Rapid Test H. pylori Ag MonlabTest® Kit (25 Test)

Description

H. pylori Ag Monlab Test – Rapid assay for the detection of Helicobacter Pylori antigens.

H. pylori Ag Monlab Test is a qualitative lateral flow immunoassay for the detection of Helicobacter Pylori antigens in human stool samples

MATERIAL IN THE BOX

• 25 Tests
• Instructions for use
• 25 vials of sample with diluent

CAMPIONING AND PREPARATION of H. pylori Ag Monlab Test

Take sufficient amount of stool sample (1-2g or mL for liquid samples). Stool samples should be stored in a clean, dry container (no preservatives or transport). Samples can be refrigerated (2-4ºC/36-40ºC) during 1-2 days before use. For longer storage they should freeze at -20ºC/-4ºF. In this case, the sample should be totally thawed reaching room temperature before use.

PROCEDURE

To process the stool sample (see drawing 1): use a sample vial with different diluent for each sample. Unscrew the top of the vial and introduce the stick at least twice into the stool sample in order to take sufficient amount of sample (250mg). Close the vial with the swab and sample. Shake to ensure good dispersion. For liquid samples, use a pipette and add 250 µL into the sample vial with diluent.

Procedure (Drawing 2) Before testing, samples and diluent must reach room temperature (15-30ºC/59-86ºF). Do not open the container until the test is performed. 1. Remove H. pylori Ag MonlabTest from its sealed container and use it as soon as possible. 2. Shake the vial with the sample to ensure good dispersion. Break the top of the vial. 3. Use a different test for each sample. Dispense 4 drops or 100µL into the sample well (S). Start the stopwatch. 4. read the result after 10 minutes of dispensing the sample.

PRECAUTIONS

• • Only for professional use in vitro diagnosis.

• Do not use after the expiration date.
• The test must be kept in a sealed container until use.
• Do not use the test if the container is damaged.
• Comply with Good Laboratory Practices, wear appropriate protective clothing, use disposable gloves, and do not eat, drink or smoke in the area of the test performance.
• All specimens must be stored in a sealed container until use.
• All specimens should be considered as potentially hazardous and should be handled in the same manner as an infectious agent.
• The test should be placed in a sanitary waste container after use.
• The test should be conducted during the two hours after the container is opened.

CONSERVATION AND STABILITY

The test should be kept in its sealed container at cool or room temperature (2-30ºC/36-86ºF). The test will remain intact until the expiration date printed on the container.

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