KINGSTON, Jamaica— Minister of Health and Wellness, Dr Christopher Tufton, says COVID-19 test kits that were imported into the island but not approved by the World Health Organization (WHO) are currently being assessed for efficacy.

“Reports of the efficacy tests will be provided to the ministry by the week of November 26, 2021. The test will provide information on the reliability and sensitivity of the kits in detecting the SARS-CoV2 virus in specimens and, therefore, determine the reliability of test results that were provided to individuals,” Tufton said.

He was speaking during the sitting of the House of Representatives on November 9.

Tufton said that the WHO Surveillance System for Substandard and Falsified Products, on October 13, 2021, forwarded an email to the ministry regarding the potential presence of unregulated Standard Q COVID-19 Ag in the Caribbean, manufactured in India and being sold at a price much lower than the average for this type of product.

Jamaica was named as one of the two countries in which the product was being used, the other being The Bahamas.

At the same time, the Pan American Health Organisation (PAHO) requested that the Ministry of Health and Wellness conduct the field operation to detect the presence of the kits on the island, obtain samples and provide a report.

“The ministry complied with the request, and it has identified that the SD Biosensor Standard Q COVID-19 antigen test kits manufactured in India were present on the island and were being used in the marketplace,” Tufton said.

He said the importer of the Indian manufactured product was contacted on October 13, 2021, and instructed to quarantine the products and to provide the ministry with samples of the products warehoused, which were delivered to the ministry on October 14.

The National Public Health Laboratory was then requested to conduct the necessary validation of the kits, given that PAHO/WHO was still conducting investigations into the authenticity of the kits.

“It is important to note that the product SD Biosensor Standard Q COVID-19 Antigen test kit had, in fact, obtained WHO Emergency Use Listing (EUL) and was approved for use in country, and importers authorised by the ministry for testing were required to submit the manufacturer’s product information,” Tufton said.

“A manufacturing site for the product was not specified by the WHO at that time when that particular kit was promoted as an approved kit. Analysis by the Standards and Regulation Division in August 2021 of permits approved for COVID-19 antigen tests revealed that import permits were issued for SD Biosensor Standard Q COVID-19 antigen test kits from two manufacturing sites – South Korea and India,” he added.

The minister also pointed that the product information submitted differed only in the name of the manufacturing site stated.