TABLE 1.
Information characterizing data sources involving SARS-CoV-2 antigen testing for analyses described in this report.
| RFID | Source RFID | Country | Total N | Reference (+) | Index (Antigen) test | Index manufacturer | Ref. (RT-PCR) test | Ref. manufacturer |
| 1 | Abdelrazik et al., 2020 | Egypt | 310 | 190 | BIOCREDIT COVID-19 Antigen Test | RapiGen Inc., South Korea | Not available | Not available |
| 2 | Abdulrahman et al., 2020 | Bahrain | 4,183 | 734 | Abbott Diagnostic GmbH, Jena, Germany | Abbott Diagnostic GmbH, Germany | TaqPathTM COVID-19 Multiplex Kit | Thermo Fisher, United States |
| 3 | Albert et al., 2020 | Spain | 412 | 56 | PanbioTM COVID-19 Ag Rapid Test Device | Abbott Diagnostic GmbH, Jena, Germany | TaqPathTM COVID-19 Multiplex Kit | Thermo Fisher, United States |
| 4 (sx/asx) | Alemany et al., 2021 | Spain | 1,406 | 954 | PanbioTM COVID-19 Ag Rapid Test Device | Abbott Diagnostic GmbH, Jena, Germany | Not available | Not available |
| 5 | Aoki et al., 2020 | Japan | 510 | 26 | Lumipulse® SARSCoV-2 Ag kit | Fujirebio Inc., Tokyo, Japan | TaqMan® Fast Virus 1-Step | Thermo Fisher Scientific, United States |
| 6 | Aoki et al., 2021 | Japan | 129 | 66 | Espline® SARS-CoV-2 | Fujirebio Inc., Japan | TaqMan® Fast Virus 1-Step | Thermo Fisher Scientific, United States |
| 7 | Beck et al., 2021 | United States | 346 | 63 | Quidel Sofia® SARS FIA | Quidel, San Diego, CA, United States | Cepheid Xpert® Xpress | Cepheid, United States |
| 8a | Berger et al., 2020 | Switzerland | 535 | 126 | PanbioTM COVID-19 Ag Rapid Test Device | Abbott Diagnostic GmbH, Germany | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 8b | 529 | 193 | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland | ||
| 9 (sx/asx) | Bulilete et al., 2020 | Spain | 1,369 | 155 | PanbioTM COVID-19 Ag Rapid Test Device | Abbott Diagnostic GmbH, Germany | TaqPath COVID-19 Multiplex Kit | Thermo Fisher Scientific, United States |
| 10 | Cerutti et al., 2020 | Italy | 330 | 107 | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Seegene Allplex® 2019 n-CoV Assay | Seegene Inc., South Korea |
| 11 | Chaimayo et al., 2020 | Thailand | 454 | 63 | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Seegene Allplex® 2019 n-CoV Assay | Seegene Inc., South Korea |
| 12 | Ciotti et al., 2021 | Italy | 50 | 43 | COVID-19 Ag Respi-Strip | Coris BioConcept, Belgium | Seegene Allplex® 2019 n-CoV Assay | Seegene Inc., South Korea |
| 13 | Colavita et al., 2020 | Italy | 941 | 208 | STANDARD FTM COVID-19 Ag FIA | SD Biosensor, South Korea | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 14 | Courtellemont et al., 2021 | France | 248 | 125 | COVID-VIRO® | AAZ, France | TaqPath COVID-19 Multiplex Kit | Thermo Fisher Scientific, United States |
| 15 | Diao et al., 2020 | China | 251 | 205 | SARS-CoV-2 AntigenFIC Assay (in house) | In-house | TaqMan One-Step RT-PCR Kit | Da An Gene, China |
| 16 | Drain et al., 2020 | United States; United Kingdom | 512 | 186 | LumiraDxTM SARS-CoV-2 Ag Test | LumiraDx, United Kingdom | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 17a (sx/asx) | Drevinek et al., 2020 | Czech R. | 591 | 596 | PanbioTM COVID-19 Ag Rapid Test Device | Abbott Diagnostic GmbH, Jena, Germany | Seegene Allplex® 2019 n-CoV Assay | Seegene Inc., South Korea |
| 17b (sx/asx) | STANDARD FTM COVID-19 Ag FIA | SD Biosensor, South Korea | Seegene Allplex® 2019 n-CoV Assay | Seegene Inc., South Korea | ||||
| 18a (sx/asx) | Favresse et al., 2021 | Belgium | 188 | 101 | Biotical SARS-CoV-2 Ag card | Biotical Health, SLU, Spain | LightMix® | Roche Diagnostics, Switzerland |
| 18b (sx/asx) | 101 | PanbioTM COVID-19 Ag Rapid Test Device | Abbott Diagnostic GmbH, Germany | LightMix® | Roche Diagnostics, Switzerland | |||
| 18c (sx/asx) | 100 | Coronavirus Ag Rapid Test Cassette | Healgen Scientific, LLC, United States | LightMix® | Roche Diagnostics, Switzerland | |||
| 18d (sx/asx) | 100 | Roche SARS-CoV-2 Rapid Antigen Test | Roche Diagnostics, Switzerland | LightMix® | Roche Diagnostics, Switzerland | |||
| 18e (sx/asx) | 101 | VITROS SARS-CoV-2 Antigen test | Ortho Clinical Diagnostics, United States | LightMix® | Roche Diagnostics, Switzerland | |||
| 19 (sx/asx) | Fenollar et al., 2021 | France | 341 | 208 | PanbioTM COVID-19 Ag Rapid Test Device | Abbott Diagnostic GmbH, Germany | Vita PCR SARS-CoV-2 Assay | Credo Diagnostics, Singapore |
| 20 | Gremmels et al., 2021 | Netherlands; Aruba | 1,369 | 206 | PanbioTM COVID-19 Ag Rapid Test Device | Abbott Diagnostic GmbH, Germany | Seegene Allplex® 2019 n-CoV Assay | Seegene Inc., South Korea |
| 21 | Hirotsu et al., 2020 | Japan | 313 | 61 | Lumipulse® SARS-CoV-2 Ag kit | Fujirebio Inc., Japan | TaqMan Fast Virus 1-Step Master Mix | Thermo Fisher Scientific, United States |
| 22 | Hirotsu et al., 2021 | Japan | 27 | 23 | Lumipulse® SARS-CoV-2 Ag kit | Fujirebio Inc., Japan | Not available | Not available |
| 23 | Hoehl et al., 2020 | Germany | 711 | 9 | RIDA® QUICK SARS-CoV-2 Antigen test | R-Biopharm, Darmstadt, Germany | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 24 | Houston et al., 2021 | United Kingdom | 728 | 284 | Innova SARS-CoV-2 Antigen Rapid Test | Lotus Global Company, United Kingdom | Not available | Not available |
| 25a | Jääskeläinen et al., 2021 | Finland | 188 | 152 | Quidel Sofia® SARS FIA | Quidel, San Diego, CA | Not available | Not available |
| 25b | 189 | 162 | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Not available | Not available | ||
| 25c | 190 | 156 | PanbioTM COVID-19 Ag Rapid Test Device | Abbott Diagnostic GmbH, Germany | Not available | Not available | ||
| 26 (sx/asx) | Jakobsen et al., 2021a | Denmark | 196 | 148 | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Luna One-step RT-qPCR kit | New England Biolabs, United States |
| 27 (sx/asx) | James et al., 2021 | United States | 2,339 | 156 | BinaxNOWTM COVID-19 Ag Card test kit | Abbott Diagnostics Inc., United States | PerkinElmer SARS-CoV-2 RT-PCR | PerkinElmer, Inc., United States |
| 28 | Kashiwagi et al., 2020 | Japan | 16 | 26 | ESPLINE® SARS-CoV-2 test | Fujirebio Inc., Japan | Not available | Not available |
| 29a | Kohmer et al., 2021 | Germany | 100 | 76 | RIDA® QUICK SARS-CoV-2 Antigen test | R-Biopharm, Darmstadt, Germany | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 29b | Roche SARS-CoV-2 Rapid Antigen Test | Roche Diagnostics, Switzerland | Roche cobas SARS-CoV-2 Assay | Roche Diagnostics, Switzerland | ||||
| 29c | NADAL® COVID-19 Ag Test | Nal von Minden GmbH, Germany | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland | ||||
| 29d | LumiraDxTM SARS-CoV-2 Ag Test | LumiraDx, United Kingdom | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland | ||||
| 30a | Krüger et al., 2020 | Germany; United Kingdom | 417 | 11 | COVID-19 Ag Respi-Strip | Coris BioConcept, Belgium | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 30b | 727 | 18 | BIOEASYTM 2019-nCoV Ag Rapid Test | BIOEASY Technology, China | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland | ||
| 30c | 1,267 | 50 | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland | ||
| 31 | Krüttgen et al., 2021 | Germany | 150 | 77 | Roche SARS-CoV-2 Rapid Antigen Test | Roche Diagnostics, Switzerland | Real Star SARS-CoV-2 RT PCR Kit | Altona, Germany |
| 32 | Lambert-Niclot et al., 2020 | France | 138 | 96 | COVID-19 Ag Respi-Strip | Coris BioConcept, Belgium | Multiple tests used | Multiple manufacturers used |
| 33 | Linares et al., 2020 | Spain | 141 | 90 | Abbott Diagnostic GmbH, Jena, Germany | Abbott Diagnostic GmbH, Germany | Seegene Allplex® 2019 n-CoV Assay | Seegene Inc., South Korea |
| 34 | Lindner et al., 2020 | Germany | 287 | 41 | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 35 | Lindner et al., 2021 | Germany | 146 | 82 | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 36 | Liotti et al., 2020 | Italy | 359 | 107 | STANDARD FTM COVID-19 Ag FIA | SD Biosensor, South Korea | Multiple tests used | Multiple manufacturers used |
| 37 | Liu et al., 2021 | China | 99 | 17 | In-house assay | Not applicable | Not available | Not available |
| 38a | Mak et al., 2020 | China | 140 | 143 | COVID-19 Ag Respi-Strip | Coris BioConcept, Belgium | Not available | Not available |
| 38b | NADAL® COVID-19 Ag Test | Nal von Minden GmbH, Germany | Not available | Not available | ||||
| 38c | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Not available | Not available | ||||
| 39 | Mak et al., 2021 | China | 105 | 108 | Abbott Diagnostic GmbH, Jena, Germany | Abbott Diagnostic GmbH, Germany | Not available | Not available |
| 40 (sx/asx) | Masiá et al., 2020 | Spain | 913 | 40 | Abbott Diagnostic GmbH, Jena, Germany | Abbott Diagnostic GmbH, Germany | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 41 | Menchinelli et al., 2021 | Italy | 594 | 196 | Lumipulse® SARS-CoV-2 Ag kit | Fujirebio Inc., Japan | Seegene Allplex® 2019 n-CoV Assay | Seegene Inc., South Korea |
| 42 | Merino-Amador et al., 2020 | Spain | 958 | 361 | Abbott Diagnostic GmbH, Jena, Germany | Abbott Diagnostic GmbH, Germany | Not available | Not available |
| 43 | Möckel et al., 2021 | Spain | 473 | 115 | Roche SARS-CoV-2 Rapid Antigen Test | Roche Diagnostics, Switzerland | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 44 | Nalumansi et al., 2020 | Uganda | 262 | 94 | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Not available | Not available |
| 45 | Ngo Nsoga et al., 2021 | Switzerland | 402 | 169 | Abbott Diagnostic GmbH, Jena, Germany | Abbott Diagnostic GmbH, Germany | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 46 | Okoye et al., 2021 | United States | 2,638 | 46 | BinaxNOWTM COVID-19 Ag Card test kit | Abbott Diagnostics, Inc., United States | TaqPath COVID-19 Multiplex Kit | Thermo Fisher Scientific, United States |
| 47a | Osterman et al., 2021 | Germany | 445 | 192 | STANDARD FTM COVID-19 Ag FIA | SD Biosensor, South Korea | RealAccurate® Quadruplex SARS CoV-2 PCR Kit | PathoFinder®, Netherlands |
| 47b | 259 | Roche SARS-CoV-2 Rapid Antigen Test | Roche Diagnostics, Switzerland | RealAccurate® Quadruplex SARS CoV-2 PCR Kit | PathoFinder®, Netherlands | |||
| 48 | Pekosz et al., 2021 a | United States | 251 | 38 | BD VeritorTM SARS-CoV-2 Rapid Antigen test | Becton, Dickinson and Company, United States | Lyra® RT-PCR Assay | Quidel Corporation, United States |
| 49a | Peto, 2021 | United Kingdom | 940 | 198 | Innova SARS-CoV-2 Antigen Rapid Test | Lotus Global Company, United Kingdom | Not available | Not available |
| 49b | 100 | Abbott Diagnostic GmbH, Jena, Germany | Abbott Diagnostic GmbH, Germany | Not available | Not available | |||
| 50 (sx/asx) | Pilarowski et al., 2020a | United States | 878 | 131 | BinaxNOWTM COVID-19 Ag Card test kit | Abbott Diagnostics Scarborough, Inc., United States | Not available | Not available |
| 51 (sx/asx) | Pilarowski et al., 2020b | United States | 3,302 | 134 | BinaxNOWTM COVID-19 Ag Card test kit | Abbott Diagnostics Scarborough, Inc., United States | Renegade XPTM | RenegadeBio, United States |
| 52 | Pollock et al., 2021b | United States | 226 | 139 | S-PLEX® SARS-CoV-2 Assay | Meso Scale Discovery, United States | Not available | Not available |
| 53 (sx/asx) | Pollock et al., 2021a | United States | 2,308 | 295 | BinaxNOWTM COVID-19 Ag Card test kit | Abbott Diagnostics Scarborough, Inc., United States | CRSP SARS-CoV-2 RT-PCR | Harvard University, United States |
| 54 | Porte et al., 2020 | Chile | 127 | 83 | BIOEASYTM 2019-nCoV Ag Rapid Test | BIOEASY Technology, China | Genesig® Real-Time PCR assay | Primerdesign Ltd., United Kingdom |
| 55 (sx/asx) | Pray et al., 2021 | United States | 1,098 | 59 | Quidel Sofia® SARS FIA | Quidel, San Diego, CA | Multiple tests used | Multiple manufacturers used |
| 56 (sx/asx) | Prince-Guerra et al., 2021 | United States | 3,419 | 226 | BinaxNOWTM COVID-19 Ag Card test kit | Abbott Diagnostics, Inc., United States | Multiple tests used | Multiple manufacturers used |
| 57 | Rastawicki et al., 2021 | Poland | 167 | 38 | PCL COVID−19 Ag rapid immunoassay | PLC, South Korea | Multiple tests used | Multiple manufacturers used |
| 58a | Schwob et al., 2020 | Switzerland | 928 | 113 | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Not available | Not available |
| 58b | 123 | Abbott Diagnostic GmbH, Jena, Germany | Abbott Diagnostic GmbH, Germany | Not available | Not available | |||
| 58c | 139 | COVID-VIRO® | AAZ, France | Not available | Not available | |||
| 59 (sx/asx) | Scohy et al., 2020 | Belgium | 148 | 93 | COVID-19 Ag Respi-Strip | Coris BioConcept, Belgium | Genesig® Real-Time PCR assay | Primerdesign Ltd., United Kingdom |
| 60 | Stokes et al., 2021 | Canada | 145 | 140 | Abbott Diagnostic GmbH, Jena, Germany | Abbott Diagnostic GmbH, Germany | Not available | Not available |
| 61 | Strömer et al., 2020 | Germany | 134 | 126 | NADAL® COVID-19 Ag Test | Nal von Minden GmbH, Germany | Not available | Not available |
| 62 (sx/asx) | Takeuchi et al., 2021 | Japan | 771 | 74 | Quick NaviTM-COVID 19 Ag Rapid Test | Otsuka Pharmaceutical Co., Ltd., Japan | Not available | Not available |
| 63 | Toptan et al., 2020 | Germany | 67 | 61 | RIDA® QUICK SARS-CoV-2 Antigen test | R-Biopharm, Darmstadt, Germany | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 64 | Torres et al., 2021 | Spain | 634 | 80 | Abbott Diagnostic GmbH, Jena, Germany | Abbott Diagnostic GmbH, Germany | TaqPath COVID-19 Multiplex Kit | Thermo Fisher Scientific, United States |
| 65 (sx/asx) | Turcato et al., 2020 | Italy | 3,410 | 227 | STANDARD QTM COVID-19 Ag Test | SD Biosensor, South Korea | Not available | Not available |
| 66 | Van der Moeren et al., 2020 | Netherlands | 352 | 125 | BD VeritorTM SARS−CoV−2 Rapid Antigen test | Becton, Dickinson and Company, United States | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 67 | Villaverde et al., 2021 | Spain | 1,620 | 79 | Abbott Diagnostic GmbH, Jena, Germany | Abbott Diagnostic GmbH, Germany | Not available | Not available |
| 68a | Weitzel et al., 2020 | Chile | 111 | 81 | Biocredit COVID-19 Antigen Test | RapiGen Inc., South Korea | Genesig® Real-Time PCR assay | Primerdesign Ltd., United Kingdom |
| 68b | 80 | Huaketai New Coronavirus | Savant Biotechnology Co., Ltd., China | Genesig® Real-Time PCR assay | Primerdesign Ltd., United Kingdom | |||
| 68c | 82 | BIOEASY 2019-nCoV Ag Rapid Test | BIOEASYTM Technology, China | Genesig® Real-Time PCR assay | Primerdesign Ltd., United Kingdom | |||
| 69 | Yamamoto et al., 2021 | Japan | 608 | 130 | In-house assay | Not applicable | Not available | Not available |
| 70 | Young et al., 2020 b | United States | 226 | 32 | BD VeritorTM SARS−CoV−2 Rapid Antigen test | Becton, Dickinson and Company, United States | Lyra® RT-PCR Assay | Quidel Corporation, United States |
| 71 | Abbott Diagnostics Scarborough Inc, 2020a | United States | 460 | 120 | BinaxNOWTM COVID-19 Ag Card test kit | Abbott Diagnostics, Inc., United States | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 72 | Abbott Diagnostics Scarborough Inc, 2020b | United States | 53 | 27 | BinaxNOWTM COVID-19 Ag Card test kit | Abbott Diagnostics, Inc., United States | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 73 | Access Bio, 2020 | United States | 126 | 46 | CareStartTM COVID-19 Rapid Test | Access Bio, Inc., United States | Not available | Not available |
| 74 | Ellume Limited, 2020 | United States | 198 | 40 | Ellume COVID-19 Home Test | Ellume Limited, United States | Not available | Not available |
| 75 | Luminostics Inc, 2020 | United States | 166 | 35 | Clip COVID-Rapid Antigen Test | Luminostics, Inc., United States | Not available | Not available |
| 76 | LumiraDx UK Ltd, 2020 | United Kingdom | 257 | 86 | LumiraDxTM SARS-CoV-2 Ag Test | LumiraDx, United Kingdom | Roche cobas® SARS-CoV-2 Assay | Roche Diagnostics, Switzerland |
| 77 | Quidel Corporation, 2020a | United States | 156 | 61 | QuickVue® SARS Antigen Test | Quidel Corporation, United States | Not available | Not available |
| 78 | Celltrion, 2020 | United States | 72 | 39 | SampinuteTM COVID-19 Antigen MIA | Celltrion, United States | Not available | Not available |
| 79 | Quidel Corporation, 2020b | United States | 209 | 33 | Quidel Sofia® SARS FIA | Quidel, United States | Lyra® RT-PCR Assay | Quidel Corporation, United States |
| 80 | Quidel Corporation, 2020c | United States | 165 | 45 | Quidel Sofia® SARS FIA | Quidel, United States | Lyra® RT-PCR Assay | Quidel Corporation, United States |
| 81 | BD, 2020a | United States | 226 | 32 | BD VeritorTM SARS−CoV−2 Rapid Antigen test | Becton, Dickinson and Company, United States | LyraTM RT-PCR Assay | Quidel Corporation, United States |
| 82 | BD, 2020b | EU | 251 | 38 | BD VeritorTM SARS−CoV−2 Rapid Antigen test | Becton, Dickinson and Company, United States | Lyra® RT-PCR Assay | Quidel Corporation, United States |
| 83 | BD, 2020c | United States | 115 | 61 | BD VeritorTM SARS−CoV−2 Rapid Antigen test | Becton, Dickinson and Company, United States | Lyra® RT-PCR Assay | Quidel Corporation, United States |
sx/ask, symptomatic/asymptomatic; SARS-CoV-2, severe acute respiratory syndrome coronavirus-2.
EU, European Union; IFU, manufacturer instructions for use; RFID, reference ID; RT-PCR, reverse transcription polymerase chain reaction.
aPekosz 2021 was only used as a data source for sensitivity analysis with Ct score stratification and for sensitivity analysis using cell culture as a reference.
bYoung 2020 was only used as a data source for sensitivity analysis for Ct score stratification.