- Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
- Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
- Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.
- Hold the buffer bottle vertically and add 1-2 drops to the sample well. If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.
- Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.Caution: The above interpreting time is based on room temperature range of 15 - 30°C. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.
Negative: The presence of only one line in the control region indicates a negative result (Figure 1).
HIV-1 Positive: The control line and HIV-1 line (T1) are visible in the result window. The test is positive for HIV-1.
HIV-2 Positive: The control line and HIV-2 line (T2) are visible in the result window. The test is positive for HIV-2.
HIV-1 and HIV-2 Positive: The control line, HIV-1 (T1) and HIV-2 (T2) lines are visible in the result window. The test is positive for HIV-1and HIV-2.
Regarding the positive results for both HIV-1 and HIV-2 in one patient, it is possible for reasons as follows：
1. There is the homology in the amino acid sequence of HIV type-1 and type-2. So, it is possible that the test results show the positive results for HIV-1 and HIV-2 in one patient, simultaneously.
2. Provisionally, you can conclude virus type according to the line density. If the line density of type-1 is darker than that of type-2 in the result window, you can read as HIV-1 positive. If the line density of type-2 is darker than that of type-1 in the result window, you can read as HIV-2 positive. If you want to determine virus type or co-infection exactly, you should perform the confirmatory assay (e.g Western blot etc.).
Invalid: If the pink color line in C region is not visible, the result is considered invalid (Figure 3) regardless of the presence or absence of the test line(s).
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.
|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||——|