AccuMed 160401 Instructions Manual
Also see for 160401: Instructions
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One Step Pregnancy Urine Test Strip Instruction InsertPlease read all the information in this Insert before performingthe test.The One Step Pregnancy Test Strip is an in vitro diagnostichome use test device intended for the rapid detection of humanchorionic gonadotropin (hCG) in urine to aid in the earlydetection of pregnancy. You can easily carry out this testyourself.It is intended for over-the-counter (OTC) use.For in vitro diagnostic use only.HOW DOES IT WORK?Human chorionic gonadotropin (hCG) is a hormone, producedby the developing placenta and secreted into the urine. Thepregnancy test contains antibodies which specifically react withthis hormone. When the sample end of the test is dipped in theurine specimen, the urine specimen is absorbed by the strip andmigrates along the strip. When hCG in the sample reaches theTest Zone region of the membrane, it will form a colored line.Absence of this colored line suggests a negative result.A colored line will appear at the Control Zone region if the testhas been performed properly.CONTENT OF THE TEST KIT1. One pouch containing a test strip.2. Insert with instructions for use.WHAT ELSE DO YOU NEED?1. A clean, dry, plastic or glass container to collect the urine.2. Timer or clock.PRECAUTIONS1. This kit is for external use only. Do not swallow.2. Discard after first use. The test strip cannot be used morethan once.3. Do not use the test after the expiration date printed on the foilpouch.4. Do not use the kit if the pouch is punctured or not well sealed.5. Keep out of the reach of children.STORAGE AND STABILITY1. Store at 39°F to 86°F (4ºC to 30ºC) in the sealed pouch up tothe expiration date.2. Keep away from direct sunlight, moisture and heat.3. DO NOT FREEZE.4. You should perform the test soon after opening the pouch.You should keep the test in a dry environment before use.WHEN TO COLLECT URINE FOR THE TEST?For many women, HCG may be detectable with this test by theday after the missed period. Any urine specimen will work forPregnancy Testing but the first morning urine specimen isoptimal because of its highest concentration of HCG.HOW TO COLLECT URINE?Urine specimens may be collected in any clean, dry, plastic orglass container.HOW TO DO THE TEST?1. The test strip and urine have to be at room temperature59-86ºF (15-30°C) for testing.2. Remove the test strip from the sealed pouch.3. Immerse the strip into the urine with the arrow pointingtowards the urine. Take the strip out after 3 seconds and lay thestrip flat on a clean, dry, non-absorbent surface (such as themouth of the urine container).IMPORTANT: Do not allow the urine level to exceed the MAX(marker line), otherwise the test will not perform correctly.4. Read results in five minutes. Positive results may sometimesappear as early as one minute but you should wait the full 5minutes before determining a negative result. Do not readresults after more than 5 minutes. |
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