TEST PROCEDURE:

1. Bring the pouched test device to room temperature(15-30℃) 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 1 drop of whole blood/serum/plasma to the sample well.
4. 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.
5. 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.

INTERPRETATION OF RESULTS:
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.
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	——