US contradicts Mkhize statements over restriction on export of Covid-19 test kits


The US has denied it placed any restrictions on the export of Covid-19 test kits, contradicting statements by Health Minister Zweli Mkhize before Parliament this week.

Mkhize told the Health Portfolio Committee on Monday there were problems with supplies of test kits for the National Health Laboratory Service's (NHLS) GeneXpert machines - a crucial element of plans to ramp up testing for Covid-19.

This week, the NHLS also refused to divulge its current stock of testing kits after a stony silence over the issue since it was first asked by News24 earlier this month.  

"The GeneXpert kits are actually produced in the US. Since the US has put a restriction on the stuff being exported … the other company is operating out of Sweden and they have got some challenges which they have reported to us.

"We are hoping that they will get over those challenges … they have promised that they will be increasing their supply to us," Mkhize said.

"We are aware the whole continent is looking for the same kits, so there is going to be quite a challenge."

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He confirmed the NHLS had received 10 000 kits for the GeneXpert machines earlier this month, and a further 15 000 were expected this week.

"The United States government has not placed any restrictions on the export of Covid-19 test kits," a representative of the US State Department said in response to queries from News24.

The spokesperson reiterated the US' commitment to assisting South Africa, saying it had committed $21.5 million to the country's Covid-19 response effort, and a further $170 million to the rest of Africa.

"We will continue to work with our partners, consistent with the needs of US citizens, to ensure the flow of vital medical supplies and to resolve disruptions to global supply chains to support the health and well-being of all people."

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Cepheid, the company that manufactures the GeneXpert machines and the accompanying test kits, reiterated a previous denial over the existence of export restrictions.

"There are no restrictions on sending tests to Africa, however, global demand is high and we are working hard to increase the number of tests we can send to all global regions that need them," it said.

cepheid testing kit covid19
The Xpert Xpress testing kit made by Cepheid can, when used in conjunction with its GeneXpert machine, test for Covid-19 in less than 45 minutes. Supplied.

A senior NHLS official, with knowledge of the discussions, said Cepheid was under an obligation to produce a certain number of kits for the US market before being allowed to export.

Neither the State Department nor Cepheid responded to a question over these quantity requirements.

Key element

The GeneXperts of which South Africa had more than 300 have so far been fitted to 17 mobile testing units and installed at laboratories around the country, the NHLS said. The machines can test four samples at a time and provide results within 45 minutes.

This would increase the number of NHLS operated testing sites around the country to 183, NHLS chief executive Dr Kamy Chetty previously told News24.

News24 reported on 5 April an unofficial clampdown by the US government on the export of the test kits was raising fears that local efforts to combat the disease might falter.

READ | Fear that US exports clampdown could hamper SA's effort to ramp up testing

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

News24 first questioned the NHLS about possible shortages on 8 April. It responded on 26 April - 18 days later - but did not provide the requested number of testing kits for not only the GeneXpert machines, but also the new Roche Cobas machines installed in laboratories.

"Small stock of 10 000 kits has been provided after validation, more kits have been ordered and delivery is dependent on the production capacity of the factory," the NHLS said when asked about the GeneXpert kits.

"The NHLS has ordered more test kits than has been delivered and would like to have received more but production is a challenge," it said of test kits for the Cobas machines.

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As of 30 April, 207 530 tests for Covid-19 have been done, 10 403 more than the 197 127 reported the day before

The reported number of tests by Tuesday was 185 497 of which 80 006 were done in NHLS laboratories and 105 491 in the private sector. The department has not provided a breakdown of tests done by public and private laboratories since 27 April.  

The NHLS' executive manager for academic affairs, research & quality assurance, Professor Kholeka Mlisana, previously said a combined daily testing capacity of 50 000 was available across public, private and research laboratories.

A widely shared goal of the NHLS was to reach a testing capacity of 30 000 per day, which could be hampered by a shortage of test kits for GeneXpert machines.

The machines have also been fitted to 17 mobile testing vans - 53 other mobile units were deployed to various provinces to conduct screening and sample collections.

The fully equipped mobile units are set to be used in areas far away from these laboratories, but will be unable to do so if test kit stocks are not readily available.  

The remaining mobile units transport samples back to the nearest NHLS laboratory for testing.

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