MATERIALS PROVIDED
<br />1. Strip: the strip test
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<br />specimen collection container
<br />2. Cassette the cassette test specimen collection container
<br />3. Midstream: the midstream test
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<br />INTENDED USE 
<br />One-step pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. The test device is intended for self-testing.
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<br />PRINCIPLE
<br />The One-step HCG pregnancy Test is a rapid qualitative one step assay for the detection of HCG in urine. The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the HCG in the test samples with an extremely high degree of sensitivity. In less than 5 minutes, levels of HCG as low as 25mlU/ml can be detected. As the test sample flows through the absorbent device, the labeled antibody-dye conjugate binds to the HCG forming an antibody-antigen complex. This complex binds to the anti-HCG antibody in the positive reaction zone (T area) and produces a pink-purple colored band when the HCG concentration is greater than 25mlIU/ml. In the absence of HCG, there is no line in the positive reaction zone. Unbound conjugate binds to the reagents in the control zone (C area), producing a pink-purple band, demonstrating that the reagents are functioning properly.
<br />STORAGE AND STABILITY 
<br />Store test at 4~ 30C (room temperature). Avoid sunlight. The test is stable until the date imprinted on the pouch label.
<br />WARNING
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<br />For IN VITRO DIAGNOSITC UES ONLY
<br />1. Read directions for use carefully before performing this test. Pay attention to the position of the C and T line.
<br />2. Do not use beyond the labeled expiration date.
<br />3. Do not reuse the test devices. Discard it in the dustbin after single use.
<br />4. Do not use if pouch is damaged or opened.
<br />5. Do not touch the membrane located within the device.
<br />6. Once open the pouch, the test device should be used immediately. Prolonged exposure to ambient humidity will cause product deterioration.
<br />7. Treat urine samples and used device as if they are potentially infectious. Avoid contact with skin.
<br />8. Examine if the urine dropper and urine cup exists before usage.
<br />9. Keep out of reach of children.
<br />10. Not for internal use.
<br />ASSAY PROCEDURE 
<br />1. DETERMINATION OF TEST DATE
<br />The test could be used from the first missing date.
<br />2.SPECIMEN COLLECTION AND HANDLING
<br />The One-step hCG pregnancy Test is formulated for use with fresh urine specimens. The test should be used right after the specimen collection. Urine cup should be used to collect specimens, and the urine does not require any special pretreatment.
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<br />3. TEST PROCEDURE
<br />Strip/ Cassette:
<br />1) Remove the test device from the foil wrapper
<br />2) Immerse the test device into the urine with the arrow end pointing toward the urine. Do not cover the urine over the MAX (maximum) line. You may take the strip out after a minimum of 15 seconds in the urine and lay the strip flatly on a non-absorptive clean surface. (See picture below)
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<br />Midstream:
<br />1) Remove the midstream test from the foil pouch
<br />2) Remove the cap .
<br />3) Hold the midstream test by the Thumb Grip with the exposed Absorbent Tip pointing downward directly into your urine stream for at least 10 seconds until it is thoroughly wet. See the illustration below.
<br />4) Note: Do not urinate on the Test and Control windows. If you prefer, you can urinate into a clean and dry container, then dip only the Absorbent Tip of the midstream test into the urine for at least 10 seconds.
<br />5) After removing the midstream test from your urine, immediately replace the cap over the Absorbent Tip, lay the midstream test on a flat surface with Test and Control windows facing upwards, and then begin timing.
<br />6) Lay the test stick down on a flat surface with the windows on top while you wait for the result.
<br />* Read the result within 5 minutes.
<br />* DO NOT INTERPRET RESULT AFTER 10 MINUTES.
<br />* Discard the test device after single use in a dustbin
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<br />LIMITATION OF THE PROCEDURE 
<br />1. Alcohol may interfere the test result. It is not recommended using the test after drinking.
<br />2. Occasionally specimens containing less than 25mlU/ml for urine also yield positive results.
<br />3. A very early pregnancy containing an extremely low concentration of hCG can give a negative result. In this case, another specimen should be obtained at least 48 hours later and tested.
<br />4. HCG levels may remain detectable for several weeks after normal delivery, delivery by caesarean section, spontaneous abortion or therapeutic abortion.
<br />5. In cases where very high levels of hCG are present (>500,000mlU/ml) a false negative result can occur due to a ??Prozone?? effect. If pregnancy is still suspected, simply dilute specimen 1:1 with deionized water and retest.
<br />If a urine sample is too dilute ( ie: low specific gravity) it may not contain a representative level of hCG. If pregnancy is still suspected, a first morning urine sample should be obtained from the user in 24-48 hours and retested.
<br />As is true with any diagnostic procedure, the user should evaluate data obtained by the use of this kit in light of other clinical information and consult to the physicians for the final diagnosis of pregnancy before make any decision of medical relevance.