INTENDED USE

The Chlamydia Rapid Test (Swab/Urine) is a rapid visual immunoassay for the qualitative presumptive detection of Chlamydia trachomatis in female cervical swab, male urethral swab and male urine specimens. This kit is intended for use as an aid in the diagnosis of Chlamydia infection.

INTRODUCTION

Chlamydia psittasi infection is associated with respiratory disease in individuals exposed to infected birds and is not transmitted from human to human. Chlamydia pneumonia, first isolated in 1983, is associated with respiratory infections and pneumonia. Traditionally, chlamydia infection has been diagnosed by the detection of chlamydia inclusions in tissue culture cells. Culture method is the most sensitive and specific laboratory method, but it is labour intensive, expensive, lengthy (2-3 days) and not routinely available in most institutions. Direct tests such as immunofluorescence assay (IFA) require specialized equipment and a skilled operator to read the result.
 

MAIN CONTENTS

Test Cassette

Disposable Pipettes

Buffer

Instructions for use

STORAGE AND STABILITY

Store at 2 ~ 30 º C in the sealed pouch for 24 months.

Keep away from direct sunlight, moisture and heat.

Do not freeze.

TEST PROCEDURE
1. Remove the test from its sealed pouch, and place it on a clean, level surface. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 3 drops of the specimen (approximately 75 µL) to each specimen well (S) of the device, then add one drop of buffer and start the timer.
3. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

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