Table 9.
Benchmarking of diagnostics for SARS-CoV-2 based on Isothermal amplification-derived methods issued with EUA, or CE mark.
| Tests | Producing company | Validation | Type of sample processing | Amplification type | Detection mechanism | Detection platform | Duration (min) | Limit of detection (copies/µL) | Type of specimen under analysis | Targets, Mulltiplex, or Multi-species | Settings |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Lucira CHECK-IT COVID-19 Test Kit | Lucira Health, Inc | EUA | Lysis step | RT-LAMP | Colorimetry, Color change induced by pH shift upon amplification, then converted in electronic signal | Microfluidics | 30 | 0.9 | Self-collected swab (NS) | Multi-target, two N gene regions and Multiplex | Home |
| Detect ™ Covid-19 | Detect, Inc | EUA | Lysis step | RT-LAMP | Colorimetry, Visual observation of specific signal upon interaction of amplicons with colored NPs and retention of the conjugates on the test point | LFA | ≈60 | 0.8 | Self-collected swab (NS) | Single target, ORF1ab | Home |
| MobileDetect Bio BCC19 Test Kit | Mobile Detect Bio Inc | EUA | Non-specified processing reagents | RT-LAMP | Colorimetry, Visual detection of color change induced by pH shift upon amplification | Single-tube | <60 | 75 | Collected by healthcare worker – URT swabs (NS,NP,OP, mid-turbinate) | Multi-target, N and E and Multiplex | Clinical |
| Color SARS-CoV-2 RT-LAMP Diagnostic Assay | Color Health, Inc | EUA | Automated full extraction | RT-LAMP | Colorimetry, Color change induced by pH shift upon amplification, then analysed spectrophotometrical | Micro-plate reader | 70 | 0.75 | Collected by healthcare worker – URT swabs (NS,NP,OP,mid-turbinate) | Multi-target, N and E, or ORF1ab,S and Multiplex | Clinical |
| SHERLOCK ™ CRISPR SARS-CoV-2Kit | Sherlock Biosciences, Inc | EUA | Manual full extraction | RT-LAMP | Fluorescence, Enzymatic-based cleavage of oligonucleotide probes containing a fluorophore and a quencher | Micro-plate reader | ≈60 | 6 | Collected by healthcare worker – URT swabs (NS,NP,OP), NS, NP aspirates and BAL | Multi-target, ORF1ab and N and Multiplex | Clinical |
| ALS SARS-CoV-2 RT-LAMP | ALS, Inc | CE -IVD | Non-specified, Non-conventional extraction | RT-LAMP | Colorimetry, Color change induced upon amplification | Single-tube | 45 | 10 | Collected by healthcare worker – URT samples | Multi-target, ORF1ab and N | Clinical |
| Procleix SARS-CoV-2 Assay | Grifols Diagnostic Solutions Inc | EUA | Automated full extraction | TMA | Chemiluminescence, using HPA | Fully automated equipment | _ | 0.06 | Collected by healthcare worker – URT swabs (NS,NP,OP), NS, NP aspirates and BAL | Multi-target and Multiplex | Clinical |
| Aptima SARS-CoV-2 Assay | Hologic, Inc | EUA, CE-IVD | Lysis step | TMA | Chemiluminescence, using HPA | Fully automated equipment | _ | 0.6 | Collected by healthcare worker – URT swabs (NS,NP, mid-turbinate) | Multi-target, two ORF1ab gene regions, Multiplex | Clinical |
| Aptima SARS-CoV-2/Flu Assay | Hologic, Inc | EUA | Lysis step | TMA | Fluorescence, similar to molecular beacons | Fully automated equipment | _ | 0.18 | Collected by healthcare worker – URT swabs (NS,NP, OP, mid-turbinate), NS and NP aspirates | Multi-target, two ORF1ab gene regions, Multiplex and Multi-species | Clinical |
| Solana SARS-CoV-2 Assay | Quidel, Inc | EUA, CE-IVD | Lysis step and heat treatment | RT-HDA | Fluorescence, oligonucleotide probes hydrolysated by RNase H2 | Fully automated equipment | 30 | 54 | Collected by healthcare worker – URT swabs (NS,NP) | Multi-target, ORF1ab | Clinical |
| ID Now COVID-19 | Abbott Diagnostics Scarborough, Inc | EUA, CE-IVD | Lysis step | Unknown | Fluorescence, molecular beacons | Fully automated equipment | ≈13 | 0.125 | Collected by healthcare worker – URT swabs (NS,NP,TH) | Single-target, ORF1ab | Clinical |
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.