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Review
. 2021 Dec:298:114293.
doi: 10.1016/j.jviromet.2021.114293. Epub 2021 Sep 20.

A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test

Antoine Aupaix  1 , Elena Lazarova  2 , Monia Chemais  2
Affiliations
Review

A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test

Antoine Aupaix et al. J Virol Methods. 2021 Dec.

Abstract

The qualitative ID Now COVID-19 assay combines claimed performance and ease of use that seem to position it as a reliable test for urgent patient management. However, the declared limit of detection (LOD) of 125 genome equivalents/mL is not confirmed by the published studies, which observed a range of LOD varying from 276 to 20.000 copies/mL. We decided to establish the LOD value on more robust basis using serial dilutions of a SARS-CoV-2 culture supernatant sample of defined concentration. Afterwards, we tested the analytical performances of the assay with 23 QCMD external quality control measurements. Hence, taking into consideration the additional dilution in the sample receiver cup, we found a lower 95 % LOD of 64 copies/mL. For its intended use and with the new established LOD, ID Now COVID-19 proved to be a suitable test for the diagnosis of COVID-19 in contagious patients, as proposed by the latest Belgian recommendations.

Keywords: COVID-19; ID Now; Molecular diagnostics; NEAR; SARS-CoV-2.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Probit graph showing concentration of SARS-CoV2 RNA in copies/mL as “Dose variable” and the fraction of positive replicates as “Response variable”. a. Probit graph showing final declared concentration of SARS-CoV2 RNA. b. Probit graph showing final calculated concentration of SARS-CoV2 RNA in the sample receiver. Horizontal reference line shows 95 % probability of positive agreement, the 95 LOD. Vertical reference line shows the concentration corresponding to the 95 % LOD.
See this image and copyright information in PMC

References

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