BVPro

BVPRO

CE marked for professional use

BVPro® is a simple, rapid, point-of-care diagnostic intended for professional use as an aid in the diagnosis of bacterial vaginosis (BV). The test detects sialidase enzyme activity in vaginal fluid, using a lateral flow immunoassay system which gives results in 15 minutes. Sialidase is an enzyme produced by bacterial pathogens in the vagina, and its presence is a well-established clinical marker of BV.

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SPECIFICATIONS

Product Name:            BVPro®

Product Code :             MBVP15  (5 tests per kit, each individually pouched)

  MBVP125        (25 tests per kit, each individually pouched)

Format:                          Lateral flow immunoassay

Sample:                          Vaginal fluid collected using a sterile swab

Detection Method:        Visual

Assay Time:                   15 minutes.

Storage:                          2o – 30oC

BACKGROUND

Bacterial vaginosis is an infection in the vagina, and is more common than both thrush and trichomoniasis.  The most common symptom is a vaginal discharge, which may become white or grey, thin and watery, with a strong fishy smell.

Untreated BV is associated with a slightly increased risk of developing complications during pregnancy, including miscarriage or preterm birth. It also increases the chance of developing an infection of the uterus following operations such as a vaginal hysterectomy, or a termination of pregnancy, and increases the risk of contracting STIs.

BV can usually be successfully treated by either a short course of antibiotic tablets, or by use of an antibiotic gel applied inside the vagina. For a number of women the first course of treatment is not effective, with the symptoms returning within three months. In these cases a different form of treatment may be prescribed.

PRINCIPLE OF THE ASSAY

BVPro® uses patented technology to detect sialidase activity; sialidase is an enzyme which degrades sugars and is reported to weaken the natural mucosal barriers in the vagina allowing anaerobic bacteria to colonise and out-compete healthy lactobacilli. BVPro® detects sialidase activity by supplying the enzyme with an artificial substrate. If sialidase is present, it will modify the substrate which is then captured on the test line using specific antibodies. Where no enzyme is present, the substrate remains unchanged and will not be captured.

A procedural control line is included to indicate that the assay has been performed correctly. The presence of a red line in addition to the Control line indicates a positive result.

BVAssay

BVPro TEST PROCEDURE

Ensure that a 15-minute time is available before starting. The test should be performed in a well-lit area.

Ensure the kit is at room temperature before use.

  1. Reconstitute the substrate pellet by opening the lid of the extraction tube, and adding the contents of one vial of buffer solution.
  2. Collect a sample of vaginal fluid using a sterile swab.
  3. Place the swab in the extraction tube, breaking the shaft at the break-point. Discard the end of the shaft, leaving the swab in the tube.
  4. Seal the lid of the extraction tube, then gently agitate the tube to encourage extraction of the vaginal fluid.
  5. Stand the tube upright and wait for 5 minutes for extraction to complete.
  6. Remove a device from the foil pouch. At the end of the extraction time, use the nozzle to dispense 4 drops of extract into the sample well.
  7. Leave on a flat surface for 10 minutes before reading visually.

BVAssay2jpg

INTERPRETATION OF RESULTS

If the test has been performed correctly, the Control line (C) will be visible as a strong red line.

If the Test line (T) is visible, this confirms sialidase activity in the vaginal fluid indicating that the patient has BV.

If no Test line (T) appears, there is no significant sialidase activity in the vaginal fluid and the patient does not have BV.

If no Control line (C) is visible, the results are invalid and the test should be repeated using a new device.

PERFORMANCE CHARACTERISTICS

A study of 40 clinical samples, with 11 BV positives and 29 negatives (by Hay-Ison reference assay), gave a sensitivity of 81.8% and a specificity of 96.5%.

The sialidase levels in these 40 samples were also assessed using a laboratory fluorimetric reference assay (based on M May et al. 2007, Avian Diseases, 51:829–33), with excellent correlation with BVPro® data (r2 0.95).

FURTHER INFORMATION

Click on the image below for the BVPro Brochure.
BVProInfoPage

Click on the image below for the IFU.

BVIFUFrint

 

This document can also be downloaded in a number of languages by clicking the following links:

DE: Gebrauchsanweisung

ES: Instrucciones de uso

FR:  Mode d’emploi

IT: Istruzioni per l’uso

 

 

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