[UPDATED] Department of Health issues guidance on covid19 rapid test kits
The Ministry of Health has released a list of antigen/antibody rapid test kits that have received a letter of no objection from the Chemistry, Food and Drugs Division (CFDD) for import into the TT. The test kits listed are intended for professional and laboratory use only.
In a statement, the ministry reminded the public that before importing any rapid antigen or antibody test kit, an application along with supporting documents and a sample of the product must be submitted to the division for evaluation and a “no objection” letter issued.
It stated under the Food and Drugs Act, Chapter 30:01, “the term ‘device’ means any instrument, apparatus or artifice, including its components, parts and accessories, manufactured, sold or represented for be used in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state or its symptoms, in humans or animals. of antigens/antibodies fall within this definition.
Approved rapid tests are branded Abbott, Fastep, CAMTECH, SD Biosensor – Standard Q (Korea), Access Bio, DNA Diagnostic, VivaChek, QUIDEL, ARIA, SURE STATUS, Co-Diagnostic Inc, EUROIMMUN, SD Biosensor (Mannheim) , BD Veritor TM System and SD Biosensor (Korea).
He said the process for issuing a letter of no objection for importing devices is as follows: once a request for a letter with relevant supporting documentation has been submitted to the CFDD, the division will process the application to determine compliance with the Food and Drugs Act, and the applicant will be informed whether the application has been accepted (and the letter is issued) or rejected.
He said a no-objection status can be changed based on new data and information about the safety or quality of the test kit. When a rapid antigen/antibody test kit is imported without the relevant CFDD approvals, the importer may be subject to a fine and/or imprisonment under the Food Act and drugs.
He recommended that the PCR test remain the internationally accepted confirmatory test for the detection and diagnosis of covid19.
He also warned importers, healthcare providers and the public about the limitations of rapid antigen/antibody test kits as the sole basis for diagnosing patients with the covid19 virus.
Further information on the application process can be obtained from CFDD at [email protected] or 868-623-5242.
The public is encouraged to immediately report instances of misleading or misleading labels and advertising that may create an erroneous impression of the character, value, composition, merit, or safety of a CFDD test kit to [email protected] or 868-623-5242.