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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 adding urine specimen to the specimen well of the test device 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.

TESTING SEPS

Allow the test and the specimen to equilibrate to room temperature (15-30°C) prior to testing

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

2.Hold the handle of the test with one hand.  Use the other hand to remove the cap and expose the absorbent.  Put the cap aside for now.

3.Point the absorbent tip downward; place the absorbent tip in urine stream for at least 3 seconds to be thoroughly wet.  Otherwise, you can collect your urine into a clean cup and dip half of the absorbent pad into the urine for at least 3 seconds.

4.Re-cap the device and wait for colored bands to appear.  Depending on the concentration of hCG in the test specimen. For all results, wait 5 to 10 minutes to confirm the observation. Do not interpret the result after 30 minutes. It is important that the background is clear before the result is read.

opening the pouch, and stable for at least 100 days at transport conditions. The test kit should be kept away from direct sunlight, moisture and heat. The expiration dating was established under these storage conditions.

CROSS REACTIVITY

The following substances were added in hCG free and 20 mIU/mL spiked samples.

None of the substances at concentration tested interfered with the assay.

INTERFERING SUBSTANCES

The following substances were added in hCG free and 20 mIU/mL spiked  samples.

None of the substances at concentration tested interfered with the assay.

COMPARISON STUDY

Other commercially available qualitative test kits were used to compare with One Step hCG Pregnancy Test for relative sensitivity and specificity in 201 urine samples. None of samples was discordant, the agreement is 100%.

Sensitivity: 100%;  Specificity: 100%