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One Step hCG Pregnancy Test Strip 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, One Step hCG Pregnancy Test shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
PRINCIPLE OF TEST
One Step hCG Pregnancy Test is a rapid chromatrographic 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 immersing the test in a urine specimen and observing the formation of pink 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 pink colored line at the test line region of the membrane. Absence of this pink colored line suggests a negative result. To serve as a procedural control, a pink colored line will always appear at the control line region if the test has been performed properly.
WARNINGS & PRECAUTION
1) In vitro diagnostic use for professional 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.
MATERIALS PROVIDED
1) One Step hCG Pregnancy Test Strip
2) Detailed Instructions for use
3) Brief Instructions are printed on each Test
INTERPRETATION OF 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 appears. Repeat the test using a new device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
PACK SIZES
The tests come in packs of 20, and are for professional use only.
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