Model Number

one-step pregnancy test

Intended Use

WH Accu Test Pregnancy is a immunoassay designed for the qualitative determination of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

SUMMARY AND EXPLANATION

Human Chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilization.  During normal pregnancy, HCG can be detected in urine as early as 7 days following conception, doubling every 1.3 to 2 days.  At the time of the last missed menstrual period, urine HCG levels are about 100mlU/ml with peak levels of 100,000 to 200,000mlU/ml seen at the end of the first trimester.  The presence of HCG soon after conception and its subsequent increase in concentration during early gestational growth make it an ideal marker for the early detection of pregnancy.

PRINCIPLE

The WH Accu Test Pregnancy test is a rapid qualitative one step assay for the detection of HCG in urine.  The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the HCG in the test samples with an extremely high degree of sensitivity.  In less than 5 minutes, levels of HCG as low as 25mlU/ml can be detected.

As the test sample flows through the absorbent device, the labeled antibody-dye conjugate binds to the HCG forming an antibody-antigen complex.  This complex binds to the anti-HCG antibody in the positive reaction zone (“T” area) and produces a pink-purple colored band when the HCG concentration is greater than 25mlIU/ml.  In the absence of HCG, there is no line in the positive reaction zone.  Unbound conjugate binds to the reagents in the control zone (“C” area), producing a pink-purple band, demonstrating that the reagents are functioning properly.

ASSAY PROCEDURE

1 DETERMINATION OF TEST DATE   

 The test could be used from the first missing date.

2.SPECIMEN COLLECTION AND HANDLING

The WH Accu Test Pregnancy is formulated for use with fresh urine specimens. The test should be used right after the specimen collection. Urine cup should be used to collect specimens, and the urine does not require any special pretreatment. 

3. TEST PROCEDURE

1.Remove the strip from the foil wrapper

2. Immerse the strip into the urine with the arrow end pointing toward the urine.  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. (See picture below).

3.Read results within five minutes.

DO NOT INTERPRET RESULT AFTER 10 MINUTES.

4. Discard the test device after single use in an appropriate place.

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 be repeated.