HCG Urine Rapid Test (Strip) Self Testing

INTENDED USE

Cortez Diagnostics, Inc. OneStep hCG Urine RapiD™ InstaTest is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine at a concentration level from 20mIU/ml or greater to aid in the early detection of pregnancy. The test is designed for over-the–counter use.

SUMMARY

hCG is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in urine as early as 7 to 10 days after conception. hCG levels continues to rise very rapidly, frequently exceeding 100mIU/mL by the first missed menstrual period, and peaking in the 100,000- 200,000mIU/mL range about 10-12 weeks into pregnancy. 7,8,9,10 The appearance of hCG in urine soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy. OneStep hCG Urine RapiDip™ InstaTest is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of 20mIU/mL. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, OneStep hCG Urine RapiDip™ InstaTest shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH and hTSH at high physiological levels.

PRECAUTION

1. For in vitro diagnostic and OTC use only.

2. Do not use test kit beyond the expiry date.

3. The test device should not be reused.

4. Urine specimens may be infectious; insure proper handling and

dispose of all used reaction devices into a biohazard container.

SPECIMEN COLLECTION AND PREPARATION

A fresh urine specimen should be used, no special pre-treatment is necessary. Specimens should be collected in a clean glass or plastic container.

The specimen may be refrigerated (2-8°C) and stored up to 2 days. For longer storage, freeze samples at -20°C or below. Refrigerated samples should be allowed to come to room temperature and mixed thoroughly before assaying. Frozen samples should be thawed completely, allowed to come to room temperature, and mixed thoroughly before assaying.

ASSAY PROCEDURE

Allow the test and the specimen to equilibrate to room temperature (15-30°C) prior to testing

1. To begin testing, open the sealed pouch by tearing along the notch. Remove the test kit from the pouch and use it as soon as possible.

2. Immerse the strip vertically into the urine sample with the arrow end pointing towards the urine. Do not immerse past the “Mark” Line. Take the strip out after 3 seconds and lay the strip flat on a clean, dry, non-absorbent surface.

3. Wait for pink colored bands to appear. Depending on the concentration of hCG in the test specimen, positive results may be observed in as soon as 40 seconds. However, to confirm negative results, the complete reaction time of 5 minutes is required. It is important that the background is clear before the result is read.

Note: A low hCG concentration might result in a weak line appearing in the test region (T) after an extended period of time; therefore, do not interpret the result after 30 minutes.

RESULTS

Negative: Only one pink colored band appears on the control region. No apparent band on the test region.

Positive: Distinct pink color bands appear on the control and test regions. The color intensity of the test bands may vary since different stages of pregnancy have different concentrations of hCG hormone.

Invalid: No line appears in the control zone “C”, the test should be voided since an improper test procedure may have been performed or deterioration of reagents may have occurred. This is due to the internal control built in which a distinct control region (C) line should always appear. Repeat the test using a new device. If the problem persists, discontinue using the test kit immediately and contact us.