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Directigen™ Meningitis Combo Test Kit
| Cat. # | Description | Qty. | Unit | ||||||
| 252360 | Directigen™ Meningitis Combo Test Kit
(90 determinations) containing: one 9 mL bottle Positive Control , one 9 mL bottle Negative Control , one 1 mL bottle H. influenzae type b antibody, Reagent 1 , one 1 mL bottle S. pneumoniae antibody, Reagent 2 , one 1 mL bottle Group B Streptococcus antibody, Reagent 3 , one 1 mL bottle N. meningitidis Groups C and W135 antibody, Reagent 4 , one 1 mL bottle N. meningitidis Groups A and Y antibody, Reagent 5 , one 1 mL bottle N. meningitidis Group B/ E. coli K1 antibody, Reagent 6 , one 8 mL bottle Specimen B one 0.5 mL bottle control latex Reagent A (rabbit) , one 0.5 mL bottle control latex Reagent B (mouse) 30 single use test cards , plastic stirrers, workstation and procedure chart
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1 | EA | ||||||
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The Directigen™ Meningitis Combo Test is a presumptive latex agglutination test for the direct qualitative detection of antigens to H. influenzae type b, S. pneumoniae, N. meningitidis groups A, B, C, Y or W135 and Escherichia coli K1 in cerebrospinal fluid (CSF), serum or urine. The test can also be used for the direct qualitative detection of antigens to group B Streptococcus in CSF and serum. 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 is reacted with its respective antibody-coated latex beads.
| Catalog # | Description | Quantity | Unit |
| 252360 |
Directigen™ Meningitis Combo Test Kit
(90 determinations) containing: one 9 mL bottle Positive Control , one 9 mL bottle Negative Control , one 1 mL bottle H. influenzae type b antibody, Reagent 1 , one 1 mL bottle S. pneumoniae antibody, Reagent 2 , one 1 mL bottle Group B Streptococcus antibody, Reagent 3 , one 1 mL bottle N. meningitidis Groups C and W135 antibody, Reagent 4 , one 1 mL bottle N. meningitidis Groups A and Y antibody, Reagent 5 , one 1 mL bottle N. meningitidis Group B/ E. coli K1 antibody, Reagent 6 , one 8 mL bottle Specimen B one 0.5 mL bottle control latex Reagent A (rabbit) , one 0.5 mL bottle control latex Reagent B (mouse) 30 single use test cards , plastic stirrers, workstation and procedure chart
|
1 | EA |
BD Directigen™ Meningitis Combo Test
Revision: 2010/11 Revision Date: 11/01/2010
The Directigen™ Meningitis Combo Test is a presumptive latex agglutination test for the direct qualitative detection of antigens to H. influenzae type b, S. pneumoniae, N. meningitidis groups A, B, C, Y or W135 and Escherichia coli K1 in cerebrospinal fluid (CSF), serum or urine. The test can also be used for the direct qualitative detection of antigens to group B Streptococcus in CSF and serum. 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 is reacted with its respective antibody-coated latex beads.
The diagnosis of bacteremia and meningitis, especially in young children, can be difficult. As many as 55% of children are seen by a physician and started on antibiotics before meningitis is detected.1 Detection of microbial antigens in the CSF is a rapid and helpful method for diagnostic microbiology. It may be the single most important test in cases of partially treated meningitis since Gram stain and culture may be negative. Detection of a specific antigen is a clinically significant finding and a valuable aid when choosing antimicrobial therapy.2
Haemophilus influenzae type b, Neisseria meningitidis, and Streptococcus pneumoniae have been reported to be the three causative agents responsible for approximately 84% of cases of bacterial meningitis.3
Group B Streptococcus and Escherichia coli K1 are major bacterial pathogens in the newborn.4-7 Strains of group B.streptococci and E. coli K1 frequently colonize in the vagina and/or rectum and may be associated with maternal septicemia and neonatal septicemia, pneumonia and meningitis.8 The E. coli K1 polysaccharide antigen has been shown to be structurally and immunologically similar to Neisseria meningitidis group B antigen.9,10 The Directigen Neisseria meningitidis group B Latex Reagent does not differentiate the two antigens, but can be useful in the diagnosis of neonatal E. coli K1 meningitis. The high morbidity and mortality associated with group B streptococci and E. coli K1 in newborns make rapid, accurate identification of these organisms extremely important.4
Immunological methods for detecting characteristic exoantigens of pathogenic microorganisms in patient fluids (CSF, serum, urine) are typically faster than traditional methods such as culture. These techniques include counterimmunoelectrophoresis (CIE) and latex agglutination.11-14 The latex agglutination procedure has been found to be more rapid and sensitive than CIE in the detection of purified antigen.15-17
Include Control + and Control - testing with each batch of specimens tested as described in step 1, "Test Procedure." Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI (formerly NCCLS) guidance and CLIA regulations for appropriate Quality Control practices.
Directigen Meningitis Combo Kit:
| Reagent 1 | (1.0 mL), | Anti-H. influenzae type b, Rabbit Polyclonal Antibody-Coated Latex Suspension, | ||
| Reagent 2 | (1.0 mL), | Anti-S. pneumoniae, Rabbit Polyclonal Antibody-Coated Latex Suspension, | ||
| Reagent 3 | (1.0 mL), | Anti-group B Streptococcus, Rabbit Polyclonal Antibody-Coated Latex Suspension, | ||
| Reagent 4 | (1.0 mL), | Anti-N. meningitidis groups C and W135, Rabbit Polyclonal Antibody-Coated Latex Suspension, | ||
| Reagent 5 | (1.0 mL), | Anti-N. meningitidis groups A and Y, Rabbit Polyclonal Antibody-Coated Latex Suspension, | ||
| Reagent 6 | (1.0 mL), | Anti-N. meningitidis group B / E. coli K1, Mouse Monoclonal Antibody-Coated Latex Suspension, | ||
| Reagent A | (0.5 mL), | Control Latex, Rabbit Immunoglobulin-Coated Latex Suspension, | ||
| Reagent B | (0.5 mL), | Control Latex, Mouse Immunoglobulin-Coated Latex Suspension, each of the above with 0.2% sodium azide (preservative), | ||
| Control + | (9.0 mL), | Polyvalent Positive Antigen Control, H. influenzae type b, S. pneumoniae, group B Streptococcus and N. meningitidis groups A, B, C, Y and W135 antigens, | ||
| Control - | (9.0 mL), | Negative Antigen Control, glycine buffered saline, each of the above with 0.2% sodium azide (preservative), | ||
| Specimen Buffer | (8.0 mL), | Specimen Buffer Solution, containing EDTA. | ||
For in vitro Diagnostic Use.
Warning: Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions"18-21 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids. Prior to discarding, sterilize specimen containers and other contaminated materials by autoclaving.
Information shown on this page is a short summary extracted from the Package Insert, available as a PDF under the Related Documents section of this page.
