Table 1.
Some examples of commercially available instrumentations for outside-lab detection of SARS-CoV-2 (white background: products based on isothermal replication; grey background: product utilizing other detection strategy. Taken from (Johns Hopkins Center for Health Security, 2022).
| Test | Manufacturer | Type of test | Sensitivity | Specificity | Sample needed for the test | Target gene | Limit of detection (LOD) | Point of application |
|---|---|---|---|---|---|---|---|---|
| Sherlock CRISPR SARS-CoV-2 Kit | Sherlock Biosciences, Inc | CRISPR,RT-LAMP | 100% | 100% | nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, nasopharyngeal wash/aspirate or nasal aspirate, and bronchoalveolar lavage | ORF1ab and N genes | 6750 copies/mL | Clinical laboratories |
| ID NOW COVID-19 | Abbott Diagnostics Scarborough | Isothermal amplification | 100% | 100% | direct nasal secretions, nasopharyngeal or throat swabs | RdRP | 125 copies/mL (3000 copies/mL as measured by the FDA reference panel) | Clinical laboratories, Point-of-care |
| Cue COVID-19 Test | Cue Health Inc. | Isothermal amplification | 100% | 92,0% | nasal swab | N gene | 1300 copies/mL | Clinical laboratories, Point-of-care |
| iAMP COVID-19 Detection Kit | Atila Biosystems, Inc | Isothermal amplification (OMEGA), patented | 100% | 100% | nasal, nasopharyngeal and/or oropharyngeal swabs | N and ORF1ab genes | 60 copies/reaction of 25 uL | Clinical laboratories |
| Cue COVID-19 Test for Home and Over The Counter (OTC) Use | Cue Health Inc. | Isothermal amplification, | 96% (symptomatic), 100% (asymptomatic) | 98% (symptomatic), 100% (asymptomatic) | anterior nares swabs | N gene | 2700 copies/mL | At-home test |
| Solana SARS-CoV-2 Assay | Quidel Corporation | Molecular isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) | 90,30% | 97,8% | nasopharyngeal (NP) and nasal (NS) swab specimens | pp1ab gene | 1.16 x 10^4 copies/mL | Clinical laboratories |
| Talis One COVID-19 Test System | Talis Biomedical Corporation | NAAT (reverse transcriptase isothermal amplification) | 100,0% | 100,00% | nasal mid-turbinate swabs | ORF1ab gene, N gene | 500 copies/mL | Clinical laboratories, Point-of-care |
| DETECTR BOOST SARS-CoV-2 Reagent Kit | Mammoth Biosciences, Inc. | RT and isothermal amplification test | 95,7% | 100,00% | nasopharyngeal, anterior nasal, mid-turbinate nasal, or oropharyngeal swabs | N gene | 100 copies/mL | Clinical laboratories |
| Detect Covid-19 Test | Detect, Inc. | RT-LAMP | 90,9% | 97,50% | anterior nasal swabs | ORF1ab | 800 copies/mL | At-home test |
| MobileDetect Bio BCC19 Test Kit | Detectachem Inc | RT-LAMP | 98% | 100% | nasopharyngeal, anterior nasal swabs, mid-turbinate nasal swabs, and oropharyngeal swab | N and E genes | 75000 copies/mL | Clinical laboratories |
| Lucira COVID-19 All-In-One Test Kit | Lucira Health, Inc | RT-LAMP | 94% | 98% | Nasal swab (self collection), nasal swab (healthcare collection) | N gene (two regions) | 2700 copies/swab (or 900 copies/mL if the sample is 100% lysed and eluted) | At-home test |
| SARS-CoV-2 DETECTR Reagent Kit | Mammoth Biosciences, Inc | RT-LAMP | 95% | 100% | nasopharyngeal swabs, oropharyngeal (throat) swabs, mid-turbinate nasal swabs, anterior nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate | N gene | 20,000 copies/mL | Clinical laboratories |
| AQ-TOP COVID-19 Rapid Detection Kit PLUS | Seasun Biomaterials, Inc | RT-LAMP | 100% | 100% | oropharyngeal and nasopharyngeal swabs, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates as well as bronchoalveolar lavage | ORF1ab and N genes | 1000 copies/mL | Clinical laboratories |
| AQ-TOP™ COVID-19 Rapid Detection Kit | Seasun Biomaterials, Inc. | RT-LAMP | 100% | 100% | oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate specimens, BAL and sputum | ORF1ab | 7000 copies/mL | Clinical laboratories |
| SynergyDx SARS-CoV-2 RNA Test | Synergy Diagnostic Laboratory, Inc., DBA SynergyDx | rRT-PCR | 100% | 100% | anterior nasal swab | ORF1ab and N genes | 20.8 copies/mL | Clinical laboratories |
| LumiraDx SARS-CoV-2 RNA STAR Complete | LumiraDx UK Ltd. | RT-qSTAR amplification | 97,8% | 98,5% | nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swabs | ORF1a | 7500 copies/mL | Clinical laboratories |
| Procleix SARS-CoV-2 Assay | Grifols Diagnostic Solutions Inc | transcription-mediated nucleic acid amplification (TMA) | 100% | 100% | anterior nasal and mid-turbinate nasal swabs, nasopharyngeal and oropharyngeal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage specimens | Not stated | 60 copies/mL | Clinical laboratories |