Tufton addresses importation of unapproved antigen test kits

The health ministry is not concerned with the track record of importers of antigen COVID-19 test kits, only the integrity of the devices, Dr Christopher Tufton told the House of Representatives yesterday.

At the same time, Dr Tufton, who heads the health and wellness ministry that has attracted heavy flak for allowing the importation of 100,000 test kits which had not been approved by the World Health Organization (WHO) and the United States Food and Drug Administration (FDA), said the ministry is encouraging more entities to import test kits, as increased competition will drive down the cost of COVID-19 testing.

He pointed out, however, that importers must apply for the required permits.

“Our job is to follow the standards that have been established in law as it relates to the integrity of the kits. Our responsibility in public health is not to determine whether the importer is a yesterday or 10-year importer. I don’t know if the entities that have applied for importation have a track record for other types of testing kits; our job is to ensure that consumers get what they’re paying for and it produces the results that it claims,” he stated.

Dr Tufton was responding to questions tabled by Opposition spokesman on health Dr Morais Guy about the importation of 100,000 SD Biosensor Standard Q COVID-19 antigen test kits from India.

The matter was first brought to national attention by the Jamaica Observer last week in a front-page story pointing to the importation of the unapproved test kits by a local company.

The WHO had indicated that the antigen test with the product code SD Biosensor Standard Q is not among those which it had approved for use. Additionally, the antigen test kits imported from India were not approved by the FDA.

Under Jamaica’s Disaster Risk Management Act (DRMA), only antigen test kits approved by the WHO or the FDA, which have been validated by the National Public Health Lab, are allowed to be imported and used in Jamaica.

There are concerns that the unapproved test kits could be significantly less reliable in determining a person’s COVID-19 status when compared with testing kits which are approved by both the WHO and the FDA.

The Observer had waited more than three weeks for answers to questions on the issue sent to National Laboratory Services Director Dr Michelle Hamilton.

After the story was published on November 2, the health ministry confirmed the information.

Yesterday, Tufton said the importation of kits was in breach of the DRMA. He added that they were withdrawn on October 13 by the ministry and a validation process launched after the WHO’s surveillance system for substandard and falsified products flagged Jamaica as one of two countries in the region which had imported the test kits.

It is unclear how many of the test kits have been used.

Tufton explained that the South Korean manufacturing base for the kits received WHO validation, but that the production process for the company’s Indian subsidiary, to which the kits were outsourced, had not. Jamaica received kits from both the South Korean and Indian companies in August.

“There are two approaches to validating a medical product  the first is to have the product itself go through a series of trials to ensure that whatever it says it can do, it does; the second is the validation of the production process, so wherever it is being produced you have to ensure that that process can in fact function with consistency, so it does not deviate from nor alter the product itself when it is competed,” he explained.

He said the Ministry of Health team had wrongly assumed that the kits from both jurisdictions had been validated and allowed the importation of the kits from India.

Dr Guy pointed out that the WHO had flagged kits themselves, not the Indian production site, and questioned whether Jamaica would still rely on the WHO’s approval of the kits, notwithstanding in-country assessment of the product itself.

In response, Dr Tufton said that the process could not be separated from the integrity of the kits, and he would therefore not split hairs on which of the two were flawed.

“If the process is flawed, then it is quite fair to say that the product also can’t be trusted sufficiently; the two are integrally connected. I’m not going to get into that kind of conversation until we get the validation that is being done [by] our own internal infrastructure,” Dr Tufton argued. He said the ministry would be transparent with the findings of the National Public Health Lab.

He told the House that the test kits are currently being assessed for efficacy and that reports would be provided to the ministry by November 26.

However, Dr Tufton refused to make any pronouncements regarding liability.

“I am not going to second-guess what the results of that process will be. My approach is to allow the process to take its course. Based on the results of those validation exercises, then we will have a conversation as to whether or not there is anything for any follow-up action,” he stated.

So far, four COVID-19 antigen test kits have been approved for use in the island.

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