Implementation of the Abbott ID Now COVID-19 assay at a tertiary care center: a prospective pragmatic implementation study during the third wave of SARS-CoV-2 in Ontario.
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ABSTRACT:
SUBMITTER: Deslandes V
PROVIDER: S-EPMC8626348 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:We compared the performance of ID NOW™ COVID-19 assay nasal swabs with RT-PCR of nasopharyngeal swabs for SARS-CoV-2 in an outbreak setting, determining whether addition of RT-PCR of residual nasal swabs (rNS) (post ID NOW™ elution) would increase overall analytic sensitivity. Devices were placed at 2 long term and 1 acute care sites and 51 participants were recruited. Prospective paired nasopharyngeal and nasal samples were collected for RT-PCR and ID NOW™. ID NOW™ had a positive and negative categorical agreement of 86% and 93% compared to RT-PCR of nasopharyngeal swabs. Sensitivity and specificity of the ID NOW™ was 86% and 100%, positive and negative predictive value was 100% and 95% (COVID-19 positivity rate: 8%). Addition of rNS RT-PCR increased the positive and negative categorical agreement to 93% and 97%. Based on these results, we propose an alternative workflow which includes complementary testing of rNS on a secondary assay.
| S-EPMC9556880 | biostudies-literature
Project description:Introduction. The ID NOW is FDA approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7 days of symptom onset for COVID-19 if tested within 1 h of specimen collection.Gap statement. Clinical data on the performance of the ID NOW are limited, with many studies varying in their study design and/or having small sample size.Aim. In this study we aimed to determine the clinical performance of the ID NOW compared to conventional RT-PCR testing.Methodology. Adults with COVID-19 in the community or hospital were recruited into the study. Paired throat swabs were collected, with one throat swab transported immediately in an empty sterile tube to the laboratory for ID NOW testing, and the other transported in universal transport media and tested by an in-house SARS-CoV-2 RT-PCR assay targeting the E gene.Results. In total, 133 individuals were included in the study; 129 samples were positive on either the ID NOW and/or RT-PCR. Assuming any positive result on either assay represents a true positive, positive per cent agreement (PPA) of the ID NOW compared to RT-PCR with 95 % confidence intervals was 89.1 % (82.0-94.1%) and 91.6 % (85.1-95.9%), respectively. When analysing individuals with symptom duration ≤7 days and who had the ID NOW performed within 1 h (n=62), ID NOW PPA increased to 98.2 %.Conclusion. Results from the ID NOW were reliable, especially when adhering to the manufacturer's recommendations for testing.
| S-EPMC8493423 | biostudies-literature
Project description:BackgroundDecisions to isolate patients at risk of having coronavirus disease 2019 (COVID-19) in the emergency department (ED) must be rapid and accurate to ensure prompt treatment and maintain patient flow whilst minimising nosocomial spread. Reverse transcription polymerase chain reaction (RT-PCR) assays are too slow to achieve this, and near-patient testing is being used increasingly to facilitate triage. The ID NOW severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) assay is an isothermal nucleic acid amplification near-patient test which targets the RNA-dependent RNA-polymerase gene.AimTo assess the diagnostic performance of ID NOW as a COVID-19 triage tool for medical admissions from the ED of a large acute hospital.MethodsAll adult acute medical admissions from the ED between 31st March and 31st July 2021 with valid ID NOW and RT-PCR results were included. The diagnostic accuracy of ID NOW [sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)] was calculated against the laboratory reference standard. Discrepant results were explored further using cycle threshold values and clinical data.FindingsTwo percent (124/6050) of medical admissions were SARS-CoV-2 positive on RT-PCR. Compared with PCR, ID NOW had sensitivity and specificity of 83.1% [95% confidence interval (CI) 75.4-88.7] and 99.5% (95% CI 99.3-99.6), respectively. PPV and NPV were 76.9% (95% CI 69.0-83.2) and 99.6% (95% CI 99.5-99.8), respectively. The median time from arrival in the ED to ID NOW result was 59 min.ConclusionID NOW provides a rapid and reliable adjunct for the safe triage of patients with COVID-19, and can work effectively when integrated into an ED triage algorithm.
| S-EPMC8863956 | biostudies-literature
Project description: Not available
| S-EPMC8091002 | biostudies-literature
Project description:BackgroundThe SARS-CoV-2 pandemic has created an urgent and unprecedented need for rapid large-scale diagnostic testing to inform timely patient management. However, robust data are lacking on the relative performance of available rapid molecular tests across a full range of viral concentrations.ObjectiveThis study aimed to compare two recently-authorized rapid tests, Cepheid Xpert Xpress SARS-CoV-2 and Abbott ID Now SARS-CoV-2, to the Roche cobas SARS-CoV-2 assay for samples with low, medium, and high viral concentrations.Study designA total of 113 nasopharyngeal swabs from remnant patient samples were tested, including 88 positives spanning the full range of observed Ct values on the cobas assay.ResultsCompared to cobas, the overall positive agreement was 73.9% with ID Now and 98.9% with Xpert. Negative agreement was 100% and 92.0% for ID Now and Xpert, respectively. Both ID Now and Xpert showed 100% positive agreement for medium and high viral concentrations (Ct value <30). However, for Ct values >30, positive agreement was 34.3% for ID Now and 97.1% for Xpert.ConclusionsWhile Xpert showed high agreement with cobas across a wide range of viral concentrations, this study highlights an important limitation of ID Now for specimens collected in viral or universal transport media with low viral concentrations. Further studies are needed to evaluate the performance of ID Now for direct swabs.
| S-EPMC7217789 | biostudies-literature
Project description:Rapid and accurate diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is essential to prevent the spread of the virus. We investigated the diagnostic accuracy of the Xpert Xpress and the ID NOW assays for rapid detection of SARS-CoV-2 using a systemic review and meta-analysis approach. A systematic literature search was performed using PubMed, Embase, and the Cochrane COVID-19 Study Register. The sensitivity and specificity of these tests for detecting viruses in patients with suspected SARS-CoV-2 infection were pooled. We used commercial and laboratory-developed reverse transcription-polymerase chain reactions as reference standards. The Quality Assessment of Diagnostic Accuracy Studies-2 tool was used to assess the risk of bias. We identified 11 studies involving 1734 subjects for the Xpert Xpress assay and 10 studies involving 1778 subjects for the ID NOW assay. The pooled sensitivity and specificity of the Xpert Xpress assay for detection of SARS-CoV-2 were 0.99 (95% confidence interval [CI], 0.97 to 0.99) and 0.97 (95% CI, 0.95 to 0.98), respectively. The pooled sensitivity and specificity of the ID NOW assay were 0.79 (95% CI, 0.69 to 0.86) and 1.00 (95% CI, 0.98 to 1.00), respectively. The studies included in our analysis seemed to have low methodological quality. The Xpert Xpress assay showed excellent diagnostic accuracy for rapid detection of SARS-CoV-2. However, as the ID NOW assay showed relatively low sensitivity, this test might miss several positive samples.
| S-EPMC8207078 | biostudies-literature
Project description:ObjectiveDiagnostic evaluation of the ID NOW coronavirus disease 2019 (COVID-19) assay in various real-world settings among symptomatic and asymptomatic individuals.MethodsDepending on the setting, the ID NOW testing was performed using oropharyngeal swabs (OPSs) taken from patients with symptoms suggestive of COVID-19, asymptomatic close contacts, or asymptomatic individuals as part of outbreak point prevalence screening. From January to April 2021, a select number of sites switched from using OPS to combined oropharyngeal and nasal swab (O + NS) for ID NOW testing. For every individual tested, two swabs were collected by a health care worker: one swab (OPS or O + NS) for ID NOW testing and a separate swab (OPS or nasopharyngeal swab) for RT-PCR.ResultsA total of 129 112 paired samples were analysed (16 061 RT-PCR positive). Of these, 81 697 samples were from 42 COVID-19 community collection sites, 16 924 samples were from 69 rural hospitals, 1927 samples were from nine emergency shelters and addiction treatment facilities, 23 802 samples were from six mobile units that responded to 356 community outbreaks, and 4762 O + NS swabs were collected from three community collection sites and one emergency shelter. The ID NOW assay sensitivity was the highest among symptomatic individuals presenting to community collection sites (92.5%; 95% CI, 92.0-93.0%) and the lowest for asymptomatic individuals associated with community outbreaks (73.9%; 95% CI, 69.8-77.7%). Specificity was >99% in all populations tested.DiscussionThe sensitivity of ID NOW severe acute respiratory syndrome coronavirus 2 testing is the highest when used in symptomatic community populations not seeking medical care. Sensitivity and positive predictive value drop by approximately 10% when tested on asymptomatic populations. Using combined oropharyngeal and nasal swabs did not improve the performance of ID NOW assay.
| S-EPMC9463071 | biostudies-literature
Project description:BACKGROUND:The SARS-CoV-2 pandemic caused a major surge in needed diagnostic capacity. In response, many EUA assays have become available for clinical laboratories, and more recently, the point of care device, Abbott ID NOW. OBJECTIVES:To determine the analytical performance of the ID NOW assay for detecting SARS-CoV-2. STUDY DESIGN:Residual NP samples collected in viral transport media were tested by the ID NOW platform in two independent laboratories. Results were compared to either the CDC or New York EUA assays, which served as reference methods. RESULTS:Overall agreement of ID NOW was 78.7%. Sensitivity was 71.7% and specificity was 100%. Notably, all false-negative results correlated to those samples that were weakly positive. CONCLUSIONS:ID NOW performs well for strong and moderately positive samples but has reduced sensitivity for weakly positive samples. This sensitivity, among other concerns, should be taken into consideration when using this test for patients with a low suspicion for COVID-19 disease.
| S-EPMC7227587 | biostudies-literature
Project description:Esophagectomy remains the gold standard in the curative intent treatment of resectable esophageal cancer. However, this procedure is complex and associated with high risk of complications. In an effort to reduce the postoperative morbidity associated with open esophagectomy various minimally invasive techniques have been introduced and developed during the recent years. The aim of the current study was to present our 4.5-year experience of the gradual implementation of various minimally invasive esophagectomy (MIE) techniques in our tertiary referral center.From May 2012 a transitional period from conventional open esophagectomy to MIE was initiated. This period was preceded by fellowships and visits to expert centers abroad. Thereafter, a gradual implementation and refinement of the new techniques followed. Technique related data were collected prospectively.Between January 1st 2011 and December 31st 2016 a total of 249 patients underwent an esophagectomy in our unit. Seventy-six cases were performed through a conventional open esophagectomy and 173 by some type of MIE. An increasing utilization of MIE over this time period was seen and finally reached 100% of treatment intentions, during the last 2 years. Ten cases (5.7%) where converted to open approach. A decrease in leak rate, operating time, peroperative bleeding and hospital stay as well as an increasing number of harvested lymph nodes was observed during the implementation period.The transition from conventional open esophagectomy to MIE was successful at our center. The implementation was overall safe with good postoperative outcomes, although changes in results required technical modifications over time.
| S-EPMC5538969 | biostudies-other
Project description:ImportanceThe coronavirus disease 2019 (COVID-19) pandemic has burdened health care resources and disrupted care of patients with cancer. Virtual care (VC) represents a potential solution. However, few quantitative data support its rapid implementation and positive associations with service capacity and quality.ObjectiveTo examine the outcomes of a cancer center-wide virtual care program in response to the COVID-19 pandemic.Design, setting, and participantsThis cohort study applied a hospitalwide agile service design to map gaps and develop a customized digital solution to enable at-scale VC across a publicly funded comprehensive cancer center. Data were collected from a high-volume cancer center in Ontario, Canada, from March 23 to May 22, 2020.Main outcomes and measuresOutcome measures were care delivery volumes, quality of care, patient and practitioner experiences, and cost savings to patients.ResultsThe VC solution was developed and launched 12 days after the declaration of the COVID-19 pandemic. A total of 22 085 VC visits (mean, 514 visits per day) were conducted, comprising 68.4% (range, 18.8%-100%) of daily visits compared with 0.8% before launch (P < .001). Ambulatory clinic volumes recovered a month after deployment (3714-4091 patients per week), whereas chemotherapy and radiotherapy caseloads (1943-2461 patients per week) remained stable throughout. No changes in institutional or provincial quality-of-care indexes were observed. A total of 3791 surveys (3507 patients and 284 practitioners) were completed; 2207 patients (82%) and 92 practitioners (72%) indicated overall satisfaction with VC. The direct cost of this initiative was CAD$ 202 537, and displacement-related cost savings to patients totaled CAD$ 3 155 946.Conclusions and relevanceThese findings suggest that implementation of VC at scale at a high-volume cancer center may be feasible. An agile service design approach was able to preserve outpatient caseloads and maintain care quality, while rendering high patient and practitioner satisfaction. These findings may help guide the transformation of telemedicine in the post COVID-19 era.
| S-EPMC7791400 | biostudies-literature