Evaluation of six different rapid methods for nucleic acid detection of SARS‐COV‐2 virus. Issue 9 (8th June 2021)

• Record Type: Journal Article
• Authors: Mahmoud, Sally A.; Ganesan, Subhashini; Ibrahim, Esra; Thakre, Bhagyashree; Teddy, Juliet G.; Raheja, Preety; Zaher, Walid A.
• Other Names: Luo Guangxiang (George) guestEditor.; Ly Hinh guestEditor.; Gao Shou‐Jiang guestEditor.
• Is Part Of: Journal of medical virology. Volume 93:Issue 9(2021)
• Page Start: 5538
• Page End: 5543
• Publication Date: 2021-06-08
• Subjects: COVID‐19 -- nucleic acid tests -- rapid tests -- SARS‐CoV‐2; Virology -- Periodicals; 616
• DOI: 10.1002/jmv.27090
• Languages: English
• ISSNs: 0146-6615

Abstract

Abstract: In the current coronavirus disease 2019 (COVID‐19) pandemic there is a mass screening of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) happening around the world due to the extensive spread of the infections. There is a high demand for rapid diagnostic tests to expedite the identification of cases and to facilitate early isolation and control spread. Hence this study evaluates six different rapid nucleic acid detection assays that are commercially available for SARS‐CoV‐2 virus detection. Nasopharyngeal samples were collected from 4981 participants and were tested for the SARS‐CoV‐2 virus by the gold standard real‐time reverse‐transcription polymerase chain reaction (RT‐PCR) method and with one of these six rapid methods of detection. Evaluation of the rapid nucleic acid detection assays was done by comparing the results of these rapid methods with the gold standard RT‐qPCR results for SARS‐COV‐2 detection. AQ‐TOP had the highest sensitivity (98%) and a strong kappa value of 0.943 followed by Genechecker and Abbot ID NOW. The POCKIT (ii RT‐PCR) assay had the highest test accuracy of 99.29% followed by Genechecker and Cobas Liat. Atila iAMP showed the highest percentage of invalid reports (35.5%) followed by AQ‐TOP with 6% and POCKIT with 3.7% of invalid reports. Genechecker system, Abbott ID NOW, and Cobas Liat were found to have the best performance and agreement when compared with the standard RT‐PCR for COVID‐19 detection. With further research, these rapid tests have the potential to be employed in large‐scale screening of COVID‐19. Highlights: The rapid nucleic acid detection kits for detection of SARS‐COV‐2, has the potential to be employed as mass testing strategy. Variable sensitivity and specificity have been identified for the different rapid detection platforms. This evaluation will help laboratories in making choices on purchasing and further evaluation of these platforms. This evaluation considers various parameters like the diagnostic reliability of the platforms, turn around time and throughput, which are not much evaluated in other papers.