Diagnostic Accuracy of SARS-CoV-2 Antigen Tests for Community Transmission Screening: A Systematic Review and Meta-Analysis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Literature Search Strategy
2.2. Inclusion and Exclusion Criteria
2.3. Quality Assessment
2.4. Statistical Analysis
3. Results
3.1. Quality Assessment
3.2. Investigation of Heterogeneity
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Study | Study Design | Testing Site | Patient Population | Prevalence (%) | Participants (Total/Data Extraction) | Age Median (Range) | Days After Symptom Onset Median (Range) | Specimen Type | Index Tests | Reference Standard | Ct Value of Positive RT-PCR Median (Range) | Threshold Value (Ct) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Pollock NR [16] 2021 | Prospective | Drive-through testing site | Asymptomatic and symptomatic | 15.6 | (1063/1498) | NA | adult: 3 (0–44) children: 3 (1–20) | Anterior nasal swab | Access Bio CareStart COVID-19 Antigen test | RT-PCR | NA | ≤25, ≤30, ≤35 |
García-Fiñana M [17] 2021 | Prospective, cross sectional, consecutive | Community testing sites | Asymptomatic | 1.3 | (5869/5504) | 50 (mean) (±18, SD) | NA | Self-administered swabs (combined throat and nose) | Innova lateral flow test | RT-PCR | NA | NA |
Lindner AK [18] 2021 | Prospective, consecutive | Ambulatory SARS-CoV-2 testing facility | Symptomatic | NA | (168/144) | 35 (mean) (±11.5, SD) | 3.4 (mean) (±2.0, SD) | Nasal swab (self-sampling) | STANDARD Q COVID-19 Ag Test | RT-PCR | NA | NA |
Krüger LJ [19] 2021 | Prospective | Drive-in testing site, clinical ambulatory testing facility | Asymptomatic and symptomatic | NA | (1261/1108) | 39.4 (mean) (±14.1, SD) | 4.01 (mean) (±3.1, SD) | Nasopharyngeal swab, oropharyngeal swab | Panbio COVID-19 Ag Rapid Test Device, immunochro-matography | RT-PCR | NA | NA |
Van der Moeren N [20] 2021 | Prospective | COVID-19 test center | Symptomatic | 4.8 | (354/351) | NA | NA | Nose/throat swabs | BD Veritor System for Rapid Detection of SARS-CoV-2 | RT-PCR | NA | NA |
Peña M [21] 2021 | Prospective | Public testing sites | Asymptomatic | 11 | (854/842) | 36.7 (mean) (±16.5, SD) | NA | Nasopharyngeal swab | STANDARD Q COVID-19 Ag Test | RT-PCR | NA | 40 |
Shah MM [22] 2021 | Prospective | Community testing site | Asymptomatic and symptomatic | 15.8 | (2127/2110) the initial BinaxNOW test | NA | ≤7 | Nasal swab (self-sampling) | BinaxNOW COVID-19 Ag card | RT-PCR | NA | 37 |
Ford L [23] 2021 | Prospective | Two universities | Asymptomatic and symptomatic | NA | (1058/1051) symptomatic: 219 asymptomatic: 832 | 15–24 (87.9%) ≥25 (12.1%) | NA | Nasal swabs | Sofia SARS Antigen, fluorescent immunoassay | RT-PCR | NA | 40 |
Berger A [24] 2021 | Prospective | Community-based testing centers | Asymptomatic and symptomatic | NA | (1064/1064) | 34 (±12.5, SD) | NA | Nasopharyngeal swab | Panbio COVID-19 Ag Rapid Test Device, Standard Q COVID-19 Ag kit, | RT-PCR | 21.5 (14.2–34.2) | NA |
Stokes W [25] 2021 | Prospective | Community COVID-19 assessment centers | Symptomatic | NA | (1641/1641) | 39 (5–90) | NA | Nasopharyngeal swab | Panbio COVID-19 Ag Rapid Test Device, immunochro-matography | RT-PCR | 22.1 (13.2–33.9), (E-gene) | 35 |
Takeuchi Y [26] 2021 | Prospective | Drive-through-type at a PCR center | Asymptomatic and symptomatic | NA | (1186/1186) | 23 | 2 | Nasopharyngeal swab | QuickNavi™-COVID19 Ag | RT-PCR | NA | NA |
Gili A [27] 2021 | Prospective | Schools, prisons, elderly care homes, and from hospital healthcare worker surveillance programs | NA | 5.2 | (1738/1738) | NA | NA | Nasopharyngeal swab | Lumipulse® SARS-CoV-2 antigen assay | RT-PCR | NA | 35 |
Pollock NR [28] 2021 | Prospective | Drive-through testing site | Asymptomatic and symptomatic | 12.7 | (2308/2308) | all ages | 7 | Anterior nasal swab | BinaxNOW COVID-19 Ag card | RT-PCR | 26.9 (for adults, asymptomatic) 20.5 (for adults, symptomatic for ≤7 days) | 40 |
Okoye NC [29] 2021 | Prospective | A university setting | Asymptomatic | 1.7 | (2645/2638) | 24 (mean) (15–86) | NA | Nasal swab | BinaxNOW COVID-19 Ag card | RT-PCR | 17.6 | NA |
Prince-Guerra JL [30] 2021 | Prospective | Two community-based testing sites | Asymptomatic and symptomatic | 8.7 | (3419/3419) | 41 (10–95) | 4 (0–210) | Anterior nasal swab | BinaxNOW COVID-19 Ag card | RT-PCR | 22 (symptomatic) 22.5 (asymptomatic) | NA |
Iglὁi Z 2021 [31] | Prospective | Drive-through testing location | Asymptomatic and symptomatic | 19.2 | (3615/970) symptomatic: 886 | 42 (18–86) | 4 | Nasopharyngeal swab | STANDARD Q COVID-19 Ag Test | RT-PCR | 23.6 (15.6–37.4), (E-gene) | NA |
Landaas ET [32] 2021 | Prospective | test station | Asymptomatic and symptomatic | 6.3 | (4025/3991) | ≥10 | NA | Throat/nasopharyngeal swabs | Panbio COVID-19 Ag Rapid Test Device, immunochro-matography | RT-PCR | 24.5 (symptomatic) 28.2 (asymptomatic) | NA |
Pilarowski G [33] 2020 | Prospective | at a plaza | Participants in an urban commercial transport hub | 7.2 | (3302/3302) | <13, 13–18, >18 | NA | Nasal swab | BinaxNOW™ COVID-19 Ag Card | RT-PCR | NA | 35 |
Study | True Positive | False Positive | False Negative | True Negative |
---|---|---|---|---|
Pollock NR [16] 2021 | 135 | 21 | 99 | 1243 |
García-Fiñana M [17] 2021 | 28 | 3 | 42 | 5431 |
Lindner AK [18] 2021 | 33 | 0 | 7 | 104 |
Krüger LJ [19] 2021 | 92 | 1 | 14 | 1001 |
Van der Moeren N [20] 2021 | 16 | 0 | 1 | 334 |
Peña M [21] 2021 | 51 | 3 | 22 | 766 |
Shah MM [22] 2021 | 258 | 7 | 76 | 1769 |
Ford L [23] 2021 | 37 | 15 | 17 | 982 |
Berger A [24] 2021 | 276 | 1 | 39 | 748 |
Stokes W [25] 2021 | 231 | 2 | 37 | 1371 |
Takeuchi Y [26] 2021 | 91 | 0 | 14 | 1081 |
Gili A [27] 2021 | 90 | 86 | 0 | 1562 |
Pollock NR [28] 2021 | 226 | 12 | 66 | 2004 |
Okoye NC [29] 2021 | 24 | 0 | 21 | 2593 |
Prince-Guerra JL [30] 2021 | 157 | 4 | 142 | 3116 |
Iglὁi Z [31] 2021 | 158 | 4 | 28 | 780 |
Landaas ET [32] 2021 | 186 | 3 | 64 | 3738 |
Pilarowski G [33] 2020 | 201 | 13 | 3 | 3085 |
Study | Risk of Bias | Applicability Concerns | |||||
---|---|---|---|---|---|---|---|
Patient Selection | Index Test | Reference Standard | Flow and Timing | Patient Selection | Index Test | Reference Standard | |
Pollock NR [16] 2021 | L | L | L | H | L | L | L |
García-Fiñana M [17] 2021 | L | L | L | H | L | L | L |
Lindner AK [18] 2021 | L | L | L | H | L | L | L |
Krüger LJ [19] 2021 | L | L | L | H | L | L | L |
Van der Moeren N [20] 2021 | U | L | L | H | L | L | L |
Peña M [21] 2021 | U | L | L | H | L | L | L |
Shah MM [22] 2021 | U | L | L | H | L | L | L |
Ford L [23] 2021 | U | L | L | H | L | L | L |
Berger A [24] 2021 | U | L | L | L | L | L | L |
Stokes W [25] 2021 | U | L | L | H | L | L | L |
Takeuchi Y [26] 2021 | U | L | L | L | H | L | L |
Gili A [27] 2021 | U | L | L | L | L | L | L |
Pollock NR [28] 2021 | L | L | L | L | L | L | L |
Okoye NC [29] 2021 | U | L | L | H | L | L | L |
Prince-Guerra JL [30] 2021 | L | L | L | H | L | L | L |
Iglὁi Z [31] 2021 | L | L | L | H | L | L | L |
Landaas ET [32] 2021 | U | L | L | H | L | L | L |
Pilarowski G [33] 2020 | L | L | L | L | L | L | L |
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Chen, C.-C.; Lu, S.-C.; Bai, C.-H.; Wang, P.-Y.; Lee, K.-Y.; Wang, Y.-H. Diagnostic Accuracy of SARS-CoV-2 Antigen Tests for Community Transmission Screening: A Systematic Review and Meta-Analysis. Int. J. Environ. Res. Public Health 2021, 18, 11451. https://doi.org/10.3390/ijerph182111451
Chen C-C, Lu S-C, Bai C-H, Wang P-Y, Lee K-Y, Wang Y-H. Diagnostic Accuracy of SARS-CoV-2 Antigen Tests for Community Transmission Screening: A Systematic Review and Meta-Analysis. International Journal of Environmental Research and Public Health. 2021; 18(21):11451. https://doi.org/10.3390/ijerph182111451
Chicago/Turabian StyleChen, Cheng-Chieh, Shou-Cheng Lu, Chyi-Huey Bai, Pei-Yu Wang, Kang-Yun Lee, and Yuan-Hung Wang. 2021. "Diagnostic Accuracy of SARS-CoV-2 Antigen Tests for Community Transmission Screening: A Systematic Review and Meta-Analysis" International Journal of Environmental Research and Public Health 18, no. 21: 11451. https://doi.org/10.3390/ijerph182111451