ONE-STEP HCG URINE PREGNANCY CASSETTE TEST

One-step HCG test is designed by sandwich principle for detection ofHCG in urine. The test owned characteristics of 25 mIU/ml sensitivity,specifity,speedy and simplicity.

Specimen Collection

Any urine specimen is appropriate for HCGtesting, but the first morning urine is optiomal because it generally contains the highest concentration of HCG. Urine specimens may be collected in any clean and dry container which be stored in the refrigerator(4-8) for up to 72 hours before assay if it can not be tested immediately. The stored specimens should be allowed to reach room temperature before testing.

Procedure

Test cassette and specimens should be brought to room temperature(20-30) prior to testing.

Before opening of the pouch to avoid condensation of moisture on the memberane label the device with testeror control indentifications.

Draw sample to the line marked on the pipettor(approximately 0.2ml)entirecontents into the sample well,Dispense 6 drops of the specimen or control into the sample well(diag one).each sample or control,use a separate pipettor and device.

Wait for 1 to 5 minutes and read the results.

Standard of interpretation

Negative:Only one pink band appears on the control region and no clear band on the test region. It means HCG in the sample is negative.

Positive: Two distinct purple bands appear on the control and test region. It means HCG in the sample is positive.

Weak Positive: The red color band in the test region of strip shows dimmer than the purple color band in the control region of strip. It means it is necessary that test be done again in the 48 hours.

Strong positive: The red color band in the test region of strip show very bright and the purple color band very dim in the control region of strip. It means the pregnancy is developing in the end of the first trimester.

Invalid: No visible red at all, it means the test is fail.

Storage and stability

Stored at normal room temperature (4-30) up to the expiration date. The test CARDs should be kept from direct sunlight,moisture and heat. Do not freeze.

Shelf life is 18 months.

Notes
The package of kit should not be opened until it reaches the room temperature after taken from the refrigerator.

The dryers in the aluminium foil package are not victuals.