With Health Minister Terrence Deyalsingh encouraging private labs to seek their CARPHA certification to do COVID-19 testing, some of them have already begun making arrangements to do so.
The director of one of the leading private medical laboratories said yesterday that his company was already making adjustments in order to do testing for the virus in a few weeks. Not wishing to be identified, he said private labs will ber sourcing their own polymerase chain reaction (PCR) kits to conduct the tests.
He said he didn’t anticipate that this will be an issue though, saying more and more international manufacturers were releasing test kits every week. In fact, the manufacturers who will be providing tests for his firm just got their kits approved by the US Food and Drug Administration.
While his company hasn’t started PCR testing as yet, he said the kits will be arriving within two-to-three weeks. He said he doesn’t anticipate that certification from CARPHA will be troublesome, given that his laboratory is an accredited ISO 15189 lab. An ISO 15189 accreditation is an international standard developed by the International Organisation for Standardisation’s Technical Committee 212.
Managing Director of Caribbean Med Labs Foundation Valerie Wilson also doesn’t foresee private labs already internationally-accredited for PCR testing encountering problems getting COVID-19 certification.
“Labs that are accredited for PCR testing should be able to have their COVID-19 testing method verified by an appropriate organisation once they are using appropriate methods and adhering to international standards,” she said.
The immunologist said Health Minister Terrence Deyalsingh, in all likelihood, is seeking to increase the country’s testing capacity by asking labs to expand their accreditation to include COVID-19 PCR testing. Still, she said given that the COVID-19 PCR test is new, labs will have to get an appropriate organisation to verify that the respective labs’ PCR method is giving accurate results.
“You want to make sure every time they test that you get an accurate result by adhering to international standards for the laboratory operations,” the one-time member of the CARPHA Laboratory Advisory Committee said.
In this instance, the organisation to do so will likely be CARPHA, as they are the only accredited body locally to carry out COVID-19 testing.
“In the United States, for example, what they did was they have these large accredited labs already accredited for PCR testing, so they had the FDA approve the tests. The Health Ministry seems to be trying to do a similar thing – by seeking to have the labs’ tests verified,” Wilson added.
As things stand, most labs in Trinidad are not accredited for PCR testing but a few are, she said. However, she added that labs could potentially perform other COVID-19 tests.
“Some of the labs may not be doing PCR, they might be doing other tests. There are rapid tests for COVID-19, as well as Antigen and Antibody tests,” she said.
The ministry is likely focusing their attention on the PCR tests because they indicate whether the patient is currently infected and contagious, Wilson noted. She added that PCR tests also work better than the simpler antigen tests. However, that approach to testing my change in the future, she suggested.
“Over the long-term, you may want to look at antibody testing to know how many people may have had asymptomatic infections, or undetected infections - and may not be protected by antibodies,” she said.
PCR samples are taken from places likely to have the virus that causes COVID-19, like the back of the nose or mouth, or deep inside the lungs. Following the collection of a sample, RNA, which is part of the virus particle, is extracted and converted to complementary DNA for testing, according to a research article entitled “Testing Individuals for Coronavirus Disease 2019.”
Antigen tests test for the presence of the genetic signature of SARS-CoV-2, the virus which causes COVID-19. A swab is used to collect a sample from inside the nose, or the back of the individual’s throat, according to the Association of the British Pharmaceutical Industry. Antibody tests test whether an individual has been exposed to COVID-19 infection and has developed antibodies, according to the ABPI.