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

Yang, Jing; Han, Yanxi; Zhang, Runling; Zhang, Rui; Li, Jinming

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. Only one kit had an 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.