Assessment of RT PCR diagnostic assays for SARS CoV-2 detection in a Molecular diagnostic & Research Lab.
European Journal of Molecular & Clinical Medicine,
2022, Volume 9, Issue 3, Pages 4988-5003
AbstractBackground: SARS CoV-2 infection took the whole world by storm in the final month of 2019.Different measures have been taken to reduce its spread by timely and accurate detection of COVID 19(coronavirus disease 2019) infection in suspected patients and theircontacts.
Aim: This study was conducted to assess commercially available five Rt pcr (reverse transcriptase polymerase chain reaction) kits from different manufacturers available in our center for diagnostic testing ofSARS CoV-2 infection .94 oropharyngeal clinical samples, previously confirmed as 64 positive and 30 negative for SARS CoV-2 were extracted and amplified separately by each of the five Rt pcr kitsand the results compared.
Results:The performance of different kits was in was satisfactory and above 90 percent in agreement with the standard kit for samples (n=47) with low Ct values (Ct values<30) . There was a significant variation in performance among the five kits while testing high Ct values (Ct value >30) samples (n=17).Significant variation in Ct values of E gene ,RdRp gene and N gene was observed in the Rt pcr kits results .
Conclusion: We conclude that it is necessary to assess the diagnostic performance of different Rt pcr kits for COVID 19 clinical samples from time to time to study the variation in Ct values, sensitivity of different gene targets of SARS CoV2 virus, with proper co -ordination with other laboratories , for development of reliable COVID 19 diagnostic centers at every level.
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