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#100174043 | Mfg #252360 | Clinical Laboratory

Rapid Test Kit Directigen™ Meningitis Combo Latex Agglutination Test Meningitis Testing Serum / Urine / Cerebrospinal Fluid (CSF) / Bacteria Colony Sample 90 Determinations CLIA Moderate Complexity for Direct AG, Visual / CLIA High Complexity for Blood Culture

TEST KIT, MENINGITIS 30TEST 8523-60 D/S4952360 (90/EA) D/S
Rapid Test Kit Directigen™ Meningitis Combo Latex Agglutination Test Meningitis Testing Serum / Urine / Cerebrospinal Fluid (CSF) / Bacteria Colony Sample 90 Determinations CLIA Moderate Complexity for Direct AG, Visual / CLIA High Complexity for Blood Culture

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

Product Specifications

MSFH #
100174043, 252360
Manufacturer #
BD, Directigen™ Meningitis Combo, Unknown
Brand
Rapid Test Kit
Manufacturer
CLIA Moderate Complexity for Direct AG
Country of Origin
Visual / CLIA High Complexity for Blood Culture
Application
(2) 0.5 mL Reagent A and B, (6) 1 mL Reagents 1 to 6, 9 mL Positive Control
CLIA Classification
9 mL Negative Control
Contents 1
8 mL Specimen Buffer
Number of Tests
90 Determinations
Reading Type
Visual Read
Sample Type
Serum / Urine / Cerebrospinal Fluid (CSF) / Bacteria Colony Sample
Storage Requirements
Requires Refrigeration
Test Format
Test Card Format
Test Name
Meningitis Testing
Test Type
Latex Agglutination Test
Time to Results
10 Minute Results
UNSPSC Code
41116129

Description

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

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

90 determinations (30 patient tests, 60 controls)

Read the test results macroscopically under a high intensity incandescent light

90 determinations (30 patient tests, 60 controls)

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