One Step HCG Pregancy Test Kit (Cassette)

Intended use

The HCG Pregnancy 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.

Test principle

The HCG Pregnancy Test Cassette utilizes a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay is conducted by filling the urine specimen to sample well and observing the formation of red-colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-HCG-colored conjugate and form a red colored line at the test line region of the membrane. 

Materials and Components

1.The HCG Pregnancy Test Cassette

2.Dropper

3.Instruction

4.Collection container (Optional)

Product Information

1.Specimen: Human fresh urine

2.Storage: 4-30℃

Test Procedure

Allow the test and the specimen to equilibrate to room temperature prior to testing.

1.Specimen Collection

Urine samples at any time of the day can be used for pregnancy testing.

Samples should be collected in a clean, dry glass or plastic container without any special pre-treatment. If specimen cannot be assayed immediately, it can be stored at 8-30℃ for up to 4 hours prior to testing, or refrigerated at 2-8℃ for 24 hours. 

2.Testing

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

3.Test Results

Wait for red colored bands to appear. The test should be read in approximately 3-5 minutes. Do not interpret results after 5 minutes.