Then and NOW: A Prospective Population-Level Validation of the Abbott ID NOW SARS-CoV-2 Device Implemented in Multiple Settings for Testing Asymptomatic and Symptomatic Individuals
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Abstract
IMPORTANCE
Since December, 2020, the ID NOW was implemented for use in 4 different populations across Alberta: in mobile units as part of community outbreak response, COVID-19 community collection sites, emergency shelters and addiction treatment facilities (ES), and hospitals.
OBJECTIVE
Diagnostic evaluation of the ID NOW in various real world settings among symptomatic and asymptomatic individuals
DESIGN
Depending on the implemented site, the ID NOW was tested on patients with symptoms suggestive of COVID-19, asymptomatic close contacts or asymptomatic individuals as part of outbreak point prevalence screening. From Jan – April, a select number of sites also switched from using oropharyngeal swabs to combined oropharyngeal + nasal (O+N) swabs. For every individual tested, two swabs were collected: one for ID NOW testing and the other for either reverse-transcriptase polymerase chain reaction (RT-PCR) confirmation of negative ID NOW results or for variant testing of positive ID NOW results.
RESULTS
A total of 129,112 paired samples were analyzed (16,061 RT-PCR positive). 81,697 samples were from 42 COVID-19 community collection sites, 16,924 from 69 rural hospitals, 1,927 from 9 ES, 23,802 samples from 6 mobile units that responded to 356 community outbreaks, and 4,762 from 3 community collection sites and 1 ES using O+N swabs for ID NOW testing. ID NOW sensitivity was highest among symptomatic individuals presenting to community collection sites [92.5%, 95% confidence interval (CI) 92.0-93.0%, n=10,633 RT-PCR positive] and lowest for asymptomatic individuals associated with community outbreaks (73.9%, 95% CI 69.8-77.7%, n=494 RT-PCR positive). Specificity was greater than 99% in all populations tested, but positive predictive value (PPV) was lower among asymptomatic populations (82.4–91.3%) compared to symptomatic populations (96.0-96.9%). There was no statistically significant differences in sensitivity with respect to age, gender, NP vs OP swab for RT-PCR confirmation, variants of concern, or with combined oropharyngeal and nasal swabs using COVID-19 ID NOW testing.
CONCLUSIONS
Sensitivity of ID NOW SARS-CoV-2 testing is highest when used on symptomatic community populations not seeking medical care. Sensitivity and PPV drops by approximately 10% when tested on asymptomatic populations. Using combined oropharyngeal and nasal swabs did not improve ID NOW performance.
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SciScore for 10.1101/2022.04.30.22274189: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The University of Alberta Research Ethics board approved this study (Pro00111835). Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical analysis was performed using Pearson Chi-squared for categorical variables and t-test for continuous variables using STATA (version 14.1). STATAsuggested: (Stata, RRID:SCR_012763)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing …SciScore for 10.1101/2022.04.30.22274189: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The University of Alberta Research Ethics board approved this study (Pro00111835). Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical analysis was performed using Pearson Chi-squared for categorical variables and t-test for continuous variables using STATA (version 14.1). STATAsuggested: (Stata, RRID:SCR_012763)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Our study had several limitations. Due to the heterogeneity of our populations tested, it is difficult to exclude confounders that may have contributed to ID NOW performance. However, no differences were observed in sensitivity based on common patient, collecting and testing characteristics, including age, gender, swab used, and variants of concern detected. Specificity was increased for RT-PCR samples collected using oropharyngeal swabs, but this difference was slight and limited to symptomatic populations. Exclusion of some ID NOW positive results from our study because of no parallel RT-PCR testing did have an impact on ID NOW performance, as evidenced by improved sensitivity (93.5% vs 92.5%), among symptomatic community patients presenting to assessment centres, when including these positive samples. Reasons behind missing parallel RT-PCR are multifactorial and include sample lost or discarded prior to testing, testing sites going against guidelines and not obtaining a second swab for RT-PCR confirmation, and patient demographic mismatches resulting in test cancellation or inability to match ID NOW and RT-PCR tests together in our electronic database. These excluded samples, however, would have little impact on ID NOW sensitivity and specificity outside of symptomatic individuals presenting to assessment centres. For instance, no significant changes in sensitivity among asymptomatic community patients that presented to assessment centres were observed when the 1822 exclud...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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