Bowel (FOB) Instructions

The Bowel test is a self-testing device used to detect human occult blood in the stool.

INTENDED USE

The Bowel Test is a lateral flow rapid chromatographic immunoassay for the qualitative detection of human occult blood in human faeces to aid in the diagnosis of gastrointestinal bleeding.

PRECAUTIONS

Please read all the information in this package insert before performing the test.

  • Do not eat, drink or smoke in the area where the specimens or kits are handled.
  • Store in a dry place at 2-30 °C (36-86 °F), avoiding areas of excess moisture. If the foil packaging is damaged or has been opened, please do not use.
  • 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.

KIT CONTENTS

  • Test Device
  • Instructions
  • Faeces Collection Device

MATERIALS REQUIRED BUT NOT PROVIDED

  • Timer

PROCEDURE

  1. Collect sufficient quantity of faeces in a clean dry collection device.
  2. Unscrew the cap of the specimen collection tube, then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites to collect approximately 50mg of faeces. Do not scoop the specimen.
  3. Insert the specimen collection applicator back into the test device.
  4. Shake the test device for 10-15 seconds to mix well. Leave the device for 2 minutes.
  5. Remove the plastic limit strip
  6. Put the test on a clean and level surface, press the device body from top to bottom and start the timer.
  7. Read the results at 5 minutes. Do not interpret the results after 10 minutes.

READING THE RESULTS

POSITIVE: Two coloured lines appear. One is in the control region (C) and another should be in the test region (T). (Note: The intensity of the line in region (T) will vary depending on the concentration of Fecal Occult Blood present in the specimen)

NEGATIVE: One coloured lines appears in the control region (C). No coloured line appears in the test line region (T)

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

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 FOB test is for in vitro diagnostic use only
  2. The FOB test will only indicate the presence of fecal occult blood, the presence of blood in the faeces does not necessarily indicate colorectal bleeding.
  3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.
  4. Other clinically available tests are required if questionable results are obtained.
  5. This test may be less sensitive for detecting upper gastrointestinal bleeding because blood degrades as it passes through the gastrointestinal tract.

PERFORMANCE CHARACTERISTICS

Clinical Performance

The performance of the FOB test has been evaluated with 260 clinical specimens in comparison with other FOB rapid tests. The results show that the relative sensitivity of the FOB test is 98.6% and the relative specificity is 98.9%

This assay 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.
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