TY - JOUR
T1 - Performance of point-of care molecular and antigen-based tests for SARS-CoV-2
T2 - a living systematic review and meta-analysis
AU - Fragkou, Paraskevi C
AU - Moschopoulos, Charalampos D
AU - Dimopoulou, Dimitra
AU - Ong, David S Y
AU - Dimopoulou, Konstantina
AU - Nelson, Philipp P
AU - Schweitzer, Valentijn A
AU - Janocha, Hannah
AU - Karofylakis, Emmanouil
AU - Papathanasiou, Konstantinos A
AU - Tsiordras, Sotirios
AU - De Angelis, Giulia
AU - Thölken, Clemens
AU - Sanguinetti, Maurizio
AU - Chung, Ho-Ryun
AU - Skevaki, Chrysanthi
N1 - Funding Information:
CS is supported by the Universities Giessen and Marburg Lung Center, the German Center for Lung Research (DZL), University Hospital Giessen and Marburg research funding according to article 2, section 3 cooperation agreement, and the Deutsche Forschungsgemeinschaft (German Reuter Foundation) Project-ID 197785619–SFB 1021, KFO 309 (P10), and SK 317/1-1 (Project number 428518790) as well as by the Foundation for Pathobiochemistry and Molecular Diagnostics. In addition, consultancy and research funding was acquired from Hycor Biomedical, Bencard Allergie, and Thermo Fisher Scientific and research funding was acquired from Mead Johnson Nutrition. These funds were received outside the submitted work. The protocol of this systematic review and meta-analysis has been registered to the International Prospective Register of Ongoing Systematic Reviews PROSPERO (Registration number: CRD42020227233). No external funding was received for this study.
Publisher Copyright:
© 2022 European Society of Clinical Microbiology and Infectious Diseases
PY - 2023/3
Y1 - 2023/3
N2 - BACKGROUND: Molecular and antigen point-of-care tests (POCTs) have augmented our ability to rapidly identify and manage SARS-CoV-2 infection. However, their clinical performance varies among individual studies.OBJECTIVES: The evaluation of the performance of molecular and antigen-based POCTs in confirmed, suspected, or probable COVID-19 cases compared with that of laboratory-based RT-PCR in real-life settings.DATA SOURCES: MEDLINE/PubMed, Scopus, Embase, Web of Science, Cochrane Library, Cochrane COVID-19 study register, and COVID-19 Living Evidence Database from the University of Bern.STUDY ELIGIBILITY CRITERIA: Peer-reviewed or preprint observational studies or randomized controlled trials that evaluated any type of commercially available antigen and/or molecular POCTs for SARS-CoV-2, including multiplex PCR panels, approved by the United States Food and Drug Administration, with Emergency Use Authorization, and/or marked with Conformitè Europëenne from European Commission/European Union.PARTICIPANTS: Close contacts and/or patients with symptomatic and/or asymptomatic confirmed, suspected, or probable COVID-19 infection of any age.TEST/S: Molecular and/or antigen-based SARS-CoV-2 POCTs.REFERENCE STANDARD: Laboratory-based SARS-CoV-2 RT-PCR.ASSESSMENT OF RISK OF BIAS: Eligible studies were subjected to quality-control and risk-of-bias assessment using the Quality Assessment of Diagnostic Accuracy Studies 2 tool.METHODS OF DATA SYNTHESIS: Summary sensitivities and specificities with their 95% CIs were estimated using a bivariate model. Subgroup analysis was performed when at least three studies informed the outcome.RESULTS: A total of 123 eligible publications (97 and 26 studies assessing antigen-based and molecular POCTs, respectively) were retrieved from 4674 initial records. The pooled sensitivity and specificity for 13 molecular-based POCTs were 92.8% (95% CI, 88.9-95.4%) and 97.6% (95% CI, 96.6-98.3%), respectively. The sensitivity of antigen-based POCTs pooled from 138 individual evaluations was considerably lower than that of molecular POCTs; the pooled sensitivity and specificity rates were 70.6% (95% CI, 67.2-73.8%) and 98.9% (95% CI, 98.5-99.2%), respectively.DISCUSSION: Further studies are needed to evaluate the performance of molecular and antigen-based POCTs in underrepresented patient subgroups and different respiratory samples.
AB - BACKGROUND: Molecular and antigen point-of-care tests (POCTs) have augmented our ability to rapidly identify and manage SARS-CoV-2 infection. However, their clinical performance varies among individual studies.OBJECTIVES: The evaluation of the performance of molecular and antigen-based POCTs in confirmed, suspected, or probable COVID-19 cases compared with that of laboratory-based RT-PCR in real-life settings.DATA SOURCES: MEDLINE/PubMed, Scopus, Embase, Web of Science, Cochrane Library, Cochrane COVID-19 study register, and COVID-19 Living Evidence Database from the University of Bern.STUDY ELIGIBILITY CRITERIA: Peer-reviewed or preprint observational studies or randomized controlled trials that evaluated any type of commercially available antigen and/or molecular POCTs for SARS-CoV-2, including multiplex PCR panels, approved by the United States Food and Drug Administration, with Emergency Use Authorization, and/or marked with Conformitè Europëenne from European Commission/European Union.PARTICIPANTS: Close contacts and/or patients with symptomatic and/or asymptomatic confirmed, suspected, or probable COVID-19 infection of any age.TEST/S: Molecular and/or antigen-based SARS-CoV-2 POCTs.REFERENCE STANDARD: Laboratory-based SARS-CoV-2 RT-PCR.ASSESSMENT OF RISK OF BIAS: Eligible studies were subjected to quality-control and risk-of-bias assessment using the Quality Assessment of Diagnostic Accuracy Studies 2 tool.METHODS OF DATA SYNTHESIS: Summary sensitivities and specificities with their 95% CIs were estimated using a bivariate model. Subgroup analysis was performed when at least three studies informed the outcome.RESULTS: A total of 123 eligible publications (97 and 26 studies assessing antigen-based and molecular POCTs, respectively) were retrieved from 4674 initial records. The pooled sensitivity and specificity for 13 molecular-based POCTs were 92.8% (95% CI, 88.9-95.4%) and 97.6% (95% CI, 96.6-98.3%), respectively. The sensitivity of antigen-based POCTs pooled from 138 individual evaluations was considerably lower than that of molecular POCTs; the pooled sensitivity and specificity rates were 70.6% (95% CI, 67.2-73.8%) and 98.9% (95% CI, 98.5-99.2%), respectively.DISCUSSION: Further studies are needed to evaluate the performance of molecular and antigen-based POCTs in underrepresented patient subgroups and different respiratory samples.
KW - Antigen-based test
KW - COVID-19
KW - Molecular test
KW - Nucleic acid amplification test
KW - Point-of-care test
KW - Rapid test
KW - SARS-CoV-2
UR - https://www.scopus.com/pages/publications/85143979396
U2 - 10.1016/j.cmi.2022.10.028
DO - 10.1016/j.cmi.2022.10.028
M3 - Review article
C2 - 36336237
SN - 1198-743X
VL - 29
SP - 291
EP - 301
JO - Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
JF - Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
IS - 3
ER -