Diachemix, LLC. 223 North Water Street Suite 500 Milwaukee, WI U.S.A. Tel: Fax:

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1 223 North Water Street Suite 500 Milwaukee, WI Tel: Fax: E mail: info@diachemix.com Website:

2 BRUCELLA ANTIBODY TEST BREAKTHROUGH TECHNOLOGY FOR BRUCELLA TESTING Diachemix is the world leader in the development of Fluorescence Polarization (FP) technology for detection of animal disease antibodies and food pathogens. FP is a versatile and robust technology that can be applied to various matrices including serum, whole blood, milk, juices, and water. Brucellosis is a zoonotic disease caused by Brucella bacteria. The disease occurs throughout the world and affects numerous species, including cattle, swine, sheep, goats, and humans. Brucellosis is a serious threat to public health and is responsible for significant economic damage in many countries world wide. In ru minants the disease is highly contagious, leading to fetal abortions and decreases in animal production value. The Brucella Fluorescence Polarization Assay (FPA) kit is a rapid, easy, accurate and cost effective diagnostic method that can be used to detect antibodies against Brucella abortus. To detect Brucella specific antibodies, the test uses an O polysaccharide (OPS) extract of Brucella abortus cells that is conjugated with a fluorescent dye. A Fluorescence Polarization instrument measures the polarization of the light emitted by the conjugated OPS compound. When antibodies bind to the conjugated compound, an increase in polarization is detected.

3 BRUCELLA FLUORECENT POLARIZATION ASSAY RAPID EASY Unrivalled speed, with test completion in as little as 5 minutes Requires no washing steps or long incubation One step solution Performed in a laboratory or field setting Few reagents required ACCURATE Leading performance, yielding quantitative results Sensitivity and specificity equivalent to or greater than existing methods COST EFFECTIVE Rapid results means more tests can be run in a shorter period of time, requiring fewer laboratory technicians APPROVED United States Department of Agriculture (USDA) approved for use as a screening or confirmatory test in cattle BRUCELLA ABORTUS ANTIBODY TEST KIT (BRUCELLA FPA) 250 1,000 10,000 Test Format General Description & Intended Use The BRUCELLA ABORTUS ANTI BODY TEST KIT is a qualitative test using Fluorescence Polarization technology designed to determine the presence of anti bodies to Brucella abortus in bovine serum. The presence of antibodies is indicative of prior infection with Brucella abortus or vaccination with a smooth strain vaccine, such as Strain 19. Bovine vaccinated with rough strain vaccine (e.g. RB 51) do not react positive in the test. Components Component 1: Positive Control Component 2: Negative Control Component 3: 25X Reaction Buffer Concentrate Component 4: Conjugate Kit Contents All components contain 0.095% sodium azide as a preservative ml 2 ml 14 ml 2.5 ml ml 2 ml 50 ml 10 ml x 1 ml 5 x 2 ml 2 x 50 ml 10 x 10 ml

4 Materials Required But Not Provided Other required materials not provided are: FPA instrument, 10x75 mm borosilicate disposable glass test tubes for single tube FPA instrument (highly recommended: VWR item number ; see 96 well black flat bottom microtitre plates for microtitre plate FPA instrument (recommended: Greiner or Costar 3915), pipettor, pipette tips, tube vortex mixer, and microtitre plate shaker (recommended: Heidolph Titramax 100, 1000; shake at maximum speed). No other reagents are needed with the exception of distilled or deionized water for buffer reconstitution. Storage & Stability FPA reagents must be stored in a refrigerator (2 7 C) and brought to room temperature (16 26 C) before usage. Diluted Reaction Buffer must be stored at room temperature (16 26 C) and given an expiration date of one month from the date of dilution. Do not use test kit past the expiration date printed on the box. A Certificate of Analysis (COA) is available upon request. Warnings FPA technology works on clear and cloudy homogeneous liquids. Avoid practices that may contaminate the test controls, test buffer, or test conjugate. Test tubes should be used only once, then discarded. Polarization readings are affected by temperature. Polarization read ings decrease by 3 mp (millipolarization units) for a temperature in crease of 4 C. Therefore, the Negative Control (Component 2) should be run in triplicate at regular intervals with the single tube assay or on every microtitre plate respectively. Avoid temperature variations of more than 1 C during one determination. All materials in the kit should be treated as any other laboratory chemi cals. Avoid ingestion, eye contact, and other potential detrimental exposure. A Material Safety Data Sheet (MSDS) is available upon request. Do not use expired or contaminated components, or components from other kits. Do not mix components from different manufactured lots. References United States Patent No.5,976,820; 1999; (Jolley, M & Nielsen, K.) USDA APHIS Doc. # ; Uniform Methods & Rules, 2003 USDA APHIS Brucellosis FP Evaluation Report; Website Report, 2004 EFSA Opinion on Brucellosis Diagnostic Methods; The EFSA Journal 2006 (432) OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, 2004 Nielsen, K. et al, OIE Scientific and Technical Review, 2004; 23: Gall, D. et al, OIE Scientific and Technical Review, 2004; 23: Jolley, M. et al, Conbinatorial Chemistry & High Throughput Screening, 2003 McGiven, J. et al, Journal of Immunological Methods, 2003; (278) Nielsen, K. et al, J. Immunoassay & Immunochemistry, 2001; 22(3): Nielsen, K. et al, Vet. Immunology & Immunopathology, 1998; 66(3 4): Nielsen, K. et al, Journal of Immunological Methods, 1996; 195(1 2): Note In : For use by or under the supervision of a veterinarian. Distribution in each State shall be limited to authorized recipients designated by proper State Officials under such additional conditions as these authorities may require.

5 223 North Water Street Suite 500 Milwaukee, WI Tel: Fax: E mail: info@diachemix.com Website: Technical Assistance 683 E. Center Street, Unit H Grayslake, IL Tel: Fax: E mail: techassistance@diachemix.com Diachemix, Rapid Definitive Detection, and Sentry are registered trademarks of as conferred by the United States Department of Patents and Trademarks.