World of Health Biotech Co., Ltd. [China]

Format: cassette efficient, accurate and easily operated

 One Step hCG Single Test Kit

 A rapid, one step test for the qualitative detection of human chorionic gonadotropin (hCG) in urine.

For professional in vitro diagnostic use only.

INTENDED USE

The One Step hCG Single Test Kit is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. 

 SUMMARY

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum as early as 7 to 10 days after conception. hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period, and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. The appearance of hCG in both urine and serum 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.

The One Step hCG Single Test Kit is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of 25 mIU/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, the One Step hCG Single Test Kit shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.

PRINCIPLE

The One Step hCG Single Test Kit is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by getting the urine specimen migrating on the test strip and observing the formation of 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 to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

REAGENTS

The test kit contains anti-hCG particles and anti-hCG coated on the membrane.

FORMAT

PACKAGE

all tests are packed in Aluminum foil pouches

   For bulk

   10,000 strips/ carton

   2,500 cassettes/carton 

   2,000 midstreams/carton 

   or

    100 strips /box

    25 cassettes /box

    1 or 2 midstreams /box

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HCG pregnancy home test cassette