How accurate is self-testing (home testing) for HIV?

How accurate is self-testing (home testing) for HIV?

HIV self-testing involves collecting your own specimen (oral fluid or blood) and using a rapid HIV test kit. You perform the whole test yourself, including reading and interpreting the test result.

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This is different from HIV self-sampling. With self-sampling, you collect your own sample and send it to a laboratory for analysis. We have another page on the accuracy of self-sampling.

Self-testing is sometimes called 'home testing', because people often do it at home. The World Health Organization (WHO) recommends that HIV self-testing should be offered alongside existing HIV testing services.

Different types of tests

Self-tests are usually modified versions of rapid, point-of-care test kits that were originally designed for healthcare professionals. Their processes, packaging and instructions have been simplified to guide you through the steps of taking a test.

With some tests, you use a lancet to release a small quantity of blood from a finger prick. Other tests require a sample of oral fluid, obtained by swabbing an absorbent pad around the outer gums, adjacent to the teeth.

Self-tests may be second- or third-generation HIV tests. They are only able to detect HIV antibodies, whereas the fourth-generation HIV tests generally used by healthcare professionals can also detect p24 antigen (a protein contained in HIV's viral core that can be detected in the first few weeks after infection). Fourth-generation tests are therefore better at picking up recent infections.

Second- and third-generation tests can accurately detect chronic (long-standing) HIV infection. However, their ability to detect recently acquired HIV varies.

Their window periods are longer than for other tests. The window period is the time immediately after infection when tests may not detect markers of infection, leading to false-negative results.

Globally, the majority of HIV self-tests are based on second-generation testing technology. They can detect immunoglobulin G (IgG) antibodies, but not immunoglobulin M (IgM) antibodies or p24 viral antigen. Since these two substances are detectable sooner after HIV infection than IgG antibodies, second-generation tests have longer window periods. The OraQuick In-Home HIV Test, SURE CHECK HIV Self Test, and autotest VIH are CE-marked second-generation self-tests.

The SURE CHECK HIV Self Test and autotest VIH are both adapted from instruments widely used by health professionals. This may be marketed as the Chembio Sure Check HIV 1/2 Assay or as the Clearview Complete HIV 1/2 Assay. In terms of use by health professionals, American regulators assessed this assay's sensitivity (the proportion of HIV-positive samples correctly identified) at 99.7% and its specificity (the proportion of HIV-negative samples correctly identified) at 99.9%. In relation to the two self-tests, studies showed that 97-98% of users followed instructions, used the test appropriately, and correctly interpreted its results.

Other HIV self-tests are based on third-generation testing technology. They can detect immunoglobulin G (IgG) antibodies and immunoglobulin M (IgM) antibodies, thereby shortening the window period. The INSTI HIV Self Test, Exacto Test HIV, and atomo HIV Self Test are CE-marked third-generation tests. In some countries, the atomo device is repackaged and marketed as the Mylan HIV Self Test or as the Newfoundland HIV Test.

The INSTI HIV Self Test is adapted from the INSTI HIV-1/HIV-2 Antibody Test for personal use. This is one of the most accurate third-generation tests available, with superior sensitivity to recent infection. When used by health professionals, the test's sensitivity and specificity were both calculated to be 99.8%.

Are people able to understand test instructions and use self-tests reliably?

A review identified 25 studies where individuals used self-tests, comparing their results with those of a healthcare worker testing them simultaneously. The original studies were conducted in a mix of North America, Africa, Europe, and Asia. Fifteen studies used oral fluid-based tests, six used blood-based tests, and four used both oral and blood specimens. Notably, several studies were evaluating professional assays not adapted for self-test use; performance might be better in commercially marketed tests.

The researchers found that most people could reliably and accurately use rapid tests. Using a statistical approach known as Cohen's kappa, where 1 represents perfect agreement between the results of a self-tester and a trained health worker and less than 1 denotes less than perfect agreement, results were highly concordant. The Cohen's kappa was 0.98 in studies where users received a demonstration of how to perform the self-test or interpret its result. In studies without such demonstration, it was 0.97. This indicates that in only a small minority of cases did the self-tester and the healthcare worker return differing results.

There were more invalid results with blood-based tests (0.4-9.5%) than with studies using oral fluid-based tests (0.2-4.5%). Common errors included improper or incomplete specimen collection, spillage or incorrect usage of the buffer solution, problems transferring blood samples, and difficulties interpreting results.

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While blood-based rapid diagnostic tests might yield more accurate results, more invalid results may occur due to user errors related to standard procedures when using capillary tubes and pipettes. Simplifying test procedures and providing clearer instructions might help reduce these problems.

Situations in which self-tests may not be accurate

Self-test performance is reduced in several situations, leading to potentially inaccurate results:

• During the test's window period, particularly in cases of recent HIV infection.
• In individuals diagnosed with HIV who are undergoing treatment. These tests are not a reliable way to confirm continued HIV infection.
• In individuals taking pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP). If they acquire HIV, they may experience a delayed antibody response, which extends the window period.

• When test instructions have not been correctly followed, such as collecting insufficient blood.

What do the test results mean?

There are three possible test results:

1) Negative (often labeled as 'non-reactive'). The test found no evidence of HIV infection, so you probably don’t have HIV (provided you’re not testing in any of the situations mentioned earlier).

2) Reactive (frequently misdescribed as 'positive' by manufacturers). The test assay has reacted to a substance in your blood, but this does not necessarily indicate that you are HIV positive. It means you should take additional tests to confirm the result, ideally at a healthcare facility with access to more reliable HIV testing technologies.

3) Indeterminate, equivocal, or invalid. The result is unclear, and another test is necessary.

Asanté ® HIV-1 Rapid Recency ® Assay

Previously collected specimens can be used in the Asanté® HIV-1 Rapid Recency® assay. It is essential to ensure that these specimens were stored under appropriate conditions.

Collected serum and plasma specimens can be stored at 4°C-8°C for a maximum of one (1) week (7 consecutive days). For long-term storage, specimens should be stored at -20°C or lower.

Whole blood specimens can be stored at 4°C-8°C for up to 24 hours prior to testing and should not be frozen.

The specimen should be collected after initially dipping the Specimen Collection Loop in the Sample Buffer. Ensure that it is properly collected by swirling the Specimen Collection Loop in the buffer multiple times.

Take care that the Specimen Collection Loop does not touch the sides of the Sample Buffer tube before contacting the buffer.

Yes, however, the test does not differentiate between HIV-1 and HIV-2 infections. In areas where HIV-2 is likely encountered, it is crucial that HIV-2 specimens be subsequently identified and excluded from test results, as they may be reported as recent infections regardless of their true infection timelines.

The second line, or Verification line, verifies that a specimen is HIV positive. The presence of only the first (Control line) and second line indicates that the infection is recent. The presence of the third line, the LT/R line, signifies that the specimen is from a long-term infection.

Specimens that yield invalid results should be retested with a new sample aliquot dispensed into a fresh Sample Buffer tube and assessed with a new Test Strip. If the retest still results in an invalid outcome, a new specimen should be collected for testing. Should the result remain invalid after testing a new specimen, it is advised to contact Sedia Customer Service.

The Asanté® HIV-1 Rapid Recency® Assay is for Research Use Only and not for diagnostic procedures. Users in the U.S. must complete and submit a Certification Regarding Research Use (download here) prior to product shipment, certifying that the product will be utilized solely for research compliant with FDA regulations.

Sedia Biosciences is currently collaborating with the Centers for Disease Control and Prevention (CDC) on the development and evaluation of this assay. Availability may be subject to CDC authorization and approval.

For regulatory or product information specific to your country outside of the U.S., please contact us.

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