Comparison of analytical sensitivity of SARS-CoV-2 molecular detection kits

Objectives: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has had a significant impact on global public health systems, making nucleic acid detection an important tool in epidemic pre-vention and control. Detection kits based on real-time reverse transcriptase PCR (rRT-PCR) have been used widely in clinics, but their analytical sensitivity (limit of detection, LOD) remains controversial. Moreover, there is limited research evaluating the analytical sensitivity of other molecular detection kits. Methods: In this study, armored ribonucleic acid reference materials developed in-house were used to evaluate the analytical sensitivity of SARS-CoV-2 detection kits approved by the National Medical Prod-ucts Administration. These were based on rRT-PCR and other molecular detection assays. Results: The percentage retesting required with rRT-PCR kits was as follows: 0%, 7.69%, 15.38%, and 23.08% for samples with concentrations ranging from 50 0 0 0 to 781 copies/ml. In total, 93% of rRT-PCR kits had a LOD < 10 0 0 copies/ml. Only one kit had an LOD > 10 0 0 copies/ml. The LOD of other molecular detection kits ranged from 68 to 2264 copies/ml. Conclusions: The study findings can help pharmaceutical companies optimize and improve detection kits, guide laboratories in selecting kits, and assist medical workers in their daily work. (c) 2021 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/ )

Automated summary

This study evaluated the analytical sensitivity of SARS-CoV-2 detection kits approved by the National Medical Products Administration using in-house developed armored ribonucleic acid reference materials. The results showed that the majority of rRT-PCR kits had a limit of detection (LOD) below 1000 copies/ml, with a wide range observed for other molecular detection kits. The findings of this study can help improve detection kits, guide laboratory selection, and support medical workers in their daily work.