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Coverage of “better” HIV self test doesn’t support the claim


3 Star

The U.K.’s New At-Home HIV Test Is Better Than Anything We Have In The U.S.

Our Review Summary

BioSure KitThis story on an at-home HIV self test now available in Britain ends with “America needs to catch up.” This concluding opinion marks the article as more advocacy than news. Throughout the story, potential benefits are highlighted in a way that’s incomplete and potentially misleading. Harms are also ignored, and evidence is absent or mischaracterized.


Why This Matters

HIV testing is a critical step in the pathway from diagnosis to treatment for what is now a chronic condition. Routine HIV screening in health care settings has been shown to be cost effective and this is now recommended by groups like the CDC and USPSTF. Home testing is potentially an interesting complement to traditional testing, especially to target the ~20% of people who are infected and do not know it. But accuracy and convenience are only part of the picture when it comes to HIV testing. Such tests are helpful only when they increase early treatment and decrease infections. Test results that are misunderstood, misinterpreted or ignored can do real harm. By arguing that self-testing will provide benefits, without providing any evidence and failing to note potential harms, this story gives readers an incomplete and unbalanced picture of how this new test fits into efforts to prevent and treat HIV infections.


Does the story adequately discuss the costs of the intervention?


The story lists the test cost of $45. However, the story would have offered a more complete picture of cost if it had estimated the annual cost of regular screening and provided costs for other tests.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story provides concrete percentages for false negative rates and does a good job explaining the different methods for calculating undiagnosed cases. But it doesn’t substantiate or quantify the main benefits that home testing should presumably deliver — earlier treatment and fewer infections. In fact, the benefits of testing that are mentioned in the story are based on studies of testing that is coupled with counseling, not self-testing. The story does not include any evidence that self-testing, unconnected with counseling, leads to either earlier treatment or safer sex behavior.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

There is an egregious disregard of harms. Imagine the trauma of receiving a preliminary test indicating you may be infected with HIV, without any counseling or other support. A false positive test would inflict at least temporary anxiety, but if a person did not seek follow-up testing the trauma of an inaccurate test could be long-lasting. It’s possible self-testing could harm people if it means they are less likely to seek care than if they had been tested in a setting that offers counseling. Also, the test may not detect infection that occurred within the previous three months, so a person who was recently infected, but gets a negative test result, may incorrectly believe he or she is uninfected and then expose others.

Some of the challenges of home testing are covered in this review article. (Dr. Ganguli is a co-author). In addition to the above, there is the issue of the test being used more by the worried well and the affluent than by those at highest risk for the disease. In surveys, Americans report that they do not want to spend more than $15 on an HIV test.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story misuses evidence from studies of HIV testing coupled with counseling to argue for benefits of self-testing at home without counseling. Indeed, it reports that there are benefits “even for patients who don’t wind up connecting with a doctor,” but the CDC publication it links to does not include any discussion of self-testing at home. The CDC document emphasizes the benefits of early treatment, which can only happen when people connect to health care providers.

The story also ignores the process of confirmatory testing after the initial home test — this is an essential step. We know that many people who get a positive initial test skip confirmatory testing. And while the story notes that there is a three-month lag between infection and when HIV can be detected by this test, the story would have been better if it had more clearly told readers that the low false-negative rate it reports applies only when people wait the right amount of time before testing themselves.

Does the story commit disease-mongering?


The story accurately reports that about one-fifth of people with early HIV infections don’t know they carry the virus. However, the story does not explain who testing is recommended for or how frequently.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

There are no independent sources identified in this story. That would be ok for an op-ed, which is how this story reads. But the byline is from a news writer, so our standard of at least one independent source applies here. Again, the independent studies reported on did not actually look at self-testing at home.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

This point is an important problem with the story. Without providing any evidence, the story pushes the assumption that self-testing at home offers the same benefits as testing that is coupled with counseling. While the story does provide some comparisons with at-home HIV tests currently available in the US, the comparisons are incomplete. It notes that users of one test have to send their blood sample to a lab and then call for results, without noting that this call provides an opportunity to explain the meaning of the test result and encourage follow-up counseling or treatment. The comparison with another test mentions only the false negative rate, without also reporting the false positive rates.

Does the story establish the availability of the treatment/test/product/procedure?


The story clearly reports that this HIV test is now available in the UK, but not in the US. However, the murky quote from an FDA spokesperson leaves readers in the dark about whether the company selling this test in Britain has, or is planning to, apply for approval in the US.

Does the story establish the true novelty of the approach?


The story explains some of the differences between this HIV test and others.

Does the story appear to rely solely or largely on a news release?


The story includes information from a variety of online sources, so it does not appears to rely on just a news release.

Total Score: 5 of 10 Satisfactory

Comments (1)

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Roger Pebody

May 6, 2015 at 4:27 am

I agree that the story you reviewed overlooked many key points. Most of all, there is a real issue that would be worth exploring – a comparison between the only self-test approved by the FDA (OraQuick In Home) and the one now available in the UK (BioSure). The headline promised this, but it was undeveloped in the piece. On that specific point, the limited data available suggest that the UK-approved test may be superior.
I’m all for your reviews deflating the blind optimism of health journalists and press releases, but the critiques sometimes ignore useful evidence. For example, in the discussion of possible harms, why privilege speculative comments from a six-year old review when a more recent systematic review of actual experience with self-testing provides reassurance on this point?