ako je nalaz nekog od potvrdnih ispitivanja pozitivan, životinja se smatra pozitivnim slučajem TSE-a i provodi se daljnje ispitivanje, kako je navedeno u točki (c).
Further examination of positive TSE cases
Daljnje ispitivanje pozitivnih slučajeva TSE-a
Primary molecular testing with a discriminatory Western blotting method
i. Primarno molekularno ispitivanje diskriminatornim testom Western blot
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.
Uzorci klinički sumnjivih slučajeva i životinja testiranih u skladu s Prilogom III. poglavljem A dijelom II. točkama 2. i 3., koje se smatraju pozitivnim slučajevima TSE-a, ali koje nakon ispitivanja prema točkama (a) ili (b) nisu atipični slučajevi grebeža ili pokazuju karakteristike koje se prema mišljenju ispitnog laboratorija moraju dalje ispitivati, ispituju se diskriminirajućom metodom Western blot navedenom u smjernicama referentnog laboratorija EU-a u službenom dijagnostičkom laboratoriju koji je imenovalo nadležno tijelo i koji je uspješno sudjelovao u posljednjoj provjeri stručne osposobljenosti koju organizira referentni laboratorij EU-a za korištenje te metode.
Secondary molecular testing with additional molecular testing methods
Sekundarno molekularno ispitivanje dodatnim metodama molekularnih ispitivanja
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.
Slučajevi TSE-a kod kojih se primarnim molekularnim ispitivanjem iz točke (i.) ne može isključiti prisutnost GSE-a u skladu sa smjernicama koje je izdao referentni laboratorij EU-a odmah se prosljeđuju referentnom laboratoriju EU-a zajedno sa svim raspoloživim relevantnim informacijama.
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.
Uzorci se podvrgavaju daljnjem ispitivanju i potvrdi najmanje jednom alternativnom metodom koja se imunokemijski razlikuje od izvorne primarne molekularne metode, ovisno o količini i naravi proslijeđenog materijala, kako je opisano u smjernicama referentnog laboratorija EU-a.
These additional tests will be carried out in the following laboratories approved for the relevant method:
Ta dodatna ispitivanja provode se u sljedećim laboratorijima odobrenima za odgovarajuću metodu:
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.
Rezultate interpretira referentni laboratorij EU-a uz pomoć odbora stručnjaka koji predstavljaju stručnu skupinu za tipiziranje sojeva (STEG), uključujući i predstavnika relevantnog nacionalnog referentnog laboratorija.
The Commission shall be informed immediately about the outcome of that interpretation.
Komisija se odmah obavješćuje o rezultatu te interpretacije.
Mouse bioassay
Biološki pokusi na miševima
Samples indicative of BSE or inconclusive for BSE, following secondary molecular testing, shall be further analysed by mouse bioassay for final confirmation.
Uzorci koji ukazuju na GSE ili pokazuju dvojbene rezultate s obzirom na GSE nakon sekundarnih molekularnih ispitivanja ponovo se analiziraju biološkim pokusima na miševima u svrhu konačne potvrde.
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.
Vrsta ili količina raspoloživog materijala može utjecati na oblik biološkog pokusa koji će odobriti referentni laboratorij EU-a uz pomoć stručne skupine za tipiziranje sojeva (STEG) od slučaja do slučaja.
Bioassays will be performed by the EU reference laboratory, or by laboratories designated by the EU reference laboratory.
Biološke pokuse će obavljati referentni laboratorij EU-a ili laboratoriji koje je imenovao referentni laboratorij EU-a.
The results shall be interpreted by the EU reference laboratory assisted by the STEG.
Rezultate interpretira referentni laboratorij EU-a uz pomoć stručne skupine za tipiziranje sojeva (STEG).
Laboratory testing for the presence of TSEs in species other than those referred to in points 3.1 and 3.2
Laboratorijske pretrage za dokazivanje prisutnosti TSE-ova u drugim vrstama životinja osim onih navedenih u točkama 3.1. i 3.2.
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.
Ako postoje metode i protokoli za pretrage koje se provode za potvrđivanje prisutnosti TSE-a na koju se sumnja u drugih vrsta životinja osim goveda, ovaca i koza, one obuhvaćaju najmanje histopatološku pretragu moždanog tkiva.
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.
Nadležno tijelo može zatražiti i laboratorijske pretrage poput imunohistokemijskog ispitivanja, Western blot pretrage ili prikaza karakterističnih vlakanaca pomoću elektronske mikroskopije ili drugih metoda za dokazivanje oblika proteina priona koji ukazuje na bolest.
In any case at least one other laboratory examination shall be carried out if the initial histopathological examination is negative or inconclusive.
U svakom slučaju mora se provesti najmanje još jedna dodatna laboratorijska pretraga ako je rezultat prve histopatološke pretrage negativan ili nejasan.
At least three different examinations with positive results shall be carried out in the event of the first appearance of the disease.
U slučaju prvog pojavljivanja bolesti moraju se provesti najmanje tri različite pretrage s pozitivnim rezultatom.
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.
Posebno, ako se sumnja na GSE kod vrsta koje nisu goveda, ti se slučajevi prosljeđuju referentnom laboratoriju EU-a kojemu pri daljnjoj karakterizaciji pomaže stručna skupina za tipiziranje sojeva (STEG).
Rapid tests
Brzi testovi
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:
Radi provedbe brzih testova u skladu s člankom 5. stavkom 3. i člankom 6. stavkom 1. sljedeće se metode koriste kao brzi testovi za praćenje GSE-a u goveda:
the immunoblotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test),
imunobloting test temeljen na postupku Western bloting za otkrivanje fragmenta PrPRes otpornoga na proteinazu K (test Prionics-Check Western),
the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test),
sendvič-metoda imunološkog određivanja PrPRres (protokol kratkoga imunološkog određivanja – SAP) koja se obavlja nakon denaturacije i koncentracije (brzi test Bio-Rad TeSeE),
the microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),
imunološko određivanje na bazi mikroploča (ELISA) kojim se otkriva PrPRes otporan na proteinazu K s monoklonskim protutijelima (Prionics-Check LIA test),
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)),
imunološko određivanje koje se temelji na selektivnom vezivanju PrPSc na kemijski polimer i detekciji monoklonskih protutijela usmjerenih prema očuvanim dijelovima molekule PrP (IDEXX HerdChek BSE Antigen Test Kit, EIA & HerdChek BSE-Scrapie Antigen (IDEXX Laboratories)),
the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP),
‚lateral flow’ imunološko određivanje uz uporabu dvaju različitih monoklonskih protutijela za otkrivanje fragmenata PrP otpornih na proteinazu 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).
dvostrano imunološko određivanje uz uporabu dvaju različitih monoklonskih protutijela usmjerenih ka dvama epitopima koji su prisutni u vrlo razvijenom obliku goveđeg PrPSc (Roboscreen Beta Prion BSE EIA Test Kit).
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:
U cilju provedbe brzih testova u skladu s člankom 5. stavkom 3. i člankom 6. stavkom 1. sljedeće se metode koriste kao brzi testovi za praćenje TSE-a u ovaca i koza:
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),
sendvič metoda imunološkog određivanja za PrPRes uz pomoć kompleta TeSeE Sheep/Goat Detection kit, provedena nakon postupka denaturizacije i koncentracije uz pomoć kompleta TeSeE Sheep/Goat Purification kit (brzi test Bio-Rad Te-SeE Sheep/Goat),
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)),
imunološko određivanje koje se temelji na selektivnom vezivanju PrPSc na kemijski polimer i detekciji monoklonskih protutijela usmjerenih prema očuvanim dijelovima molekule PrP (HerdChek BSE-Scrapie Antigen (IDEXX Laboratories)),
the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics — Check PrioSTRIP SR, visual reading protocol).
,lateral-flow' imunološko određivanje uz uporabu dvaju različitih monoklonskih protutijela za otkrivanje fragmenata PrP otpornih na proteinazu K (Prionics-Check PrioSTRIP SR, protokol za vizualno očitavanje).
In all rapid tests, sample tissue on which the test must be applied must comply with the manufacturer's instructions for use.
Kod svih brzih testova uzorak tkiva koji se koristi za testiranje mora biti u skladu s uputama proizvođača.
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.
Proizvođači brzih testova moraju imati uspostavljen sustav osiguranja kvalitete koji je odobrio referentni laboratorij EU-a i kojim se jamči da se učinkovitost testa ne mijenja.
Producers must provide the EU reference laboratory with the test protocols.
Proizvođači moraju dostaviti protokole testiranja referentnom laboratoriju EU-a.
Changes to rapid tests and to test protocols may only be made after prior notification to the EU reference laboratory and provided that the EU reference laboratory finds that the change does not alter the sensitivity, specificity or reliability of the rapid test.
Izmjene brzih testova ili protokola ispitivanja mogu se izvršiti samo uz prethodnu obavijest poslanu referentnom laboratoriju EU-a i uz uvjet da referentni laboratorij EU-a utvrdi da ta promjena ne umanjuje osjetljivost, specifičnost ili pouzdanost brzog testa.
That finding shall be communicated to the Commission and to the national reference laboratories.
Taj se nalaz dostavlja Komisiji i nacionalnim referentnim laboratorijima.
Alternative tests
Alternativni testovi
(To be defined)’
(Potrebno ih je utvrditi)”
The new package insert for this test has been approved by the European Union Reference laboratory for TSEs on 2 May 2013.
Nove upute o veterinarsko-medicinskom proizvodu za taj test odobrio je referentni laboratorij Europske unije za TSE-ove 2. svibnja 2013.
Furthermore, on 6 December 2013, the Enfer Group informed that it has ceased the manufacture of the Enfer Version 3 TSE diagnostic kit and requested the deletion of this kit from the list of approved BSE rapid tests in bovine animals.
Nadalje, trgovačko društvo Enfer Group je 6. prosinca 2013. obavijestilo da je obustavilo proizvodnju dijagnostičkog kompleta za TSE Enfer Version 3 i zatražilo brisanje tog kompleta s popisa odobrenih brzih testova GSE-a kod goveda.
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Institute of Food Safety, Animal Health and Environment (BIOR) Lejupes Str.
Institute of Food Safety, Animal Health and Environment (BIOR)
National Food and Veterinary Risk Assessment Institute J. Kairiūkščio str.
National Food and Veterinary Risk Assessment Institute
Veterinary Virology Research Unit- TSEs
Veterinary Virology Research Unit - TSEs