scholarly journals Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0251661
Author(s):  
Elisa Kortela ◽  
Vesa Kirjavainen ◽  
Maarit J. Ahava ◽  
Suvi T. Jokiranta ◽  
Anna But ◽  
...  
Keyword(s):  
Clinical Decision Making ◽  
False Negative ◽  
Real Life ◽  
Clinical Decision ◽  
Population Based ◽  
Clinical Suspicion ◽  
Rt Pcr ◽  
Clinical Sensitivity ◽  
High Clinical Suspicion ◽  
Pcr Test

Background Understanding the false negative rates of SARS-CoV-2 RT-PCR testing is pivotal for the management of the COVID-19 pandemic and it has implications for patient management. Our aim was to determine the real-life clinical sensitivity of SARS-CoV-2 RT-PCR. Methods This population-based retrospective study was conducted in March–April 2020 in the Helsinki Capital Region, Finland. Adults who were clinically suspected of SARS-CoV-2 infection and underwent SARS-CoV-2 RT-PCR testing, with sufficient data in their medical records for grading of clinical suspicion were eligible. In addition to examining the first RT-PCR test of repeat-tested individuals, we also used high clinical suspicion for COVID-19 as the reference standard for calculating the sensitivity of SARS-CoV-2 RT-PCR. Results All 1,194 inpatients (mean [SD] age, 63.2 [18.3] years; 45.2% women) admitted to COVID-19 cohort wards during the study period were included. The outpatient cohort of 1,814 individuals (mean [SD] age, 45.4 [17.2] years; 69.1% women) was sampled from epidemiological line lists by systematic quasi-random sampling. The sensitivity (95% CI) for laboratory confirmed cases (repeat-tested patients) was 85.7% (81.5–89.1%) inpatients; 95.5% (92.2–97.5%) outpatients, 89.9% (88.2–92.1%) all. When also patients that were graded as high suspicion but never tested positive were included in the denominator, the sensitivity (95% CI) was: 67.5% (62.9–71.9%) inpatients; 34.9% (31.4–38.5%) outpatients; 47.3% (44.4–50.3%) all. Conclusions The clinical sensitivity of SARS-CoV-2 RT-PCR testing was only moderate at best. The relatively high false negative rates of SARS-CoV-2 RT-PCR testing need to be accounted for in clinical decision making, epidemiological interpretations, and when using RT-PCR as a reference for other tests.

scholarly journals Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients

2020 ◽  
Author(s):  
Elisa Kortela ◽  
Vesa Kirjavainen ◽  
Maarit J. Ahava ◽  
Suvi T. Jokiranta ◽  
Anna But ◽  
...  
Keyword(s):  
Clinical Decision Making ◽  
False Negative ◽  
Real Life ◽  
Clinical Decision ◽  
Population Based ◽  
Clinical Suspicion ◽  
Rt Pcr ◽  
Clinical Sensitivity ◽  
High Clinical Suspicion ◽  
Pcr Test

AbstractImportanceUnderstanding the false negative rates of SARS-CoV-2 RT-PCR testing is pivotal for the management of the COVID-19 pandemic and it has practical implications for patient management in healthcare facilities.ObjectiveTo determine the real-life clinical sensitivity of SARS-CoV-2 RT-PCR testing.DesignA retrospective study on case series from 4 March – 15 April 2020.SettingA population-based study conducted in primary and tertiary care in the Helsinki Capital Region, Finland.ParticipantsAdults who were clinically suspected of SARS-CoV-2 infection and underwent SARS-CoV-2 RT-PCR testing, and who had sufficient data for grading of clinical suspicion of COVID-19 in their medical records were eligible. All 1,194 inpatients admitted to COVID-19 cohort wards during the study period were included. The outpatient cohort of 1,814 individuals was sampled from epidemiological line lists by systematic quasi-random sampling. Altogether 83 eligible outpatients (4.6%) and 3 inpatients (0.3%) were excluded due to insufficient data for grading of clinical suspicion.ExposuresHigh clinical suspicion for COVID-19 was used as the reference standard for the RT-PCR test. Patients were considered to have high clinical suspicion of COVID-19 if the physician in charge recorded the suspicion on clinical grounds, or the patient fulfilled specifically defined clinical and exposure criteria.Main measuresSensitivity of SARS-CoV-2 RT-PCR by using manually curated clinical characteristics as the gold standard.ResultsThe study population included 1,814 outpatients (mean [SD] age, 45.4 [17.2] years; 69.1% women) and 1,194 inpatients (mean [SD] age, 63.2 [18.3] years; 45.2% women). The sensitivity (95% CI) for laboratory confirmed cases, i.e. repeatedly tested patients were as follows: 85.7% (81.5–89.1%) inpatients; 95.5% (92.2–97.5%) outpatients, 89.9% (88.2–92.1%) all. When also patients that were graded as high suspicion but never tested positive were included in the denominator, the following sensitivity values (95% CI) were observed: 67.5% (62.9–71.9%) inpatients; 34.9% (31.4–38.5%) outpatients; 47.3% (44.4–50.3%) all.Conclusions and relevanceThe clinical sensitivity of SARS-CoV-2 RT-PCR testing was only moderate at best. The relatively high false negative rates of SARS-CoV-2 RT-PCR testing need to be accounted for in clinical decision making, epidemiological interpretations and when using RT-PCR as a reference for other tests.Key PointsQuestionWhat is the clinical sensitivity of SARS-CoV-2 RT-PCR test?FindingsIn this population-based retrospective study on medical records of 1,814 outpatients and 1,194 inpatients, the clinical sensitivity of SARS-CoV-2 RT-PCR was 47.3–89.9%.MeaningThe false negative rates of SARS-CoV-2 RT-PCR testing need to be accounted for in clinical decision making, epidemiological interpretations and when using RT-PCR as a reference for other tests.

scholarly journals COVID-19 clinical and laboratory diagnosis overview

2021 ◽  
Vol 96 (1) ◽  
Author(s):  
Rania A. Zayed ◽  
Dalia Omran ◽  
Abeer A. Zayed
Keyword(s):  
False Negative ◽  
Clinical Decision ◽  
Laboratory Diagnosis ◽  
Clinical Suspicion ◽  
Laboratory Diagnostics ◽  
Main Body ◽  
Rt Pcr ◽  
Serological Tests ◽  
Negative Results ◽  
Important Approach

Abstract Background COVID-19 was identified in Wuhan, China, in December 2019, and rapidly spread worldwide, being declared global pandemic on the 11th of March 2020. Since its emergence, COVID-19 has raised global concerns associated with drastic measures that were never adopted in any previous outbreak, to contain the situation as early as possible. Main body The 2019 novel corona virus (2019-nCoV) or SARS-CoV-2 is the causative agent of COVID-19. 2019-nCoV genetic sequence was rapidly identified within few days since the first reported cases and RT-PCR kits became available for COVID-19 diagnosis. However, RT-PCR diagnosis carries a risk of false-negative results; therefore, additional serologic tests are needed. In this review, we summarize the clinical scenario that raises suspicion of COVID-19 and available laboratory diagnostics. Conclusion The most important approach in the battle against COVID-19 is rapid diagnosis of suspicious cases, timely therapeutic intervention and isolation to avoid community spread. Diagnosis depends mainly on PCR testing and serological tests. However, even in the context of negative lab test results and clinical suspicion of COVID-19 infection, clinical decision should be based on clinical suspicion.

scholarly journals Superiority of MALDI-TOF Mass Spectrometry over Real-Time PCR for SARS-CoV-2 RNA Detection

Viruses ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 730
Author(s):  
Magda Rybicka ◽  
Ewa Miłosz ◽  
Krzysztof Piotr Bielawski
Keyword(s):  
Mass Spectrometry ◽  
Gold Standard ◽  
Viral Genome ◽  
False Negative ◽  
Rt Pcr ◽  
Rna Detection ◽  
Maldi Tof ◽  
Negative Results ◽  
False Negative Results ◽  
Pcr Test

At present, the RT-PCR test remains the gold standard for early diagnosis of SARS-CoV-2. Nevertheless, there is growing evidence demonstrating that this technique may generate false-negative results. Here, we aimed to compare the new mass spectrometry-based assay MassARRAY® SARS-CoV-2 Panel with the RT-PCR diagnostic test approved for clinical use. The study group consisted of 168 suspected patients with symptoms of a respiratory infection. After simultaneous analysis by RT-PCR and mass spectrometry methods, we obtained discordant results for 17 samples (10.12%). Within fifteen samples officially reported as presumptive positive, 13 were positive according to the MS-based assay. Moreover, four samples reported by the officially approved RT-PCR as negative were positive in at least one MS assay. We have successfully demonstrated superior sensitivity of the MS-based assay in SARS-CoV-2 detection, showing that MALDI-TOF MS seems to be ideal for the detection as well as discrimination of mutations within the viral genome.

scholarly journals Incorporating false negative tests in epidemiological models for SARS-CoV-2 transmission and reconciling with seroprevalence estimates

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Rupam Bhattacharyya ◽  
Ritoban Kundu ◽  
Ritwik Bhaduri ◽  
Debashree Ray ◽  
Lauren J. Beesley ◽  
...  
Keyword(s):  
False Negative ◽  
Population Based ◽  
Training Data ◽  
Epidemiological Models ◽  
Rt Pcr ◽  
Antibody Prevalence ◽  
Igg Antibody ◽  
False Negatives ◽  
Seir Model ◽  
Study Population

AbstractSusceptible-Exposed-Infected-Removed (SEIR)-type epidemiologic models, modeling unascertained infections latently, can predict unreported cases and deaths assuming perfect testing. We apply a method we developed to account for the high false negative rates of diagnostic RT-PCR tests for detecting an active SARS-CoV-2 infection in a classic SEIR model. The number of unascertained cases and false negatives being unobservable in a real study, population-based serosurveys can help validate model projections. Applying our method to training data from Delhi, India, during March 15–June 30, 2020, we estimate the underreporting factor for cases at 34–53 (deaths: 8–13) on July 10, 2020, largely consistent with the findings of the first round of serosurveys for Delhi (done during June 27–July 10, 2020) with an estimated 22.86% IgG antibody prevalence, yielding estimated underreporting factors of 30–42 for cases. Together, these imply approximately 96–98% cases in Delhi remained unreported (July 10, 2020). Updated calculations using training data during March 15-December 31, 2020 yield estimated underreporting factor for cases at 13–22 (deaths: 3–7) on January 23, 2021, which are again consistent with the latest (fifth) round of serosurveys for Delhi (done during January 15–23, 2021) with an estimated 56.13% IgG antibody prevalence, yielding an estimated range for the underreporting factor for cases at 17–21. Together, these updated estimates imply approximately 92–96% cases in Delhi remained unreported (January 23, 2021). Such model-based estimates, updated with latest data, provide a viable alternative to repeated resource-intensive serosurveys for tracking unreported cases and deaths and gauging the true extent of the pandemic.

Clinical Conundrums When Integrating the QbTest into a Standard ADHD Assessment of Children and Young People

2021 ◽  
Author(s):  
Carsten Vogt
Keyword(s):  
Clinical Practice ◽  
Clinical Decision Making ◽  
Ecological Validity ◽  
Neuropsychological Test ◽  
Real Life ◽  
Clinical Decision ◽  
Hyperactivity Disorder ◽  
Standard Clinical Practice ◽  
Novel Method ◽  
The Impact

AbstractThe uptake of the QbTest in clinical practice is increasing and has recently been supported by research evidence proposing its effectiveness in relation to clinical decision-making. However, the exact underlying process leading to this clinical benefit is currently not well established and requires further clarification. For the clinician, certain challenges arise when adding the QbTest as a novel method to standard clinical practice, such as having the skills required to interpret neuropsychological test information and assess for diagnostically relevant neurocognitive domains that are related to attention-deficit hyperactivity disorder (ADHD), or how neurocognitive domains express themselves within the behavioral classifications of ADHD and how the quantitative measurement of activity in a laboratory setting compares with real-life (ecological validity) situations as well as the impact of comorbidity on test results. This article aims to address these clinical conundrums in aid of developing a consistent approach and future guidelines in clinical practice.

scholarly journals Frailty Changes Predict Mortality in 4 Longitudinal Studies of Aging

2020 ◽  
Author(s):  
Erwin Stolz ◽  
Emiel O Hoogendijk ◽  
Hannes Mayerl ◽  
Wolfgang Freidl
Keyword(s):  
Mortality Risk ◽  
Clinical Decision Making ◽  
Frailty Index ◽  
Credible Interval ◽  
Clinical Decision ◽  
Population Based ◽  
Time To Event Data ◽  
Longitudinal Aging Study Amsterdam ◽  
Aging Study ◽  
Longitudinal Aging Study

Abstract Background Baseline frailty index (FI) values have been shown to predict mortality among older adults, but little is known about the effects of changes in FI on mortality. Methods In a coordinated approach, we analyzed data from 4 population-based cohorts: the Health and Retirement Study (HRS), the Survey of Health, Ageing and Retirement in Europe (SHARE), the English Longitudinal Survey of Ageing (ELSA), and the Longitudinal Aging Study Amsterdam (LASA), comprising a total of 24 961 respondents (65+), 95 897 observations, up to 9 repeated FI assessments, and up to 23 years of mortality follow-up. The effect of time-varying FI on mortality was modeled with joint regression models for longitudinal and time-to-event data. Results Differences (of 0.01) in current FI levels (hazard ratio [HR] = 1.04, 95% credible interval [CI] = 1.03–1.05) and baseline FI levels (HR = 1.03, 95% CI = 1.03–1.05) were consistently associated with mortality across studies. Importantly, individuals with steeper FI growth also had a higher mortality risk: An increase in annual FI growth by 0.01 was associated with an increased mortality risk of HR = 1.56 (95% CI = 1.49–1.63) in HRS, HR = 1.24 (95% CI = 1.13–1.35) in SHARE, HR = 1.40 (95% CI = 1.25–1.52) in ELSA, and HR = 1.71 (95% CI = 1.46–2.01) in LASA. Conclusions FI changes predicted mortality independently of baseline FI differences. Repeated assessment of frailty and individual’s frailty trajectory could provide a means to anticipate further health deterioration and mortality and could thus support clinical decision making.

Music Therapy Pre-internship Education and Training: Support for a Methods-Based Approach

2021 ◽  
Author(s):  
Susan C Gardstrom ◽  
James Hiller ◽  
Annie Heiderscheit ◽  
Nancy L Jackson
Keyword(s):  
Music Therapy ◽  
Best Practice ◽  
Clinical Decision Making ◽  
Well Being ◽  
Clinical Decision ◽  
Education And Training ◽  
Population Based ◽  
Music Therapists ◽  
Training Support ◽  
And Training

Abstract As music therapists, music is our primary realm of understanding and action and our distinctive way of joining with a client to help them attain optimal health and well-being. As such, we have adopted and advocate for a music-focused, methods-based (M-B) approach to music therapy pre-internship education and training. In an M-B approach, students’ learning is centered on the 4 music therapy methods of composing, improvising, re-creating, and listening to music and how these music experiences can be designed and implemented to address the health needs of the diverse clientele whom they will eventually encounter as practicing clinicians. Learning is highly experiential, with students authentically participating in each of the methods and reflecting on these self-experiences as a basis for their own clinical decision-making. This is differentiated from a population based (P-B) approach, wherein students’ attention is directed at acquiring knowledge about the non-musical problems of specific “clinical populations” and the “best practice” music interventions that are presumed to address these problems. Herein, we discuss both approaches, identifying the limitations of a P-B perspective and outlining the benefits of an M-B curriculum and its relevance to 21st-century music therapy practice.

Point of Care Ultrasound in Geriatric Patients: Prospective Evaluation of a Portable Handheld Ultrasound Device

2019 ◽  
Vol 41 (03) ◽  
pp. 308-316 ◽  
Author(s):  
Eckhart Fröhlich ◽  
Katharina Beller ◽  
Reinhold Muller ◽  
Maria Herrmann ◽  
Ines Debove ◽  
...  
Keyword(s):  
Decision Making ◽  
Geriatric Patients ◽  
Clinical Decision Making ◽  
Point Of Care ◽  
False Negative ◽  
Clinical Decision ◽  
Point Of Care Ultrasound ◽  
Handheld Device ◽  
Ultrasound Device ◽  
Handheld Ultrasound

Abstract Purpose The aim of the current study was to evaluate point of care ultrasound (POCUS) in geriatric patients by echoscopy using a handheld ultrasound device (HHUSD, VScan) at bedside in comparison to a high-end ultrasound system (HEUS) as the gold standard. Materials and Methods Prospective observational study with a total of 112 geriatric patients. The ultrasound examinations were independently performed by two experienced blinded examiners with a portable handheld device and a high-end ultrasound device. The findings were compared with respect to diagnostic findings and therapeutic implications. Results The main indications for the ultrasound examinations were dyspnea (44.6 %), fall (frailty) (24.1 %) and fever (21.4 %). The most frequently found diagnoses were cystic lesions 32.1 % (35/109), hepatic vein congestion 19.3 % (21/109) and ascites 13.6 % (15/110). HHUSD delivered 13 false-negative findings in the abdomen resulting in an “overall sensitivity” of 89.5 %. The respective “overall specificity” was 99.6 % (7 false-positive diagnoses). HHUSD (versus HEUS data) resulted in 13.6 % (17.3 %) diagnostically relevant procedures in the abdomen and 0.9 % (0.9 %) in the thorax. Without HHUSD (HEUS) 95.7 % (100 %) of important pathological findings would have been missed. Conclusion The small HHUSD tool improves clinical decision-making in immobile geriatric patients at the point of care (geriatric ward). In most cases, HHUSD allows sufficiently accurate yes/no diagnoses already at the bedside, thereby clarifying the leading symptoms for early clinical decision-making.

A population-based model for predicting sentinel lymph node (SLN) status for cutaneous melanoma patients and a clinical decision rule (CDR) for sparing a SLN biopsy (SLNB).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9589-9589
Author(s):  
Phyllis A. Gimotty ◽  
Giorgos Karakousis ◽  
Meghan A. Buckley ◽  
DuPont Guerry
Keyword(s):  
Validation Cohort ◽  
False Negative ◽  
Clinical Decision ◽  
Mitotic Rate ◽  
Population Based ◽  
Multivariable Logistic Regression Model ◽  
Related Factors ◽  
C Statistic ◽  
Definitive Surgery ◽  
The One

9589 Background: Generally, a SLNB is offered to the patient whose likelihood of positivity is ≥ 5%. Using population-based cohorts, we sought to [1] develop and validate a predictive model to estimate the individualized risk (IR) of SLNB positivity (SLNBp) and its confidence interval (CI), [2] evaluate an IR-based CDR to identify patients with sufficiently low IRs to avoid SLNB, and [3] compare the performance of the CDR with that of the 2019 NCCN guideline. Methods: The learning cohort (n = 18,214; SLNBp rate = 10.7%; 2010-2014) and validation cohort (n = 3,924; SLNBp rate = 11%; 2015) included SEER patients 18-99 years old who had a SLNB as part of definitive surgery. A multivariable logistic regression model for SLNBp, including 4 AJCC related-factors (thickness, ulceration, level and mitotic rate) and age, was used to estimate the IR of SLNBp and its one-sided 95% CI. The CDR was defined using the IR and CI and then used to classify patients into 3 categories: SLNB not indicated (IR and upper limit of the one-sided CI < 5%), SLNB indicated (IR and lower limit of the one-sided CI ≥ 5%), and borderline. Results: In the learning cohort all 5 factors were significant in the multivariate model, which had a c-statistic of 0.742 (95%CI, 0.731-0.753). In the validation cohort the model c-statistic was 0.728. Based on the CDR, 21.6%, 56.9%, and 21.5% of patients would not be offered SLNB, would be offered SLNB, or would need further shared decision making. Compared to the guideline, the CDR classified more patients as “SLNB not indicated” (21.6% vs. 7.1%) and fewer as “SLNB indicated” (56.9% vs. 68.5%). Of the 16,137 SLNB negative patients, 3815 (23.6%) would not be offered SLNB based on the CDR compared to 1258 (7.8%) who would not be offered SLNB based on the guideline. The false negative rates associated with “not indicated” by the CDR and guideline were 4.6% and 1.2%, respectively. Conclusions: Use of this CDR rather than the NCCN guideline will spare more low-risk patients the expense and harms of SLNB and increase only marginally their likelihood of a false negative test (still < 5%).

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