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Meta-Analysis
. 2021 Jul;21(7):733-740.
doi: 10.1080/14737159.2021.1933449. Epub 2021 Jun 1.

The diagnostic accuracy of seven commercial molecular in vitro SARS-CoV-2 detection tests: a rapid meta-analysis

Zulvikar Syambani Ulhaq  1 , Gita Vita Soraya  2
Affiliations
Meta-Analysis

The diagnostic accuracy of seven commercial molecular in vitro SARS-CoV-2 detection tests: a rapid meta-analysis

Zulvikar Syambani Ulhaq et al. Expert Rev Mol Diagn. 2021 Jul.

Abstract

Objective: To compare the accuracy parameters of seven commercial molecular in vitro diagnostic tests for detecting SARS-CoV-2.

Methods: Studies evaluating the accuracy of seven different commercial molecular diagnostic tests for detecting SARS-CoV-2 (Cepheid Xpert Xpress SARS-CoV-2 test, Simplexa COVID-19 Direct, Abbott ID NOW COVID-19, Cobas SARS-CoV-2, Allplex 2019-nCoV Assay, Panther Fusion SARS-CoV-2, and BioFire COVID-19 Test) were included. The quality of the included studies was assessed using the QUADAS-2 checklist. A bivariate random-effects regression model was implemented.

Results: Meta-analysis of 12 included studies showed that the performances of commercial COVID-19 molecular in vitro diagnostic tests were high, with a summary sensitivity of 95.9% (95% CI 93.9-97.2%, I2 = 60.22%) and specificity of 97.2% (95% CI 95.5-98.3%, I2 = 56.66%). Among seven evaluated tests, the Abbott ID NOW COVID-19 and Simplexa COVID-19 Direct displayed lower sensitivity (91.6%, 95% CI 80.5-96.6% and 92%, 95% CI 86.2-95.5, respectively).

Conclusion: All evaluated tests showed good accuracy. However, the slightly lower sensitivity observed in the Abbott ID Now COVID-19 and Simplexa COVID-19 Direct should be considered when deciding on a test platform. Moreover, the diagnostic accuracy of COVID-19 commercial diagnostic tests should be weighed against their ease of use and speed.

Keywords: COVID-19; SARS-CoV-2; diagnostic accuracy; diagnostic performance; molecular in vitro diagnostic tests.

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Figures

Figure 1.
Figure 1.
Flowchart of included studies
Figure 2.
Figure 2.
Forest plot of pairs of sensitivity and specificity in each study included stratified by brand name. TP: true positive; FP: false positive; FN: false negative; TN: true negative
Figure 3.
Figure 3.
Summary of ROC curves from seven commercial molecular in vitro diagnostic tests for detecting SARS-CoV-2
Figure 4.
Figure 4.
Methodological quality of the included studies. (a) Individual assessment and (b) summary
See this image and copyright information in PMC

References

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    2. • Elucidating the role of IL-6 as a discriminat for COVID-19 severity.

    1. Soraya GV, Ulhaq ZS. Interleukin-6 levels in children developing SARS-CoV-2 infection. Pediatr Neonatol. 2020;61:253–254. - PMC - PubMed
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    1. Ulhaq ZS, Soraya GV. The prevalence of ophthalmic manifestations in COVID-19 and the diagnostic value of ocular tissue/fluid. Graefes Arch Clin Exp Ophthalmol Albrecht Von Graefes Arch Klin Exp Ophthalmol. 2020;258:1351–1352. - PMC - PubMed