scholarly journals Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room

Diagnostics ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. 669 ◽  
Author(s):  
Zeno Bisoffi ◽  
Elena Pomari ◽  
Michela Deiana ◽  
Chiara Piubelli ◽  
Niccolò Ronzoni ◽  
...  
Keyword(s):  
Emergency Room ◽  
Latent Class ◽  
Single Gene ◽  
Molecular Test ◽  
Clinical Context ◽  
Serological Tests ◽  
Predictive Values ◽  
Molecular Tests ◽  
Sensitivity Specificity

Background: We assessed the sensitivity, specificity and positive and negative predictive value (PPV and NPV) of molecular and serological tests for the diagnosis of SARS-CoV-2 infection. Methods: A total of 346 patients were enrolled in the emergency room. We evaluated three Reverse Transcriptase-real time PCRs (RT-PCRs) including six different gene targets, five serologic rapid diagnostic tests (RDT) and one ELISA. The final classification of infected/non-infected patients was performed using Latent Class Analysis combined with clinical re-assessment of incongruous cases. Results: Out of these, 24.6% of patients were classified as infected. The molecular test RQ-SARS-nCoV-2 showed the highest performance with 91.8% sensitivity, 100% specificity, 100.0% PPV and 97.4% NPV respectively. Considering the single gene targets, S and RdRp of RQ-SARS-nCoV-2 had the highest sensitivity (94.1%). The in-house RdRp presented the lowest sensitivity (62.4%). The specificity ranged from 99.2% for in-house RdRp and N2 to 95.0% for E. The PPV ranged from 97.1% of N2 to 85.4% of E and the NPV from 98.1% of S to 89.0% of in-house RdRp. All serological tests had < 50% sensitivity and low PPV and NPV. VivaDiag IgM (RDT) had 98.5% specificity, with 84.0% PPV, but 24.7% sensitivity. Conclusion: Molecular tests for SARS-CoV-2 infection showed excellent specificity, but significant differences in sensitivity. Serological tests have limited utility in a clinical context.

scholarly journals Sensitivity, specificity and predictive values of molecular and serological tests for COVID-19. A longitudinal study in emergency room.

2020 ◽  
Author(s):  
Zeno Bisoffi ◽  
ELENA POMARI ◽  
Michela Deiana ◽  
Chiara Piubelli ◽  
Niccolo Ronzoni ◽  
...  
Keyword(s):  
Emergency Room ◽  
Diagnostic Tests ◽  
Latent Class ◽  
Single Gene ◽  
High Specificity ◽  
Elisa Test ◽  
Serological Tests ◽  
Predictive Values ◽  
Molecular Tests ◽  
Sensitivity Specificity

Accuracy of diagnostic tests is essential for suspected cases of Coronavirus Disease 2019 (COVID-19). This study aimed to assess the sensitivity, specificity and positive and negative predictive value (PPV and NPV) of molecular and serological tests for the diagnosis of SARS-CoV-2 infection. A total of 346 consenting, adult patients were enrolled at the emergency room of IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Italy. We evaluated three RT-PCR methods including six different gene targets; five serologic rapid diagnostic tests (RDT); one ELISA test. The final classification of infected/not infected patients was performed using Latent Class Analysis in combination with clinical re-assessment of incongruous cases and was the basis for the main analysis of accuracy. Of 346 patients consecutively enrolled, 85 (24.6%) were classified as infected. The molecular test with the highest sensitivity, specificity, PPV and NPV was RQ-SARS-nCoV-2 with 91.8% (C.I. 83.8-96.6), 100% (C.I. 98.6-100.0), 100.0% (C.I. 95.4-100.0) and 97.4% (C.I. 94.7-98.9) respectively, followed by CDC 2019-nCoV with 76.2% (C.I. 65.7-84.8), 99.6% (C.I. 97.9-100.0), 98.5% (C.I. 91.7-100.0) and 92.9% (C.I. 89.2-95.6) and by in-house test targeting E-RdRp with 61.2% (C.I. 50.0-71.6), 99.6% (C.I. 97.9-100.0), 98.1% (C.I. 89.9-100.0) and 88.7% (C.I. 84.6-92.1). The analyses on single gene targets found the highest sensitivity for S and RdRp of the RQ-SARS-nCoV-2 (both with sensitivity 94.1%, C.I. 86.8-98.1). The in-house RdRp had the lowest sensitivity (62.4%, C.I. 51.2-72.6). The specificity ranged from 99.2% (C.I. 97.3-99.9) for in-house RdRp and N2 to 95.0% (C.I. 91.6-97.3) for E. The PPV ranged from 97.1% (C.I. 89.8-99.6) of N2 to 85.4% (C.I. 76.3-92.00) of E, and the NPV from 98.1% (C.I. 95.5-99.4) of gene S to 89.0% (C.I. 84.8-92.4) of in-house RdRp. All serological tests had <50% sensitivity and low PPV and NPV. One RDT (VivaDiag IgM) had high specificity (98.5%, with PPV 84.0%), but poor sensitivity (24.7%). Molecular tests for SARS-CoV-2 infection showed excellent specificity, but significant differences in sensitivity. As expected, serological tests have limited utility in a clinical context.

scholarly journals COVID-19 Seroprevalence among Healthcare Workers of a Large COVID-19 Hospital in Rome Reveals Strengths and Limits of Two Different Serological Tests

2021 ◽  
Vol 18 (5) ◽  
pp. 2650
Author(s):  
Giuseppe Vetrugno ◽  
Daniele Ignazio La Milia ◽  
Floriana D’Ambrosio ◽  
Marcello Di Pumpo ◽  
Roberta Pastorino ◽  
...  
Keyword(s):  
Blood Test ◽  
Healthcare Workers ◽  
Point Of Care ◽  
Venous Blood ◽  
Administrative Staff ◽  
Serological Tests ◽  
Predictive Values ◽  
Work From Home ◽  
Significant Difference ◽  
Sensitivity Specificity

Healthcare workers are at the forefront against COVID-19, worldwide. Since Fondazione Policlinico Universitario A. Gemelli (FPG) IRCCS was enlisted as a COVID-19 hospital, the healthcare workers deployed to COVID-19 wards were separated from those with limited/no exposure, whereas the administrative staff were designated to work from home. Between 4 June and 3 July 2020, an investigation was conducted to evaluate the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin (IgG) antibodies among the employees of the FPG using point-of-care (POC) and venous blood tests. Sensitivity, specificity, and predictive values were determined with reverse-transcription polymerase chain reaction on nasal/oropharyngeal swabs as the diagnostic gold standard. The participants enrolled amounted to 4777. Seroprevalence was 3.66% using the POC test and 1.19% using the venous blood test, with a significant difference (p < 0.05). The POC test sensitivity and specificity were, respectively, 63.64% (95% confidence interval (CI): 62.20% to 65.04%) and 96.64% (95% CI: 96.05% to 97.13%), while those of the venous blood test were, respectively, 78.79% (95% CI: 77.58% to 79.94%) and 99.36% (95% CI: 99.07% to 99.55%). Among the low-risk populations, the POC test’s predictive values were 58.33% (positive) and 98.23% (negative), whereas those of the venous blood test were 92.86% (positive) and 98.53% (negative). According to our study, these serological tests cannot be a valid alternative to diagnose COVID-19 infection in progress.

scholarly journals Bayesian evaluation of three serological tests for the diagnosis of bovine brucellosis in Bangladesh

2019 ◽  
Vol 147 ◽  
Author(s):  
A. K. M. A. Rahman ◽  
S. Smit ◽  
B. Devleesschauwer ◽  
P. Kostoulas ◽  
E. Abatih ◽  
...  
Keyword(s):  
Latent Class ◽  
Latent Class Model ◽  
Dairy Farm ◽  
Agglutination Test ◽  
Enzyme Linked Immunosorbent Assay ◽  
Bovine Brucellosis ◽  
Class Model ◽  
Serological Tests ◽  
Predictive Values ◽  
Conditional Dependence

AbstractWe evaluated the performance of three serological tests – an immunoglobulin G indirect enzyme linked immunosorbent assay (iELISA), a Rose Bengal test and a slow agglutination test (SAT) – for the diagnosis of bovine brucellosis in Bangladesh. Cattle sera (n = 1360) sourced from Mymensingh district (MD) and a Government owned dairy farm (GF) were tested in parallel. We used a Bayesian latent class model that adjusted for the conditional dependence among the three tests and assumed constant diagnostic accuracy of the three tests in both populations. The sensitivity and specificity of the three tests varied from 84.6% to 93.7%, respectively. The true prevalences of bovine brucellosis in MD and the GF were 0.6% and 20.4%, respectively. Parallel interpretation of iELISA and SAT yielded the highest negative predictive values: 99.9% in MD and 99.6% in the GF; whereas serial interpretation of both iELISA and SAT produced the highest positive predictive value (PPV): 99.9% in the GF and also high PPV (98.9%) in MD. We recommend the use of both iELISA and SAT together and serial interpretation for culling and parallel interpretation for import decisions. Removal of brucellosis positive cattle will contribute to the control of brucellosis as a public health risk in Bangladesh.

A unique antiphospholipid assay recognizing phospholipid mixture compared with criteria antiphospholipid immunoassays in lupus patients

Lupus ◽  
2016 ◽  
Vol 26 (6) ◽  
pp. 606-615 ◽  
Author(s):  
Y Zuo ◽  
R Willis ◽  
E Papalardo ◽  
M Petri ◽  
E N Harris ◽  
...  
Keyword(s):  
Lupus Erythematosus ◽  
Clinical Manifestations ◽  
Case Series ◽  
Likelihood Ratios ◽  
Serum Samples ◽  
Predictive Values ◽  
Pregnancy Morbidity ◽  
Commercial Kits ◽  
Sensitivity Specificity

Background While essential for the classification of antiphospholipid syndrome (APS), anticardiolipin (aCL) assays lack specificity and anti-β2glycoproteinI (anti-β2GPI) assays lack sensitivity in this regard. Our aim was to perform a comparative analysis of the APhL ELISA assay (IgG/IgM) and criteria antiphospholipid (aPL) immunoassays in identifying APS-related clinical manifestations in a large group of patients with systemic lupus erythematosus (SLE). Methods Serum samples from 1178 patients from the Hopkins ( n = 543), LUMINA ( n = 588) and Jamaican SLE cohorts ( n = 47) were examined for IgG/IgM positivity in aCL (in-house), anti-β2GPI (two commercial kits) and APhL (Louisville APL) ELISA assays. Correlation of assay positivity with clinical manifestations and sensitivity, specificity, positive and negative predictive values and likelihood ratios were evaluated. A case series analysis was also performed in patients for whom there was isolated positivity in the specific aPL assays. Results The prevalence of aCL positivity was 34.9%, anti-β2GPI kit A was 22.6%, APhL was 11.5% and anti-β2GPI kit B was 7.6% in the study population. Anti-β2GPI kit B, aCL and APhL assays were correlated with venous thrombosis, while only APhL was significantly correlated with arterial thrombosis and consistently correlated with pregnancy-related morbidity. No significant correlations were noted for anti-β2GPI kit A. Sensitivity was greatest for aCL assays followed by anti-β2GPI kit A, APhL and anti-β2GPI kit B, while specificity was greatest and equal for anti-β2GPI kit B and APhL assays. Conclusions Overall, APhL antibodies, especially IgG, represent a promising biomarker for the classification of APS patients in the context of autoimmunity and in risk assessment with regards to pregnancy morbidity and thrombotic manifestations.

scholarly journals Validation of an extended French version of ID Migraine™ as a migraine-screening tool

Cephalalgia ◽  
2014 ◽  
Vol 35 (5) ◽  
pp. 437-442 ◽  
Author(s):  
Sylvie Streel ◽  
Anne-Françoise Donneau ◽  
Nadia Dardenne ◽  
Axelle Hoge ◽  
Olivier Bruyère ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Screening Tool ◽  
Epidemiological Studies ◽  
Predictive Values ◽  
French Version ◽  
Gender Education ◽  
French Speaking ◽  
Id Migraine ◽  
Sensitivity Specificity

Introduction Migraine has a considerable social, economic, physical and emotional burden but remains underdiagnosed and undertreated. A specific migraine screening tool could help remove barriers to health care and be an attractive instrument for epidemiological studies. The objective of this work was to assess the validity of an extended French version of ID Migraine™ as a migraine-screening tool. Methods Sixty-seven subjects from the NESCaV study (2010–2012) completed the migraine screen and were diagnosed by a neurologist specializing in headache medicine using the International Classification of Headache Disorders, 2nd edition criteria (gold standard). Agreement between the two diagnoses was evaluated by Cohen kappa coefficient (κ). Sensitivity, specificity and predictive values of the migraine screen were calculated. Results Migraine was diagnosed in 21 (31.3%) of the 67 subjects according to the screening tool and in 24 (35.8%) by the neurologist (κ = 0.90). The prevalence of migraine was unrelated to age, gender, education and perception of financial resources. Sensitivity and specificity of the screen were 87.5% and 100%, respectively. The screen prevalence of migraine with aura was 10.4% (sensitivity and specificity: 83.3% and 96.7%, respectively). Conclusion The extended French version of ID Migraine™ (ef-ID Migraine) is a validated tool to screen migraine in French-speaking countries.

scholarly journals Dog Savior: Immediate Scent-Detection of SARS-COV-2 by Trained Dogs

2020 ◽  
Author(s):  
Omar Vesga ◽  
Andres F. Valencia ◽  
Alejandro Mira ◽  
Felipe Ossa ◽  
Esteban Ocampo ◽  
...  
Keyword(s):  
Infected Individual ◽  
High Sensitivity ◽  
The Body ◽  
High Rate ◽  
Diagnostic Tools ◽  
Predictive Values ◽  
Infected People ◽  
Molecular Tests ◽  
Production And Distribution ◽  
Sensitivity Specificity

AbstractMolecular tests for viral diagnostics are essential to confront the COVID-19 pandemic, but their production and distribution cannot satisfy the current high demand. Early identification of infected people and their contacts is the key to being able to isolate them and prevent the dissemination of the pathogen; unfortunately, most countries are unable to do this due to the lack of diagnostic tools. Dogs can identify, with a high rate of precision, unique odors of volatile organic compounds generated during an infection; as a result, dogs can diagnose infectious agents by smelling specimens and, sometimes, the body of an infected individual. We trained six dogs of three different breeds to detect SARS-CoV-2 in respiratory secretions of infected patients and evaluated their performance experimentally, comparing it against the gold standard (rRT-PCR). Here we show that viral detection takes one second per specimen. After scent-interrogating 9,200 samples, our six dogs achieved independently and as a group very high sensitivity, specificity, predictive values, accuracy, and likelihood ratio, with very narrow confidence intervals. The highest metric was the negative predictive value, indicating that with a disease prevalence of 7.6%, 99.9% of the specimens indicated as negative by the dogs did not carry the virus. These findings demonstrate that dogs could be useful to track viral infection in humans, allowing COVID-19 free people to return to work safely.

scholarly journals Diagnostic reliability of a simplified epidemiologic tool to detect high-risk overjet for dental trauma.

2015 ◽  
Vol 18 (4) ◽  
pp. 68
Author(s):  
Andressa Reisen ◽  
Alessandra Ramos Parpaiola ◽  
Arlete Maria Gomes Oliveira ◽  
Luciane Zanin ◽  
Flávia Martão Flório
Keyword(s):  
High Risk ◽  
Dental Trauma ◽  
Diagnostic Reliability ◽  
Gold Standard Method ◽  
Predictive Values ◽  
Simplified Method ◽  
External Examiner ◽  
Study Population ◽  
Sensitivity Specificity

<strong>Objective:</strong> To evaluate the diagnostic reliability of a simplified tool to detect high-risk overjet for dental trauma. <strong>Material and </strong><strong>Methods:</strong> The study population was composed of 131 volunteers divided into two groups according to the overjet measurement in terms of risk for traumatic dental injury (GRAB: risk absent and GRPR: risk present). The distance between the most prominent labial surface and its corresponding counterpart was measured using both the conventional (WHO, 1997) and the simplified tool. The measurements were taken independently and on separate occasions by two previously calibrated dental surgeons (Kappa=0.86). The gold standard method, as recommended by the WHO (1997), was performed by an external examiner. The simplified method, based on pencil-marked wooden tongue depressors was carried out in a blind manner by the other examiner. Sensitivity, specificity, positive and negative predictive values were calculated for the classification of risk for dental trauma in terms of overjet using the simplified method and compared to the conventional method. <strong>Results:</strong> The results revealed high values for sensitivity (S=1), specificity (E=0.93), positive (PPV=0.95) and negative predictive value (NPV=1). <strong>Conclusion:</strong> The examination using the simplified tool was reliable in identifying high-risk overjet, thus offering an alternative to the conventional examination.

Development of Guidelines for Idiopathic Normal-pressure Hydrocephalus: Introduction

Neurosurgery ◽  
2005 ◽  
Vol 57 (suppl_3) ◽  
pp. S2-1-S2-3 ◽  
Author(s):  
Anthony Marmarou ◽  
Marvin Bergsneider ◽  
Norman Relkin ◽  
Petra Klinge ◽  
Peter McL. Black
Keyword(s):  
Normal Pressure Hydrocephalus ◽  
Scientific Evidence ◽  
Normal Pressure ◽  
The United States ◽  
Independent Study ◽  
Evidence Based ◽  
Predictive Values ◽  
Sensitivity Specificity ◽  
Evidence Based Guidelines

Abstract OBJECTIVE: There are no currently accepted evidence-based guidelines for the diagnosis and management of the normal-pressure hydrocephalus (NPH) patient. As a result, an independent study group was assembled to address this issue and determine the feasibility of developing standardized guidelines, which would be acceptable in the United States and abroad and would be based on the available scientific evidence. The guidelines were to encompass value of clinical presentation, value of supplementary diagnostic tests, surgical management, and outcome assessment. METHODS: Initially, a series of 10 questions were formulated in the areas of pathophysiology, diagnosis, and treatment to obtain a consensus by panels of experts (see Acknowledgments) assembled in San Antonio, TX, in September 2000. This workshop provided significant insight into the difficulties in developing NPH guidelines, and a consensus was reached as to those questions involving expert opinion. Subsequently, evidentiary tables were developed on the basis of the available evidence. Only those studies with 20 or more idiopathic NPH (INPH) patients were included. RESULTS: Sensitivity, specificity, and positive and negative predictive values for INPH diagnostic criteria were assessed, and guidelines were developed on the basis of the available evidence. Recommendations for classification of INPH and additional studies were documented. CONCLUSION: The development of the guidelines was made difficult because systematic studies of INPH and patient numbers were few. It was decided to maintain the classification of NPH into two major categories, INPH and those of known cause (secondary NPH). Many studies “mixed” these classifications, and as a result, they could not be used in the evidentiary tables. Despite these problems, evidence-based guidelines were developed, and it is hoped that they will be useful in guiding clinical management of the INPH patient.

scholarly journals Do routine hospital data accurately record comorbidity in advanced kidney disease populations? A record linkage cohort study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ailish Nimmo ◽  
Retha Steenkamp ◽  
Rommel Ravanan ◽  
Dominic Taylor
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
International Classification Of Diseases ◽  
Medical Conditions ◽  
Hospital Data ◽  
Full Spectrum ◽  
Predictive Values ◽  
Advanced Chronic Kidney Disease ◽  
Sensitivity Specificity

Abstract Background Routine healthcare datasets capturing clinical and administrative information are increasingly being used to examine health outcomes. The accuracy of such data is not clearly defined. We examine the accuracy of diagnosis recording in individuals with advanced chronic kidney disease using a routine healthcare dataset in England with comparison to information collected by trained research nurses. Methods We linked records from the Access to Transplant and Transplant Outcome Measures study to the Hospital Episode Statistics dataset. International Classification of Diseases (ICD-10) and Office for Population Censuses and Surveys Classification of Interventions and Procedures (OPCS-4) codes were used to identify medical conditions from hospital data. The sensitivity, specificity, positive and negative predictive values were calculated for a range of diagnoses. Results Comorbidity information was available in 96% of individuals prior to starting kidney replacement therapy. There was variation in the accuracy of individual medical conditions identified from the routine healthcare dataset. Sensitivity and positive predictive values ranged from 97.7 and 90.4% for diabetes and 82.6 and 82.9% for ischaemic heart disease to 44.2 and 28.4% for liver disease. Conclusions Routine healthcare datasets accurately capture certain conditions in an advanced chronic kidney disease population. They have potential for use within clinical and epidemiological research studies but are unlikely to be sufficient as a single resource for identifying a full spectrum of comorbidities.

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