CMLS raises concerns over erroneous PCR test reports

By Sheain Fernandopulle  

Several malpractices and erroneous COVID 19 test reports are being released  by certain external PCR laboratories conducting COVID-19 PCR Tests, the College of Medical Laboratory Science claimed.
It is said that such shortcomings were reported from  laboratories that did not come under the Ministry of Health.
“We have observed violation of certain fundamental facts which can badly affect the whole process of COVID 19 pandemic control programme in Sri Lanka,” CMLS Secretary Ravi Kumudesh said yesterday in a letter to Health Ministry Secretary.  

He said factors such as use of inappropriate reagents, lack of professionally  qualified Medical Laboratory Professionals and use of instruments and equipment which  were not validated for particular purpose, resulted in confusion in  the PCR tests.  
“As per the ISO 15189 clause 5.3 on Instrumentation, it states that, the analytical system in a laboratory should consist of the instruments, reference materials, and validated reagents and required consumables for all test parameters of the analytical process. In-vitro testing instruments and equipment, they have to be validated for the purpose to diagnose conditions, guide treatment decisions, and even mitigate or prevent future disease,” Secretary Kumudesh said.  

“Hence, CMLS highly recommends using “validated” reagents, instruments and equipment specifically designed for IVD testing purpose to diagnose conditions, guide treatment decisions, and to even mitigate or prevent future disease,” he said.  “As a responsible professional organisation, we urge relevant authorities to adhere to the good laboratory practices and ISO 15189 Medical Laboratory Guidelines in order to avoid all negative impacts leading to malpractices,” he added.    

“We have observed violation of certain fundamental facts which can badly affect the whole process of COVID 19 pandemic control programme in Sri Lanka,”