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BVPro rapid diagnostic for Bacterial Vaginosis (BV). For professional use.

MOLOGIC PRODUCT NUMBER MBVP-1 0R-25

INTENDED USE

BVPro® is intended for professional use at the point of care, as an aid in the diagnosis of bacterial vaginosis (BV). It detects sialidase activity in vaginal fluid. Sialidase is an enzyme produced by bacterial pathogens in the vagina. The BVPro test is indicated for use in women suspected of having BV infection, e.g. if experiencing unusual vaginal discharge, or if they have a history of BV. Test results should be considered in conjunction with other clinical and patient information. BVPro is not intended for self-testing in the home.

SUMMARY & EXPLANATION OF THE TEST

Bacterial vaginosis is the most frequent vaginal infection in women of child bearing age. It is characterised by an imbalance in the microbial population in the vagina. The causes are not fully understood, but BV has been associated with serious health problems. Treatment usually involves administration of antibiotics.

BVPro is a rapid, easy-to-use test for the detection of sialidase activity in vaginal fluid. Elevated sialidase activity is associated with BV infection [A M Briselden et al., 1992, J. Clin. Microbiol., 30(3):663-666].

To perform the test, a sample of vaginal fluid is taken using a swab. The swab is placed in an extraction solution for 5 minutes. If sialidase enzyme is present, it reacts with a special substrate molecule. After 5 min, 4 drops of the resultant solution are applied to the lateral flow test device, which detects the modified substrate. The result is displayed and read after 10 minutes. If sialidase was present in the swab sample, a red test line appears, confirming that the patient has BV.

PRINCIPLES OF THE TEST

During extraction of the vaginal swab, sialidase activity modifies a special substrate, which can then be detected in the immunoassay lateral flow test. Elevated sialidase enzyme activity results in a positive TEST line, which indicates BV infection.

The appearance of the CONTROL line confirms that the test has been performed correctly.

KIT COMPONENTS (ALL SINGLE USE ONLY)

Each pack contains sufficient components for 5 or 25 tests. Each test comprises:

MATERIALS REQUIRED BUT NOT PROVIDEDTube stand and stopwatch/timer.

SAMPLE WELL

READ WINDOW

T C

DISC

STERILE SWAB

PLASTIC EXTRACTION BUFFER AMPOULE

SWAB EXTRACTION TUBE

LATERAL FLOW TEST DEVICE

PERFORMANCE CHARACTERISTICS

STORAGE

LIMITATIONS OF USE

Typical time to run test is 16-17 minutes.

Sensitivity/Specificity: 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).

This product should stored in the fridge. Allow to come to room temperature before use.

SAMPLE STORAGE

If the test cannot be carried out within 30 minutes of taking the sample it is recommended that samples are frozen until required.

For use with vaginal samples only.

For accurate results, please follow the instructions provided.

BVPro test results should be used in conjunction with other clinical and patient information.

BVPro indicates bacterial sialidase enzyme activity in a vaginal sample. Other types of infection, such as Candida, are not detected.

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WARNINGS & PRECAUTIONS

This product is intended for use with vaginal fluid swab samples only.

For in vitro diagnostic use only.

Single use. Used tests must not be re-used.

Do not use after the expiry date printed on the packaging.

Store in the fridge.

Allow test kit components to come to room temperature before use

Dispose of used kit components (swab, ampoule, extraction tube & lateral flow test device) in clinical waste.

If the extraction buffer is spilled, mop up with a tissue. If it contacts skin or eyes, rinse with fresh water.

QUALITY CONTROL

Before performing the BVPro test, please check that: the swab packaging is sealed and unopened. the foil pouch containing the extraction tube and the lateral flow test device is unopened and the silica gel desiccant is orange (if green, discard and use a new pouch).

the sample extraction tube contains a white disc. the buffer ampoule is sealed and there is no evidence of leakage of contents.

After performing the test ensure that the CONTROL line (C) has appeared as a red line in the lateral flow test device read window.If unsure about any of these observations, re-run the test with fresh components.

OPERATING PROCEDURE

1

Seal the tube by folding the lid and cap into place.

Gently agitate the tube to encourage the extraction of the vaginal fluid.

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1. Confirm that the patient has not recently (<2 days) used topical vaginal preparations (creams or ointments), or douched.

2. The test can tolerate low levels of menstrual blood, however we recommend using a blood free sample.

3. Check BVPro packaging is undamaged and unopened.

4. Check product is within expiry date.5. Allow the the test components to come up to

ambient temperature before use (10 min).

Confirm suitability of patient & check BVPro kit components

OPERATING PROCEDURE

Remove the extraction tube and lateral flow test device from the foil pouch (ensure that the dessicant sachet is orange). Stand the extraction tube in a suitable receptacle or tube stand, so it is vertical.

Check that the white disc is at the bottom of the tube, gently tapping the tube if necessary.

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Return the extraction tube to the receptacle/tube stand. Wait 5 minutes (use timer).

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iv). Apply extract to lateral flow test

OPERATING PROCEDURE

Open the lid of the extraction tube.

4

Gently twist and break off the top of the extraction buffer ampoule.

5

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When the 5 minute extraction has elapsed, take the extraction tube from the rack and remove the cap from the nozzle. Invert and carefully dispense 4 drops of extract into the sample well on the lateral flow test device by gently squeezing the tube. Wait 10 minutes (use a timer).

T C

x4

10 minutes

OPERATING PROCEDURE

Pour the contents into the extraction tube. (In case of spills, mop up with a tissue and if in contact with skin or eyes, rinse with fresh water.)

Remove the swab from its sterile packaging and collect a vaginal fluid sample from the patient, avoiding the cervix.

Perform the test within 15 minutes of sample collection.

6 7ii). Collect vaginal swab sample

Read the TEST (T) and CONTROL (C) lines visually after 5-10 minutes but do not read after 20 minutes.

17 18 Quality Control & Interpretation of the Test Resultsv). Read the test

results

T C

If the test has been performed successfully, the CONTROL line (C) will be visible as a red line. If the CONTROL line is not visible, the results are invalid and the test should be repeated using a fresh swab.

OPERATING PROCEDURE

8iii). Extract the swab

9

Place the swab in the extraction tube with the break-point (marked halfway up the swab handle) near the top edge of the tube.

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T C T C

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

If the TEST line is not visible, there is no significant sialidase activity in the vaginal fluid and the patient does not have BV.

OPERATING PROCEDURE

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Gently apply pressure to the shaft so that it snaps at the break-point.

Discard the end of the shaft, leaving the swab in the tube.

All used components and packaging should be disposed of as clinical waste.

vii). Disposal

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HELP LINE If you have any questions, please call us at +44 (0) 1234 780020, Monday – Friday 09:00 to 17:00, or email info@mologic.co.uk

Our professional staff will assist you. To learn more, please visit us at www.mologic.co.uk

BVPro is a registered trademark of Mologic Ltd

Mologic Ltd, Bedford Technology Park, Thurleigh, Bedford MK44 2YA, UK

BVPRO IFU, MAR 2017

© 2017 Mologic Ltd (UK)

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