Precision

A study was conducted which consisted of performing a series of replicate assays using 25 mIU/ml and 100 mIU/ml hCG in urine. All the test results were consistent .

Storage and Stability

1. Store as packaged in the sealed pouched at room temperature (4-30℃). The kit is stable within the expiration date printed on the labeling.

2. Once open the pouch, the test strip should be used within 1 hours. Prolonged exposure to ambient humidity will cause product deterioration.

Test Procedure

· Read the entire procedure carefully prior to performing any tests.

Allow test Cassette and urine samples to equilibrate to room temperature (20-30℃) prior to testing.

1. Remove the test stick from its foil pouch by tearing at the notch and take the cap off the test stick.

2. To perform the test, turn the test stick so the absorbent tip is pointing in a downward direction and hold the test stick in your stream of urine so the urine makes contact with the absorbent area. Hold it for at least ten seconds so that adequate urine goes into the absorbent part of the tip. Do not allow urine to splash into the result window.

3. Re-cap the pregnancy test stick and lay the test stick flat on a horizontal surface with the result window facing upwards.

4. Wait for red lines to appear. The test should be read in approximately 3-5 minutes. Do not interpret results after the specified reaction time.

Interpretation of Results

Positive: Two distinct red lines will appear, one in the test region (T) and one in the control region (C).Positive test results are possible but not definitive for the diagnosis of pregnancy. It is strongly recommended that an additional urine specimen be obtained after 48-72 hours and tested again, or consulting your physician.

Negative: Only a single red line appears in the control region (C). No apparent red or pink line appears in the test region (T). Negative test results mean that you may not be pregnant.However, you should re-test with the first morning specimen obtained 48-72 hours later.

Invalid: Control band fails to appear which means improper testing procedures or deterioration of reagents probably occurred. In any event, repeat the test. If the problem persists, discontinue using the lot immediately and contact your local distributor.

Notes: The shade of red color in the test region (T) will vary depending on the concentration of hCG present. However, neither the quantitative value nor the rate of increase in hCG can be determined by this qualitative test.

Diagnostic sensitivity and specificity

Studies were performed which consisted of testing 48 positive and 52 negative specimens using the hCG Pregnancy Test Cassette versus a reference hCG immunoassay. Both of these studies demonstrate 100% (relative) correlation.