Human Chorionic Gonadotropin (HCG) Test (Pregnancy Tests)

Women Pregnancy Urine Test Kit Human Chorionic Gonadotropin Rapid Detection Cassette In Vitro Diagnostic

Intended Use

Human Chorionic Gonadotropin (HCG) tests are single use, rapid immunoassay for in vitro qualitative determination of human chorionic gonadotropin (HCG) in urine to aid in the early detection of pregnancy. It is intended for use by the lay users.

Principle

Antibodies to HCG are precoated onto membrane as a capture reagent on the test zone. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with antibodies to HCG.

If HCG is present, a red colored line will develop on the membrane in proportion to the amount of HCG present in the specimen. To serve as a procedural control, red colored line in the control zone will always appear regardless of the presence of HCG.

In normal pregnancy, HCG can be detected in urine after fertilization. Usually, concentration of HCG in urine is at least 25mIU/ml as early as seven to ten days after conception. The concentration increases steadily and reaches its maximum between the eighth and eleventh weeks of pregnancy.

The appearance of HCG soon after conception and its subsequent rise in concentration during early gestational growth make it an excellent marker for the early detection of pregnancy

Reagents and Materials Provided

Each kit contains:

☀ Each pouch contains one cassette with one desiccant bag

☀ Instruction for use

☀ Urine cup

☀ Disposable plastic dropper

Materials Required But Not Provided

Timer or stopwatch

Sample Collection and Test Preparation

☀ First morning urine typically contains the highest concentration of HCG and is therefore the best sample for performing the urine test. However, any urine specimen may be used.

☀ Collect the urine specimen in a clean container. Do not use preservatives.

☀ If the specimen is not used immediately following collection, but is to be used within 48 hours it should be refrigerated (2 to 8℃), and brought back to room temperature before testing. If the specimen is not going to be used for more than 48 hours, it should be frozen at -20℃. A frozen specimen should not be used if stored longer than 2 weeks. Prior to testing, the frozen specimen must be completely thawed, thoroughly mixed, and brought to room temperature.

☀ Urine samples exhibiting visible precipitates should be filtered, centrifuged, or allowed to settle and clear aliquots obtained for testing.

Assay Procedure

Allow the test, urine specimen and/or controls to reach room temperature prior to testing.

☀ Before opening, allow the test cassette to reach room temperature. Use it immediately after opening.

☀ Place the test cassette on a dry, clean, non-absorbent flat surface, add 2-3 drops of urine into Sample well, and start the timer and wait for the colored line(s) to appear.

☀ Read results at 1-5 minutes. Do not interpret the result after 10 minutes.

Interpretation of Results

Negative: Only one colored band appears on the control region (C). No colored band in the test region(T).

Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).

Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.

Built-In Control

Human Chorionic Gonadotropin (HCG) tests have a built in procedural control that demonstrates assay validity. A red line appearing adjacent to the control zone (C) indicates that the test runs correctly.

Storage

Human Chorionic Gonadotropin (HCG) tests should be stored at room temperature (4-30℃, do not freeze) for 24 months from the date of manufacture. Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, perform the test as early as possible (within 1 hour) to avoid test cassette from becoming moist.