Comparison of Abbott ID Now and Abbott m2000 Methods for the Detection of SARS-CoV-2 from Nasopharyngeal and Nasal Swabs from Symptomatic Patients

Harrington, Amanda; Cox, Brian; Snowdon, J. A.; Bakst, Jonathan; Ley, Erin; Grajales, Patricia; Maggiore, Jack A.; Kahn, Stephen E.

doi:10.1128/jcm.00798-20

Cited by 162 publications

(187 citation statements)

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“…Nasal swabs directly tested on the ID NOW assay had 48% positive agreement compared to the CRS, whereas Simplexa had 88%, m2000 had 96% and Xpert had 100% positive agreement (Table 1). While the deficit in positive percent agreement (PPA) seen in ID NOW test results is consistent with other early release studies in the scientific literature ((1–4, 7–9)), it is surprising given the ID NOW’s LOD claim of 125 genome equivalents/mL, which is similar to the 100 copies/mL claimed by the m2000 method, 250 copies/mL claimed by Xpress and 242 copies/mL claimed by Simplexa. To clarify this apparent discrepancy, a direct assessment of the analytic sensitivity of all assays in this comparison was performed utilizing dilutions of inactivated SARS-CoV-2 whole virus (ZeptoMetrix).…”

Section: Resultssupporting

confidence: 74%

“…In the absence of clinical trials and a gold standard for COVID-19 diagnosis, the clinical performance of SARS-CoV-2 assays is unclear. Anecdotal claims of poor NAAT performance exist in the lay press, and limited studies have shown variable performance of rapid POC tests (1–9). As a surrogate for a gold standard, a composite reference standard (CRS) can be used to determine the consensus of comparable assays and identify outlier assays in terms of clinical performance (10).…”

Section: Introductionmentioning

confidence: 99%

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Comparative study of four SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) platforms demonstrates that ID NOW performance is impaired substantially by patient and specimen type

Lephart

Bachman

LeBar

et al. 2020

Preprint

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14The advent of the COVID-19 pandemic in the United States created a unique situation 15 where multiple molecular diagnostic assays with various indications for use in the detection of 16 SARS-CoV-2 rapidly received Emergency Use Authorization by the FDA, were validated by 17 laboratories and utilized clinically, all within a period of a few weeks. We compared the 18 performance of four of these assays that were being evaluated for use at our institution: Abbott 19 RealTime m2000 SARS-CoV-2 Assay, DiaSorin Simplexa COVID-19 Direct, Cepheid Xpert 20 Xpress SARS-CoV-2 and Abbott ID NOW COVID-19. Nasopharyngeal and nasal specimens 21 were collected from 88 ED and hospital-admitted patients and tested by the four methods in 22 parallel to compare performance. ID NOW performance stood out as significantly worse than 23 the other three assays despite demonstrating comparable analytic sensitivity. Further study 24 determined that the use of a foam nasal swab compared to a nylon flocked nasopharyngeal swab, 25 as well as use in a population chronically vs. acutely positive for SARS-CoV-2, were significant 26 factors in the poor comparable performance. 27 and with different turnaround time needs demanded that laboratories implement more than one 36 type of NAAT to respond to the crisis. 37SARS-CoV-2 testing in our laboratory began with the CDC EUA assay performed on 38 Abbott m2000, but due to that assay's significant throughput constraints (24 specimens in 8 39 hours), we quickly verified and switched to the Abbott RealTime SARS-CoV-2 EUA Assay 40 (m2000) once released (94 specimens in ~8 hours). Although this assay provided capacity for 41 our outpatient testing needs, we also verified the DiaSorin Simplexa COVID-19 Direct 42 (Simplexa) assay, capable of resulting 8 specimens in 90 minutes, and used this assay as a rapid 43 turn-around time (TAT) option for our inpatient and emergency department (ED) populations. 44 Within a few weeks, additional SARS-CoV-2 NAAT options emerged that were specifically 45 designed for rapid testing of patients in the point of care setting: the Cepheid Xpert Xpress 46 SARS-CoV-2 (Xpert) assay, which could provide results in 45 minutes, and the Abbott ID NOW 47 82Dilutions were prepared from ZeptoMetrix inactivated SARS-CoV-2 virus (1.70 x 10 5 83 TCID50/ml) that was internally quantified to 10 9.62 copies/mL relative to a standard curve of 84 AccuPlex™ SARS-CoV-2 Reference Material (SeraCare) constructed on the m2000 assay. From 85 that stock, dilutions were made in VTM (1,042, 521, 260, 130, 65 and 32.5 copies/mL) and 86 tested on the m2000, Simplexa, and Xpert SARS-CoV-2 assays. A separate set of ZeptoMetrix 87 dilutions in VTM were made so that when added to the 2.5 ml of elution buffer in the ID NOW 88 receiver cup, equivalent concentrations were achieved (1,042, 522, 262, 105 and 53 copies/mL). 89In this way, the concentrations of viral copies in the ID NOW buffer were equivalent to the VTM 90 dilutions used for the other three instruments. Five replicates at each dilution wer...

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Section: Resultssupporting

confidence: 74%

Section: Introductionmentioning

confidence: 99%

Comparative study of four SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) platforms demonstrates that ID NOW performance is impaired substantially by patient and specimen type

Lephart

Bachman

LeBar

et al. 2020

Preprint

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“…32 Another study determined that the POC test (ID NOW) was less sensitive compared with the traditional RT-PCR assay. 33 Furthermore, to prepare for the upcoming flu season, diagnostic assays that can simultaneously detect for SARS-CoV-2 and the influenza virus to determine the cause of infection will be important to clinical treatment, infection control, and community mitigation efforts.…”

Section: Assay Performance and Limitationsmentioning

confidence: 99%

COVID‐19 Clinical Diagnostics and Testing Technology

2020

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Given the global nature of the coronavirus disease 2019 (COVID‐19) pandemic, the need for disease detection and expanding testing capacity remains critical priorities. This review discusses the technological advances in testing capability and methodology that are currently used or in development for detecting the novel coronavirus. We describe the current clinical diagnostics and technology, including molecular and serological testing approaches, for severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2) testing as well as address their advantages and limitations. Nucleic acid amplification technology for molecular diagnostics remains the gold standard for virus detection. We highlight alternative molecular detection techniques used for developing novel COVID‐19 diagnostics on the horizon. Antibody response against SARS‐CoV‐2 remains poorly understood and proper validation of serology tests is necessary to demonstrate their accuracy and clinical utility. In order to bring the pandemic under control, we must speed up the development of rapid and widespread testing through improvements in clinical diagnostics and testing technology as well as access to these tools.

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“…The diagnostic test, capable of delivering results in 5 to 13 minutes. 3 Because of the novelty of this virus as well as the recent introduction of these tests into the health care market, there are little comparison data in any emergency setting to measure performance. Given the criticality of maximizing accuracy and getting some quantification of a false-negative rate, the aim of this study was to evaluate the agreement of the diagnostic performance of the ID NOW COVID-19 with the Abbott m2000 real-time PCR, the institutional presumed reference standard, for SARS-CoV-2 in patients presenting to an urban ED.…”

mentioning

confidence: 99%

“…This was supported by prior in-house testing, validation data, and recent literature. 3 If ID NOW returned negative, the paired NP sample was then tested on the m2000 instrument for concordance. During the study period, results were used to determine patient disease status in standard care.…”

mentioning

confidence: 99%

Diagnostic Performance of a Rapid Point‐of‐care Test for SARS‐CoV‐2 in an Urban Emergency Department Setting

McDonald

Courtney

Clark

et al. 2020

Academic Emergency Medicine

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Comparison of Abbott ID Now and Abbott m2000 Methods for the Detection of SARS-CoV-2 from Nasopharyngeal and Nasal Swabs from Symptomatic Patients

Abstract: The ID NOW COVID-19 (IDNCOV) assay performed on the ID Now Instrument (Abbott Diagnostics, Scarborough, Inc. Scarborough, ME) is a rapid diagnostic test that can be performed in a point of care setting equivalent to CLIA waived testing.…

Cited by 162 publications

References 0 publications

Comparative study of four SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) platforms demonstrates that ID NOW performance is impaired substantially by patient and specimen type

Comparative study of four SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) platforms demonstrates that ID NOW performance is impaired substantially by patient and specimen type

COVID‐19 Clinical Diagnostics and Testing Technology

Diagnostic Performance of a Rapid Point‐of‐care Test for SARS‐CoV‐2 in an Urban Emergency Department Setting

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