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CE
This test is a single use, rapid device intended for qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in Saliva. It is intended for use in medical institution and self testing as an aid for the diagnosis and management of patients related to infection with HIV .
TEST PROCEDURE:
1. Bring the pouched test device to room temperature (15-30°C) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3.Use the pipette to draw and slowly add 2 drops of solution-treated sample to the sample well.
4.Read test results between 15-20 minutes. Do not interpret after 20 minutes.
INTERPRETATION OF RESULTS：2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3.Use the pipette to draw and slowly add 2 drops of solution-treated sample to the sample well.
4.Read test results between 15-20 minutes. Do not interpret after 20 minutes.
Positive: Two colored lines appear in the result window, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line. The test is positive for HIV-1 /2 .
Negative: Only the control line appears in the result window. The test result is negative and antibodies to HIV-1/2 have been detected.
Invalid: If the control line does not appear in the result window, the test results are invalid regardless of the presence or absence of the test line.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.
SPECIFICATION:
| Description | Specimen | Format | Catalog No. | Sensitivity | Package Size | Strip Width | Certificate |
| HIV1+2 Test | Serum/Plasma | Strip | C10-11 | 99.61% | 50 Tests | 3.5 mm | CE2265 |
| Cassette | C10-20 | 25 Tests | 4.0 mm | ||||
| whole blood | Strip | C10-12 | 50 Tests | 3.5 mm | —— | ||
| Cassette | C10-21 | 25 Tests | 4.0 mm | ||||
| Cassette | C10-22 | 1 Test | 4.0 mm | ||||
| Urine | Strip | C10-U11 | 97.19% | 50 Tests | 3.0 mm | ||
| Cassette | C10-U20 | 25 Tests | 4.0 mm | ||||
| Cassette | C10-U22 | 1 Test | 4.0 mm | ||||
| HIV1+2 Test (Saliva) | Saliva | Cassette | C10-23 | 100% | 1 Test | 4.0 mm | —— |
| HIV1+2 P24 Ag Test | whole blood | Cassette | C11-21 | 100% | 25 Tests | 4.0 mm | —— |