Pitfalls in the performance of real time PCR tests for SARS CoV-2 and time to improve these tests

Document Type : Letter to the Editor

Author

Genekam Biotechnology AG, Duissernstr. 65a, 47058 Duisburg, Germany

Abstract

This letter is about the quality of real time PCR tests used to detect SARS CoV-2 for last 3 years. As there are many pitfalls found, which are leading to false results, therefore this problem is discussed here and the issue can be solved through in house validation of the kits before the laboratory uses them.
Some of measurements are suggested e.g. each country should have its own reference laboratories to compare the performance of different kits of different manufacturers as well as in house assays as this can lead to find the best performing kits, which may be mutation resistant and robust. The laboratories need to pay attention and have experience to identify questionable kits as early as possible in order to remove such poor-quality kits from system. In this way, one can improve the quality of diagnostics. The manufacturer should also provide the proof that it has strong knowledge of virology to develop good quality real time PCR kits.

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