SPECIMEN COLLECTION AND HANDLING
Any urine specimen is appropriate for hCG testing, but the first morning urine is optimal because it generally contains the highest concentration of hCG. Urine specimens may be collected in any clean, dry, plastic or glass container. If specimens cannot be assayed immediately, they may be stored in the refrigerator (2oC to 8oC) for up to 72 hours prior to assay. Preservatives are not required.
Specimen should be allowed to reach room temperature before testing. Very turbid urine specimen should be centrifuged or filtered prior to use. Samples with visible precipitates should be allowed to settle and the clear supernatant used for testing.
TEST PROCEDURE
Test strips, patient samples, controls and reference materials should be brought to room temperature (20oC to 30oC) prior to testing.
1. Tear open pouch, remove strip from package. Label the strip with patient or control identification.
2. Immerse the strip into the urine with the arrow end pointing towards the urine. Do not immerse pass the MAX (maximum) line. You may leave the strip in the urine or you may take the strip out after a minimum of 10 seconds and lay the strip flat on a clean, dry, non-absorbent surface (e.g. mouth of the urine container).
3. Wait for coloured bands to appear. Depending on the concentration of hCG in the test specimen, positive results may be observed in as short as 10-30 seconds. However, to confirm negative results, the complete reaction time of 5 minutes is required. Do not interpret results after 10 minutes.
INTERPRETATION OF RESULTS
1. Positive: Distinct colour bands appear on the control and test region. Colour intensity of the test and control bands may vary.
2. Negative: Only one colour band appears on the control region. No apparent band on the test region.
3. Invalid: No visible band at all or no visible band at the control region. Repeat test.