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Specimen Collection: The urine specimen must be collected in a clean dry container either plastic or glass, without preservative. Specimens collected at any time may be used. However the first morning urine generally contains the highest concentration of hormone. Urine specimen may be refrigerated (2-8°C) and stored up to 72 hours prior to use. If samples are refrigerated, they must be equilibrated to room temperature before testing. Urine samples exhibiting visible precipitates should be filtered, centrifuged, or allowed to settle and clear aliquots obtained for testing.
Assay Procedure: To begin testing, open the sealed pouch by tearing along the notch. Remove the test cassette from the pouch.
1. Draw 0.2ml (about 4 drops) sample into the pipette, and dispense it into the sample well on the cassette.
2. Wait for the coloured bands to appear. Depending on the concentration of HCG in the test specimen, positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time 5-10 (minutes) is required. Do not read results after 10 minutes.
Interpretation of Results: Negative: Only one color band appears on the control region. No apparent band on the test region. This indicates that no pregnancy has been detected.
Positive: Distinct color bands appear on the control and test regions. Presence of both test line and control line indicate that you are probably pregnant. The color intensity of the test bands may vary since different stages of pregnancy have different concentrations of HCG hormone.
Invalid: No visible band at all or no band appears on the control (C) region. Repeat with a new test kit. If the problem persists, discontinue using the test kit immediately and contact the local distributor.
Quality Control: Each test cassette has its own built-in quality control indicator. If after performing the test and no line is visible on test cassette, the test cassette may have deteriorated. Repeat the assay using a new cassette.
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