One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™

doi:10.1016/j.jcv.2021.104896

. 2021 Aug:141:104896.

doi: 10.1016/j.jcv.2021.104896. Epub 2021 Jun 12.

One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™

Affiliations

¹ Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada.
² Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
³ Shared Hospital Laboratory, Toronto, ON, Canada.
⁴ North York General Hospital, Toronto, ON, Canada.
⁵ Combined Containment Level 3 Unit, University of Toronto,Toronto, ON, Canada.
⁶ Michael Garron Hospital, Toronto, ON, Canada.
⁷ Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada; Public Health Ontario Laboratory, Toronto, ON, Canada.
⁸ Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada; Shared Hospital Laboratory, Toronto, ON, Canada; North York General Hospital, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
⁹ Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada; Shared Hospital Laboratory, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada. Electronic address: rob.kozak@sunnybrook.ca.

PMID: 34174710
PMCID: PMC8196482
DOI: 10.1016/j.jcv.2021.104896

One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™

Laura E Burnes et al. J Clin Virol. 2021 Aug.

. 2021 Aug:141:104896.

doi: 10.1016/j.jcv.2021.104896. Epub 2021 Jun 12.

Authors

Affiliations

¹ Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada.
² Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
³ Shared Hospital Laboratory, Toronto, ON, Canada.
⁴ North York General Hospital, Toronto, ON, Canada.
⁵ Combined Containment Level 3 Unit, University of Toronto,Toronto, ON, Canada.
⁶ Michael Garron Hospital, Toronto, ON, Canada.
⁷ Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada; Public Health Ontario Laboratory, Toronto, ON, Canada.
⁸ Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada; Shared Hospital Laboratory, Toronto, ON, Canada; North York General Hospital, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
⁹ Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada; Shared Hospital Laboratory, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada. Electronic address: rob.kozak@sunnybrook.ca.

PMID: 34174710
PMCID: PMC8196482
DOI: 10.1016/j.jcv.2021.104896

Abstract

Background: Point-of-care tests (POCT) are promising tools to detect SARS-CoV-2 in specific settings. Initial reports suggest the ID NOW™ COVID-19 assay (Abbott Diagnostics Inc, USA) is less sensitive than standard real-time reverse transcription polymerase chain reaction (rRT-PCR) assays. This has raised concern over false negatives in SARS-CoV-2 POCT.

Objectives: We compared the performance of the ID NOW™ COVID-19 assay to our in-house rRT-PCR assay to assess whether dry swabs used in ID NOW™ testing could be stored in transport media and be re-tested by rRT-PCR for redundancy and to provide material for further investigation.

Methods: Paired respiratory swabs collected from patients at three acute care hospitals were used. One swab in transport media (McMaster Molecular Media (MMM)) was tested for SARS-CoV-2 by a laboratory-developed two-target rRT-PCR assay. The second was stored dry in a sterile container and tested by the ID NOW™ COVID-19 assay. Following ID NOW™ testing, dry swabs were stored in MMM for up to 48 h and re-tested by rRT-PCR. Serially diluted SARS-CoV-2 particles were used to assess the impact of heat inactivation and storage time.

Results: Respiratory swabs (n = 343) from 179 individuals were included. Using rRT-PCR results as the comparator, the ID NOW™ COVID-19 assay had positive (PPA) and negative (NPA) percent agreements of 87.0% (95% CI:0.74-0.94) and 99.7% (95% CI:0.98-0.99). Re-tested swabs placed in MMM following ID NOW testing had PPA and NPA of 88.8% (95% CI:0.76-0.95) and 99.7% (95% CI:0.98-0.99), respectively.

Conclusions: Storing spent dry swabs in transport media for redundancy rRT-PCR testing is a potential approach to address possible false negatives with the ID NOW™ COVID-19 assay.

Keywords: Abbott ID NOW™ COVID-19; COVID-19; Point-of-care testing; SARS-CoV-2.

PubMed Disclaimer

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.**
rRT-PCR Ct comparison between respiratory swabs stored in MMM and dry swabs tested on ID NOW™ and subsequently stored in MMM. Data are shown with median Ct for each group (horizontal line) with 95% confidence interval.

See this image and copyright information in PMC

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References

1. World Health Organization. 2021. WHO Coronavirus Disease (COVID-19) Dashboard. https://covid19.who.int/. Last accessed February 16, 2021.
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1. Hengel B., Causer L., Matthews S., Smith K., Andrewartha K., Badman S., Spaeth B., Tangey A., Cunningham P., Phillips E., Ward J., Watts C., King J., Applegate T., Shephard M., Guy R. A decentralised point-of-care testing model to address inequities in the COVID-19 response. Lancet Infect. Dis. 2020 doi: 10.1016/S1473-3099(20)30859-8. - DOI - PMC - PubMed
1. Li C., Ren L. Recent progress on the diagnosis of 2019 Novel Coronavirus. Transbound. Emerg. Dis. 2020;67:1485–1491. doi: 10.1111/tbed.13620. - DOI - PMC - PubMed
1. Basu A., Zinger T., Inglima K., Woo K.M., Atie O., Yurasits L., See B., Aguero-Rosenfeld M.E. 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 doi: 10.1128/JCM.01136-20. e01136-20. - DOI - PMC - PubMed

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[1] World Health Organization. 2021. WHO Coronavirus Disease (COVID-19) Dashboard. https://covid19.who.int/. Last accessed February 16, 2021.

[2] World Health Organization. 2021. WHO Coronavirus Disease (COVID-19) Dashboard. https://covid19.who.int/. Last accessed February 16, 2021.

[3] D’Cruz R.J., Currier A.W., Sampson V.B. Laboratory testing methods for novel severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) Front. Cell Dev. Biol. 2020;8:468. doi: 10.3389/fcell.2020.00468. - DOI - PMC - PubMed

[4] D’Cruz R.J., Currier A.W., Sampson V.B. Laboratory testing methods for novel severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) Front. Cell Dev. Biol. 2020;8:468. doi: 10.3389/fcell.2020.00468. - DOI - PMC - PubMed

[5] Hengel B., Causer L., Matthews S., Smith K., Andrewartha K., Badman S., Spaeth B., Tangey A., Cunningham P., Phillips E., Ward J., Watts C., King J., Applegate T., Shephard M., Guy R. A decentralised point-of-care testing model to address inequities in the COVID-19 response. Lancet Infect. Dis. 2020 doi: 10.1016/S1473-3099(20)30859-8. - DOI - PMC - PubMed

[6] Hengel B., Causer L., Matthews S., Smith K., Andrewartha K., Badman S., Spaeth B., Tangey A., Cunningham P., Phillips E., Ward J., Watts C., King J., Applegate T., Shephard M., Guy R. A decentralised point-of-care testing model to address inequities in the COVID-19 response. Lancet Infect. Dis. 2020 doi: 10.1016/S1473-3099(20)30859-8. - DOI - PMC - PubMed

[7] Li C., Ren L. Recent progress on the diagnosis of 2019 Novel Coronavirus. Transbound. Emerg. Dis. 2020;67:1485–1491. doi: 10.1111/tbed.13620. - DOI - PMC - PubMed

[8] Li C., Ren L. Recent progress on the diagnosis of 2019 Novel Coronavirus. Transbound. Emerg. Dis. 2020;67:1485–1491. doi: 10.1111/tbed.13620. - DOI - PMC - PubMed

[9] Basu A., Zinger T., Inglima K., Woo K.M., Atie O., Yurasits L., See B., Aguero-Rosenfeld M.E. 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 doi: 10.1128/JCM.01136-20. e01136-20. - DOI - PMC - PubMed

[10] Basu A., Zinger T., Inglima K., Woo K.M., Atie O., Yurasits L., See B., Aguero-Rosenfeld M.E. 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 doi: 10.1128/JCM.01136-20. e01136-20. - DOI - PMC - PubMed

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One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™

Affiliations

One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

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References

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Abstract

Conflict of interest statement

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