The urine specimen must be collected in a clean, dry container, Specimens collected randomly may be used. However, the first morning urine generally contains the highest concentration of hormone. Urine specimens may be refrigerated (2° - 8°C) and stored up to 72 hours prior to assay. If specimens are refrigerated, they must be equilibrated to room temperature before testing. Urine samples exhibiting visible precipitates should be filtered, centrifuged, or allowed to settle (obtaining clear aliquots) before testing.
Materials Provided:
Test strip or cassette containing monoclonal mouse-hCG colored conjugate and goat anti-hCG antibody pre-coated on a porous test membrane. A suitable clean urine collection cup or device (preferably glass) for the test procedure should be provided by the test subject. AimStick™ One-step test strip pre-packaged in foil pouch stamped with lot# and expiration date. AimStep™ test cassettes are prepackaged with a transfer pipette in fog pouch stamped with lot# and expiration date. Both tests are pre-calibrated at 20mIU/ml hCG sensitivity detection level. Both tests are FDA approved and CLIA waived for professional and OTC use.
The test is negative if only one band appears in the Control (C) Zone. The test is positive if two colored bands appear in the test panel (see the animated graphic to the right). One colored band will appear in the Test (T) Zone and one in the Control (C) Zone. Any colored band in the Test Zone should be considered a positive result if the band appeared within 3-5 minutes of starting the test procedure. The colored band in the Control Zone may be lighter or darker in color and/or intensity than the Test Zone band; this is not relevant to test interpretation, only the presence of a test band is important to test interpretation. The test is invalid if no band appears in the Control Zone even if a colored band appears in the Test Zone. This can be caused by not immersing the test strip for at least 5 seconds, immersing it beyond the "Stop Line", or with the cassette format, not adding enough sample to the sample well. Exposure to the test development area of the test devices to water or other fluids, or touching these areas can contaminate and/or prevent the proper operation of the test.
Each test includes a built in quality and procedural control. Correct procedural technique and test strip performance is confirmed when a colored band appears at the Control Zone of the membrane.
Negative results are expected in healthy non-pregnant women and healthy men. Healthy pregnant women have hCG present. The amount will vary greatly with gestational age and between individuals. First morning urine specimens approximate hCG levels which reach 5 to 50 mIU/ml within 1 week of gestational age. AimStick PBD/AimStep tests can detect pregnancy as early as 1 day after a missed menses.
Accuracy:
A multi-center clinical evaluation was conducted comparing the results obtained using AimStick PBD Pregnancy and another commercially available membrane test. The study included 150 specimens and both assays found 72 negative and 78 positive results. AimStick PBD Pregnancy showed a 100% concordance with the other commercially available membrane test.
AimStick PBD Pregnancy detects hCG concentrations of 20 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard of mIU or standard international unit. The addition of LH (300 mIU/ml), FSH (1000 mIU/ml), and TSH (1000 IU/ml) to negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine showed no cross-reactivity.
The test strips should be stored at room temperature (15° to 30° C) for the duration of the shelf-life. The test strip must remain in the foil wrap or fog pouch until ready for use. Once the wrap or pouch has been opened the test strips are good for 90 days only.
The following potential interfering substances were added to hCG negative and positive samples.
None of the substances above at the concentration shown interfered with test results.
