4th Generation HIV Test Kit

Instructions

Before starting the test, the testing cassette, specimen, and buffer fluid need to be allowed to reach room temperature (15‐30°C / 59-86°F). Then:

1. Remove the testing cassette from its packaging and place it on a clean and level surface. For best results, use within one hour of unpacking.
2. Wash the fingertip from which the blood sample will be collected with soap and warm water, or clean it with an alcohol swab. Allow to dry.
3. Puncture the tip of the finger with the provided sterile lancet; the first sign of blood should be wiped away with an alcohol swab.
4. Squeeze the finger gently until a round drop of blood forms
5. Use the provided capillary tube to collect the blood sample, then transfer 2 drops of the blood to the specimen well (S) of the testing cassette.
1. Alternatively, drip 2 drops of blood directly onto the centre of the specimen well (S) straight from the fingertip while avoiding touching the specimen well (S) directly with the finger.
6. Add 1 drop of buffer (approximately 40μL) and start the timer.
7. Wait for the coloured line(s) toappear. The result should be ready in 10 minutes. Do not interpret results after 20 minutes.
   
   

Interpretation of results

Positive Result:

HIV Ab Positive:* The coloured line in the control line region (C) appears, and a coloured line appears in test line region 1 (T1). The result is positive
for HIV 1 and/or HIV 2 infection.

P24 Ag Positive:* The coloured line in the control line region (C) appears, and a coloured line appears in test line region 2 (T2). The result is positive
for HIV P24 Positive.

HIV Ab and P24 Positive:* The coloured line in the control line region (C)
appears, and two coloured lines should appear in test line regions 1 and 2
(T1 and T2). The colour intensities of the lines do not have to match. The
result is positive for HIV 1&2 infection and HIV P24 Positive.

Negative Result:

The coloured line in the control line region (C) appears. No line appears in
test line regions 1 or 2 (T1 or T2).

Invalid Result:

Control line (C) falls to appear. Insufficient buffer volume or incorrect

procedural techniques are likely reasons for failure in the control line.
Review the procedure and repeat the procedure with a new test device. If
the problem persists, discontinue using the test kit immediately and
contact our customer service

*NOTE: The intensity of the colour in the test line region (T) will vary depending on the concentration of HIV antibodies or antigens in the specimen. Any shade of colour that appears in the test region (T) should be considered to indicate a positive result.

** INVALID RESULT: If the control line (C) fails to appear, insufficient buffer fluid volume or incorrect procedural techniques are the most likely causes. Repeat the procedure with a new test cassette. If the problem persists, contact us for a free replacement.

A fourth-generation HIV test is generally moderately accurate at various periods after potential exposure to the virus. Here are the estimated accuracy percentages for a fourth-generation HIV test at different times after exposure:

1. After 7 days (1 week): The test is usually not very reliable after just one week. It is possible that the test may not yet detect an HIV infection because the body may not have developed detectable levels of the p24 antigen and HIV antibodies.
   
   
2. After 14 days (2 weeks): Accuracy of the test improves somewhat after two weeks, but it is still not optimal. At this point, the test may occasionally detect HIV infections, but there is still a significant chance of a false-negative result.
   
   
3. After 21 days (3 weeks): After three weeks, the test becomes much more reliable. Most people infected with HIV will test positive at this time. Accuracy typically ranges between 95% and 99%.
   
   
4. After 28 days (4 weeks): Test reliability significantly increases after four weeks. At this point, the test is usually highly accurate, with an accuracy rate of about 99.7%.

Please note that test accuracy can also vary depending on individual factors, such as the person's immune system and viral load. For the most accurate results, it is recommended to wait for at least 28 days after potential exposure.

The 4th generation HIV test should be read between 10 and a maximum of 20 minutes after performing the test. Within this time frame, the test antibodies and p24 antigen can react sufficiently to provide a reliable result.

It is important to emphasize that reading the result after 20 minutes is not reliable, as the test can even change. Therefore, it is crucial to stay within the specified time frame for the most accurate interpretation.

If you have any questions about reading the result, please consult the test instructions or contact us for advice.

The window period of 4^th Generation HIV combo (antigen/antibody) tests is between 13 and 28 days, with 18 days being the median detectability timeframe (50% infections detected). Results obtained on or after the 28th day are considered conclusive by some Western countries such as the UK.

At-home 4^th generation HIV test kits are as accurate as rapid HIV tests done in clinical settings. The CDC reports that 4^th generation at-home HIV test kits have relative sensitivity (true positives) between 99.7% and 99.9% and relative specificity (true negatives) of 99.5% or higher. This indicates that false positive and false negative results are extremely rare, and those seeking testing can have nearly full trust in their results.

An HIV antigen (also known as the p24 antigen) is a protein the virus introduces into the immune system of the infected person, triggering it to start making antibodies.

This structural protein makes up most of the HIV viral core, or 'capsid,' and its present in high levels in the blood serum of recently infected individuals during the short period between infection and seroconversion.

Certain tests can screen for HIV antigens and detect primary infection much more reliably than only tests that screen for antibodies.

The 4^th Generation of HIV tests is a rapid chromatographic immunoassay for the qualitative detection of antibodies to HIV 1 and/or HIV 2 and p24 antigen in whole blood, serum, or plasma

The membrane of the testing strip located in the specimen well of the testing cassette is pre‐coated with latex conjugate and multiple recombinant HIV proteins, which selectively detect antibodies to HIV 1/2 and the p24 antigen. When introduced to the strip, the sample of whole blood, serum, or plasma interacts with these coated particles, then migrates chromatographically up the membrane via capillary action and interacts with recombinant HIV antigen on the membrane in the test line area.

If the sample contains antibodies to HIV 1 and/or HIV 2 or the p24 antigen, a colored line will appear in the test line region, indicating a positive result. A colored line will not appear in the test line region if the material does not contain HIV 1 and/or HIV 2 antibodies nor the p24 antigen, indicating a negative result. A colored line will always appear in the control line region to act as a procedural check, indicating that the right volume of specimen and buffer fluid have been added.

Thanks to its ability to analyze samples for both HIV antibodies and p24 antigen proteins, 4^th Generation testing technology is far more advanced than 3^rd Generation technology, which can only screen for antibodies. The benefits are: earlier HIV detection (13-28 days compared to 3-12 weeks) and higher reliability due to the dual assay employed.