Diagnostic accuracy of Siemens SARS-CoV-2 Antigen (CoV2Ag) chemiluminescent immunoassay for diagnosing acute SARS-CoV-2 infection : a pooled analysis
© 2023 Walter de Gruyter GmbH, Berlin/Boston..
BACKGROUND: This article provides a critical literature review and pooled analysis of diagnostic accuracy of the fully-automated Siemens SARS-CoV-2 Antigen (CoV2Ag) chemiluminescent immunoassay for diagnosis of acute SARS-CoV-2 infections.
METHODS: An electronic search was conducted in Scopus, PubMed and medRxiv using the keywords ["Siemens AND CoV2Ag"] OR ["Siemens AND SARS-CoV-2 AND antigen"] for capturing studies that investigated the accuracy of Siemens CoV2Ag for diagnosing acute SARS-CoV-2 infection against a reference SARS-CoV-2 molecular test. The retrieved information was used for constructing a 2 × 2 table and for calculating pooled diagnostic sensitivity, specificity, Summary Receiver Operating Characteristic Curve (SROC) and Agreement. This study followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting checklist.
RESULTS: Four studies totalling 1,310 respiratory samples (612 with high viral load) were finally included in our analysis. The cumulative area under the curve, accuracy, sensitivity, specificity, were 0.964 (95% CI, 0.957-0.971), 86.9% (95% CI, 84.9-88.7%), 0.79 (95% CI, 0.76-0.82) and 0.98 (95% CI, 0.96-0.99), respectively. The negative (NPV) and positive (PPV) predictive values were 0.77 (0.74-0.79) and 0.98 (95% CI, 0.96-99), respectively. The diagnostic sensitivity in samples with high viral load (i.e., Ct<29-30) was 0.95 (95% CI, 0.93-0.97).
CONCLUSIONS: The Siemens CoV2Ag fully-automated and high-throughput immunoassay approximates the minimum performance criteria for general SARS-CoV-2 antigen testing and displays excellent performance in samples with high viral load, thus representing a valuable screening solution for risk assessment in COVID-19 and for limiting viral spread.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:61 |
|---|---|
| Enthalten in: |
Clinical chemistry and laboratory medicine - 61(2023), 7 vom: 27. Juni, Seite 1133-1139 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Lippi, Giuseppe [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antigen |
|---|
| Anmerkungen: |
Date Completed 30.05.2023 Date Revised 24.01.2024 published: Electronic-Print Citation Status MEDLINE |
|---|
| doi: |
10.1515/cclm-2022-1287 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM35145263X |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM35145263X | ||
| 003 | DE-627 | ||
| 005 | 20240125231827.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1515/cclm-2022-1287 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1270.xml |
| 035 | |a (DE-627)NLM35145263X | ||
| 035 | |a (NLM)36634305 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Lippi, Giuseppe |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Diagnostic accuracy of Siemens SARS-CoV-2 Antigen (CoV2Ag) chemiluminescent immunoassay for diagnosing acute SARS-CoV-2 infection |b a pooled analysis |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 30.05.2023 | ||
| 500 | |a Date Revised 24.01.2024 | ||
| 500 | |a published: Electronic-Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 Walter de Gruyter GmbH, Berlin/Boston. | ||
| 520 | |a BACKGROUND: This article provides a critical literature review and pooled analysis of diagnostic accuracy of the fully-automated Siemens SARS-CoV-2 Antigen (CoV2Ag) chemiluminescent immunoassay for diagnosis of acute SARS-CoV-2 infections | ||
| 520 | |a METHODS: An electronic search was conducted in Scopus, PubMed and medRxiv using the keywords ["Siemens AND CoV2Ag"] OR ["Siemens AND SARS-CoV-2 AND antigen"] for capturing studies that investigated the accuracy of Siemens CoV2Ag for diagnosing acute SARS-CoV-2 infection against a reference SARS-CoV-2 molecular test. The retrieved information was used for constructing a 2 × 2 table and for calculating pooled diagnostic sensitivity, specificity, Summary Receiver Operating Characteristic Curve (SROC) and Agreement. This study followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting checklist | ||
| 520 | |a RESULTS: Four studies totalling 1,310 respiratory samples (612 with high viral load) were finally included in our analysis. The cumulative area under the curve, accuracy, sensitivity, specificity, were 0.964 (95% CI, 0.957-0.971), 86.9% (95% CI, 84.9-88.7%), 0.79 (95% CI, 0.76-0.82) and 0.98 (95% CI, 0.96-0.99), respectively. The negative (NPV) and positive (PPV) predictive values were 0.77 (0.74-0.79) and 0.98 (95% CI, 0.96-99), respectively. The diagnostic sensitivity in samples with high viral load (i.e., Ct<29-30) was 0.95 (95% CI, 0.93-0.97) | ||
| 520 | |a CONCLUSIONS: The Siemens CoV2Ag fully-automated and high-throughput immunoassay approximates the minimum performance criteria for general SARS-CoV-2 antigen testing and displays excellent performance in samples with high viral load, thus representing a valuable screening solution for risk assessment in COVID-19 and for limiting viral spread | ||
| 650 | 4 | |a Meta-Analysis | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a antigen | |
| 650 | 4 | |a diagnosis | |
| 650 | 4 | |a immunoassay | |
| 700 | 1 | |a Henry, Brandon M |e verfasserin |4 aut | |
| 700 | 1 | |a Plebani, Mario |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical chemistry and laboratory medicine |d 1998 |g 61(2023), 7 vom: 27. Juni, Seite 1133-1139 |w (DE-627)NLM095304118 |x 1437-4331 |7 nnns |
| 773 | 1 | 8 | |g volume:61 |g year:2023 |g number:7 |g day:27 |g month:06 |g pages:1133-1139 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1515/cclm-2022-1287 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 61 |j 2023 |e 7 |b 27 |c 06 |h 1133-1139 | ||