Human Chorionic Gonadotropin HCG Rapid Test

INTENDED USE

hCG Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine specimens. This kit is intended for use as an aid in the early detection of pregnancy. For in vitro self test only.

INTRODUCTION

Human chorionic gonadotropin (hCG), a glycoprotein hormone secreted by viable placental tissue during pregnancy, is excreted in urine approximately 20 days after the last menstrual period. hCG levels rise rapidly, reaching peak levels after 60-80 days. The appearance of hCG in urine soon after conception and its rapid rise in concentration makes it an ideal marker for the early detection and confirmation of pregnancy. However, elevated hCG levels are frequently associated with trophoblastic and non-trophoblastic neoplasms and hence these conditions should be considered before a diagnosis of pregnancy can be made.

MAIN CONTENTS

Rapid Test Cassette

Package insert

STORAGE AND STABILITY

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

The test must remain in the sealed pouch until use.

Keep away from direct sunlight, moisture and heat.

Do not freeze.

OPERATION
1. Remove test Strip, Device or Midstream from the sealed pouch.
2.1 Strip: Remove test strip from the sealed pouch. Dip the arrowed end of the test strip into the container with urine sample, take it out in 5 seconds and lay flat.
2.2 Device/Cassette: Remove test device/cassette from the sealed pouch. Lay the device flat, add 2-3 drops of urine specimen by sample dropper into the sample well.
2.3 Midstream/Pen: Remove test midstream from the sealed pouch. Open the midstream cup, dip the sample collection head into urine sample, take it out in 5 to 10 seconds and lay it flat.
3. Read the results

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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