Faulty PCR reports issued by external research labs could jeopardise COVID-19 containment: CMLS-SL
ECONOMYNEXT – Faulty PCR test reports issued by external research laboratories that don’t come under the purview of the Ministry of Health could jeopardise Sri Lanka’s efforts to contain the COVID-19 pandemic, the College of Medical Laboratory Science Sri Lanka (CMLS-SL) warned.
CMLS-SL President Ravi Kumudesh told EconomyNext that research laboratories belonging to the country’s universities being used for PCR tests as opposed to ministry-affiliated diagnostic laboratories which are better suited for the purpose could potentially undermine the progress made so far.
“This is not an indictment of the university laboratories, which are of high standards. They just happen to be research labs and not diagnostic labs that are needed for PCR tests,” said Kumudesh.
CMLS-SL previously took the matter up with President Gotabaya Rajapaksa in writing. However, in a press release issued yesterday, the Sri Lanka Association of Government Medical Laboratory Technologists, affiliated with CMLS-SL, said previous warnings had been disregarded as nitpicking of the government’s efforts.
The sea guard who had returned from India and tested positive for the novel coronavirus last week in Jinthupitiya, Colombo, subsequently tested negative. According to CMLS-SL, the initial PCR report which later turned out to be inaccurate was not issued by a diagnostic laboratory under the purview of the health ministry. The five PCR tests that later identified the patient as not being COVID-19-positive, CMLS-SL said, all came from ministry affiliated diagnostic labs.
Repeated requests made by the lab technologists from health officials to not task university research labs with PCR tests have allegedly fallen on deaf ears.
“It’s still unclear as to why PCR tests are being carried out by external labs when the ministry’s labs aren’t even close to full capacity,” said Kumudesh.
‘Some PCR laboratories especially the external research laboratories which are involved in COVID 19 PCR testing use Research Use Only (RUO) Reagents. As per the report issued by FDA in 2013 on “Guidance for Industry and Food and Drug Administration staff”, it has clearly stated that “the RUO labeling is meant to serve as a warning to prevent such products from being used in clinical diagnosis, patient management, or an investigation”1 due to the reason of RUO reagent is basically for research where ISO procedures don’t apply and RUO does not imply anything related to the quality or validation of the reagent itself. Labels of such products also mention that they are “Not for use in diagnostic procedures,’ CMLS-SL had said in a previous statement issued in May.
Meanwhile, RUO kits are also being used by some health ministry laboratories, which according to Kumudesh could cast doubt on the reports issued by the ministry in the future.
CMLS-SL requests an inquiry on the matter as well as a consensus on the laboratories and their equipment in order to present such an eventuality. (Colombo/Jul7/2020)