The Caribbean Public Health Agency (CARPHA) has absolutely no jurisdiction to validate any private medical lab in the country, former health minister Dr Fuad Khan said reiterating the agency has no legal standing to do so. Health Minister Terrence Deyalsingh recently said any private lab wanting to conduct covid19 tests, has to first be validated by CARPHA.
Contacted on the issue, Khan who is also the San Juan/Barataria MP said, “CARPHA is a private lab in its own right, they are not a stand alone body to validate labs in this country because labs in this country are not subject to that. I put a bill through Parliament in 2013, called the national accreditation bill to accredit labs and assess them, but I had to withdraw it because they did not want to de-register labs. CARPHA cannot justify assessing labs.”
He advised that the state ensure private labs have the equipment and that this equipment is of internationally recognised standards to carry out the tests. “Once you have the kits you can do the tests, so all labs can do it if they have the proper kits.”
Khan said what CARPHA can do is ensure that the testing kits coming into the country are internationally certified by recognised agencies whose job it is to ensure that kits used in medical issues satisfy certain quality criteria.
“There are some coming out of China that are not internationally accepted, but there are kits from South Korea which they make themselves and which are internationally accepted. Tests done with the Chinese kits do not give standardised results. CARPHA cannot determine that.”
Khan said since he was responsible for bringing CARPHA to TT, he can firmly say the agency does not have the capacity to handle the number of tests that really should be done.
Molecular and clinical pathologist Dr Derek Emmanuel said his lab is more than willing to help by doing covid 19 tests since his lab has both the expertise and the kits. He said there are only a few labs locally which can do the test for covid19.
Speaking on the issue of accreditation, Emmanuel said his lab is accredited by the College of American Pathologists (CAP), but there is no legal requirement for any private lab in TT to be accredited or registered with any government institution.
“But any lab that wants to be credible can go through the accreditation process that follows international guidelines. This would be ISO 1589 or CAP. Even the labs at hospitals are not accredited, but are operational because they are integral for the effective management of a patient.”
Emmanuel said if the Health Minister wants to bring other labs into the fold first he has to see that they are accredited and what body accredits them since this would speak to the validity of results coming out of that lab.
“With covid19, because it is new and there is a lot of information still being gathered about it, the PCR (polymerase chain reaction) test is a test for anything that involves DNA or RNA. You use PCR for paternity testing, forensic testing and to detect organisms such as the coronavirus. The minister was alluding that he wanted the labs to perform with the PCR test.”
Emmanuel said since the PCR test is expensive, there is a cheaper antibody test that can be done. “Once you are infected, the body develops antibodies of the virus you are infected with. So there are some antibody tests that aren’t used specifically to identify the virus, but what it does is tell if you have been exposed to the virus. Those tests are much cheaper and could cost $300 to $400, as compared to the PCR test which cost upwards of $1,000.”
The antibody test can be given to people who have never been exposed to the virus. “If you get a positive you then refer them to a lab that does the PCR (test). As with any test, you want to make sure if it tests positive that you are positive. If it tests negative you want to make sure you are really negative. You don’t want false positives or false negatives,” Emmanuel said.
Health Minister Terrence Deyalsingh, earlier in April, encouraged private labs to get certified by CARPHA so they can start covid19.
He warned however that test results must first go to the Chief Medical Officer (CMO) Dr Roshan Parasram instead of the patient and that a breach of this fundamental rule could attract a $50,000 fine or even jail. The test results from private labs will be included in a nation covid19 database. A list of accredited private medical labs was also to have been issued by the ministry.