Table 8.
Benchmarking of diagnostics for SARS-CoV-2 based on non-isothermal amplification methods issued with EUA, or CE mark.
| Tests | Producing company | Validation | Type of sample processing | Ready for Pooling | Amplification method | Detection strategy | Detection platform | Duration (min) | Detection limit (copies/µL) | Specimen under analysis | Targets, Multiplex, or Multi-species |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Cobas SARS-CoV-2 | Roche Molecular Systems, Inc | EUA, CE-IVD | Automated full extraction | Yes | RT-qPCR | Fluorescence, Taqman probes | Fully automated equipment | <210 | 0.046 | Self-collected – URT swab (NS)//Collected by healthcare worker – URT swabs (NS,NP,OP) | Multi-target, ORF1ab and E and Multiplex |
| NeuMoDx SARS-CoV-2 assay | NeuMoDx Molecular, Inc | EUA, CE-IVD | Automated full extraction | No | RT-qPCR | Fluorescence, Taqman probes | Fully automated equipment | _ | 0.050 (saliva) or 0.150 (NP) | Supervised self-collection – saliva collected with NeuMoDx Saliva Collection Kit//Collected by healthcare worker - URT swabs (NS, NP, OP) and BAL | Multi-target, ORF1ab (NSP2) and N and Multiplex |
| Xpert Omni SARS-CoV-2 Assay | Cepheid | EUA, CE-IVD | Automated full extraction | No | RT-qPCR | Fluorescence, Nos-specified oligonucleotide hydrolysis probes | Fully automated equipment | _ | 0.4 | Collected by healthcare worker – URT swabs (NS,NP,OP, mid-turbinate) and NS wash, or aspirate | Multi-target, N and E and Multiplex |
| Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay kit | Bio-Rad Laboratories, Inc | EUA | Manual, or Automated full extraction | No | RT-qPCR | Fluorescence, No-specified oligonucleotide probes | qPCR equipment | _ | 0.125-0.250 | Collected by healthcare worker – URT swabs (NS,NP, OP, mid-turbinate), nasal aspirates and nasal washes | Multi-target, two N gene regions and Multiplex |
| BioFire COVID-19 Test | BioFire Diagnostics,LLC | EUA | Automated full extraction | Yes | N-RT-qPCR | End-point Melting Curve data | qPCR equipment | 50 | 5.4 | Collected by healthcare worker – URT swabs (NS,OP, mid-turbinate), LRT samples (sputum, tracheal aspirates and BAL) | Multi-target, two ORF1ab regions and ORF8, Multiplex |
| Lyra SARS-CoV-2 Assay | Quidel, Inc | EUA, CE-IVD | Automated full extraction | No | RT-qPCR | Fluorescence, Taqman probes | qPCR equipment | 135 | 6 | Collected by healthcare worker – URT swabs (NP,OP) | Single-target, ORF1ab |
| Quest SARS-CoV-2 rRT-PCR | Quest Diagnostics Infectious Disease, Inc | EUA | Automated full extraction | Yes | RT-qPCR | Fluorescence, Taqman probes | qPCR equipment | _ | 0.136 | Self-collected – URT swab (NS)//Collected by healthcare worker – URT (NP,OP) swabs and LRT samples (sputum, tracheal aspirates and BAL) | Multi-target, two N gene regions and Multiplex |
| Quest SARS-CoV-2 rRT-PCR | BioFire Diagnostics, LLC | EUA | Automated full extraction | No | N-RT-qPCR | End-point Melting Curve data | Fully automatedequipment | 50 | 0.5 (SARS-CoV-2), in the range 0.01 to 3 for other pathogens | Collected by healthcare worker - URT swab (NP) | Multi-target, S and M (for SARS-CoV-2),Multiplex and Multi-species, |
| Quest SARS-CoV-2 rRT-PCR | Bio-Rad Laboratories, Inc | EUA | Manual or Automated full extraction | No | RT-ddPCR | Fluorescence, Taqman probes | Digital PCR equipment | <500 | 0.4 | Collected by healthcare worker - URT swabs (NS, NP, OP, mid-turbinate), aspirates (NS,NP) and BAL | Multi-target, two N gene regions and Multiplex |
| LumiraDx SARS-CoV-2 RNA STAR Complete | Lumira Dx UK Ltd | EUA, CE-IVD | Brief lysis step | No | qSTAR | Fluorescence, Molecular beacons | qPCR equipment | <20 | 1.875 | Collected by healthcare worker - URT swabs (NS, NP, OP, mid-turbinate) and BAL | Single-target, ORF1ab |
All the information was retrieved from the instruction for use supplied in FDA website (https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2) and the data sheets attached to each test validated with CE-IVD, which are listed in European Comission website (https://covid-19-diagnostics.jrc.ec.europa.eu/devices?device_id=&manufacturer=&text_name=&marking=Yes&method=&rapid_diag=&target_type=&search_method=AND#form_content). Both sites were last accessed on 02.02.2022.