Gov't approves importation of self-testing kitsWednesday, December 01, 2021
BY ALPHEA SUMNER
The Government has given the nod for importation and use of COVID-19 self-testing kits approved by the World Health Organization (WHO) and the US Food and Drug Administration (FDA).
Health and Wellness Minister Dr Christopher Tufton made the announcement in Parliament yesterday, saying that the Administration is in support of expanding the test kits available on the market.
He urged private entities to apply to the standards and regulations division of the ministry for approval to import from the pool of 30 WHO/FDA-approved test kits that are now available.
“Once those test kits meet the standards of the FDA, including self-administered kits, we will quickly process and validate and allow permission and permits to import,” he stated.
Earlier this month, Tufton had indicated that the ministry was investigating the potential use of COVID-19 self-test kits locally for personal and firm-level surveillance of the novel coronavirus.
“This has become more popular globally, as the technology evolves and is becoming now a more important part of the overall self-check at the organisation level,” he told the House of Representatives at the time.
Yesterday, as well, he said that the ministry had, in partnership with the Jamaica National Agency for Accreditation, contacted 52 laboratories to participate in an inter-lab comparison by the National Public Health Lab to expand COVID-19 testing capacity. So far, 14 have not responded, while two were previously approved and another three were recently approved. He said that by Friday another seven labs are expected to complete the process.
“Within another 10 days, if there is timely return of samples and the resultant success in the inter-lab comparison, we could have 18 testing sites fully operational… in other words, the public health lab sends a panel of samples, those entities will take that panel and do the test, and they return the results, including a margin of error. If they meet up to 80 per cent accuracy in determining positive or negative, then they are certified or validated to become a testing site. It's important that we do that because the false negative or the false positive doesn't help with the management of COVID-19” he explained.
Dr Tufton also advised that the ministry is finalising training dates with the manufacturer of the genome sequencing machine which it acquired late October, and is selecting samples that will be used to test for COVID-19 variants locally.
The ministry is also procuring a second sequencer, through leased funding from the US Centers for Disease Control and Prevention (CDC). He said while this is being finalised, the ministry will continue to collaborate with the CDC, the Pan-American Health Organization (PAHO), and the Caribbean Public Health Agency (CARPHA), to send samples for genome sequencing.
This week, 49 samples were sent to PAHO, 80 to the CDC and 20 to CARPHA, he told the House.