LumiraDX SARS-CoV-2 Antigen Test for Diagnosing Acute SARS-CoV-2 Infection : Critical Literature Review and Meta-Analysis
We present here a critical literature review and meta-analysis on the accuracy of the LumiraDX SARS-CoV-2 Antigen Test for diagnosing acute SARS-CoV-2 infection. An electronic search was conducted in the Scopus and Medline databases using the keywords "LumiraDX" AND "COVID-19" OR "SARS-CoV-2", without date (i.e., up to 1 February 2022) or language restrictions, for detecting clinical studies where the diagnostic accuracy of the LumiraDX SARS-CoV-2 Antigen Test was compared with reference molecular diagnostic methods. All studies where the rates of true positive, true negative, false positive and false negative cases were available for constructing a 2 × 2 table and providing pooled estimates of diagnostic sensitivity, specificity and accuracy were included in a pooled analysis. The study was conducted in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) reporting checklist. Eleven studies (n = 8527 samples) could be included in our pooled analysis, while five additional documents provided diagnostic accuracy data but could not be extracted for construction of a 2 × 2 table. The pooled diagnostic sensitivity and specificity were 0.86 (95%CI, 0.84-0.88) and 0.99 (95%CI, 0.98-0.99), respectively, while the area under the summary receiver operating characteristic curve was 0.974 (95%CI, 0.965-0.983) and the agreement was 96.8% (95%CI, 96.4-97.1%), with kappa statistics of 0.87 (95%CI, 0.85-0.88). In conclusion, the diagnostic performance of the LumiraDX SARS-CoV-2 Antigen Test would allow the conclusion that it may be seen as a reliable alternative to molecular testing for the rapid preliminary screening of acute SARS-CoV-2 infections.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
Diagnostics (Basel, Switzerland) - 12(2022), 4 vom: 11. Apr. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lippi, Giuseppe [VerfasserIn] |
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| Links: |
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| Themen: |
Antigen |
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| Anmerkungen: |
Date Revised 16.07.2022 published: Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.3390/diagnostics12040947 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM339831669 |
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| 520 | |a We present here a critical literature review and meta-analysis on the accuracy of the LumiraDX SARS-CoV-2 Antigen Test for diagnosing acute SARS-CoV-2 infection. An electronic search was conducted in the Scopus and Medline databases using the keywords "LumiraDX" AND "COVID-19" OR "SARS-CoV-2", without date (i.e., up to 1 February 2022) or language restrictions, for detecting clinical studies where the diagnostic accuracy of the LumiraDX SARS-CoV-2 Antigen Test was compared with reference molecular diagnostic methods. All studies where the rates of true positive, true negative, false positive and false negative cases were available for constructing a 2 × 2 table and providing pooled estimates of diagnostic sensitivity, specificity and accuracy were included in a pooled analysis. The study was conducted in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) reporting checklist. Eleven studies (n = 8527 samples) could be included in our pooled analysis, while five additional documents provided diagnostic accuracy data but could not be extracted for construction of a 2 × 2 table. The pooled diagnostic sensitivity and specificity were 0.86 (95%CI, 0.84-0.88) and 0.99 (95%CI, 0.98-0.99), respectively, while the area under the summary receiver operating characteristic curve was 0.974 (95%CI, 0.965-0.983) and the agreement was 96.8% (95%CI, 96.4-97.1%), with kappa statistics of 0.87 (95%CI, 0.85-0.88). In conclusion, the diagnostic performance of the LumiraDX SARS-CoV-2 Antigen Test would allow the conclusion that it may be seen as a reliable alternative to molecular testing for the rapid preliminary screening of acute SARS-CoV-2 infections | ||
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