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Version Superseded: 03/09/2008
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Textual Amendments
The demonstration by modified acid-fast or immunospecific staining of organisms of Brucella morphology in abortion material, vaginal discharges or milk provides presumptive evidence of brucellosis, especially if supported by serological tests.
After isolation, the species and biovar should be identified by phage lysis and/or oxidative metabolism tests, cultural, biochemical and serological criteria.
The techniques and media used, their standardisation and the interpretation of results must conform to that specified in the OIE Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000, Chapter 2.3.1 (bovine brucellosis), Chapter 2.4.2 (caprine and ovine brucellosis) and Chapter 2.6.2 (porcine brucellosis).
the OIEISS,
the weak positive OIE ELISA standard serum (OIEELISA WP SS),
the strong positive OIE ELISA standard serum (OIEELISA SP SS),
The negative OIE ELISA standard serum (OIEELISA N SS).
The technique used and the interpretation of results must have been validated in accordance with the principles laid down in Chapter 1.1.3 of the OIE Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000, and should at least include laboratory and diagnostic studies.
a 1/150 pre-dilution (1) of the OIEISS or a 1/2 pre-dilution of the OIEELISA WP SS or a 1/16 pre-dilution of the OIEELISA SP SS made up in a negative serum (or in a negative pool of sera) should give a positive reaction;
a 1/600 pre-dilution of the OIEISS or a 1/8 pre-dilution of the OIEELISA WP SS or a 1/64 pre-dilution of the OIEELISA SP SS made up in a negative serum (or in a negative pool of sera) should give a negative reaction;
the OIEELISA N SS should always give a negative reaction.
a 1/150 pre-dilution of the OIEISS or a 1/2 pre-dilution of the OIEELISA WP SS or a 1/16 pre-dilution of the OIEELISA SP SS made up in a negative serum (or in a negative pool of sera) and again diluted in negative sera by the number of samples making up the pool should give a positive reaction;
the OIEELISA N SS should always give a negative reaction;
the test must be adequate to detect evidence of infection in a single animal of the group of animals, of which samples of serum have been pooled.
a 1/1000 pre-dilution of the OIEISS or a 1/16 pre-dilution of the OIEELISA WP SS or a 1/125 pre-dilution of the OIEELISA SP SS made up in a negative serum (or in a negative pool of sera) and again diluted 1/10 in negative milk should give a positive reaction;
the OIEELISA N SS diluted 1/10 in negative milk should always give a negative reaction;
the test must be adequate to detect evidence of infection in a single animal of the group of animals, of which samples of milk or whey have been pooled.
bovine serum: 56 to 60 o C for 30 to 50 minutes,
porcine serum: 60 o C for 30 to 50 minutes.
control of the anti-complementary effect of the serum;
control of the antigen;
control of sensitised red blood cells;
control of the complement;
control using a positive serum of sensitivity at the start of the reaction;
control of the specificity of the reaction using a negative serum.
The OIEISS contains 1 000 international CFT units (ICFTU) per ml. If the OIEISS is tested in a given method the result is given as a titre (T OIEISS ). The test result for the test serum given as titre (T TESTSERUM ) must be expressed in ICFTU per ml. In order to convert the expression of a titre into ICFTU, the factor (F) necessary to convert a titre of an unknown test serum (T TESTSERUM ) tested by that method into the ICFTU expression can be found from the formula:
and the content of international CFT units per ml of test serum (ICFTU TESTSERUM ) from the formula:
A serum containing 20 or more ICFTU per ml is considered to be positive.
on a column of milk of at least 25 mm height and on a volume of milk of 1 ml to which either 0,03 ml or 0,05 ml of one of the standardised stained antigens has been added,
on a column of milk of at least 25 mm height and on a volume of milk of 2 ml to which 0,05 ml of one of the standardised stained antigens has been added,
on a volume of milk of 8 ml to which 0,08 ml of one of the standardised stained antigens has been added.
negative reaction: coloured milk, colourless cream;
positive reaction:
identically coloured milk and cream, or
colourless milk and coloured cream.
serum (20-30 μl) is mixed with an equal volume of antigen on a white tile or enamel plate to produce a zone approximately 2 cm in diameter. The mixture is rocked gently for 4 minutes at ambient temperature, and then observed in a good light for agglutination;
an automated method may be used but must be at least as sensitive and accurate as the manual method.
Any visible reaction is considered to be positive, unless there has been excessive drying round the edges.
Positive and negative working standards should be included in each series of tests.
Antigens may be delivered in the concentrated state provided the dilution factor to be used is indicated on the bottle label.
EDTA may be added to the antigen suspension to 5 mM final test dilution to reduce the level of false positives to the serum agglutination test. Subsequently the pH of 7,2 must be readjusted in the antigen suspension.
It may also be advisable to compare the reactivity of new and previously standardised batches of antigen using a panel of defined sera.
At least three dilutions must be prepared for each serum. Dilutions of suspect serum must be made in such a way that the reading of the reaction at the positivity limit is made in the median tube (or well for the microplate method).
The degree of Brucella agglutination in a serum must be expressed in IU per ml.
A serum containing 30 or more IU per ml is considered to be positive.
The brucellosis skin test shall not be used for the purpose of certification for intra-Community trade.
The brucellosis skin test is one of the most specific tests for the detection of brucellosis in unvaccinated animals, however diagnosis should not be made on the basis of positive intradermal reactions alone.
Bovine animals, tested with negative result in one of the serological tests defined in this Annex and reacting positively to the BST shall be regarded as infected.
Bovine animals, tested with positive result in one of the serological tests defined in this Annex may be subject to a BST in order to support the interpretation of the serological test results, in particular where in brucellosis free or officially free herds a cross-reaction with antibodies against other bacteria cannot be excluded.
One of such preparation is Brucellin INRA prepared from a non smooth strain of B. melitensis . The requirements for its production are detailed in Section B2 of Chapter 2.4.2. of the OIE Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000.
Strong reactions are easily recognised by local swelling and induration.
Skin thickening of 1,5 to 2 mm shall be considered as positive reaction to the BST.
The cELISA shall not be used for the purpose of certification for intra-Community trade.
The cELISA has shown to have a higher specificity than for example the indirect ELISA and may therefore be used in order to support the interpretation of the serological test results.
The test shall be carried out in accordance with the prescription in the OIE Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000, Chapter 2.3.1(2)(a).
National reference laboratories shall be responsible for:
the approval of the results of the validation studies demonstrating the reliability of the test method used in the Member State;
determination of the maximum number of samples to be pooled in ELISA kits used;
calibration of the standard secondary reference national standard sera ( ‘ working standards ’ ) against the primary international standard serum referred to in paragraph 2.1;
quality checks of all antigens and ELISA kits batches used in the Member State;
cooperation within the European Union Network of National Reference Laboratories for Brucellosis.
AT | AGES: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH — Institut für veterinärmedizinische Untersuchungen Mödling (Austrian Agency for Health and Consumer Protection-Institute for veterinary investigations Mödling) Robert Koch-Gasse 17 A-2340 Mödling Tel.: +43 (0) 505 55-38112 Fax: +43 (0) 505 55-38108 E-mail: vetmed.moedling@ages.at |
BE | CODA — CERVA — VAR Veterinary and Agrochemical Research Centre Groeselenberg 99 B-1180 Brussels |
[F4BG | Национален диагностичен научноизследователски ветеринарномедицински институт Проф. д-р Георги Павлов, Национална референтна лаборатория Бруцелоза по животните, бул. Пенчо Славейков 15, София 1606 (National Diagnostic Veterinary Research Institute Prof. Dr. Georgi Pavlov, National Reference Laboratory for Brucellosis, 15, Pencho Slaveykov Blvd., 1606 Sofia)] |
CY | State Veterinary Laboratory Veterinary Services 1417 Athalassa Nicosia |
CZ | Státní veterinární ústav Olomouc Jakoubka ze Stříbra 1 779 00 Olomouc |
[F5DE | Friedrich-Loeffler-Institut Bundesforschungsinstitut für Tiergesundheit Boddenblick 5a 17493 Greifswald — Insel Riems Tel. (49-38351) 7-0 Fax (49-38351) 7-219 E-Mail: poststelle@fli.bund.de |
DK | National Veterinary Institute, Technical University of Denmark Bülowsvej 27 DK-1790 Copenhagen V] |
EE | Veterinaar- ja Toidulaboratoorium Kreutzwaldi 30, 51006 Tartu, Estonia Tel.: +372 7 386 100 Faks: +372 7 386 102 E-post: info@vetlab.ee |
ES | Laboratorio Central de Sanidad Animal de Santa Fe Camino del Jau s/n Santa Fe 18320 (Granada) Tel.: 34 958 440 375/440 400 Fax: 34 958 441 200 Fulgencio Garrido Abellán E-mail: clvgr@mapya.es |
FI | Finnish Food Safety Authority Animal Diseases and Food Safety Research Mustialankatu 3 FI-00790 Helsinki, Finland E-mail: info@evira.fi Tel.: +358 20 772 003 (exchange) Fax: +358 20 772 4350 |
[F5FR | Laboratoire d’études et de recherches en pathologie animale et zoonoses AFSSA-LERPAZ 23, avenue du Général-de-Gaulle F-94703 Maisons-Alfort Cedex] |
GB | Veterinary Laboratories Agency New Haw, Addlestone, Weybridge Surrey KT15 3NB, UK Tel. (44-1932) 341111 Fax (44-1932) 347046 Immunodiagnostics Department Veterinary Sciences Division Stoney Road Stormont Belfast BT4 3SD, UK |
GR | Hellenic Ministry of Rural Development and Food National Veterinary Laboratory of Larisa 6o Km, National Highway Larisa-Trikala Tel.: + 30 2410 617 980-617 981 Fax: + 30 2410 617982 |
[F5HU | Mezőgazdasági Szakigazgatási Hivatal Központ, Állat-egészségügyi Diagnosztikai Igazgatóság Central Agricultural Office, Veterinary Diagnostic Directorate Address: 1149 Budapest, Tábornok u. 2. Mailing Address: 1581 Budapest, 146. Pf. 2. Tel.: +36 1 460-6300 Fax: +36 1 252-5177 E-mail: titkarsag@oai.hu] |
IE | The Blood Testing Laboratory Department of Agriculture and Food Model Farm Road Cork Co. Cork |
IT | Centro di Referenza Nazionale per le brucellosi c/o Istituto zooprofilattico sperimentale dell’ Abruzzo e del Molise Via Campo Boario I- 64100 Teramo |
LT | Nacionalinė veterinarijos laboratorija, J. Kairiūkščio g. 10, LT-2021 Vilnius |
LU | CODA — CERVA — VAR Veterinary and Agrochemical Research Centre Groeselenberg 99 B-1180 Brussels |
LV | Nacionālais diagnostikas centrs (National Diagnostic Centre) Lejupes iela 3, Rīga, LV-1076 Tel.: +371 7620526 Fax: +371 7620434 E-mail: ndc@ndc.gov.lv |
MT | — |
NL | Centraal Instituut voor DierziekteControle CIDC-Lelystad Hoofdvestiging: Houtribweg 39 Nevenvestiging: Edelhertweg 15 Postbus 2004 8203 AA Lelystad |
PL | Laboratory Departament of Microbiology Państwowy Instytut Weterynaryjny – Państwowy Instytut Badawczy, Al. Partyzantów 57, 24-100 Puławy Tel.: +48.81.886 30 51 Fax: +48.81.886 25 95 E-mail: sekretariat@piwet.pulawy.pl |
PT | Laboratório Nacional de Investigação Veterinária (LNIV) Estrada de Benfica, 701 P-1549-011 Lisboa |
[F4RO | Institutul de Diagnostic și Sănătate Animală Strada Dr. Staicovici nr. 63, sector 5 codul 050557, București] |
SE | Statens Veterinärmedicinska Anstalt SE-751 89 Uppsala |
SI | Univerza v Ljubljani Veterinarska fakulteta Nacionalni veterinarski inštitut Gerbičeva 60, SI-1000 Ljubljana |
SK | Štátny veterinárny ústav Pod dráhami 918 SK-960 86 Zvolen] ] ] |
Textual Amendments
F3 Substituted by Commission Decision of 5 December 2006 amending Council Directives 64/432/EEC, 90/539/EEC, 92/35/EEC, 92/119/EEC, 93/53/EEC, 95/70/EC, 2000/75/EC, 2001/89/EC, 2002/60/EC and Decision 2001/618/EC as regards lists of national reference laboratories and State institutes (notified under document number C(2006) 5856) (Text with EEA relevance) (2006/911/EC).
F4 Inserted by Council Directive 2006/104/EC of 20 November 2006 adapting certain Directives in the field of agriculture (veterinary and phytosanitary legislation), by reason of the accession of Bulgaria and Romania.
F5 Substituted by Commission Decision of 7 November 2007 amending Council Directives 64/432/EEC, 90/539/EEC, 92/35/EEC, 92/119/EEC, 93/53/EEC, 95/70/EC, 2000/75/EC, 2001/89/EC, 2002/60/EC, and Decisions 2001/618/EC and 2004/233/EC as regards lists of national reference laboratories and State institutes (notified under document number C(2007) 5311) (Text with EEA relevance) (2007/729/EC).
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