Analytical and Clinical Performance of Droplet Digital PCR in the Detection and Quantification of SARS-CoV-2.

ABSTRACT:

Background and objective

Since the initial coronavirus disease outbreak in late 2019 (COVID-19), reverse-transcription real-time polymerase chain reaction (RT-qPCR) has become the gold standard test to detect severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2). However, a more sensitive and accurate diagnostic tool was required. Therefore, droplet digital polymerase chain reaction (ddPCR) was suggested as an alternative method. Here, we evaluated the performance of ddPCR to detect SARS-CoV-2 and compared it to the performance of RT-qPCR.

Methods

The analytical performances, including limit of blank and limit of detection, were established using positive and negative SARS-CoV-2 reference materials. A total of 366 RNA extracts (173 positive and 193 negative by

SUBMITTER: Kim KB 

PROVIDER: S-EPMC8316104 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature