By Clara Quainoo – GIJ Intern
The Ministry of Health (MoH) has approved the Polymerase Chain Reaction (PCR) Test as method for screening and medical testing of Covid-19 in the country.
This decision was taken by Ministry to stop people who import Rapid Diagnostic Test (RDT) kits as tools for self-test, screening and diagnosis of Coronavirus from doing so.
According to a Press Release issued by the Food and Drugs Authority (FDA), the use of unvalidated and unauthorized RDTs may result in false positive or false negative results.
“The consequence of unnecessary quarantine and tracing or spread of infection by persons with the disease. These results if used for policy decision-making, could undermine public confidence and hamper national efforts being put in place to control the disease,” the release stated.
In view of the confirmation of PCR Test by the MoH, the FDA is also cautioned the public who are using and importing the RDT Kits must ensure they are validated within the appropriate settings and target population before they can be approved for use.
The FDA stated that the validation process is guided by independently evaluating the diagnostics for assurance of quality and performance through collaboration with Research laboratories and Public Health laboratories and the expert Technical Advisory Committee for Medical Devices.
According to the FDA, commercially marketed test kits that passed the evaluation or validation process will be granted Emergency Use Authorization (EUA) for use during this pandemic.
Ever since the novel Covid-19 hit Ghana, the government as well the health sector with support and aids of other countries and individuals have been putting measures and efforts in place to curb the pandemic.
Some individuals however see it as an opportunity to exploit and make money by importing kits claiming they are used to test Corona virus.
Meanwhile, the FDA believes that the introduction of the PCR Test will put to rest public concerns and some misconceptions about the efficacy of the RDTs in the system.