Direct Testing Systems and Serology

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1 Direct Testing Systems and Serology Rapid Manual Tests 6-2 Serology Diagnostics 6-6 BD Diagnostics Diagnostic Systems Catalog 2005/

2 Rapid Manual Tests Meningitis Test Systems Directigen Meningitis Combo Test Kit Directigen Meningitis Combo Test is a presumptive latex agglutination test for the direct qualitative detection of antigens to H. influenzae type b, S. pneumoniae, Group B Streptococcus, N. meningitidis Groups A, B, C, Y or W135, and Escherichia coli K1 in cerebrospinal fluid (CSF), serum, urine or blood culture media. In addition, the test kit provides confirmation and serogrouping capabilities from suspected colonies of H. influenzae type b, S. pneumoniae, Group B Streptococcus, and N. meningitidis Groups A/Y, B or C/ W135. Visible agglutination occurs when a sample containing any of these bacterial antigens reacts with the respective antibody-coated latex beads. Contains reagents for 30 tests Directigen Meningitis Combo Test Cards Contains 30 single use test cards for use with the Directigen Meningitis Combo Test Kit (Cat. No ) Directigen H. influenzae type B Test Kit Directigen H. influenzae type B test kit is a presumptive latex agglutination test for the direct qualitative detection of antigens to H. influenza type b. Contains reagents for 30 patient tests Directigen S. pneumoniae Test Kit Directigen S. pneumoniae test kit is a presumptive latex agglutination test for the direct qualitative detection of S. pneumoniae. Contains reagents for 30 tests Directigen N. meningitidis Group B/E. coli K1 Test Kit Directigen N. meningitidis Group B/E. coli K1 Test Kit is a presumptive latex agglutination test for the direct qualitative detection of antigens to N. meningitidis Group B and E. coli K1. Contains reagents for 30 tests Directigen N. meningitidis Groups A, C, Y and W135 Kit Directigen N. meningitidis Groups A, C, Y and W135 Test Kit is a presumptive latex agglutination test for the direct qualitative detection of antigens to N. meningitidis Groups A, C, Y and W135. Contains reagents for 30 tests Directigen Meningitis Specimen Buffer 8 ml solution containing EDTA for use with Cat. Nos , , , , and Neisseria gonorrhoeae Coagulation and Colorimetric Tests GonoGen II Monoclonal antibody-based colorimetric test intended for the confirmatory identification of Neisseria gonorrhoeae from culture. The GonoGen II test for N. gonorrhoeae contains a specific anti-gonococcal reagent composed of a pool of murine monoclonal antibodies (IgG) that have been prepared against a purified outer membrane protein, Protein I of N. gonorrhoeae. Contains reagents for 24 tests. BD Diagnostics Diagnostic Systems Catalog 2005/

3 Rapid Manual Tests Staphylococcus aureus Tests Staphyloslide Latex Test Kit Used for the identification of Staphylococcus aureus by detection of clumping factor and/or Protein A. Sufficient for 100 tests. Streptococcus Tests LINK 2 Strep A Rapid Test Kit LINK 2 Strep A is a lateral flow, one-step immunoassay for the rapid, qualitative detection of group A streptococcal antigen from throat swabs. The test is intended for use as an aid in the diagnosis of group A streptococcal infection. Sufficient for 25 tests Directigen Group B Strep Test Kit Directigen Group B Strep Test Kit is a presumptive latex agglutination test for the direct qualitative detection of Group B streptococci. Contains reagents for 30 tests Streptocard Enzyme Latex Test Kit Used for identification of Lancefield streptococcal groups A, B, C, F and G from streptococcus colonies that are ß-hemolytic and non-hemolytic. Contains reagents for 50 tests Streptocard Acid Latex Test Kit Used for identification of Lancefield streptococcal groups A, B, C, F and G from streptococcus colonies that are ß-hemolytic. Contains reagents for 50 tests Streptocard Group A Latex Reagent (50 ml) Streptocard Group B Latex Reagent (50 ml) Streptocard Group D Latex Reagent (50 ml) Streptocard Acid Extraction Reagent (50 ml) Streptocard Enzyme Extraction Reagent (50 ml) Streptocard Positive Control (50 ml) Streptocard Reaction Cards (50 cards) 6-4 BD Diagnostics Diagnostic Systems Catalog 2005/2006

4 Rapid Manual Tests Stool Diagnostics ColorPAC Toxin A Test Kit ColorPac Toxin A Test is a rapid chromatographic assay for the qualitative detection of Clostridium difficile toxin A (enterotoxin) in stool specimens from patients suspected of having C. difficile-associated disease. The test can be used for confirmation of suspected colonies of toxigenic C. difficile from agar plates or BHI broth. Contains reagents for 30 tests Culturette CDT (C. difficile) Test Kit The Culturette CDT (Clostridium-Difficile-Test) test is a rapid, 20 minute latex agglutination test intended for the detection of Clostridium difficile antigens in stool specimens. Contains reagents for 25 tests Culturette CDT Buffer Solution For use with Culturette CDT (C. difficile) Test Kit ( ). Contains 6 bottles (18 ml each). Culturette Toxin CD Test Kit The Culturette Toxin CD Test is a rapid 70-min enzyme immunoassay (EIA) for the detection of Clostridium difficile toxin A (enterotoxin) in human stool samples. Contains reagents for 96 tests. BD Diagnostics Diagnostic Systems Catalog 2005/

5 Serology Diagnostics BD Macro-Vue RPR Kits Macro-Vue RPR Card Test Kit (No.100) The Macro-Vue RPR (Rapid Plasma Reagin) 18-mm Circle Card Tests and Tear-drop Tests are nontreponemal testing procedures for the serological detection of syphilis. RPR Card antigen suspension is a carbon particle cardiolipin antigen which detects reagin, an antibody-like substance present in serum or plasma from syphilitic persons. Binding of reagin to cardiolipinlecithin-coated cholesterol particles on the test antigen causes macroscopic flocculation. Contains reagents for 100 tests Macro-Vue RPR Card Test Kit (No.104) Nontreponemal testing procedure for the serologic detection of syphilis. Contains two ampules of antigen (3 ml each), 20G dispensing needle, antigen dispensing bottle, stirrers, 30 cards with ten circle spots (diameter 18 mm), 300 capillaries (0,05 ml). Sufficient for 300 tests Macro-Vue RPR Card Test Kit (No.110) Nontreponemal testing procedure for the serologic detection of syphilis. Contains three ampules of antigen (3 ml each), 20G dispensing needle, antigen dispensing bottle, 50 cards with ten circle spots (diameter 18 mm), Dispenstirs devices, 500 capillaries (0.05 ml). Sufficient for 500 tests Macro-Vue RPR Card Test Kit (No.112) Nontreponemal testing procedure for the serologic detection of syphilis. Contains five ampules of antigen (3 ml each), 20G dispensing needle, antigen dispensing bottle, 15 cards with ten circle spots (diameter 18 mm), Dispenstirs devices, 150 capillaries (0.05 ml). Sufficient for 150 tests Macro-Vue RPR Card Test Kit (No.115) Nontreponemal testing procedure for the serologic detection of syphilis. Contains 1 ampule of antigen (3 ml), 20G dispensing needle, antigen dispensing bottle, 15 cards with ten circle spots (diameter 18 mm), Dispenstirs devices, 150 capillaries (0.05 ml). Sufficient for 150 tests. BD Macro-Vue RPR Controls Macro-Vue RPR Control Cards For the serologic detection of syphilis; circle spots have a diameter of 18 mm each. Results are classified as R, RM, or NR [Reactive (++), Minimal Reactive (+), NonReactive (-)]. Macro-Vue RPR Liquid Controls 1.5 ml of liquid for use with Macro-Vue RPR Control Cards ( ). 6-6 BD Diagnostics Diagnostic Systems Catalog 2005/2006

6 Serology Diagnostics BD Macro-Vue RPR Components Macro-Vue RPR Card Antigen Suspension RPR Card Antigen Suspension in 3 ml ampules. Macro-Vue RPR Card Antigen Suspension RPR Card Antigen Suspension in 3 ml ampules. Macro-Vue RPR (Rapid Plasma Reagin) Card Antigen Suspension RPR Card Antigen Suspension in 1 ml ampules. Cards, Brewer Diagnostic RPR, 18 mm circle, quantitative, 30 spot cards. Cards, Brewer Diagnostic RPR, 18 mm circle, quantitative, 15 spot cards. Cards, Brewer Diagnostic RPR, 18 mm circle, qualitative, 10 spot cards. Antigen (Plastic) Dispensing Bottle Dispenstirs Device 0.05 ml volume (for use with 18 mm circle RPR card tests) Needles, Dispensing (square cut) 20G. Yellow hub Macro-Vue Card Test Rotator Accessories Package Package contains: One 7 X 15'' rotator extension top, two humidifying covers BD Diagnostics Diagnostic Systems Catalog 2005/

7 Serology Diagnostics Syphilis Reagents VDRL Cardiolpin Antigen With 60 ml VDRL buffered saline. This reagent is used in the qualitative and quantitative determination in the following nontreponemal serologic tests for syphilis: VDRL Slide Qualitative Test with Serum, VDRL Slide Quantitative Test with Serum, VDRL Slide Qualitative Test with Cerebrospinal Fluid, VDRL Slide Quantitative Test with Cerebrospinal Fluid. The VDRL antigen has been standardized by comparison with an antigen of known reactivity to produce standard reactivity in the tests listed above. The VDRL Buffered Saline is for the preparation of antigen emulsion for the VDRL and the tube flocculation tests VDRL Cardiolpin Antigen With 60 ml VDRL Buffered saline. This reagent is used in the qualitative and quantitative determination in the following nontreponemal serologic tests for syphilis: VDRL Slide Qualitative Test with Serum, VDRL Slide Quantitative Test with Serum, VDRL Slide Qualitative Test with Cerebrospinal Fluid, VDRL Slide Quantitative Test with Cerebrospinal Fluid. The VDRL antigen has been standardized by comparison with an antigen of known reactivity to produce standard reactivity in the tests listed above. The VDRL Buffered Saline is for the preparation of antigen emulsion for the VDRL and the tube flocculation tests. VDRL Test Control Serum Set Venereal Disease Research Laboratory. Rehydrate to 3 ml per vial; Contains: Nontreponemal Antigen Reactive Serum - 1 vial VDRL Weakly Reactive Serum - 1 vial Nontreponemal Antigen Nonreactive Serum - 1vial Diagnostic Reagent Droppers FTA Antigen (1 ml) x 3 ml FTA Sorbent (5 ml) Standardized extract of non-pathogenic Reiters treponeme containing group treponemal antigens. FTA Sorbent Control (5 ml) Non-specific control. USR Test Control Serum Set Rehydrate to 3 ml per vial. Contains: Nontreponemal Antigen Reactive Serum - 1 vial USR, Weakly Reactive Serum - 1 vial, Nontreponemal Antigen - 1 vial, Aliquot Vials - 3 vials USR Antigen Unheated Serum Reagin (USR) Antigen 6-8 BD Diagnostics Diagnostic Systems Catalog 2005/2006

8 Serology Diagnostics Viral Diagnostic Testing Systems Directigen Flu A Test Kit In vitro enzyme immunoassay (EIA) membrane test for the direct rapid and qualitative detection of influenza A viral antigen from suitable specimens of symptomatic patients. 20 tests Directigen Influenza A+B, 20 Tests Directigen Influenza A+B Test is a rapid immunoassay membrane assay that detects and differentiates influenza A and B viral antigens. This complete testing system is suitable for testing a variety of specimens, including nasopharyngeal aspirate, nasopharyngeal swab, nasopharyngeal wash, lower nasal swab, and throat swab. Results are produced in less than 15 minutes and are based on visual color development in ColorPAC wells that indicate the presence or absence of influenza A and influenza B antigen in the specimen Directigen RSV Test Kit In vitro enzyme immunoassay (EIA) membrane test for the rapid and qualitative detection of RSV (Respiratory Syncytial Virus) antigen directly from nasopharyngeal specimens has 20 tests; has 40 tests VZVscan Card Test Kit Varicella-zoster Virus Antibody Card Test. 30 tests VZVscan Card Test Kit Varicella-zoster Virus Antibody Card Test. 100 tests Directigen EZ RSV Test Kit The BD Directigen EZ RSV Test utilizes only one reagent and one device for rapid RSV (Respiratory Syncytial Virus) detection. The testing device employs innovative lateral flow technology, where dried reagents have already been applied to the testing strip. Workflow is reduced to a two-step process, with clear-cut results shown by the appearance of an easy-toread double line, indicating a positive result for RSV, along with the Internal Control line. BD Diagnostics Diagnostic Systems Catalog 2005/

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