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The Ministry of Health has withdrawn a particular brand of COVID-19 test kits imported into Jamaica following an alert from the World Health Organization (WHO).
Health Minister Dr. Christopher Tufton says assessments are being carried out on the reliability of the test kits and a report on the tests will be provided to the ministry by November 26.
The concerns relate to the SD Biosensor Standard Q COVID-19 Antigen Test Kits manufactured in India.
Speaking in the House of Representatives on Tuesday afternoon, Dr. Tufton revealed that the ministry was notified by the WHO Surveillance System for Substandard and Falsified Products on October 13 about the potential presence of the unregulated test kits in the island and the entity requested that an investigation be done.
After being alerted by the WHO, Dr. Tufton said the ministry complied with the request to investigate and it contacted the Indian manufacturer of the test kits on October 13 and requested samples of the product that were delivered to the ministry on October 14.
"The National Public Health Lab was then requested to conduct the necessary validation of the kits, given that PAHO/WHO were still conducting investigations into the authenticity of the particular kit," Dr. Tufton told the House.
The Health Minister explained that that brand of test kits had been given emergency approval by the WHO. However, he said the health organisation had not specified the manufacturing site.
"The site that was approved, however, was this South Korean site, which is the original creator of this particular kit. Subsequent to that, that very same kit or the kit bearing the same name was outsourced to be manufactured in India and the Indian manufacturing process was not approved by the WHO," he pointed out.
According to Dr. Tufton, an importer brought in the India-manufactured kits to Jamaica, which sparked the notification from WHO and the Pan American Health Organization (PAHO).
He said the kits were being sold at a price much lower than the average for this type of product.
Dereliction of duty
However, Opposition Spokesman on Health Dr. Morais Guy has accused the Health Ministry of dereliction of duty in relation to the test kits in question.
Dr. Guy indicated that the WHO, when it approved the test kits made in South Korea, had given a particular product code for those kits.
"The one that was approved was 09COVBOD. The one out of India is 10COVC10. So even though they might be the same name, Madam Speaker, they came with different specification and certainly it’s a dereliction on the part of those at the ministry who gave the approval," he argued.
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