Table 1.
Overview of RT-PCR-based in-vitro diagnostic assays for SARS-COV-2 approved for Emergency Use of Authorizations by FDA.
| Type of Sample | Target Gene | Sensitivity/limit of the Assay | Apparatus Used | Manufacturer | |
|---|---|---|---|---|---|
| Single Target Gene Assay | |||||
| Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV | Nasopharyngeal swab, throat swabs and BALF | ORF1ab gene | 100-150 copies /mL | Applied Biosystems 7500 Real-Time PCR System | BGI Genomics Co. Ltd |
| Panther Fusion SARS-CoV-2 | Nasopharyngeal and oropharyngeal swab | ORF1ab gene | 100 copies/ml | Panther Fusion system | Hologic, Inc. |
| ePlex SARS-CoV-2 Test | Nasopharyngeal swab | Nucleocapsid (N) gene | 100000 copies/ml | GenMark ePlex instrument and Software | GenMark Diagnostics, Inc. |
| Ipsum Diagnostics Coronavirus Test | Nasopharyngeal swab | nucleocapsid (N) gene | 8500 copies / mL | Thermofisher Applied Biosystems QuantStudio 12 K Flex instrument. | Ipsum Diagnostics Atlanta GA |
| COVID-19 RT-PCR Test | Nasopharyngeal, oropharyngeal swab, sputum, lower respiratory tract aspirates, BAL and nasopharyngeal wash/aspirate or nasal aspirate) | Nucleocapsid (N) gene | 6250 copies/ mL. | Applied Biosystems QuantStudio7 Flex (QS7) instrument with software version 1.3 | Laboratory Corporation of America (LabCorp) |
| ScienCell™ SARS-CoV-2 Coronavirus Real-time RT-PCR | Nasopharyngeal, oropharyngeal swab | Nucleocapsid (N) gene. | 3162 copies/ mL. | LightCycler® 96 Real-Time PCR System with LightCycle | Scien Cell Research Laboratories, Inc. |
| New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)- PCR | Nasopharyngeal and oropharyngeal swab and sputum | Nucleocapsid (N) gene. | 1000 copies/ mL. | Applied Biosystems 7500 Fast Dx Real-Time PCR System with SDS version 1.4 software | Wadsworth Center, New York State Department of Public Health's |
| CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) | Nasopharyngeal oropharyngeal swab, sputum, lower respiratory tract aspirates, BAL and nasopharyngeal wash/aspirate or nasal aspirate) | Nucleocapsid (N) gene | 1000 copies/ mL. | Applied Biosystems 7500 Fast Dx Real-Time PCR System with SDS version 1.4 software. | Centers for Disease Control and Prevention's (CDC) |
| NeuMoDx SARS-CoV-2 Assay | Nasopharyngeal and oropharyngeal swab | Nucleocapsid (N) gene. | 150 copies/ml. | NeuMoDx Molecular Systems | NeuMoDx Molecular, Inc |
| Quest SARS-CoV-2 rRT-PCR | Nasopharyngeal, oropharyngeal swab, sputum, tracheal aspirates and BALF | Nucleocapsid (N) gene. | 51 copies/ml | Applied Biosystems 7500 Real Time PCR System | Quest diagnostic |
| BioGX SARS-CoV-2 | Nasopharyngeal and orophanryngeal swab | Nucleocapsid (N) gene. | 4 0 copies/mL | BD MAX System | BioGX (USA) |
| Lyra SARS-CoV-2 AssayTaqPath COVID-19 Combo Kit | Nasopharyngeal swab, nasopharyngeal aspirate and BAL | Non-structural polyprotein (pp1ab) | 800 copies/ mL | Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500 Standard, Roche 93 LightCycler 480, or Qiagen Rotor-Gene Q | Quidel Corporation |
| Logix Smart™ Coronavirus Disease 2019 (COVID-19) Kit | Nasopharyngeal and oropharyngeal swab | RdRp gene | 4290 copies/mL | BioMolecular system | Co-Diagnostics, Inc |
| Primerdesign Ltd COVID-19 genesig® Real-Time PCR assay | Oropharyngeal swab | RdRp gene | 330copies/ mL | Applied Biosystems 7500 Real-Time PCR System, or Roche Light Cycler 480 II, or Bio-Rad CFX 96 | Primer design Ltd |
| Two target Gene assays | |||||
| Abbott RealTime SARS-CoV-2 | Nasopharyngeal swab | N and RdRp genes | 100 copies/ml | m2000 Real time System | Abbott Laboratories,USA |
| Xpert Xpress SARS-CoV-2 | Nasopharyngeal, nasal, or mid-turbinate swab and/or nasal wash/ aspirate specimens | N2 and E genes | 250 copies/ml | Gene Xpert Instrument | Cepheid |
| Simplexa™ COVID-19 Direct | Nasopharyngeal swab | ORF1ab and S genes | 500 copies/ml | LIAISON MDX | DiaSorin Molecular |
| BioFire® COVID-19 Test | Nasopharyngeal swab | ORF1ab and ORF8 genes | 330 copies/ml | FilmArray 2.0 and/or the FilmArray Torch Instrument Systems | BioFire diagnostic |
| PerkinElmer New Corona virus Nucleic Acid Detection Kit | Nasopharyngeal and oropharyngeal swab | ORF1ab and N genes | 20 copies/ml | Pre-NAT II Automated Workstation and Applied Biosystems 7500 Real-Time PCR | PerkinElmer, Inc |
| cobas SARS-CoV-2 | Nasopharyngeal and oropharyngeal swab | ORF1 and E genes | 0.007 and 0.004 TCID50/ml | Cobas 6800/8800 Systems | Roche Diagnostics |
| ARIES SARS-CoV-2 Assay | Nasopharyngeal swab | ORF1ab and N genes | No info | MAGPIX System | Luminex Corporation |
| Multiple target gene Assays | |||||
| QIAstat-Dx Respiratory 2019-nCoV Panel | Nasopharyngeal swab | ORF 1b poly gene, RdRp gene and E gene | 500 copies/ml. | QIAstat-DX | QIAGEN GmbH |
| NxTAG CoV Extended Panel Assay | Nasopharyngeal swab | ORF1ab, N and E genes. | 5000 copies /mL | MAGPIX® instrument using NxTAGCoV Extended Panel Assay File for SYNCT™ Software | Luminex Molecular Diagnostics, Inc. |
| TaqPath™ COVID-19 Combo Kit | Nasopharyngeal swab, nasopharyngeal aspirate, and BAL | ORF1ab, N gene, S gene, MS2 | 10GCE/reaction | Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument | Thermo Fisher Scientific, Inc Life Technologies Corporation |
CDC= Centre for disease control and prevention ; EUA = Emergency Use Authorization; FDA = U.S. Food and Drug Administration. N=Nucleocapsid, E= envelop, ORF= open reading frame, RdRp= RNA-dependent RNA polymerase, BALF= Bronchoalveolar lavage fluid