Pitfalls found in SARS CoV-2 specific test performance during the comparison between WHO recommended method and a commercial test

Abstract

Aim: One of the important methods to detect the SARS CoV-2 is polymerase chain reaction (PCR) during the pandemic outbreak. There are a number of real time PCR tests, which are recommended from World Health Organization (WHO). Usually, the WHO recommended test should give correct and reproducible results. Material and Methods: The real time PCR tests are conducted to perform the comparisons between WHO test for N gene and ready to use PCR kit FR475 of Genekam Biotechnology AG. Results: It was found that WHO test gave false positive in the negative samples and correct positive results in positive samples. As this method is used from many laboratories as in-house method and many commercial companies around the world have developed their kits based on WHO tests. The results of this research work are showing that there should be around 30% false positive results as well as there are problems of reproducibility of the results. Conclusion: There is a need that the laboratories should run the tests to show that these in-house or commercial assays are free from these above-mentioned pitfalls.