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#100365609 | Mfg #446252 | Clinical Laboratory

Test Kit Affirm™ VPIII Microbial Identification Candida Species / Gardnerella Vaginalis / Trichomonas Vaginalis Vaginal Secretion Sample 24 Tests Non-CLIA Waived

TEST KIT, AFFIRM VPIII (24/KT)
Test Kit Affirm™ VPIII Microbial Identification Candida Species / Gardnerella Vaginalis / Trichomonas Vaginalis Vaginal Secretion Sample 24 Tests Non-CLIA Waived

The Affirm™ VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species, Gardnerella vaginalis and Trichomonas vaginalis nucleic acid in vaginal fluid specimens

Product Specifications

MSFH #
100365609, 446252
Manufacturer #
Affirm™ VPIII, BD
Brand
Unknown
Manufacturer
Test Kit
Country of Origin
Non-CLIA Waived
Application
(24) Filter Tips, 15 mL Buffer Solution, 10.8 mL Lysis Solution, 3.4 mL Substrate Solution, (24) Reagent Cassettes, (24) Probe Analysis Cards, (24) Sample Collection Cups
CLIA Classification
(24) Sample Collection Tubes
Contents 1
(24) Sterile Swabs
Number of Tests
24 Tests
Product Dating
MSFH Acceptable Dating: we will ship >= 60 days
Reading Type
Visual Read
Sample Type
Vaginal Secretion Sample
Storage Requirements
Requires Refrigeration
Test Format
Test Card Format
Test Name
Candida Species / Gardnerella Vaginalis / Trichomonas Vaginalis
Test Type
Microbial Identification
Time to Results
45 Minute Results
UNSPSC Code
41116129

Description

The test uses two distinct single-stranded nucleic acid probes for each organism, a capture probe and a color development probe, that are complementary to unique genetic sequences of the target organisms

The capture probes are immobilized on a bead embedded in a Probe Analysis Card (PAC), which contains a separate bead for each target organism

The color development probes are contained in a multi-well Reagent Cassette (RC)

Kit includes: 24 Probe Analysis Cards (PAC), 24 Reagent Cassettes (RC), 3.4 mL Substrate Solution, 10.8 mL Lysis Solution, 15 mL Buffer Solution, 24 Filter Tips, 24 Sample Collection Cups, 24 Sample Collection Tubes, 24 Sterile Swabs

Individually packaged cards, wrapped in an absorbent paper towel moistened with a solution containing sodium azide (0.1%, w/v) as a preservative

Each PAC contains the following five beads: Negative Control, Trichomonas, Gardnerella, Candida, and Positive Control

Reagents are sealed in multi-well, foil covered cassettes

Each cassette has seven wells

All reagents are supplied ready for use

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