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CE
This test is a single use, rapid cassette intended for qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in whole blood and serum or plasma samples. It is intended for use in medical institution as an aid for the diagnosis and management of patients related to infection with HIV and for screening of blood donors, or blood products as well.
TEST PROCEDURE:
1) Let the pouched test come to room temperature (15-30°C) . Remove the test cassette from the foil pouch, and place it on a flat, dry surface.
2) Use the pipette to draw and slowly add 1 drop (25μl) of whole blood/serum/plasma to the sample well.
3) Hold the buffer bottle vertically and add 1-2 drops (80μl) of buffer to the sample well. Or if using pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops (100-120μl) of buffer to the sample well.
4) Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.
Caution: The above interpreting time is based on reading the test results at room temperature range of 15-30°C. If your room temperature is significantly lower than 15°C, then the interpreting time should be properly increased to 30 minutes.
INTERPRETATION OF RESULTS：
2) Use the pipette to draw and slowly add 1 drop (25μl) of whole blood/serum/plasma to the sample well.
3) Hold the buffer bottle vertically and add 1-2 drops (80μl) of buffer to the sample well. Or if using pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops (100-120μl) of buffer to the sample well.
4) Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.
Caution: The above interpreting time is based on reading the test results at room temperature range of 15-30°C. If your room temperature is significantly lower than 15°C, then the interpreting time should be properly increased to 30 minutes.
1) A colored band will appear in the "C" region of the result window to show that the test is working properly. This band is the Control Band.
2) The“T" region of the result window indicates the test results. If another colored band appears in the“T" region of the result window, this band is the Test Band 1 of HIV-1 or/and Test band 2 of HIV-2.
Negative Result:The presence of only one band on the control region indicates a negative result.2) The“T" region of the result window indicates the test results. If another colored band appears in the“T" region of the result window, this band is the Test Band 1 of HIV-1 or/and Test band 2 of HIV-2.
Positive Result:The presence of not less than two color bands ("1" , "2" and "C") within the result window, no matter which band appears first,indicates a positive result for HIV-1 or/and HIV-2 respectively.
Invalid Result: If the pink color band in C region is not visible within the result window after performing the test, the result is considered invalid. The directions may not have been followed correctly or the test may have deteriorated. It is recommended that perform the test with a new device.
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 | —— |