THIRUVANANTHAPURAM: The state health department is set to assess the quality of laboratories performing RT-PCR tests. This follows incidents in which some COVID-19 test results showed false negatives and positives. According to the department, an assessment of this kind will help in raising the bar of the laboratories and ensure that there is no chance of an error except for reasons beyond their control. Eighteen laboratories will be covered under the quality assessment and quality control exercise which will be carried out with the help of 36 assessors.
“There were complaints regarding the performance of some laboratories as these reported some false negative and positive results, creating confusion. Against this backdrop, it has been decided to introduce a quality assessment of laboratories performing RT-PCR for COVID-19,” said an officer of the health department. According to the officer, while the quality of the labs will be assessed using a set of questionnaires, the quality control mechanism in a lab will be assessed by randomly collecting samples which tested positive and negative and reconfirming the results by sending the samples to the National Institute of Virology, Alappuzha.
“For assessing quality control, the assessors shall randomly select an aliquot (portion of a larger whole) each of three samples that tested positive and of three others that tested negative in the previous two weeks from the list of samples tested by the lab. If no positive samples are present, then negative samples may be taken. The samples would be packed as per the existing guidelines and sent to NIV, Alappuzha,” added the officer.
It has been stipulated that the quality assessment activity shall be performed twice a month. Earlier, commenting on the confusion involved with the declaration of some results and test results coming up with false negatives and positives, Chief Minister Pinarayi Vijayan said that on such cases a second-round validation is conducted and in that correct results are received. At the same time, principal secretary health Rajan Khobragade said any minute variation in the process involving swab collection, its transportation and the manner of reception at the lab also may impact test result.