The PRONTO study: Clinical performance of ID NOW in individuals with compatible SARS-CoV-2 symptoms in walk-in centres—accelerated turnaround time for contact tracing

Abstract

Background: This PRONTO study investigated the clinical performance of the Abbott ID NOWTM (IDN) COVID-19 diagnostic assay used at point of care and its impact on turnaround time for divulgation of test results. Methods: Prospective study conducted from December 2020 to February 2021 in acute symptomatic participants presenting in three walk-in centres in the province of Québec. Results: Valid paired samples were obtained from 2,372 participants. A positive result on either the IDN or the standard-of-care nucleic acid amplification test (SOC-NAAT) was obtained in 423 participants (prevalence of 17.8%). Overall sensitivity of IDN and SOC-NAAT were 96.4% (95% CI: 94.2–98.0%) and 99.1% (95% CI: 97.6–99.8), respectively; negative predictive values were 99.2% (95% CI: 98.7–99.6%) and 99.8% (95% CI: 99.5–100%), respectively. Turnaround time for positive results was significantly faster on IDN. Conclusion: In our experience, IDN use in symptomatic individuals in walk-in centres is a reliable sensitive alternative to SOC-NAAT without the need for subsequent confirmation of negative results. Such deployment can accelerate contact tracing, reduce the burden on laboratories and increase access to testing.

Evaluation of water gargle samples for SARS‐CoV‐2 detection using Abbott ID NOW COVID‐19 assay

“…It is authorized as a lab‐based and POC diagnostic assay for the qualitative detection of nucleic acids from direct anterior nasal, nasopharyngeal, or throat swabs from individuals suspected of having COVID‐19, within the first 7 days of symptom onset 18 . ID NOW has been shown as a reliable and sensitive alternative to RT‐PCR testing from NPS or nasal samples in symptomatic patients, without the need for subsequent confirmation of negative results 19,20 …”

“…18 ID NOW has been shown as a reliable and sensitive alternative to RT‐PCR testing from NPS or nasal samples in symptomatic patients, without the need for subsequent confirmation of negative results. 19 , 20 …”

“…18 ID NOW has been shown as a reliable and sensitive alternative to RT-PCR testing from NPS or nasal samples in symptomatic patients, without the need for subsequent confirmation of negative results. 19,20 The main objective of this study was to evaluate the performance of natural spring water gargle samples for the detection of SARS-CoV-2 using the ID NOW, compared to standard of care (SOC) NAAT assay.…”

Update of European Society of Clinical Microbiology and Infectious Diseases coronavirus disease 2019 guidelines: diagnostic testing for severe acute respiratory syndrome coronavirus 2

“… In patients with severe or critical COVID-19, we recommend the use of laboratory-based NAAT versus rapid antigen detection testing for the diagnosis of COVID-19. Strong against Very low [ [3] , [4] , [5] , [6] , [7] , [8] , [9] , [10] ] 12 In patients with signs and symptoms compatible with COVID-19, should rapid antigen detection testing be used, compared with the standard NAAT (commercial and/or in house) for diagnosis of COVID-19 in nasopharyngeal samples ? In patients with signs and symptoms compatible with COVID-19, we suggest the use of laboratory based NAAT in nasopharyngeal samples versus rapid antigen detection testing in nasopharyngeal samples for the diagnosis of COVID-19.…”

“… In patients with signs and symptoms compatible with COVID-19 of equal or less than 7 days-onset, we suggest the use of rapid antigen detection testing versus laboratory-based NAAT for the diagnosis of COVID-19. Weak for Very low [ 3 , 7 , 39 , 41 , 46 , 53 , 60 , 61 , 63 , 65 , 73 , 78 , 9 , 79 , 83 , [91] , [92] , [93] , 96 , 97 , 100 , 101 , 104 , 11 , 106 , 108 , 109 , 114 , 118 , 119 , 126 , [129] , [130] , [131] , 13 , [132] , [133] , [134] , [135] , [136] , 14 , 17 , 21 , 36 , 37 ] 16 In patients with signs and symptoms compatible with COVID-19 of more than 7 days-onset , should rapid antigen detection testing be used, compared with standard NAAT (commercial and/or in house) for diagnosis of COVID-19? In patients with signs and symptoms compatible with COVID-19 of more than 7 days-onset, we suggest the use of laboratory-based NAAT versus rapid antigen detection testing for the diagnosis of COVID-19.…”