The Ghana Association of Medical Laboratory Scientists (GAMLS) has issued a warning to healthcare givers and the public to be wary of vendors claiming to supply Rapid Diagnostic Test (RDT) kits for COVID-19.
The FDA, the Association warned, has not approved any RDT (Coronavirus testing kit) for sale in Ghana.
It however acknowledged that while some countries have approved the use of some of these RDTs, nucleic acid amplification based tests, such as PCR and genome sequencing, remain a basic test for SARS-COV2 testing.
The global spread of the COVID-19 pandemic has placed immense pressure on countries and governments to provide expanded and timely testing.
The World Health Organization (WHO) is currently encouraging the development of cheaper serological tests though there is scanty or no validation or performance data for these tests and is currently validating kits in collaboration with Foundation Innovation in New Diagnostics (FIND).
The Medical Laboratory Scientists Association expressed concerns therefore that many rapid screening and diagnostics tests kits for COVID-19 are being advertised to medical laboratory professionals and the public to procure and use.
“As much as we seek innovative and prompt approaches to screen and diagnose individuals with COVID-19 infections, no such kit is approved in Ghana.
“We call on the Ghana FDA to collaborate with its sister agencies across the world and device manufacturers and their agents to ensure that validated RDTS are approved for sale in Ghana in an expedited manner to meet potential increases in demand for testing.
“In the same vein, we call on distributors and kit manufacturers to submit their products and data to the FDA for approval before continuing their distribution”, a release signed by Dr. Ignatius A. A. Nchor, President of the Association said.
The GAMLS appealed to the government, local and international stakeholders to offer grants to local test kit manufacturing companies to speed up their work on producing COVID-19 test kits to boost local research and development projects.
“And to boost local capacity to respond to potential increase in demand for COVID-19 testing as has become the norm across the world,” he added.
The Association urged health facilities to observe all testing and biosafety standards including interim guidelines for collecting, handling and testing clinical specimens from patients under investigation for the COVID-19.
