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. 2021 Feb 26;104(4):1516–1518. doi: 10.4269/ajtmh.20-1484

Table 2.

Comparison of 2019-nCoV CDC EUA (IDT), COVID-19 Nucleic Acid Test Kit (eDiagnosis), and 2019-nCoV Nucleic Acid Diagnostic Kit (Sansure Biotech)

SARS-CoV-2 RT-PCR kit (company/country) Viral gene targets LoD observed (promised by the manufacturer) EUA
2019-nCoV CDC EUA (IDT) N1, N2 1,000 viral copies/mL FDA
COVID-19 Nucleic Acid Test Kit (eDiagnosis) N, ORF1ab 500 viral copies/mL (500 viral copies/mL) C-CDC
2019-nCoV Nucleic Acid Diagnostic Kit (Sansure Biotech) N, ORF1ab 1,000 viral copies/mL (200 viral copies/mL) FDA C-CDC

C-CDC = Chinese CDC; EUA = Emergency Use Authorization; FDA = Federal Drug Administration; LoD = limit of detection.