Will UN health agency give green light for using COVID-19 self-tests?

Shobha Shukla / Bobby Ramakant *

If we get infected with an infectious disease, will we not want to protect our family and others from it? But, unless we know our disease status timely and reliably, how can we help prevent further infection transmission? How will we link up, and benefit from, health and clinical care pathways until we know ourselves that we are infected?

When self-tests for COVID-19 are available, there is no excuse not to make them affordable and accessible to everyone without any further delay, so that these easy to use tests can complement the confirmatory RT-PCR tests and other diagnostics for those who need them - and serve as an entry point for health and clinical care pathways.

That is why more than one hundred global organizations and experts have issued an open letter calling upon the United Nations health agency (World Health Organization – WHO) to authorize and recommend the use of COVID-19 rapid antigen detection tests for self-testing in low- and middle-income nations. People should be able to know their COVID-19 status in a simple, cheap and non-discriminatory manner.

Such an information will help them to take prompt action to break the chain of onward infection transmission, and rapid linkage to healthcare pathway will be another important outcome of this, argues this open letter that was issued towards the end of January 2022.

Why self-test?

More than 10 billion COVID-19 vaccine doses have been administered globally in a world of over 7 billion people. But more 3 billion people have yet to receive even their first dose. Vaccine inequity has cost unnecessary human suffering and untimely deaths. Now, inequity in accessing self-tests is a looming danger we cannot, and must not, have to deal with if we are to deliver on the tall promise of health for all where “no one is left behind”.

85% of global population lives in low- and middle-income nations yet only 40% of COVID-19 tests were done in these places. “The reported average per capita daily testing rate of high-income countries is nearly 10 times higher than that of middle-income countries and close to 100 times higher than that of low-income countries" reads the open letter.

In Africa alone, 85% of COVID-19 infections are going undetected according to WHO. This inequity in access to the diagnostic tools that trigger life-saving individual and public health measures is part of the same ‘medical apartheid’ that has plagued the rollout of COVID-19 vaccines, added the open letter.

Self-testing is a necessary tool to enable rapid linkage to care and initiation of outpatient treatment to prevent hospitalisation and death, especially among those at high risk of disease progression.

There is another reason why home self-tests are important to be made available, affordable, and accessible to all. A photograph published in news in early February 2022 shows 'healthcare workers under police protection' going door to door to conduct COVID-19 testing.

Noted infectious diseases expert Dr Ishwar Gilada is right in commenting on this news that “Looking here, people have been right in doing home self-tests using rapid antigen detection tests and following self-quarantine if they were positive for COVID-19, without notifying to authorities! Who wants to be stigmatised in this way? Look at the health team without social distancing and posing [with the person being tested fully visible].”

We do not know if the health authorities and police (or media) took permission from the person, who is being tested in the photograph, to take and make the photo public, but we do know that such top-down approaches to infection control have been counterproductive for public health as well as for human rights.

Open letter calls upon WHO to issue self-testing guidelines

The open letter calls upon the WHO to expedite the finalisation and release of a self-testing guideline for SARS-CoV-2 infection that includes a strong recommendation in favour of widespread access to self-testing. It is believed that the Guideline Development Process of WHO is currently underway, due to which the open letter emphasises the urgency of WHO making an immediate statement in favour of this important tool for COVID-19 control in the interim.

Dr Ishwar Gilada, who was among the first doctors to begin HIV medical management when the first HIV infection case was diagnosed in India, said to CNS (Citizen News Service): "It is very important that home self-testing be made available to everyone. We need to empower and trust people as equal partners with dignity in the fight against COVID-19. I have not seen anyone who is ‘wanting to infect others’. So this fear is unfounded. People will like to protect their families and others who they come in contact with, provided they know their COVID-19 status. We saw this approach work in rights-based health responses to control other infectious diseases.”

Self-testing has the capacity of greatly expanding the number of people who know that they have contracted COVID-19 and are likely to be infectious to others. Access to self-tests promises significant benefits, particularly in resource-limited and geographically remote settings that lack sufficient RT-PCR testing capacity. Even in areas with RT-PCR testing know- how, self-testing can increase uptake among marginalised populations who are less able and/ or likely to engage with the health system because of stigma, discrimination or unaffordability.

Dr Gilada added that during the peak of Omicron wave in Maharashtra state of India, RT-PCR test results came back in 2-4 days. “What is the use of getting RT-PCR test results so late as symptoms come and go in 3 days usually. If we do not get timely reports then the person may be under a false sense of security. This will not only delay linking with clinical care pathway but also put family and others at risk of getting infected. We should make rapid antigen detection tests available for all so that people can use them to know their status, and act accordingly to prevent any further transmission, as well as link up with the health and clinical care pathways.” He rightly calls for WHO and governments to strictly regulate the price of home self-tests.

Instead of bluntly recommending against self-testing, WHO should address its specific concerns directly with complementary recommendations that ensure countries pair access to self-tests with knowledge that empowers people to properly collect their sample, notify positive test results to public health bodies and understand the risk of false negatives. Additionally, WHO should recommend that health authorities must incentivise people to report their results and engage with the health system by offering supportive care, treatment options, and PPE to all those who need them, reads the open letter.

The open letter calls upon the WHO that its forthcoming guideline on COVID-19 diagnostics should recommend self-tests as a screening strategy on the basis of emerging yet strong evidence of the benefit to individual, community and population health and rights.

The open letter says that in the absence of urgent action by WHO, national health systems and individual people have already begun to use and rely on self-testing as a risk management tool for avoiding exposing others, and to manage individual risk as well as to increase national diagnostic capacity. No health system should be waiting for WHO to overcome its conservative approach to the evidence. Accordingly, even in the absence of WHO guidance, countries need to act- in particular, if countries are buying antivirals, they need to ensure they have a testing strategy that is able to support their treatment strategy.

By acting with urgency now, WHO can help ensure that supportive public health messaging and complementary strategies are properly designed and emphasised by national health authorities recommending self-testing and implementing programmes to make rapid antigen detection tests accessible, states the open letter.

The over one hundred organizations that are signatories to this open letter, include: Amnesty International, AVAC, CNS (Citizen News Service), Drugs for Neglected Diseases initiative, Global Network of People Living with HIV, Global Network of Sex Work Projects, Health Global Access Project (Health GAP), Health Justice Initiative South Africa, International Community of Women Living with HIV/AIDS (ICW) Latina, International Treatment Preparedness Coalition, Oxfam, Partners in Health (PIH), Third World Network, Treatment Action Group, Treatment Advocacy and Literacy Campaign Zambia, among others.

Prominent global health experts, who have endorsed the letter, include: Dr Madhukar Pai, McGill University; Mark Harrington, Treatment Action Group; Sharonann Lynch, O’Neill Institute for National and Global Health Law, Georgetown University; Mitchell Warren, AVAC; Bobby Ramakant, CNS; Dr Chris Beyrer, Desmond Tutu Professor in Public Health and Human Rights, Johns Hopkins Bloomberg School of Public Health; Gregg Gonsalves, Yale School of Public Health; Dr Kenneth Mayer, Harvard Medical School; Mercy Annapoorani, Blossom Trust India; among others.