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

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%, I 2 = 60.22%) and specificity of 97.2% (95% CI 95.5–98.3%, I 2 = 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.

Evaluation of Factors that Affect the Performance of COVID-19 Molecular Assays Including Presence of Symptoms, Number of Detected Genes and RNA Extraction Type

“…We found that Xpert ® Xpress SARS-CoV-2 test had the highest sensitivity among all tests, compared to the reference kit. This finding was not surprising in light of data from previous publications that have presented even higher sensitivities of this assay (97–100%), compared to the current study [ 7 – 9 ]. Additionally, a recent report that compared the performances of seven different primer-probe sets concluded that primers that target the N2 or the E genes, as in the Xpert ® Xpress SARS-CoV-2 test, have higher sensitivity, compared to primers with other gene targets [ 10 ].…”

“…For example, in the current study, all assays were compared to the Allplex™ 2019-nCoV Assay. Different studies have used other assays as their reference kit [ 7 – 9 , 11 , 12 ]. Therefore, the performance of a specific kit may change when compared to a different assay.…”

Application experience of a rapid nucleic acid detection system for COVID-19

“…Currently, many commercial SARS-CoV-2 nucleic acid POCT products for COVID-19 have been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-2-positive patients, including the Xpert Xpress SARS-CoV-2 test (Cepheid), ID NOW COVID-19 (Abbott Diagnostics Scarborough, Inc.), BioFire COVID-19 Test (BioFire Defense, LLC), Simplex COVID-19 Direct (DiaSorin Molecular LLC), Cobas SARS-CoV-2 (Roche Molecular Systems, Inc.), Panther Fusion SARS-CoV-2 (Hologic, Inc.), and Allplex SARS-CoV-2 Assay (Seegene Inc.) [ 7 ]. Studies on the performance of these seven FDA-approved and commercially available SARS-CoV-2 nucleic acid POCT products showed that the overall performance of commercial SARS-CoV-2 nucleic acid POCT products was 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%) [ [8] , [9] , [10] , [11] , [12] , [13] , [14] ]. However, the ID NOW COVID-19 (Abbott) and the Simplex COVID-19 Direct exhibited lower sensitivity than other platforms, consistent with previously reported studies [ [9] , [10] , [11] , [12] , [13] , [14] ].…”

Behind the curtain of a weak diagnosis of acute SARS-CoV-2 infection in children

“…[ 2 , 3 ] Huge scientific advances have been made in COVID-19 diagnosis, and several high-performance technologies have been developed in recent years. 2 , 3 , 4 Consequently, it is essential to select cost-effective diagnostic methods for monitoring in a different type of action settings, especially in ambulatory care backgrounds, where case management, isolation, contact tracing and quarantine are relevant to prevent viral transmission in the community. [3] …”