Bacterial Vaginosis Test Kit (Comprehensive 4-Parameter Test) For In Vitro Diagnostics*

This kit is designed for qualitative detection of hydrogen peroxide (H2O2), leukocyte esterase (LE), sialidase catalytic activity (SNa), and pH levels (pH) in female vaginal secretions. Normal levels of these factors are altered during bacterial infection with common vaginosis strains (Gardnerella vaginalis, Peptostreptococcus spp., Prevotella spp., Bacteroides spp., and others).

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ENZ4-BV-20

Diagnostic Significance

Bacterial vaginosis (BV), also known as non-specific vaginitis, is a common infectious disease in women of childbearing age. The disease has a high infection rate, common occurrence of reinfection, and is easily transmitted (both sexually, and non-sexually). BV also predisposes women to an increase risk of premature delivery, endometriosis, pelvic inflammatory disease, vaginal cellulitis, and other reproductive tract infections. Failure to promptly identify and treat the disease can lead to further complications.

Bacterial infections in the vaginal tract are controlled via an acidic environment (~pH 4.0). When an infection occurs, pH levels can rise into a more basic environment. Bacterial pathogens in BV can also express an enzyme SNa, and can induce an inflammatory response where leukocyte infiltration elevates the levels of LE. Finally, as a bacterial infection develops, the loss of H2O2 producing Lactobacilli spp. can occur in the vaginal tract.

This comprehensive bacterial vaginosis test kits can test vaginal swabs for all of these factors simultaneously. The levels of H2O2, LE, SNa, and the pH of the vaginal samples can be immediately measured. Together this kit uses a combinatorial method to test for BV in patients.

Kit Components

The kit contains the following components. The entire kit can be used for 20 Comprehensive BV tests.

Component Size
BV Detection Cassette 20 individual cassettes
Sample Diluent 1 bottle, 20mL*
Coloring Reagent 1 bottle, 3mL**
Instruction Manual 1
Color Card 1

Note: The components of different lot numbers are not interchangeably.

* Add 20mL of deionized water to the Sample Diluent bottle

** Add 3mL of deionized water to the Coloring Solution bottle

Additional Materials Required

  • Precision pipettes
  • Cotton swabs for vaginal sample isolation
  • Distilled or deonized water
  • 1.5mL or larger volume test tube
  • 37°C or similar incubator

Storage and Stability

Store kit and individual packages at 2 – 8° centigrade, away from moisture, and away from light. Avoid freezing. Overall kit and individual cassettes are good for 12 months.

The Sample Diluent is good for 10 days after reconstitution. The individual cassette packages should only be opened when detection begins, and the cassette is only good for 4 hours after being opened.

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Usage

*Not approved for diagnostic or therapeutic use in the USA