Malawi could be at risk: US gave African countries faulty HIV kits that gave wrong blood testing results

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Picture yourself going to a VCT clinic for an HIV test in order to learn your status. The health worker collects your blood. The clock starts ticking. For about 15 minutes you will have to wait for your results. At any other time of life, 15 minutes is a relatively short period of time.

However, when waiting for a possibly life changing result, that 15 minutes can feel like 15 hours. Either way, the wait is over. Your results are in. The results, as you had feared, are that you are HIV positive. You are immediately put on medication.

But what if the testing kit got it all wrong?

The United States Agency for International Development (USAID), the Centres for Disease Control and Prevention (CDC) have actually acknowledged that they have been providing to several countries in Africa faulty HIV testing kits that might have given thousands if not millions of people wrong blood testing results.

The two US agencies have been forced to issue a conceding statement following a study by Médecins sans Frontières (MSF), a Non-Governmental Organisation (NGO) that works on health.

In its study, MSF researchers discovered that dominant HIV kits used in some African countries that were provided by the US government through its agencies failed to meet crucial quality tests leading to patient misdiagnosis.

hiv test

HIV testing kits put under the microscope

The study reveal that the HIV kits, widely used in resource‐constrained countries like Malawi, failed the tests despite being certified by WHO.

“Most kits performed more poorly than in WHO evaluations, with only one test (STAT-PAK) meeting the recommended thresholds,” lead author Cara S Kosack of MSF told the Standard of newspaper of Kenya that broke the story.

The study, which examined HIV kits used in Guinea, Uganda, Cameroon and Democratic Republic of Congo, calls for “the urgent need for a comprehensive, systematic evaluation of these tests”.

The study notes that wrong HIV testing results can lead to severe psychological trauma and profound social effects including draining off of already scarce resources in deprived communities.

“Given the potential for severe psychological and social impacts of HIV misdiagnosis, it is imperative that HIV diagnosis is highly sensitive and specific…In addition to the psychological trauma a misdiagnosis can induce in the individual patient, who may inappropriately have been initiated on treatment that is both costly and potentially harmful, there is also the considerable programmatic impact of false positives, which siphon off scarce resources and may undermine client‐patient confidence in the testing” reads part of the report from the research.

Incorrect diagnosis and treatment for an HIV-negative person can also lead to medical resistance due to “unneeded regular treatment and potential associated toxicities”.

The findings also back the recommendation by the World Health Organization (WHO) that the diagnosis of HIV should not be based on results from a single HIV rapid diagnostic test and from one geographical area.

The US embassy in Malawi had not responded to our question on whether Malawi is among those affected by the faulty kits and measures that have been put in place to address any misdiagnosis despite waiting for several weeks for a response.

But in rejoinder study, the US, through President’s Emergency Plan for AIDS Relief (PEPFAR) which has also been funding HIV prevention and management projects in Malawi, argue that the faulty kits “would not be expected to have a significant impact on diagnostic accuracy and overall programming in most countries”.

Nonetheless, the US acknowledges that “the consequences of any misdiagnoses of HIV status are serious, with negative impacts on both the individual and the health system [and that] ensuring the accuracy of the HIV‐testing process has been a priority for the global community and extensive quality assurance mechanisms have been put in place”.

In the same response note, the US further believes the results by MSF study “provide important new clues in the understanding of diagnostic accuracy, as previous reports of misdiagnosis in resource‐limited settings have been primarily hypothesized to be the result of factors such as user errors”.

Currently, official statistics states that Malawi has a prevalence rate of 9.6%, meaning in every 100 people, about 9 people are HIV positive. According to UNAIDS, these figures are one of the highest in the world, pinning Malawi among top 10 countries in with the highest HIV prevalence rate in the world.

But if some of the faulty kits have been used in the country, there a possibility the number of people living with HIV could be significantly lower than projected. No study has been conducted in Malawi to establish the extent of HIV misdiagnosis and the false positives in the national prevalence figures.

Meanwhile, another study in Swaziland found that 13 in 100 people living with HIV who had participated in the study were false positive, that is they were HIV negative but had wrongly been tasted positive. The Swaziland study does not, however, does not provide an explanation on what could caused the misdiagnosis.

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