Port of Spain, Trinidad and Tobago. 22 July 2020. The Caribbean Public Health Agency's Caribbean Regulatory System (CARPHA - CRS) has issued the first ever recommendation of a diagnostic test kit for the novel SARS-CoV-2 coronavirus 2019 for emergency use authorisation and/or import by CARICOM Member States during the current pandemic. Based on guidance developed by the Pan American Health Organization (PAHO), the CARPHA-CRS implemented a verification review process for medicines, vaccines and test kits, that were approved for emergency use by recognised regulatory authorities.
The recommended test kit LabGun COVID-19 RT-PCR Kit developed by LabGenomics Co. Ltd, Republic of Korea is a real-time polymerase chain reaction test kit. The kit is authorised for use on respiratory samples collected from individuals who are suspected of COVID-19 by their healthcare provider and is recommended for use only during the pandemic period, by authorised agencies and/or laboratory personnel.
Dr Joy St. John Executive Director of CARPHA stated “In pandemic emergency situations, national regulatory authorities must make the best decisions they can, based on available evidence of risk-benefit, which in some cases may be limited. The application of this approach by the CRS will assist national regulatory authorities to identify products that have been assessed by trusted regulatory authorities, thereby reducing the time and resources needed to undertake local review, and enable faster access for use in CARICOM Member States.”
CARPHA-CRS has verified that the kit is the same product granted emergency authorisation by the US Food and Drug Administration (US FDA), and integrates technical aspects of CARPHA’s Guidance for the Evaluation and Selection of Diagnostic Tests for the COVID-19 Response.
According to the technical specifications provided by the company, the kit has a sensitivity and specificity > 95%, and meets the standard ISO 13485 for medical devices.
The recommendation for use is based on the emergency use authorization (EUA) issued by the US FDA for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, or oropharyngeal, anterior nasal and mid-turbinate nasal swabs, as well as nasopharyngeal wash/aspirate or nasal aspirate specimens and sputum.
Additional information about the CARPHA CRS can be found here. Information on the technical requirements for the EUA review procedure by the CRS may be found at: https://carpha.org/What-We-Do/CRS/Operational-Policy. The CRS team may be reached at CRSRegistration@carpha.org.