Health Ministry Engaging With Private Sector To Increase PCR And Antigen Testing Labs

The Ministry of Health and Wellness will be engaging with the private sector to expand the number of testing laboratories for the coronavirus (COVID-19) polymerase chain reaction (PCR) and antigen tests.

This initiative involves partnership with the Jamaica National Agency for Accreditation (JANAAC) in the Ministry of Industry, Investment and Commerce as well as the Jamaica Hotel and Tourist Association (JHTA) and the Private Sector Organisation of Jamaica (PSOJ).

Portfolio Minister, Dr. the Hon. Christopher Tufton, who made the disclosure during a statement to the House of Representatives on November 9, said that the first step in this approach will involve validation of the test kits that are to be utilized in the country.

“Already, the Ministry has expanded the possible kits, both antigen and PCR that can be validated for use in the country. It is now the responsibility of importers to apply to the Standards and Regulation Division of the Ministry of Health and Wellness to have the kits validated and approved for importation,” Dr. Tufton said.

He informed that the process for approval entails submission of application for consideration, along with the medical devices application, with all required attachment and fees.

The samples of the kits are then submitted to the National Public Health Laboratory for validation, which includes an assessment of the performance of the kits for detecting the virus.

Once the product is found to be efficacious, safe and of good quality, and all the regulatory requirements are met, the product will be registered for use in the market.

A registration certificate is then issued to the applicant, who will be required to apply for the import permit using the import permit application form, which is to be submitted to the Pharmaceutical and Regulatory Affairs Branch.

Once the permit has been issued, the applicant can proceed to the Jamaica Customs Department to conduct the transaction of importing and distribution.

Dr. Tufton emphasized that these steps are for the approval of the kits only, noting that the approval and authorisation of laboratories to use these kits will be facilitated by the existing processes outlined through JANAAC, and will utilise the ISO 15189 accreditation for medical laboratories and ISO/IEC 17025 accreditation for laboratories offering testing and calibration services.

The Minister said some 15 laboratories are currently being assessed, 10 of which are at an advanced stage of accreditation to conduct COVID-19 testing in the population.

“These labs will join the current cadre of testing sites, which includes 12 laboratories approved for antigen testing, seven laboratories for PCR testing, and one collection centre/reference site,” he noted.

Dr. Tufton said that the two-pronged approach of increasing the number of kits available for testing and the number of laboratories offering tests, will expand the level of testing within the population for various activities, increasing awareness of infection rates in organisations, and meet the increased requirements for travel.