Table 1.
Study | Country | Number of samples | Index test | Comparison test (RT-PCR) | Type of specimens | Quality assessment | |||
---|---|---|---|---|---|---|---|---|---|
Test name | Manufacturer | Test name | Manufacturer | Risk of bias | Concern regarding applicability | ||||
Agulló [15] | Spain | 1311 | Panbio COVID-19 Ag rapid test device | Abbott, USA | Cobas Z 480 Real-Time PCR Analyzer | Roche, Switzerland | Nasal, saliva | High | Low |
Albert [16] | Spain | 412 | Panbio COVID-19 Ag rapid test device | Abbott, USA | TaqPath COVID-19 Combo Kit | Thermo Fisher Scientific, USA | NP | Unclear | Low |
Beck [17] | USA | 346 | Sofia SARS Ag assay | Quidel, USA | Hologic Aptima SARS-CoV-2 transcription-mediated amplification test | Hologic, USA | NP | High | Low |
Cerutti [18] | Italy | 330 | Standard Q COVID-19 Ag test | SD-Biosensor, South Korea | Allplex 2019 n-CoV Assay, DiaSorin Simplexa, and Cobas 6800 | Seegene, South Korea; Diasorin, Italy; and Roche, Switzerland | NP | High | High |
Chaimayo [19] | Thailand | 454 | Standard Q COVID-19 Ag test | SD-Biosensor, South Korea | Allplex 2019 n-CoV Assay | Seegene, South Korea | NP, Throat, endotracheal aspirates | High | Low |
Diao [20] | China | 251 | Laboratory developed test | N/A, China | TaqMan One-Step RT-PCR Kit | Da An Gene, China | NP | Low | Low |
Fenollar [21] | France | 341 | Panbio COVID-19 Ag rapid test device | Abbott, USA | VitaPCR SARS-Cov-2 assay | Credo Diagnostics, Singapore | NP | High | Low |
Hirotsu [22] | Japan | 313 | Lumipulse SARS-CoV-2 Ag kit | Fujirebio, Japan | StepOnePlus Real- Time PCR System | Thermo Fisher Scientific, USA | NP | High | High |
Krüttgen [23] | Germany | 150 | SARS-CoV-2 Rapid Antigen Test | Roche, Switzerland | Real Star SARS-CoV-2 RT PCR Kit | Altona, Germany | NP | High | High |
Lambert-Niclot [24] | France | 138 | COVID-19 Ag Respi-strip | Coris BioConcept, Belgium | Real Star SARS-CoV-2 RT PCR Kit, Bosphore novel coronavirus (2019-nCoV) detection kit, and Cobas 6800 | Altona, Germany; Anatolia Geneworks, Turkey; and Roche, Switzerland | NP | High | High |
Lanser [25] | Austria | 53 | Panbio COVID-19 Ag rapid test device | Abbott, USA | Cobas analyzer | Roche, Switzerland | 53 | High | Low |
Linares [26] | Spain | 255 | Panbio COVID-19 Ag rapid test device | Abbott, USA | Allplex 2019 n-CoV Assay | Seegene, South Korea | NP | High | Low |
Liotti [27] | Italy | 359 | Standard Q COVID-19 Ag test | SD Biosensor, South Korea | Real Star SARS-CoV-2 RT PCR Kit, Allplex 2019 n-CoV Assay, DiaSorin Simplexa, and Cobas 6800 | Altona, Germany; Seegene, South Korea; Diasorin, Italy; and Roche, Switzerland | NP | High | High |
Mertens [28] | Belgium | 328 | COVID-19 Ag Respi-strip | Coris BioConcept, Belgium | Real Star SARS-CoV-2 RT PCR Kit, StepOnePlus Real-Time PCR System, and Panther Fusion Assay | Altona, Germany; Thermo Fisher Scientific, USA; and Hologic, USA | NP, Broncho-Alveolar Lavage | High | Low |
Nalumansi [29] | Uganda | 262 | Standard Q COVID-19 Ag test | SD-Biosensor, South Korea | Applied Biosystems PCR platform | Thermo Fisher Scientific, USA | NP | High | Low |
Pilarowski [30] | USA | 3302 | BinaxNOW COVID-19 Ag Card | Abbott, USA | RenegadeXP test | Renegade.bio, USA | Nasal | High | Low |
Porte [31] | Chile | 127 | SARS-CoV-2 Ag test | Bioeasy Biotechnology, China | COVID- 19 Genesig Real-Time PCR assay | Primerdesign Ltd, UK | NP and OP | High | High |
Pray [32] | USA | 1098 | Sofia SARS Ag assay | Quidel, USA | TaqPath COVID-19 Combo Kit | Thermo Fisher Scientific, USA | Nasal | High | Low |
Scohy [33] | Belgium | 148 | COVID-19 Ag Respi-strip | Coris BioConcept, Belgium | COVID- 19 Genesig Real-Time PCR assay | Primerdesign Ltd, UK | NP | High | Low |
Strömer [34] | Germany | 134 | Nadal COVID-19 Ag test | Nal von Minden GmbH, Germany | Laboratory-developed triplex RT-PCRs | N/A | NP | High | High |
Toptan [35] | Germany | 67 | RIDA®QUICK SARS-CoV-2 Ag test | R-Biopharm, Germany | Luna Universal One-Step RT-qPCR Kit | New England Biolabs | Respiratory samples | High | High |
Turcato [36] | Italy | 3410 | Standard Q COVID-19 Ag test | SD-Biosensor, South Korea | NA | NA | NP | High | High |
Weitzel [37] | Chile | 348 | [A] Biocredit One Step SARS-CoV-2 Ag test, [B] StrongStep COVID-19 Ag test, [C] Huaketai SARS-CoV-2 N Protein Detection Kit, and [D] Diagnostic Kit for 2019-Novel Coronavirus Ag test | [A] RapiGen, South Korea, [B] Liming Bio-Products, China, [C] Savant Biotechnology, China, and [D] Bioeasy Biotechnology, China | NA | NA | NP, OP, Throat, and sputum | Unclear | Low |
Young [38] | USA | 251 | Veritor System for Rapid Detection of SARS-CoV-2 | BD, USA | Lyra SARS-CoV-2 assay | Quidel, USA | Nasal | High | Low |
Ag, Antigen; COVID-19, coronavirus disease 2019; NA, not available; NP, nasopharyngeal; OP, oropharyngeal; RT-PCR, reverse-transcription polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.