Audited Supplier
Positive: In addition to the control band, a distinct colored band also appears in the test region.
Invalid: If no bands appear, or a test band appear with out a control band, the test shoud be repeated using a new test cassette.
Note:
Test must be in room temperature (10oC to 30oC)
1. Open the sealed pouch by tearing along the notch. Remove the test device from the pouch.
2. Hold the one side of the device with one hand. Use the other hand to pull out the cap and
expose the absorbent end.
3. Immerse the absorbent end into the urine sample about 10 seconds. Make sure that the urine
level is not above the "MAX" line printed on the front of the device.
4. Lay the device flat on a clean, dry, non-absorbent surface.
5. Read the result at 5 minutes. Do not read after 5 minutes.
INTENDED USE
The HCG test is a chromatographic immunoassay for the early detection of human chronic Gonadotropin(HCG) in urine and serum.
HCG is a glycoprotein hormone secreted by the developing placenta during pregnancy. The concentration of HCG in serum is approximately equal to the concentration of HCG in urine. The concentrations of HCG in urie and serum continue to rise during the first trimester of pregnancy to as high as 100,000 mIU/ml HCG test shows no cross-reactivity with structurally related hormones (FSH, LH, TSH) in normal maximum physiological concentration.
| Format | Specimen | Sensitivity | Size(mm) |
| Strip | Urine/Serum | 10-25mIU/ml | 2.5,3.0,3.5 |
| Cassette | Urine/Serum | 10-25mIU/ml | 3.0,4.0 |
| Midstream | Urine/Serum | 10-25mIU/ml | 4.5,5.5,6.0 |
1.Remove the test cassette from pouch by tearing the foil pouch.
2.Draw specimen (urine or serum) into dropper and dispense it into the sample well on the cassette (2-3 drops, approximately 100ul). Be careful not to overfill the absorbent pad.
3.Read results within five minutes.
4.Discard the test device after a single use.
Depending on the concentration of HCG in the urine sample, positive results may be seen within 40 seconds. Wait the full five minutes to confirm the result. Do not read the Cassette Test after 5 minutes as this may also give an incorrect test result.
Negative: Only one colored band appears on the control region. No colored band in the test region.
Positive: In addition to the control band, a distinct colored band also appears in the test region.
Invalid: If no bands appear, or a test band appear with out a control band, the test shoud be repeated using a new test cassette.
