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Laboratory evaluation of the Abbott ID NOW rapid severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) amplification assay and its potential use in the emergency department

Published online by Cambridge University Press:  02 August 2021

Georgios Meletis*
Affiliation:
Department of Microbiology, AHEPA University Hospital, S. Kiriakidi str. 1, 54636, Thessaloniki, Greece
Ioanna Gkeka
Affiliation:
Department of Microbiology, AHEPA University Hospital, S. Kiriakidi str. 1, 54636, Thessaloniki, Greece
Areti Tychala
Affiliation:
Department of Microbiology, AHEPA University Hospital, S. Kiriakidi str. 1, 54636, Thessaloniki, Greece
Barbara Fyntanidou
Affiliation:
Department of Emergency Medicine, AHEPA University Hospital, S. Kiriakidi str. 1, 54636, Thessaloniki, Greece
Lydia Kouroudi
Affiliation:
Department of Microbiology, AHEPA University Hospital, S. Kiriakidi str. 1, 54636, Thessaloniki, Greece
Lemonia Skoura
Affiliation:
Department of Microbiology, AHEPA University Hospital, S. Kiriakidi str. 1, 54636, Thessaloniki, Greece
*
Author for correspondence: Georgios Meletis, E-mail: meletisg@hotmail.com
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Abstract

Type
Letter to the Editor
Copyright
© The Author(s), 2021. Published by Cambridge University Press on behalf of The Society for Healthcare Epidemiology of America

To the Editor—Rapid laboratory detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is of outmost importance nowadays and affects clinical and epidemiological decisions regarding therapy initiation, carrier isolation, and adoption of public health measures. The implementation of rapid antigen tests even in the form of self-testing has been recently applied in some countries to reduce the turnaround time to result required to perform real-time reverse-transcription polymerase chain reaction (RT-PCR).

However, molecular techniques remain the gold standard. Reference Lim and Lee1

Isothermal amplification technology (IAT) provides an alternative that improves dramatically the time to result, reduces costs, and maintains the molecular basis of SARS-CoV-2 identification in clinical samples. IAT is the amplification of nucleic acids without thermocycling, and unlike PCR, it does not require skilled personnel and specialized laboratory equipment. Reference James and Alawneh2

The Abbott ID NOW COVID-19 3 is a loop-mediated isothermal amplification (LAMP) assay Reference James and Alawneh2 that was recently evaluated in our hospital as a rapid alternative to the already present real-time RT-PCR–based techniques that are used in everyday practice. We obtained 30 nasopharyngeal samples from patients with clinical suspicion of COVID-19 admitted at the emergency department of our hospital, which is one of the referral settings for COVID-19 in northern Greece. The samples were tested in parallel with the Abbott ID NOW, the NeuMoDx SARS-CoV-2, and the Abbott RealTime SARS-CoV-2 assays according to the manufacturers’ respective instructions. Regarding the ID NOW, a dry swab without transport medium (as recommended by the US Food and Drug Administration) was used. 4

In our evaluation, the performance of ID NOW was identical to that of NeuMoDx and was comparable to that of the Abbott RealTime SARS-CoV-2 assay, except for 2 cases (cases 14 and 28, Table 1). Compared to the Abbott RealTime SARS-CoV-2 assay, the sensitivity of ID NOW was 85.71%, the specificity was 100%, the positive predictive value was 100%, the negative predictive value was 88.89%, and the κ coefficient of agreement was 0.805 (P < .005). The time to result of ID NOW was 5 minutes or less for positive samples and 10–15 minutes for negative samples. The rapid times to positive results of the ID NOW were achieved regardless of the Ct values obtained by NeuMoDx and Abbott RealTime assays for the respective positive samples.

Table 1. Result Comparison Between Abbott ID NOW, NeuMoDx SARS-CoV-2 Assay, and Abbott RealTime SARS-CoV-2 Assay

Note. POS, positive; NEG, negative; Ct, cycle threshold; N, nucleocapside gene; Nsp2, nonstructural protein 2 gene; RdRp, RNA-dependent RNA polymerase gene.

Previous studies have reported low sensitivity for the ID NOW test using nasopharyngeal swabs in transport media. Reference Basu, Zinger and Inglima5Reference Zhen, Smith, Manji, Schron and Berry8 In a recent large study by Sepulveda et al Reference Sepulveda, Abdulbaki and Sands9 in which dry swabs were used, ID NOW showed very high sensitivity for detection of patients with high levels of SARS-CoV-2 RNA but lower overall sensitivity compared with the Xpert SARS-CoV-2 assay. In our evaluation, the 2 cases of disagreement with the Abbott RealTime SARS-CoV-2 assay had high Ct values, indicating the presence of low viral loads.

Considering that low-viral-load samples are commonly unable for viral growth in cell cultures, Reference Sepulveda, Abdulbaki and Sands9 the clinical impact of ID NOW should be approached with respect to the advantage of saving time in detecting infected patients and the disadvantage of false negatives with lower viral loads. Even though IATs are not yet ready to entirely replace real-time RT-PCR, the implementation of assays such as ID NOW could be beneficial in reducing turnaround times, especially in emergency departments, as well as the overall costs of SARS-CoV-2 detection.

Acknowledgments

Financial support

No financial support was provided relevant to this article.

Conflicts of interest

All authors report no conflicts of interest relevant to this article.

References

Lim, J, Lee, J. Current laboratory diagnosis of coronavirus disease 2019. Korean J Intern Med 2020;35:741748.CrossRefGoogle ScholarPubMed
James, AS, Alawneh, JI. COVID-19 infection diagnosis: potential impact of isothermal amplification technology to reduce community transmission of SARS-CoV-2. The carbapenemase menace: do dual mechanisms code for more resistance? Diagnostics (Basel) 2020;10:399.CrossRefGoogle Scholar
Canadian Public Health Laboratory Network and the Canadian Society of Clinical Chemists. Interim guidance on the use of the Abbott ID NOW instrument and COVID-19 assay. Can Commun Dis Rep 2020;46:422426.CrossRefGoogle Scholar
Office of the Commissioner. Coronavirus (COVID-19) update: FDA informs public about possible accuracy concerns with Abbott ID NOW point-of-care test. US Food and Drug Administration website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-informs-public-about-possible-accuracy-concerns-abbott-id-now-point. Published 2020. Accessed July 3, 2021.Google Scholar
Basu, A, Zinger, T, Inglima, K, et al. Performance of Abbott ID Now COVID-19 rapid nucleic acid amplification test using nasopharyngeal swabs transported in viral transport media and dry nasal swabs in a New York City academic institution. J Clin Microbiol 2020;58:e0113620.CrossRefGoogle Scholar
Harrington, A, Cox, B, Snowdon, J, et al. Comparison of Abbott ID Now and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients. J Clin Microbiol 2020;58:e0079820.CrossRefGoogle ScholarPubMed
Smithgall, MC, Schebekova, I, Whitter, S, Green, DA. Comparison of Cepheid Xpert Xpress and Abbott ID Now to Roche cobas for the rapid detection of SARS-CoV-2. J Clin Virol 2020;128:104428.CrossRefGoogle ScholarPubMed
Zhen, W, Smith, E, Manji, R, Schron, D, Berry, GJ. Clinical evaluation of three sample-to-answer platforms for detection of SARS-CoV-2. J Clin Microbiol 2020;58:e0078320.CrossRefGoogle ScholarPubMed
Sepulveda, JL, Abdulbaki, R, Sands, Z, et al. Performance of the Abbott ID NOW rapid SARS-CoV-2 amplification assay in relation to nasopharyngeal viral RNA loads. J Clin Virol 2021;140:104843.CrossRefGoogle ScholarPubMed
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Table 1. Result Comparison Between Abbott ID NOW, NeuMoDx SARS-CoV-2 Assay, and Abbott RealTime SARS-CoV-2 Assay