Sensitivity and specificity of the AdenoPlus point-of-care system in detecting adenovirus in conjunctivitis patients at an ophthalmic emergency department: a diagnostic accuracy study

2015 ◽  
Vol 99 (9) ◽  
pp. 1186-1189 ◽  
Author(s):  
K Y Ronald Kam ◽  
Hon Shing Ong ◽  
Catey Bunce ◽  
Lola Ogunbowale ◽  
Seema Verma
Keyword(s):  
Emergency Department ◽  
Diagnostic Accuracy ◽  
Sensitivity And Specificity ◽  
Point Of Care ◽  
Diagnostic Accuracy Study ◽  
Point Of Care System ◽  
Accuracy Study ◽  
Care System

scholarly journals Sensitivity and specificity of breast cancer ICD-9-CM codes in three Italian administrative healthcare databases: a diagnostic accuracy study

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e020627 ◽  
Author(s):  
Iosief Abraha ◽  
Diego Serraino ◽  
Alessandro Montedori ◽  
Mario Fusco ◽  
Gianni Giovannini ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Diagnostic Accuracy ◽  
Sensitivity And Specificity ◽  
Invasive Breast Cancer ◽  
Carcinoma In Situ ◽  
Case Definition ◽  
Administrative Databases ◽  
Diagnostic Accuracy Study ◽  
Accuracy Study

ObjectivesTo assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying patients diagnosed with incident carcinoma in situ and invasive breast cancer in three Italian administrative databases.DesignA diagnostic accuracy study comparing ICD-9-CM codes for carcinoma in situ (233.0) and for invasive breast cancer (174.x) with medical chart (as a reference standard). Case definition: (1) presence of a primary nodular lesion in the breast and (2) cytological or histological documentation of cancer from a primary or metastatic site.SettingAdministrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli VeneziaGiulia (FVG) Region.ParticipantsWomen with breast carcinoma in situ (n=246) or invasive breast cancer (n=384) diagnosed (in primary position) between 2012 and 2014.Outcome measuresSensitivity and specificity for codes 233.0 and 174.x.ResultsFor invasive breast cancer the sensitivities were 98% (95% CI 93% to 99%) for Umbria, 96% (95% CI 91% to 99%) for NA and 100% (95% CI 97% to 100%) for FVG. Specificities were 90% (95% CI 82% to 95%) for Umbria, 91% (95% CI 83% to 96%) for NA and 91% (95% CI 84% to 96%) for FVG.For carcinoma in situ the sensitivities were 100% (95% CI 93% to 100%) for Umbria, 100% (95% CI 95% to 100%) for NA and 100% (95% CI 96% to 100%) for FVG. Specificities were 98% (95% CI 93% to 100%) for Umbria, 86% (95% CI 78% to 92%) for NA and 90% (95% CI 82% to 95%) for FVG.ConclusionsAdministrative healthcare databases from Umbria, NA and FVG are accurate in identifying hospitalised news cases of carcinoma of the breast. The proposed case definition is a powerful tool to perform research on large populations of newly diagnosed patients with breast cancer.

scholarly journals Novel lipoarabinomannan point-of-care tuberculosis test for people with HIV: a diagnostic accuracy study

2019 ◽  
Vol 19 (8) ◽  
pp. 852-861 ◽  
Author(s):  
Tobias Broger ◽  
Bianca Sossen ◽  
Elloise du Toit ◽  
Andrew D Kerkhoff ◽  
Charlotte Schutz ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Diagnostic Accuracy Study ◽  
Accuracy Study

scholarly journals Blood-based host biomarker diagnostics in active case finding for pulmonary tuberculosis: a diagnostic accuracy study

2021 ◽  
Author(s):  
Flora Martinez Figueira Moreira ◽  
Renu Verma ◽  
Paulo Cesar Pereira dos Santos ◽  
Alessandra Leite ◽  
Andrea da Silva Santos ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Screening Program ◽  
Point Of Care ◽  
Case Finding ◽  
National Council ◽  
Active Case Finding ◽  
Diagnostic Accuracy Study ◽  
Active Case ◽  
Accuracy Study ◽  
Triage Test

SummaryBackgroundThere is a need to identify scalable tuberculosis screening strategies among high burden populations. The WHO has identified a non-sputum-based triage test as a development priority.MethodsWe performed a diagnostic accuracy study of point-of-care C-reactive protein (CRP) and Xpert-MTB-Host-Response (Xpert-MTB-HR) assays in the context of a mass screening program for tuberculosis in two prisons in Brazil. Incarcerated individuals irrespective of symptoms were screened by sputum Xpert-MTB/RIF and sputum culture. CRP was quantified in serum by a point-of-care assay (iChroma-II) and a 3-gene expression score was quantified from whole blood using the Xpert-MTB-HR cartridge. We evaluated receiver operating characteristic area under the curve (AUC) and assessed specificity at 90% sensitivity and sensitivity at 70% specificity, consistent with WHO target product profile (TPP) benchmarks.FindingsTwo hundred controls controls and 100 culture- or Xpert-positive tuberculosis cases were included. Half of tuberculosis cases and 11% of controls reported any tuberculosis symptoms. AUC for CRP was 0.79 (95% CI: 0.73-0.84) and for Xpert-MTB-HR was 0.84 (95% CI: 0.79-0.89). At 90% sensitivity, Xpert-MTB-HR had significantly higher specificity (53.0%, 95% CI: 45.0-69.0%) than CRP (28.1%, 95% CI: 20.2-41.8%) (p=0.003). Among individuals with medium or high sputum Xpert semi-quantitative load, sensitivity (at 70% specificity) of CRP (90.3%, 95% CI: 74.2-98.0) and Xpert-MTB-HR (96.8%, 95% CI: 83.3-99.9%) was higher.InterpretationFor active case finding in this high tuberculosis-burden setting, CRP and Xpert-MTB-HR did not meet TPP benchmarks for a triage test. However, Xpert-MTB-HR was highly sensitive in detecting individuals with medium or high sputum bacillary burden.FundingNational Institutes of Health (R01 AI130058 and R01 AI149620) and Brazilian National Council for Scientific and Technological Development (CNPq-404182/2019-4). Xpert-MTB-HR cartridges were provided by Cepheid.

scholarly journals Sample size calculation and re-estimation based on the prevalence in a single-arm confirmatory diagnostic accuracy study

2020 ◽  
Vol 29 (10) ◽  
pp. 2958-2971 ◽  
Author(s):  
Maria Stark ◽  
Antonia Zapf
Keyword(s):  
Diagnostic Accuracy ◽  
Sample Size ◽  
Sensitivity And Specificity ◽  
Sample Size Calculation ◽  
Type I ◽  
Diagnostic Accuracy Study ◽  
Optimal Sample Size ◽  
Optimal Sample ◽  
Accuracy Study ◽  
The One

Introduction In a confirmatory diagnostic accuracy study, sensitivity and specificity are considered as co-primary endpoints. For the sample size calculation, the prevalence of the target population must be taken into account to obtain a representative sample. In this context, a general problem arises. With a low or high prevalence, the study may be overpowered in one subpopulation. One further issue is the correct pre-specification of the true prevalence. With an incorrect assumption about the prevalence, an over- or underestimated sample size will result. Methods To obtain the desired power independent of the prevalence, a method for an optimal sample size calculation for the comparison of a diagnostic experimental test with a prespecified minimum sensitivity and specificity is proposed. To face the problem of an incorrectly pre-specified prevalence, a blinded one-time re-estimation design of the sample size based on the prevalence and a blinded repeated re-estimation design of the sample size based on the prevalence are evaluated by a simulation study. Both designs are compared to a fixed design and additionally among each other. Results The type I error rates of both blinded re-estimation designs are not inflated. Their empirical overall power equals the desired theoretical power and both designs offer unbiased estimates of the prevalence. The repeated re-estimation design reveals no advantages concerning the mean squared error of the re-estimated prevalence or sample size compared to the one-time re-estimation design. The appropriate size of the internal pilot study in the one-time re-estimation design is 50% of the initially calculated sample size. Conclusions A one-time re-estimation design of the prevalence based on the optimal sample size calculation is recommended in single-arm diagnostic accuracy studies.

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