Table 1.
Molecular diagnostic tests used to detect viral genetic material in SARS-CoV-2 approved by the NMPA.
| No. | Manufacture, organization name | Test name | Test type | Gene or region detected | Sample source | Limits of detection | Test result time/additional information | Throughput information | Country of approval |
|---|---|---|---|---|---|---|---|---|---|
| 1 | Shanghai ZJ Bio-Tech Co., Ltd. | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-fluorescence probing) | Real-time RT-PCR | ORF1ab, E and N gene | Throat swab, sputum, and BALF | 1000 copies/mL | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400057) 1/26/2020, WHO, CE |
| 2 | Shanghai GeneoDX Biotech Co., LTD | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-fluorescence probing) | Real-time RT-PCR | ORF1ab and N gene | Nasopharyngeal swab and BALF | 500 copies/mL | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400058) 1/26/2020 |
| 3 | BGI Biotechnology (Wuhan) CO., LTD | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-fluorescence probing) | Real-time RT-PCR | ORF1ab | Throat swab and Bronchoalveolar Lavage Fluid (BALF) samples | 100 copies/mL | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400060) 1/26/2020/CE Marked/FDA Authorized/PMDA Approved |
| 4 | Daan Gene Co., Ltd. of Sun Yat-Sen University | 2019 Novel Coronavirus (2019-nCOV) RNA Detection Kit | Real-time RT-PCR | ORF1ab and N gene | Throat swab, sputum, nasopharyngeal swab | 500 copies/mL | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400063) 1/28/2020, CE |
| 5 | Sansure Biotech Inc. | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence probing) | Real-time RT-PCR | ORF1ab and N gene | Throat swab and Bronchoalveolar Lavage Fluid (BALF) samples | 200 copies/mL | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400064) 1/28/2020, CE, FDA EUA |
| 6 | Shanghai BioGerm Medical Biotechnology Co., Ltd. | Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit | Real-time RT-PCR | ORF1ab and N gene | Oropharyngeal, nasopharyngeal, and sputum | 500 copies/mL | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400065) 1/31/2020 |
| 7 | Beijing Applied Biological Technologies Co., Ltd. | Multiple Real-time PCR kit for Detection of 2019-nCoV | Real-time RT-PCR | ORF1ab, E and N gene | Sputum and throat swab | 200 copies/mL | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400179) 2/27/2020, CE |
| 8 | Maccura Biotechnology Co., Ltd. | SARS-CoV-2 Fluorescent PCR Kit (for the COVID-19 Coronavirus) | Real-time RT-PCR | ORF1ab, E and N gene | Throat swab and Sputum | 1000 copies/mL | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400184) 3/1/2020 |
| 9 | Wuhan EasyDiagnosis Biomedicine Co. Ltd | COVID-19 (SARS-CoV-2) Nucleic Acid test Kit | Real-time RT-PCR | ORF1ab and N gene | Oropharyngeal, nasopharyngeal, and sputum | 137 copies/mL | Results in ~ 3 h after extraction | Depended on the real-time instrument | China NMPA (20203400212) 3/12/2020, CE, TGA, Brazil, South Africa, South East Asia |
| 10 | Shanghai Fosun Long March Medical Science Co., Ltd. | Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit | Real-time RT-PCR | ORF1ab, E and N gene | Throat swab and Sputum | - | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400299) 3/24/2020 |
| 11 | Beijng Kinghawk Pharmaceutical Co., Ltd. | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-fluorescence probing) | Real time RT-PCR | ORF1ab and N gene | Throat swab and Sputum | 500 copies/mL | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400322) 4/3/2020 |
| 12 | Jiangsu Bioperfectus Technologies Co., Ltd | COVID-19 Coronavirus Real Time PCR Kit | Real time RT-PCR | ORF1ab and N gene | Oropharyngeal, nasopharyngeal, and sputum | - | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400384) 4/16/2020 |
| 13 | Zhejiang Oriental genetic biological products Co., Ltd | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-fluorescence probing) | Real time RT-PCR | ORF1ab and N gene | Throat swab and Sputum | 500 copies/mL | Results in 50-75 min | Depended on the real-time instrument | China NMPA (20203400520) 5/21/2020, PEUA |
| 14 | Shenzhen United Medical Science and Technology Co., Ltd. | Real Time PCR Kit for Novel Coronavirus 2019-nCoV (ORF1ab, N) | Real time RT-PCR | ORF1ab gene | Throat swab and Sputum | 200 copies/mL | Results in ~ 1.5 h | Depended on the real-time instrument | China NMPA (20203400535) 6/5/2020 |
| 15 | Beijing NaGene Diagnosis Reagent Co., Ltd | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-fluorescence probing) | Real time RT-PCR | ORF1ab and N gene | Oropharyngeal swab and sputum specimens | - | Results in ~ 2 h after extraction | Depended on the real-time instrument | China NMPA (20203400537) 6/9/2020 |
| 16 | Coyote Bioscience Co., Ltd. | DirectDetect™COVID-19 Detection Kit | Real time RT-PCR | ORF1ab and N gene | Oropharyngeal swab and sputum specimens | 400 copies/mL | Results in 30 min ~ 90 min with the instrument of Mini8 plus | 4 samples/run | China NMPA (20203400644) 7/13/2020, CE, Mexico, Columbia, Indonesia, the Philippines, Aaudi Arabia, Australia |
| 17 | Daan Gene Co., Ltd. of Sun Yat-Sen University | Detection Kit for SARS-CoV-2 RNA (Fast PCR-Fluorescence Probing) | Real time RT-PCR | ORF1ab and N gene | Throat swab or sputum | 500 copies/mL | Results in 50-62 min, with the instrument of AGS4800 | 8 samples/run | China NMPA (20203400749) 9/21/2020, CE |
| 18 | BGI Biotechnology (Wuhan) CO., LTD | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (Combined probe anchored polymerization sequencing) | Sequencing | SARS-CoV-2 | Throat swab and Bronchoalveolar Lavage Fluid (BALF) samples | 100 copies/mL | Gene sequencer DNBSEQ-T7,and Automatic sample loading instrument MGIDL-T7 | - | China NMPA (20203400059) 1/16/2020/CE Marked/FDA Authorized/PMDA Approved |
| 19 | Chengdu CapitalBio Jingxin Biotechnology Co., Ltd. | Nucleic Acid Detection Kits for Six Kinds of Respiratory Virus (isothermal amplification based on chip) | Isothermal Amplification based on Disk Chip | SARS-CoV-2 S and N gene, Influenza A, new Influenza A H1N1 Virus (2009) Influenza A H3N2, Influenza B, RSV | Throat swab | - | - | - | China NMPA (20203400178) 2/22/2020 |
| 20 | Ustar Biotechnologies (Hangzhou), Ltd. | EasyNAT Diagnostic Kit for 2019-nCoV RNA (Isothermal Amplification Real Time Florescence Assasy) | Isothermal Amplification-rt-PCR | ORF1ab and N gene | Throat swab and sputum specimens | 1000 copies/mL | Results in 79 min | 2 samples/run | China NMPA (20203400241) 3/16/2020, CE |
| 21 | Anbio (Xiamen) Biotechnology Co., Ltd | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (RNA Hybrid Capture-Immunofluorescence Assay) | Hybrid capture-immunofluorescence assay | ORF1ab, N and E gene | Throat swab and sputum specimens | 500 copies/mL | Results in 45 min | 120 samples in 1 h, instantaneous measurement | China NMPA (20203400298) 3/24/2020 |
| 22 | Rendu (Shanghai) Biotechnology Co., Ltd | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (RNA Hybrid Capture-Immunofluorescence Assay) | Magnetic based target RNA capturing technology, Isothermal Amplification and real-time Immunofluorescence assay | ORF1ab gene | Oropharyngeal swab and sputum | 250 copies/mL | Results in 90 min | 80 samples/run | China NMPA (20203400300) 3/26/2020 |
| 23 | Wuhan Zhongzhi Biotechnologies Inc. | Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (RNA Amplification Lateral Flow Assay) | Isothermal Amplification and gold probe-based Chromatography | ORF1ab and E gene | Throat swab, sputum specimens, nasopharyngeal swab and Bronchoalveolar Lavage Fluid (BALF) samples | 1000 copies/mL | Results in 1 h | 1 sample/run, continuously detected | China NMPA (20203400301) 3/31/2020, CE |
| 24 | Wuhan Zhongzhi Biotechnologies Inc. | Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Dual amplification) | Isothermal Amplification based on reverse amplification and T7 RNA polymerase, and chemiluminescence | ORF1ab and E gene | Throat swab, sputum specimens, nasopharyngeal swab and Bronchoalveolar Lavage Fluid (BALF) samples | 100 copies/mL | Results in ~ 3 h | Highthroughput, 192 samples in 1 run in 3 h | China NMPA (20203400302) 3/31/2020 |
Note: “-” means information was not available