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

Specimen  collection.

Any urine specimen is appropriate for HCG testing, 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 strips and specimens should be brought to room temperature(20-30℃) prior to testing.

1. Open the kit,hold the strip at the end without arrow or colored sign.
2. Inserted the end with arrow or colored sign of the strip into the urine sample figure 1,waiting for only 3 seconds. Do not immerse the strip into the urine sample over the signed band!
3. Take the strip out and lay the strip flat on a clean, dry and nonabsorbent surface.
4. Wait for 1 to 5 minutes and read the results as showed in figure 2.

Standard of interpretation

1. Negative:only one purple band appears on the control region and no clear band on the test region. It means hcg in the sample is negative.
2. Positive: two distinct purple bands appear on the control and test region. It means hcg in the sample is positive.
3. 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.
4. 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.
5. 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 strips should be kept from direct sunlight,moisture and heat. Do not freeze.

Shelf life is 18 months.

Notes

1. The package of kit should not be opened until it reaches the room temperature after taken from the refrigerator.
2. The dryers in the aluminium foil package are not victuals.

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