• Journal of Veterinary Clinics
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• v.33 no.2
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• pp.97-101
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• 2016

In the field of clinical medicine, diagnostic accuracy studies refer to the degree of agreement between the index test and the reference standard for the discriminatory ability to identify a target disorder of interest in a patient. The receiver operating characteristic (ROC) curve offers a graphical display the trade-off between sensitivity and specificity at each cutoff for a diagnostic test and is useful in assigning the best cutoff for clinical use. In this end, the ROC curve analysis is a useful tool for estimating and comparing the accuracy of competing diagnostic tests. This paper reviews briefly the measures of diagnostic accuracy such as sensitivity, specificity, and area under the ROC curve (AUC) that is a summary measure for diagnostic accuracy across the spectrum of test results. In addition, the methods of creating an ROC curve in single diagnostic test with five-category discrete scale for disease classification from healthy individuals, meaningful interpretation of the AUC, and the applications of ROC methodology in clinical medicine to determine the optimal cutoff values have been discussed using a hypothetical example as an illustration.

• The Journal of Korean Physical Therapy
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• v.35 no.3
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• pp.57-63
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• 2023

Purpose: The aim of this study was to conduct a systematic review of randomized controlled studies from 2012 to present that explore the diagnostic accuracy of clinical tests used for diagnosing anterior cruciate ligament (ACL) injury. Methods: Study design: Systematic review. Literature search of the PubMed and Scholar databases was conducted using keywords related to diagnostic accuracy of clinical tests for ACL injury. The PRISMA Guidelines were followed to conduct this study. The Cochrane Risk of Bias Tool was utilized to assess the quality of each included study. Results: As a result, 8 studies were included, and 6 clinical tests used in ACL tears were evaluated for diagnostic accuracy. The pivot shift test was reported as having the highest +LR (29.5) value with a sensitivity of 59% and a specificity of 98%. However, the test with the lowest -LR value was the lever test, and the values were as follows: -LR (0.08), +LR (4.7), specificity (80%), sensitivity (94%). Conclusion: In this study, it was concluded that a single clinical test is not sufficient to determine the presence of ACL injury. Test combinations have a higher diagnostic accuracy than a single test. In this study, the accuracy of the clinical tests was examined without considering the amount of ACL rupture and acute-chronic condition. Further research is required to examine the impact of these two factors on diagnostic accuracy of clinical test.

• Journal of Veterinary Clinics
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• v.32 no.4
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• pp.319-323
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• 2015

The performance of diagnostic test accuracy is usually summarized by a variety of statistics such as sensitivity, specificity, predictive value, likelihood ratio, and kappa. These indices are most commonly presented when evaluations of competing diagnostic tests are reported, and it is of utmost importance to compare the accuracies of diagnostic tests to decide on the best available test for certain medical disorder. However, it is important to emphasize that specific point values of these indices are merely estimates. If parameter estimates are reported without a measure of uncertainty (precision), knowledgeable readers cannot know the range within which the true values of the indices are likely to lie. Therefore, when evaluations of diagnostic accuracy are reported the precision of estimates should be stated in parallel. To reflect the precision of any estimate of a diagnostic performance characteristic or of the difference between performance characteristics, the computation of confidential interval (CI), an indicator of precision, is widely used in medical literatures in that CIs are more informative to interpret test results than the simple point estimates. The majority of peer-reviewed journals usually require CIs to be specified for descriptive estimates, whereas domestic veterinary journals seem less vigilant on this issues. This paper describes how to calculate the indices and associated CIs using practical examples when assessing diagnostic test performance.

• Clinics in Shoulder and Elbow
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• v.26 no.2
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• pp.182-190
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• 2023

Elbow traumas represent a relatively common condition in clinical practice. However, there is a lack of evidence regarding the most accurate tests for screening these potentially serious conditions and excluding elbow fractures. The purpose of this investigation was to analyze the literature concerning the diagnostic accuracy of clinical tests for the detection or exclusion of suspected elbow fractures. A systematic review was performed using the Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) guidelines. Literature databases including PubMed, Cumulative Index to Nursing and Allied Health Literature, Diagnostic Test Accuracy, Cochrane Library, the Web of Science, and ScienceDirect were searched for diagnostic accuracy studies of subjects with suspected traumatic elbow fracture investigating clinical tests compared to imaging reference tests. The risk of bias in each study was assessed independently by two reviewers using the Quality Assessment of Diagnostic Accuracy Studies 2 checklist. Twelve studies (4,485 patients) were included. Three different types of index tests were extracted. In adults, these tests were very sensitive, with values up to 98.6% (95% confidence interval [CI], 95.0%-99.8%). The specificity was very variable, ranging from 24.0% (95% CI, 19.0%-30.0%) to 69.4% (95% CI, 57.3%-79.5%). The applicability of these tests was very high, while overall studies showed a medium risk of bias. Elbow full range of motion test, elbow extension test, and elbow extension and point tenderness test appear to be useful in the presence of a negative test to exclude fracture in a majority of cases. The specificity of all tests, however, does not allow us to draw useful conclusions because there was a great variability of results obtained.

• Asian Pacific Journal of Cancer Prevention
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• v.16 no.2
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• pp.657-660
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• 2015

Background: A diagnosis of H. pylori infection can be made by invasive or non-invasive methods. Several noninvasive diagnostic tests based on the detection of H. pylori stool antigen (HpSA) have been developed. The Genx H. pylori stool antigen card test is a new rapid, non-invasive test that is based on monoclonal immunochromatographic assay. The aim of this study was to determine its sensitivity, specificity, and diagnostic accuracy for diagnosing H. pylori infection in adult patients. Materials and Methods: A total of 162 patients were included in the study. A gastric biopsy was collected for histopathology and rapid urease testing. Stool specimens for HpSA testing were also collected. Patients were considered H. pylori positive if two invasive tests (histological and rapid urease tests) were positive. Results: Using the reference test, 50.6% of the samples were positive for H. pylori infection. The Genx H. pylori antigen test was positive in 19.7% of patients. The sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of the Genx H. pylori antigen test were 51.6%, 96.0%, 88.8%, 76.1%, and 79.0%, respectively. Conclusions: The Genx H. pylori stool antigen card test is a new non-invasive method that is fast and simple to perform but provides less reliable results.

• Journal of Veterinary Clinics
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• v.32 no.1
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• pp.73-77
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• 2015

There has been increasing attention on sample size requirements in peer reviewed medical literatures. Accordingly, a statistically-valid sample size determination has been described for a variety of medical situations including diagnostic test accuracy studies. If the sample is too small, the estimate is too inaccurate to be useful. On the other hand, a very large sample size would yield the estimate with more accurate than required but may be costly and inefficient. Choosing the optimal sample size depends on statistical considerations, such as the desired precision, statistical power, confidence level and prevalence of disease, and non-statistical considerations, such as resources, cost and sample availability. In a previous paper (J Vet Clin 2012; 29: 68-77) we briefly described the statistical theory behind sample size calculations and provided practical methods of calculating sample size in different situations for different research purposes. This review describes how to calculate sample sizes when assessing diagnostic test performance such as sensitivity and specificity alone. Also included in this paper are tables and formulae to help researchers for designing diagnostic test studies and calculating sample size in studies evaluating test performance. For complex studies clinicians are encouraged to consult a statistician to help in the design and analysis for an accurate determination of the sample size.

• Journal of Biomedical Engineering Research
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• v.40 no.3
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• pp.97-104
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• 2019

To examine different types of influenza diagnostic test kits automatically, automated rapid influenza diagnostic test method based on image recognition is proposed in this paper. First, the proposed methods classify a variety of the rapid influenza diagnostic test kit based on support vector machine that analyzes the kits' feature point. Then, to improve the accuracy of test, the proposed methods match the histogram of both the target image of influenza kit and the input image of influenza kit for minimizing the effect of environment factors, such as lighting and exposure variations. And, to minimize the effect from composition of the hand-helds devices, the proposed methods extract the feature point and match point-by-point between target image of influenza kit and input image of influenza kit. Experimental results of 124 experimental group show that the proposed methods significantly have effectiveness, which shows 90% accuracy in moderate antigen, for the preliminary examination of influenza, and provides the opportunity for taking action against influenza.

• Journal of Gastric Cancer
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• v.16 no.3
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• pp.141-151
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• 2016

Purpose: The aim of the present study was to elucidate the clinicopathological significance and diagnostic accuracy of immunohistochemistry (IHC) for determining the mesenchymal epidermal transition (c-MET) expression in patients with gastric cancer (GC). Materials and Methods: The present meta-analysis investigated the correlation between c-MET expression as determined by IHC and the clinicopathological parameters in 8,395 GC patients from 37 studies that satisfied the eligibility criteria. In addition, a concordance analysis was performed between c-MET expression as determined by IHC and c-MET amplification, and the diagnostic test accuracy was reviewed. Results: The estimated rate of c-MET overexpression was 0.403 (95% confidence interval [CI], 0.327~0.484) and it was significantly correlated with male patients, poor differentiation, lymph node metastasis, higher TNM stage, and human epidermal growth factor receptor 2 (HER2) positivity in IHC analysis. There was a significant correlation between c-MET expression and worse overall survival rate (hazard ratio, 1.588; 95% CI, 1.266~1.992). The concordance rates between c-MET expression and c-MET amplification were 0.967 (95% CI, 0.916~0.987) and 0.270 (95% CI, 0.173~0.395) for cases with non-overexpressed and overexpressed c-MET, respectively. In the diagnostic test accuracy review, the pooled sensitivity and specificity were 0.56 (95% CI, 0.50~0.63) and 0.79 (95% CI, 0.77~0.81), respectively. Conclusions: The c-MET overexpression as determined by IHC was significantly correlated with aggressive tumor behavior and positive IHC status for HER2 in patients with GC. In addition, the c-MET expression status could be useful in the screening of c-MET amplification in patients with GC.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.25 no.4
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• pp.312-320
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• 2022

Purpose: Screening serologic tests are important tools for the diagnosis of celiac disease (CD). Immunoglobulin (Ig)G anti-deamidated gliadin peptide (anti-DGP) is a relatively new autoantibody thought to have good diagnostic accuracy, comparable to that of anti-tissue transglutaminase (anti-tTG) antibody. Methods: Pediatric patients (n=86) with a clinical suspicion of CD were included. Duodenal biopsy, anti-tTG, and IgG anti-DGP antibody tests were performed. The patients were divided into CD and control groups based on the pathological evaluation of duodenal biopsies. The diagnostic accuracy of serological tests was determined. Results: IgA anti-tTG and IgG anti-DGP antibodies were positive in 86.3% and 95.4% of patients, respectively. The sensitivity, specificity, and diagnostic accuracy of the IgA anti-tTG test were 86.3%, 50.0%, and 68.6%, respectively, and those of the IgG anti-DGP test were 95.4%, 85.7%, and 90.7%, respectively. The area under the receiver operating characteristic (ROC) curve was 0.84 (95% confidence interval [CI], 0.74-0.91) for IgA anti-tTG test and 0.93 (95% CI, 0.86-0.97) for IgG anti-DGP test. The comparison of IgA anti-tTG and IgG anti-DGP ROC curves showed a higher sensitivity and specificity of the IgG anti-DGP test. Conclusion: IgG anti-DGP is a reliable serological test for CD diagnosis in children. High tTG and DGP titers in the serum are suggestive of severe duodenal atrophy. The combined use of IgA anti-tTG and IgG anti-DGP tests for the initial screening of CD can improve diagnostic sensitivity.

• Journal of Genetic Medicine
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• v.8 no.1
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• pp.28-34
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• 2011

Most clinicians understand clinical trials as the evaluation process for new medicine before their use. However, clinical trials can also be applied to laboratory diagnostic tests (LDTs) to verify diagnostic accuracy and efficacy before their clinical laboratory implementation for patients. The clinical trial of LDT has two distinctive characteristics that are different from the case of pharmaceuticals and thus worth special consideration. One of them is the level of evidence. The well-designed randomized controlled trials (RCTs) are known to provide the best evidence to prove the clinical efficacy of any pharmaceutical products. However, RCTs lose practicality when applied to LDTs due to various issues including ethical complications. For this reason, comparative study format is considered more feasible approach for LDTs. In addition pharmaceuticals and LDTs are different in that the user's intervention is not required for the former but critical to the latter. Moreover, in the case of pharmaceuticals, end-products are produced by manufacturers before being used by clinicians. However, in LDTs, once reagents and instruments are provided by manufacturers, they are first utilized by clinical laboratories to produce test results in order for clinicians to use them later. In other words, when it comes to LDTs, clinical laboratories play the role of manufacturers, providing reliable test results with improved quality assurance. Considering the distinctive characteristics of LDTs, we would like to offer detailed suggestions to successfully perform clinical trials in LDTs, which include analytical performance measures, clinical test performance measures, diagnostic test accuracy measures, clinical effectiveness measures, and post-implementation surveillance.