Comparison of the ID Now Influenza A & B 2, Cobas Influenza A/B, and Xpert Xpress Flu Point-of-Care Nucleic Acid Amplification Tests for Influenza A/B Virus Detection in Children

Abstract

Early diagnosis of influenza (Flu) is critical for patient management and infection control. The ID Now influenza A & B 2 (ID Now) assay (Abbott Laboratories), Cobas influenza A/B nucleic acid test (LIAT; Roche Molecular Systems, Inc.), and Xpert Xpress Flu (Xpert; Cepheid) are rapid, point-of-care molecular assays for Flu virus detection. The study aim was to compare the performances of these three commercially available Clinical Laboratory Improvement Amendments (CLIA)-waived Flu virus assays. We prospectively enrolled 201 children <18 years old from January to April 2018 and collected nasopharyngeal swab specimens in viral medium. Aliquots were frozen for testing on different diagnostic platforms, as per the manufacturers’ instructions. CDC Flu A/B PCR was used as a reference method to evaluate the performances of these three platforms. Among the 201 specimens tested, the CDC Flu A/B PCR assay detected Flu A/B virus in 107 samples (Flu A virus, 73 samples; Flu B virus, 36 samples; dual Flu A/B virus positive, 2 samples), while the ID Now virus detected 102 samples (Flu A virus, 69 samples; Flu B virus, 37 samples; dual Flu A/B virus positive, 4 samples; invalid rate, 1/201 [0.5%]), the LIAT detected 112 samples (Flu A virus, 74 samples; Flu B virus, 38 samples; invalid rate, 11/201 [5.5%]), and the Xpert assay detected 112 samples (Flu A virus, 76 samples; Flu B virus, 36 samples; invalid rate, 6/201 [3.0%]). The overall sensitivities for the ID Now assay, LIAT, and Xpert assay for Flu A virus detection (93.2%, 100%, and 100%, respectively) and Flu B virus detection (97.2%, 94.4%, and 91.7%, respectively) were comparable. The specificity for Flu A and B virus detection by all methods was >97%. These molecular assays had higher sensitivity than did a historical standard-of-care test from the BD Veritor antigen test (Flu A virus, 79.5%; Flu B virus, 66.7%).

Scientific research progress of COVID‐19/SARS‐CoV‐2 in the first five months

“…Recently, Abbott ID NOW molecular diagnostic platform technology developed ultra-fast DNA or RNA amplification, combined with fluorescence detection system based on the nicking endonuclease amplification reaction (NEAR) technology, which could get bacterial or virus test results within 13 minutes or less (positive results within 5 minutes, negative results within 15 minutes). This technology will substantially speed up the population screening and COVID-19 patient identification 67.…”

PCR Past, Present and Future

“…The miniaturization of PCR will continue with the development of new systems integrating sample preparation with the qPCR, moving toward truly portable sample-to-answer systems for POC applications. The COVID pandemic sped up this development, causing a boom in POC systems by converting existing devices such as LAMP-based ID NOW originally developed for influenza into a SARS-CoV-2 diagnostic tool by changing primers [ 72 , 73 ]. There will likely be more POC devices developed for SARS-CoV-2 and later converted into diagnostics for other RNA viruses.…”

A critical review of point-of-care diagnostic technologies to combat viral pandemics

“…The ID NOW for influenza A/B has been shown to be effective at diagnosing both influenza A and B, offering a quick turnaround of fewer than 13 min, or 5 min in the slightly less specific “early callout” mode. It is able to consistently achieve sensitivities at and above 95% and is overall considered to be one of the most effective tests for influenza A and B [ [42] , [43] , [44] ]. When adapted for SARS-CoV-2 detection, the ID NOW test continues to require less than 13 min, but only achieves overall sensitivity of 73.9%, which drops to only 34.3% for low viral load cases [ 45 ].…”