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HIV 1+2 Test Device Whole Blood (Strip)

HIV 1+2 Test Device Whole Blood (Strip) Image

Accessories:
  Chasing buffer, sterile lancet, pipette, instruction for use 
  Principle of Test:
  Immunochromatographic assay
  Product Performance:
  Sensitivity: 99.40%

Product Name Specimen Format Catalog No. Sensitivity Package Size Strip Width
HIV 1+2 Test Serum/

Plasma

Cassette C10-20 99.40% 25 Tests 4.0 mm
Strip C10-11 50 Tests 3.5 mm
 

Whole Blood

 

Cassette C10-21 25 Tests 4.0 mm
C10-22 1 Test 4.0 mm
Strip C10-21 50 Tests 3.5 mm

INTENDED USE: This test is a single use, rapid device intended for qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in whole blood, serum or plasma specimens. 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. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay. 
2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Hold the dropper vertically and transfer 1 drop of WB/ Serum/Plasma to the sample pad of the test strip. Then hold the buffer bottle vertically and add 1 drop and start the timer.
4. Wait for the red line to appear. Read result between 10-20 minutes. Do not interpret the result after 20 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 area. The test is positive for HIV-1.

HIV-2 Positive: The control line and HIV-2 line (T2) are visible in the result area. The test is positive for HIV-2.

HIV-1 and HIV-2Positive: The control line, HIV-1 (T1) and HIV-2 (T2) lines are visible in the result area. The test is positive for HIV-1 and 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 area, 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 coinfection 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 strip. If problem persists, please contact your local distributor.

HIV 1+2 Test Device Whole Blood (Strip)

HIV 1+2 Test Device Whole Blood (Strip) Image

Accessories:
  Chasing buffer, sterile lancet, pipette, instruction for use 
  Principle of Test:
  Immunochromatographic assay
  Product Performance:
  Sensitivity: 99.40%

Product Name Specimen Format Catalog No. Sensitivity Package Size Strip Width
HIV 1+2 Test Serum/

Plasma

Cassette C10-20 99.40% 25 Tests 4.0 mm
Strip C10-11 50 Tests 3.5 mm
 

Whole Blood

 

Cassette C10-21 25 Tests 4.0 mm
C10-22 1 Test 4.0 mm
Strip C10-21 50 Tests 3.5 mm

INTENDED USE: This test is a single use, rapid device intended for qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in whole blood, serum or plasma specimens. 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. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay. 
2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Hold the dropper vertically and transfer 1 drop of WB/ Serum/Plasma to the sample pad of the test strip. Then hold the buffer bottle vertically and add 1 drop and start the timer.
4. Wait for the red line to appear. Read result between 10-20 minutes. Do not interpret the result after 20 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 area. The test is positive for HIV-1.

HIV-2 Positive: The control line and HIV-2 line (T2) are visible in the result area. The test is positive for HIV-2.

HIV-1 and HIV-2Positive: The control line, HIV-1 (T1) and HIV-2 (T2) lines are visible in the result area. The test is positive for HIV-1 and 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 area, 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 coinfection 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 strip. If problem persists, please contact your local distributor.