Most Africans could not get a COVID-19 test unless they were hospitalised or could afford to pay a private laboratory for a pricey test – yet rapid tests were being dished out free in the US and Europe.

High prices, slow regulatory approval, and outdated ideas about self-testing were some of the barriers that prevented low and middle income countries, particularly in Africa, from getting COVID-19 tests, according to a forthcoming report from the People’s Vaccine Alliance.

And these problems will repeat themselves in the next pandemic unless there are systematic global and regional efforts to ensure better access to diagnostics, according to Dr Fifa Rahman, lead author of the report.

“Most African countries were reliant on Cepheid’s GeneXpert machines to run PCR tests, but some of the patents, for example for the expensive cassettes, run until 2037,” said Rahman, the principal consultant at Matahari Global and the civil society representative at the ACT Accelerator.

“Then there are different patents for the doors, and other things. If we have a pandemic before 2037, and we know that space between pandemics is shrinking, then African countries are going to be reliant on Cepheid again,’ said Rahman.

WHO diagnostics resolution

Eswatini, on behalf of the Africa region, has proposed a resolution on diagnostics that will be presented to next week’s World Health Organization (WHO) executive board (EB) meeting. It proposes a range of measures to boost access to diagnostics, including support for the local manufacturing of tests, and is likely to be put forward by the EB for discussion at the World Health Assembly in May.

“The reliance [on imported diagnostic machines] is something that really needs to sorted, but there also need to be African-made, automated PCR machines, in conjunction with automatic [patent] waivers during pandemics,” said Rahman.

The initial cost of each rapid test was $2.50, and barriers to African companies producing the tests including a lack of the basics to construct these tests – the plastic, the extraction tubes, the cassettes  – 

The report, due for imminent release on the People’s Vaccine Alliance website, proposes increased investment for the local production of diagnostics along the entire pipeline, to reduce reliance on foreign supplies, diversification of molecular platforms to reduce reliance on patented technologies and monopolies, and the expansion of the WTO June 2022 TRIPS ministerial decision to include diagnostics.

But Rahman is also wary of country dependence on WHO processes, pointing out that the regulatory process within the global body had delayed access to COVID tests because it required guidelines to be published before manufacturers could apply for emergency use listing. In addition, some WHO officials also wanted a feasibility study on self-tests.

“The WHO finally published the [self-test] guidelines in March of 2022, which is of course too late, as manufacturers could only apply for regulatory approval after that, and that takes a long time,” said Rahman.

Three steps to fast-track tests

The report proposes three key steps to fast-track diagnostics ahead of the next pandemic.

First, regions need to ensure that they improve their regulatory expertise to lessen their dependence on the WHO.

“Africa CDC buffing up regulatory capacity is essential, so that they don’t have to wait for WHO. Essentially, if WHO doesn’t have the resources to expedite the processes, regions need to do that themselves. They need to ensure that they can take decisions regionally. So they need to fund the degrees and training to create that regulatory expertise before the next pandemic,” says Rahman.

Second, countries also need national diagnostic plans to come into force as soon as possible, and technical experts are on hand to assist to draft those implementations plans. 

The third measure is one that Rahman describes as “more philosophical” as it involves a shift away from seeing diagnostics simply in terms of PCR tests for the sake of surveillance and data, to factoring in all kinds to ensure wider access nd equity – including rapid tests that can be easily distributed by community health workers.

“A lot of leaders see PCR tests as the gold standard in terms of surveillance and data, but if a PCR lab is 60 kilometres away from a village, tand a person doesn’t have time to come to the lab to get a PCR test, a self test is really the best solution,” says Rahman.

Diagnostics to prevent antimicrobial resistance

Earlier in the week, a report published by Health Action International (HAI) has appealed for urgent investment in the development of effective diagnostics to fight antimicrobial resistance (AMR).

“Currently, treatment decisions are often made without diagnostic tests, increasing the chance that an ineffective therapy could be prescribed, for example, an antibiotic to treat a viral infection, or a bacterial infection resistant to that drug,” according to the ‘Diagnostics to treat AMR’ report.  

“In the UK, for example, 70-80% of all antibiotics are prescribed in the community and 60% are for respiratory tract infections (RTI). Twenty percent of RTI prescriptions are thought to be unnecessary or inappropriate as RTIs are often viral so antibiotics are not required.”

HAI proposes the development of diagnostic tests to determine the broad type of infection – bacterial, viral, or fungal; identify the specific pathogen causing an infection and to identify the antimicrobial susceptibility of a pathogen.

A number of such tests already exist, according to HAI. For example, Abbott’s Afinion test can detect an inflammatory biomarker CRP in the blood to indicate if a bacterial infection is likely, which has a turnaround time of four minutes.

“For health systems to manage the challenge of AMR and enhance antimicrobial stewardship, the development of more accurate and rapid diagnostics for a range of clinical indications remains a priority,” argues the report.

Image Credits: Maxpixel, DNDi.