3-in-1 Vaginal Health Test

The Vaginal Health Test is a 3-in-1 panel Antigen Rapid test Kit is an immunochromatographic assay that detects trichomonas vaginalis, candida albicans yeast, and gardnerella vaginalis antigen from a sample of your urine.

INTENDED USE

The Trichomonas V./C. albs (yeast) /Gardnerella V STD 3in1 panel Antigen Rapid test Kit is an immunochromatographic assay that detects trichomonas vaginalis, candida albicans yeast, and gardnerella vaginalis antigen from urine. This test is an in vitro diagnostic for screening Trichomonas vaginalis, candida albicans (yeast) and Gardnerella vaginalis with a self-collected urine sample at home.

KIT CONTENTS

  • 1 x The test cassette
  • 1 x Sample buffer bottle
  • 1 x Dropper: 0.5 ml pipette
  • 1 x Urine sample collection cup
  • 1 x Package Insert

MATERIALS REQUIRED BUT NOT PROVIDED

  • Timer

PROCEDURE

  1. Take out the urine cup from the package. Use it to collect your urine sample. Place the urine cup on a clean, empty, flat surface.
  2. Open the Sample Buffer Bottle (take care and do not let the buffer overflow).
  3. Take the dropper from the package and pipette 0.5 ml of the urine into the Sample Buffer Bottle.
  4. Secure the Purple Cap on the top of the Sample Buffer Bottle.
  5. Swirl the Sample Buffer Bottle 5 or more times.
  6. Put the Sample Buffer Bottle on a clean, empty, flat surface.
  7. Remove the Test Device from its protective package and place on a flat surface.
  8. Break the purple cap off of the top of the buffer bottle.
  9. Squeeze 4 drops of liquid from the buffer bottle into each of the TV, CA, GV wells on the Test Device.
  10. Keep Test Device flat on table. Set your timer to 15 minutes.
  11. Read the result at 15 minutes.

Additional Notes:

  • Do not read the result earlier than 15 minutes or after 30 minutes.
  • Note: A Control (C) line may appear in the result window within a few minutes, but a Test (T) line may take as long as 15 minutes to appear.
  • After 30 minutes the result might become inaccurate.

READING THE RESULTS

POSITIVE: Two coloured lines appear. If you see two lines, Control (C) line and Test (T)line, this means trichomonas, and/or candida albicans and/or Gardnerella vaginalis antigen was detected.

NEGATIVE: One coloured line appears. Only control line (C) appears. This result means trichomonas, and/or candida albicans and/or Gardnerella vaginalis antigen was not detected.

INVALID: No control (C) line is present. This may be the result of an incorrect test procedure and the test should be repeated.

CONTROL PROCEDURE

A procedural control is included in the test. A coloured line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique.

LIMITATIONS

  1. The contents of this kit are to be used for the qualitative detection of trichomonas vaginalis (TV) and/ or Gardnerella Vaginalis (GV) antigen from urine. Other specimen types may lead to incorrect results and must not be used.
  2. Failure to follow the instructions for test procedure and interpretation of test results may adversely affect test performance and/or produce invalid results.
  3. A confirmed diagnosis should only be made by a health care professional after all clinical and laboratory findings have been evaluated.
  4. A negative test result may occur if the specimen was collected, extracted or transported improperly. If symptoms continue, you should repeat the test.
  5. You are also advised to continue following local guidelines for self-isolation and consult your doctor.
  6. Reading the test results earlier than 15 minutes or later than 30 minutes may give incorrect results.

PERFORMANCE CHARACTERISTICS

The clinical performance of the Trichomonas V. /C.albs. (yeast)/ Gardnerella V 3 in 1 panel STD rapid Test Kit using vaginal swab specimen & urine specimen was compared with the various gold standard methods (Culture, PCR). Total 200 specimens of vaginal swab & urine respectively were collected from same person. All results are described as below.

  • This test kit is intended to be used as a preliminary test only and repeatedly abnormal results should be discussed with doctor or medical professional.
  • Follow the indicated time strictly.
  • Use the test only once. Do not dismantle and touch the test window of the test cassette.
  • The kit must not be frozen or used after the expiration date printed on the package.
  • Keep out of the reach of children.
  • The used test should be discarded according to local regulations.

STORAGE AND STABILITY

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30 °C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date.

Manufacturer Manufacturer Tests per kit Tests per kit Do not reuse Do not reuse
In Vitro For In Vitro use only Use by Use by Catalogue # Catalogue #
Temperature Store between 2-30 degrees C Lot number Lot number Authorized representative in EU Authorized representative in EU
Package damaged Do not use if package is damaged Instructions for use Consult Instructions for use Caution Caution