An unofficial clampdown by the US government on the exports of test kits crucial to South Africa’s plans to ramp up coronavirus testing, is raising fears that local efforts to combat the disease may falter.

South Africa does not manufacture machines or kits capable of testing for Covid-19, the disease caused by the novel coronavirus, and as a result is reliant on imports from companies in the US, China, South Korea and Switzerland, among others.

Globally, supply chains for crucial testing and treatment equipment, such as ventilators, test kits and protective gear for healthcare workers, are under severe strain to keep up with demand.

On Wednesday, Health Minister Zweli Mkhize launched 60 new mobile testing and screening units at the headquarters of the National Health Laboratory System (NHLS) intended to increase the numbers of tests conducted by the NHLS.

Mkhize said last week it was crucial that the country moved from reactive testing – meaning only testing people who showed symptoms or had been in contact with a person who had tested positive – to proactive testing coupled with extensive screening.

One unit at the launch, which will not be deployed yet, was fitted with four GeneXpert machines – state-of-the-art units capable of testing four samples at a time, with results ready in 45 minutes.

he GeneXperts are manufactured by California-based company Cepheid and the NHLS plans to have at least 20 mobile units equipped with these machines in the coming weeks, NHLS chief executive Dr Kamy Chetty told News24 on Thursday.

Cepheid also manufactures the test kits to be used by the GeneXperts, which are also being rolled out to meet testing demand in the US.

But also on Wednesday, The Guardian reported that Cepheid was one of three US companies manufacturing similar types of test kits which “have been told not to export them, leaving Africa… with a single supplier, Roche in Switzerland”.

A senior NHLS official told News24 that Cepheid “had to commit to manufacturing a certain amount [of test kits] and above that amount they can supply other countries”.

No current restrictions

Cepheid, in response to questions from News24, would not be drawn into the number of test kits it will deliver to South Africa or the timeline in which it would do so.

“Currently, we are not experiencing restrictions and have shipped tests outside of US, including to South Africa,” Cepheid said on Friday.

The NHLS expected delivery of the first Cepheid test kits this week, after which they would be validated, Chetty confirmed.

News24 was not able to ascertain the number of kits the NHLS has ordered from Cepheid.

On Friday, head of department for virology at Wits University and also a senior NHLS official, Dr Florette Treurnicht, said during an interview on Talk Radio 702 the NHLS had ordered the test kits three weeks ago, and was looking at engaging with Cepheid’s local supplier on future procurement of more machines.

News24 also reached out to a representative of the US State Department in South Africa for clarity on whether there was curtailment on exports by companies such as Cephied, but at the time of writing had not received feedback.

Roche supplies South Africa with machines and kits used in stationary machines installed in laboratories. Newly acquired Roche machines named Cobas 6800 and 8800 were recently delivered to the NHLS and will significantly boost testing capacity.

Roche also announced in recent weeks it was ramping up production of its test kits for Covid-19.

But the second leg of South Africa’s planned increase in testing numbers relies heavily on the GeneXpert machines and the accompanying test kits, the steady supply of which is now seemingly under threat.

News24 reported this week that, of the 60 new mobile units launched by Mkhize, only five were deployment-ready on Thursday and a further five would be dispatched on Monday.

In addition, these units were to be utilised for screening and collecting of samples, which would still need to be transported to one of 10 NHLS labs around the country to be processed.

Only one unit fitted

The first 10 units would not be equipped with state of the art GeneXpert machines immediately and so far only one unit fitted with the machines exists.

But this unit could not yet be deployed until the Cepheid test kits were validated and available.

Tests in private laboratories are paid for by those who can afford them, which results in a discrepancy in tests on impoverished communities that mostly live in densely populated townships near metropolitan areas.

The mobile testing units were aimed at addressing this problem.

The fully equipped GeneXpert units were intended for rural areas far away from its laboratories, Treurnicht explained.

At the time of the mobile units being launched, the NHLS had conducted a little more than 6 000 tests out of 44 000 total tests in the country. The remainder were conducted in private laboratories.

In a few weeks Mkhize said, they hoped the capacity to test would reach 30 000 per day, with the NHLS’s immediate goal at 5 000 per day, as he warned we were experiencing “the calm before a potentially devastating storm”.

 

[news24]