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.