Pregnancy Test Operating Instructions

Pregnancy Test Operating Instructions

 

Introduction

This product is composed of the glass fiber strips of monoclonal antibody against human chorionic gonadotropin (hCG), anti-mouse lgG solid cellulose nitrate membrane and the bonders of absorptive colloidal gold – monoclonal antibody against hCG. It adopts the principles of double antibody sandwich method and immunochromatography to test the hCG in the urine.

 

Intended use

Used for early diagnosis of pregnancy.

 

Test procedure

Before the use please prepare a timer and urine cup.

1. The Pregnancy test is formulated for use with fresh urine specimens.

2. Urine cups should be used to collect specimens. Remove the strip from the foil wrapper.

3. Immerse the strip into the urine with the arrow end pointing toward the urine.

4. Do not cover the urine over the MAX (maximum) line. You may take the strip out after a minimum of 15 seconds in the urine and lay the strip flatly on a non-absorptive clean surface.

5. Read the result within 5 minutes.

6. Discard the test device after single use in the dustbin.

 

Interpretation of results

Negative

If only one pink line appears in the control area, you can assume that you are not pregnant.

Positive

If two pink lines appear both in the control area and test area, you can assume that you are pregnant.

Invalid

If there is no distinct pink-purple colored band visible both in the TEST area and CONTROL area, the test is inconclusive. It is recommended that in this case the test should be repeated. If the problem persists, contact your local distributor.

 

Warnings and precautions

For in vitro diagnostic use only

1. As with all diagnostic tests, a definitive diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and lab findings have been evaluated.

2. Read directions for use carefully before performing this test. Pay attention to the position of the C and T line.

3. Do not use the kit beyond the labeled expiry date.

4. Do not reuse the test devices. Discard it in the dustbin after single use.

5. Do not use if pouch is damaged or opened.

6. Do not touch the membrane area.

7. Once you open the pouch, the test device should be used immediately. Prolonged exposure to ambient humidity will cause product deterioration.

8. Treat urine samples and used devices as if they are potentially infectious. Avoid contact with skin.