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. 2023 Apr 8;4(2):e228. doi: 10.1002/mco2.228

TABLE 2.

Molecular and serological assays used for SARS‐CoV‐2 diagnosis.

Test Name Manufacturer name Sample source Detected region Total result time Ref.
Real‐time reverse transcription‐polymerase chain reaction
CDC 2019‐Novel Coronavirus Real‐Time RT‐PCR Diagnostic Panel CDC Sputum, nasal aspirate, NS, OS N gene – 67
Simplexa COVID‐19 Direct Kit DiaSorin Molecular NS ORF1ab and S gene ~ 1 h 68
COVID‐19 RT‐PCR Test Laboratory Corporation of America Sputum, nasal aspirate, NS, OS N gene 48–96 h 69
ARIES SARS‐CoV‐2 Assay Luminex Corporation NS ORF1ab and N gene ~ 2 h 70
Novel Coronavirus (2019‐nCoV) Nucleic Acid Diagnostic Kit Sansure Biotech Inc. NS, OS, alveolar lavage fluid, sputum, whole blood, feces ORF1ab and N genes 30 min 71
COVID‐19 Coronavirus Real Time PCR Kit Eagle Biosciences NS, OS, anterior nasal swabs, mid‐turbinate nasal swabs, nasal aspirates, nasal washes, BAL fluid, sputum ORF1ab and N genes 72 min 72
COVID‐19 RT‐PCR PNA Kit BioTNS NS, OS, anterior nasal swabs, mid‐turbinate nasal swabs, BAL, nasopharyngeal wash/aspirates, nasal aspirates specimens N and RdRP genes 140 min 73
STANDARD M nCoV Real‐Time Detection Kit SD Biosensor Inc. NS, OS, nasal mid‐turbinate, anterior nares specimen, sputum N and RdRP genes 90 min 74
Bio‐Speedy Direct RT‐qPCR SARS‐CoV‐2 Bioeksen R&D Technologies Inc. NS, OS, BAL, nasopharyngeal aspirate, sputum, saliva, gargle ORF1ab 65 min 75
RT‐LAMP
ID NOW COVID‐19 Abbot Diagnostics Scarborough, Inc. Nasal, throat, NS RdRp gene 5–13 min 76
Isopollo COVID‐19 Detection Kit M Monitor Inc. NS, OS, sputum, BAL N and RdRP genes 30 min 77
Loopamp™ SARS‐CoV‐2 Detection Kit Eiken Chemical Co. Ltd. NS, OS, saliva N and RdRP genes 60 min 78
MobileDetect Bio BCC19 Test Kit Detectachem Inc. Nasal swab, NS, OS E and N genes 30 min 79
Detect COVID‐19 Test Detect Inc. Anterior nasal swabs ORF1ab 1 h 80
Lucira™ COVID‐19 All‐In‐One Test Kit Lucira Health Nasal swab N gene 30 min 81
Clustered regularly interspaced short palindromic repeats (CRISPR)
SARS‐CoV‐2 DETECTR Mammoth Biosciences Respiratory samples E and N genes 30–40 min 82
Sherlock CRISPR SARS‐CoV‐2 Kit Sherlock Biosciences Anterior nasal swabs, NS, OS, nasopharyngeal wash/aspirate, nasal aspirate, BAL ORF1ab, N gene ~ 1 h 83
TATA MD CHECK CRISPR SARS‐COV‐2 KIT 1.0 Tata Medical and Diagnostics NS, OS S gene 1.67 h 84
Amplicon‐based metagenomic sequencing
ISARIC 4C (scientific work) ISARIC 4C Consortium NS ORF1ab 8 h 43
Nucleic acid hybridization using microarray + RT‐PCR
DetectX‐Rv PathogenDx, Inc. NS, OS, mid‐turbinate nasal swabs, anterior nasal swabs, nasal aspirates, nasopharyngeal wash/aspirates, BAL N1, N2 genes – 85
CovidArray Italy (scientific work) NS N1, N2 genes 125 min 86
Enzyme‐linked immunosorbent assay (ELISA)
SARS‐CoV‐2 IgG ELISA Kit Creative Diagnostics Serum, plasma IgG – 87
EDI Novel Coronavirus COVID‐19 IgM ELISA Kit Epitope Diagnostics, Inc. Serum, plasma IgM 120 min 88
AMP ELISA TEST SARS‐COV‐2 AB AMEDA Labordiagnostik GmbH Serum, plasma Total Antibody 70 min 89
Anti‐SARS‐CoV‐2 QuantiVac ELISA (IgG) EUROIMMUN AG Fingerprick blood, serum, plasma IgG 120 min 90
GB SARS‐CoV‐2 Ab ELISA General Biologicals Corporation Serum, plasma Antibody 120 min 91
Lateral flow test
COVID‐19 IgM/IgG Rapid Test BioMedomics Inc. Fingerprick or whole blood, serum, plasma samples IgG/IgM 10 min 51
COVID‐19 Ag Respi‐Strip Coris Bioconcept NS N protein antigen 15–30 min 92
CRT COVID‐19 Rapid Test Oncosem Onkolojik Sistemler San. ve Tic. A.S. Blood, plasma, serum IgG/IgM 10–15 min 93
Rapid COVID‐19 IgM/IgG Combo Test Kit Megna Health Inc. Serum, ACD plasma, fingerstick whole blood IgG/IgM 15 min 94
Pilot™ COVID‐19 At‐Home Test SD Biosensor Inc. Anterior nasal swabs N protein antigen 20 min 95
INDICAID COVID‐19 Rapid Antigen At‐Home Test PHASE Scientific International, Ltd. Nasal swabs, NS N protein antigen 20 min 96
VivaDiag™ SARS‐CoV‐2 IgM/IgG Rapid Test VivaChek Biotech Co., Ltd. Plasma, serum, whole blood IgG/IgM 15 min 97
SCoV‐2 Ag Detect Rapid Self‐Test InBios International Inc. Anterior nasal swabs N protein antigen 25 min 98
BinaxNOW COVID‐19 Ag Card Home Test Abbott Diagnostics Scarborough, Inc. Anterior nasal swabs N protein antigen 15 min 99
iHealth COVID‐19 Antigen Rapid Test Pro iHealth Labs, Inc. Anterior nasal swabs N protein antigen 15 min 100
SPERA COVID‐19 Ag Test Xtrava Health Anterior nasal swabs N protein antigen 15 min 101
NIDS COVID‐19 Antigen Rapid Test Kit ANP Technologies, Inc. Mid‐turbinate nasal swabs N protein antigen 15 min 102

Abbreviations: ACD, acid citrate dextrose; BAL, bronchoalveolar lavage; CDC, Centers for Disease Control and Prevention; DETECTR, deoxyribonucleic acid (DNA) endonuclease‐targeted CRISPR trans reporter; IgG, immunoglobulin G; IgM, immunoglobulin M; NS, nasopharyngeal swabs; OS, oropharyngeal swabs; RdRp, ribonucleic acid (RNA)‐dependent RNA polymerase.