Bacterial Vaginosis Test Kit (Sialidase Detection Method) For In Vitro Diagnostics*

This kit is designed for qualitative detection of sialidase catalytic activity in female vaginal secretions. This enzyme is commonly produced from vaginal bacterial pathogens (Gardnerella vaginalis, Peptostreptococcus spp., Prevotella spp., Bacteroides spp., and others).

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ENZ1-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 increased 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.

The enzyme sialidase is commonly associated with most BV related bacterial pathogens. Furthermore, sialidase activity can easily be measured in the vaginal secretions of potential BV patients, and the presence of its activity highly correlates with coincident infection with BV pathogens. As such, the presence of sialidase activity is diagnostically relevant for detecting a potential BV infection.

Kit Components

The kit contains the following components. The entire kit can be used for 20 BV sialidase level measurements.

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