The hCG Test Cassette is a rapid, one step test for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. The test is intended for in vitro diagnostic self-testing.

The hCG Pregnancy Test Cassette adopts the principles of double antibody sandwich method and immunochromatography to test the human chrionic gonadotropin (hCG) in the test region (T) and anti-mouse antibodies in the control rregion (C.) During testing, the urine sample reacts with the colored conjugate region (mouse anti-hCG antibody colloidal gold conjugate) which has been pre-coated on the test strip. The mixture then migrates upwaard on the membrane to react with anti-hCG antibodies in the test region and generate a red line. Presence of the red line indicates a positive result, while its absence indicates a nigative result. Regardless of the presence of hCG, as the region will always apear. The presence of this red line serves as verification for sufficient sample volume and proper flow and as a control for the reagents.

The test cassette consists of a polyester membrane pre-treated with mouse anti-ahCG monoclonal pre-coated with mouse anti-bhCG monclonal antibody on the test line and goat-anti-mouse lgG polyclonal antibody on the control line.
Each puch contains one test cassette, one dropper and one desiccant. Each box contains 20 pouches and one intruction for use.

The urin specimen must be collected in a clean, dry plastic or glass contianer. The first morning urin is preferred since it generally contains the highest concentration of hCG. However, urine collected at any time of day maay be used. Urine specimen may be stored at 2-8'C for up to 48 hours prior to assay.

Positiv: Two distinct red line will appear, one in the test region (T) and one in the control region (C). Positive test results are possible but not definitional urine specimen be obtained after 48-72 hours and tested again, or consulting your physician.

Negative: Only a aingle red line appears in the control region (C). No appearent red or pink line apears in the 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 distributer.

Notes: The shade of red color in test region (T) will very depending value nor the rate of increase in hCG can be determined by this qualitative test.

1. A procedural control is included in the test. A red line apearing in the contorl region (C) is considered an internal positive procedural control.A clear background in the results window is considered an internal negative procedural control.
2. It is recommended that a positive hCG control (containing 25-100 mlU/ml hCG) and a negative hCG control (conataining "0" mlU/ml hCG) be included in each testing to verify proper test performance.

Sensitivity
The analystical sensitivity of the hCG Pregnancy Test Cassette is 25lU/ml. The sensitivity was established by repetitive testing of samples containing 25mlU/ml hCG during a period of several weeks.
Specificity
The specifity of the hCG Pregnancy Test Cassette was determind from cross-reactivity studies with know amonts of Luteinizing Hormone (hLH), Follicle Stimulating Hormone (hFSH), and Thyroid Stimulating Hormone (hTSH). Negative results were obtained from all tests conducted with 300mlU/ml hLH,100 mlU/ml hFSH, 100 ulU/ml hTSH and negative hCG specimen.
Precision
Astudy was conducted which consited of performing a series of replicate assays using 25 mlU/ml and 100 mlU/ml hCG in uring. All the test results were consitent.
Diagnostic sensitivity and specificity
Studies were perfomens using the hCG Pregnancy Test Cassette versus a rederence hCG immunoassay. Both of these studies demonstrate 100% (relative) correlation.