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

Objectives Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has significantly impacted the global public health system, making nucleic acid detection an important tool in epidemic prevention and control. Detection kits based on real-time reverse transcriptase polymerase chain reaction (rRT-PCR) have been widely used in clinics, but their analytical sensitivity (limit of detection) remains controversial. Moreover, there is limited research evaluating the analytical sensitivity of other molecular detection kits. Methods In this study, we used self-developed armored ribonucleic acid reference materials to evaluate the analytical sensitivity of SARS-CoV-2 detection kits approved by the National Medical Products Administration. These were based on rRT-PCR and other molecular detection assays. Results The percentage re-testing required with rRT-PCR kits is as follows: 0%, 7.69%, 15.38%, and 23.08% for samples with concentrations ranging from 50,000 to 781 copies/mL. In total, 93% of rRT-PCR kits had a limit of detection (LOD) 1000 copies/mL. The LOD of other molecular detection kits ranged from 68 to 2,264 copies/mL. Conclusions Our findings can help pharmaceutical companies optimize and improve detection kits, guide laboratories in selecting kits, and assist medical workers in their daily work.