One Step Test Device STD Testing In Home HIV1/2 Rapid Test Kit
Sexually Transmitted Disease Infectious Disease Test Kit
HIV(1+2) Antibody Rapid Test Kit
For qualitative detection of HIV(1+2) antibodies in serum/plasma
and whole blood
Main Features
1. Qualitative Test For The Early Detection Of Antibodies To
Hiv-1and Hiv-2 In Human Serum, Plasma and Whole Blood Specimens
2. Winner of "The National HIV Antigen Diagnostic Kit for Clinical
Performance Assessment
3. Unique 3-line patented design
4. Reliable: Able to differentiate HIV Type I and Type II
5. Certified by Authoritative Certification
6. One-step test, visual reading, no machine required
7. High sensitivity & high specificity, accurate, convenient
Summary Description
The HIV 1/2 Rapid Test Device (Whole Blood/Serum/ Plasma) is a
rapid test to qualitatively detect the presence of antibody to HIV
1 and/or HIV 2 in whole blood, serum or plasma specimen. The test
utilizes latex conjugate and multiple recombinant HIV proteins to
selectively detect antibodies to the HIV 1/2 in whole blood, serum
or plasma.
Directions for Use
Allow the test device, specimen, buffer, and/or controls to
equilibrate to room temperature prior to testing.
1. Remove the test device from the foil pouch and use it as soon as
possible. Best results will be obtained if the assay is performed
within one hour.
2. Place the test device on a clean and level surface.
3. For Serum, Plasma or Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 1 drop of
serum, plasma or venipuncture whole blood (approximately 25ml) to
the specimen well(s) of the test device, then add 1 drop of buffer
(approximately 40ml) and start the timer. See illustration below.
4. For Fingerstick Whole Blood specimen:
5. To use a capillary tube: Fill the capillary tube and transfer
approximately 25ml of fingerstick whole blood specimen to the
specimen well (S) of the test device, then add 1 drop of buffer
(approximately 40ml) and start the timer.
6. To use hanging drop: Allow 1 hanging drop of fingerstick whole
blood specimen (approximately 25ml) to fall into the center of the
specimen well(s) on the test device, then add 1 drop of buffer
(approximately 40ml) and start the timer. See illustration below.
7. Wait for the red line(s) to appear. The result should be read at
15 minutes. Do not interpret results after 30 minutes.
Interpretation of Results
Negative: No apparent band in the test region (1 and 2), only one red band
appears in the control region (C). This indicates that no HIV1/2
antibodies have been detected.
Positive: In addition to the band in the control region (C), other one or
two red bands will appear in the test region (1 and 2). This
indicates that the specimen contains HIV1/2 antibodies.
Invalid: If no band appears in the control region(C), regardless of the
presence or absence of line in the test region (1 and 2). It
indicates a possible error in performing the test. The test should
be repeated using a new device.
Storage and Stability
The kit can be stored at room temperature or refrigerated (4-25°C).
The test device is stable through the expiration date printed on
the sealed pouch. The test device must remain in the sealed pouch
until use. DO NOT FREEZE. Do not use beyond the expiration date.
