• 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.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.

• Biomedical Science Letters
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• v.29 no.4
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• pp.344-354
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• 2023

This study emphasizes the importance of early diagnosis and response to COVID-19, leading to the development of a rapid diagnostic kit using quantum dots. The research focuses on finely tuning bioconjugation with quantum dots to enhance the accuracy and sensitivity of COVID-19 diagnosis. We have developed a COVID-19 rapid diagnostic kit that exhibits a sensitivity more than 50 times higher than existing COVID-19 diagnostic kits. Quantum dots enable the accurate detection of COVID-19 viral antigens even at low concentrations, providing a rapid response in the early stages of infection. The COVID-19 quantum dot diagnostic kit offers quick analysis time, utilizing the quantum properties of particles to swiftly measure COVID-19 infection for immediate response and isolation measures. Additionally, this diagnostic kit allows for multiple analyses with ease, as multiple quantum dots can detect various antigens and antibodies simultaneously in a single experiment. This efficiency enhances testing, reduces sample requirements, and lowers experimental costs. The application of this diagnostic technology is anticipated in the future for early diagnosis and monitoring of other infectious diseases.

• Journal of Korean Academy of Nursing
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• v.43 no.6
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• pp.746-759
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• 2013

Purpose: Infrared thermometers are increasingly used as a convenient, non-invasive assessment method for febrile children. However, the diagnostic accuracy of the infrared thermometer for children has been questioned, particularly in relation to sensitivity and specificity. The aim of this study was to evaluate diagnostic accuracy of infrared thermometers in febrile children. Methods: Articles published between 1966 and 2012 from periodicals indexed in the Ovid Medline, Embase, CINAHL, Cochrane, KoreaMed, NDSL, KERIS and other databases were selected, using the following keywords: 'infrared thermometer'. The QUADAS-II was applied to assess the internal validity of the diagnostic studies. Selected studies were analyzed using meta-analysis with MetaDisc 1.4. Results: Nineteen diagnostic studies with high methodological quality, involving 4,304 children, were included. The results of meta-analysis showed that the pooled sensitivity, specificity and AUC (Area Under the Curve) of infrared tympanic thermometers in children over 1 year were 0.80 (95% CI 0.78, 0.81), 0.94 (95% CI 0.93, 0.95) and 0.95 respectively. However the diagnostic accuracy of infrared tympanic thermometers in children with hyperthermia was low. Conclusion: The diagnostic accuracy of infrared tympanic thermometer was similar to axillary and rectal thermometers indicating a need for further research to substantiate these findings in children with hyperthermia.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.11
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• pp.5517-5523
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• 2012

Purpose: To evaluate the diagnostic accuracy of ultrasonograph and fine-needle aspiration cytologic examination (USG-FNAC) in the staging of axillary lymph node metastasis in breast cancer patients.Methods: We conducted an electronic search of the literature addressing the performance of USG-FNAC in diagnosis of axillary lymph node metastasis in databases such as Pubmed, Medline, Embase, Ovid and Cochrane library. We introduced a series of diagnostic test indices to evaluate the performance of USG-FNAC by the random effect model (REM), including sensitivity, specificity, likelihood ratios, and diagnostic odds ratios and area under the curve (AUC). Results: A total of 20 studies including 1371 cases and 1289 controls were identified. The pooled sensitivity was determined to be 0.66 (95% CI 0.64-0.69), specificity 0.98 (95% CI 0.98-0.99), positive likelihood ratio 22.7 (95% CI 15.0-34.49), negative likelihood ratio 0.32 (95% CI 0.25-0.41), diagnostic OR 84.2 (95% CI 53.3-133.0). Due to the marginal threshold effect found in some indices of diagnostic validity, we used a summary SROC curve to aggregate data, and obtained a symmetrical curve with an AUC of 0.942. Conclusion: The results of this meta-analysis indicated that the USG-FNAC techniques have acceptable diagnostic validity indices and can be used for early staging of axillary lymph node in breast cancer patients.

• Communications for Statistical Applications and Methods
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• v.18 no.1
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• pp.57-69
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• 2011

Researchers are continuously trying to find innovative diagnostic tests and published articles are accumulating at an enormous rate in many medical fields. Meta-analysis enables previously published study results to be reviewed and summarized; therefore, an objective assessment of diagnostic tests can be done with a meta-analysis of sensitivities and specificities. Data obtained by applying two diagnostic tests to a well-defined group of diseased patients produce a pair of sensitivity and by applying the same medical tests to a group of non-diseased subjects produce a pair of specificity. The statistical tests in the meta-analysis need to consider the correlatedness of the results from two diagnostic tests applied to the same diseased and non-diseased subjects. The associations between two diagnostic test results are often found to be unequal for the diseased and non-diseased subjects. In this paper, multivariate meta-analytic methods are studied by taking into account the different associations between correlated variables. On the basis of Monte Carlo simulations, we evaluate the performance of the multivariate meta-analysis methods proposed in this paper.

• 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.

• Asian Pacific Journal of Cancer Prevention
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• v.16 no.6
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• pp.2361-2368
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• 2015

Objective: To evaluate the diagnostic accuracy of contrast-enhanced ultrasonography (CEUS) in differentiating between benign and malignant enlarged lymph nodes using meta-analysis. Materials and Methods: Pubmed, Embase, SCI and Cochrane databases were searched for studies (up to September 1, 2014) reporting the diagnostic performance of CEUS in discriminating between benign and malignant lymph nodes. Inclusion criteria were: prospective study; histopathology as the reference standard; and sufficient data to construct $2{\times}2$ contingency tables. Methodological quality was assessed using Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2). Patient clinical characteristics, sensitivity and specificity were extracted. The summary receiver operating characteristic curve was used to examine the accuracy of CEUS. A meta-analysis was performed to evaluate the clinical utility in identification of benign and malignant lymph nodes. Sensitivity analysis was performed after omitting outliers identified in a bivariate boxplot and publication bias was assessed with Egger testing. Results: The pooled sensitivity, specificity and AUROC were 0.92 (95%CI, 0.85-0.96), 0.91 (95%CI, 0.82-0.95) and 0.97 (95%CI, 0.95-0.98), respectively. After omitting 3 outlier studies, heterogeneity decreased. Sensitivity analysis demonstrated no disproportionate influences of individual studies. Publication bias was not significant. Conclusions: CEUS is a promising diagnostic modality in differentiating between benign and malignant lymph nodes and can potentially reduce unnecessary fine-needle aspiration biopsies of benign nodes.

• Korean Journal of Radiology
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• v.24 no.8
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• pp.739-751
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• 2023

Objective: This systematic review and meta-analysis evaluated the accuracy of preoperative breast magnetic resonance imaging (MRI) features and tumor-to-nipple distance (TND) for diagnosing occult nipple-areolar complex (NAC) involvement in breast cancer. Materials and Methods: The MEDLINE, Embase, and Cochrane databases were searched for articles published until March 20, 2022, excluding studies of patients with clinically evident NAC involvement or those treated with neoadjuvant chemotherapy. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Two reviewers independently evaluated studies that reported the diagnostic performance of MRI imaging features such as continuity to the NAC, unilateral NAC enhancement, non-mass enhancement (NME) type, mass size (> 20 mm), and TND. Summary estimates of the sensitivity and specificity curves and the summary receiver operating characteristic (SROC) curve of the MRI features for NAC involvement were calculated using random-effects models. We also calculated the TND cutoffs required to achieve predetermined specificity values. Results: Fifteen studies (n = 4002 breast lesions) were analyzed. The pooled sensitivity and specificity (with 95% confidence intervals) for NAC involvement diagnosis were 71% (58-81) and 94% (91-96), respectively, for continuity to the NAC; 58% (45-70) and 97% (95-99), respectively, for unilateral NAC enhancement; 55% (46-64) and 83% (75-88), respectively, for NME type; and 88% (68-96) and 58% (40-75), respectively, for mass size (> 20 mm). TND had an area under the SROC curve of 0.799 for NAC involvement. A TND of 11.5 mm achieved a predetermined specificity of 85% with a sensitivity of 64%, and a TND of 12.3 mm yielded a predetermined specificity of 83% with a sensitivity of 65%. Conclusion: Continuity to the NAC and unilateral NAC enhancement may help predict occult NAC involvement in breast cancer. To achieve the desired diagnostic performance with TND, a suitable cutoff value should be considered.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.22
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• pp.9865-9869
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• 2014

Background: Transthoracic fine needle aspiration (FNA) is one of several methods for establishing tissue diagnosis of lung lesions. Other tissue or cell sources for diagnosis include sputum, endobronchial biopsy, washing and brushing, endobronchial FNA, transthoracic core needle biopsy, biopsy from thoracoscopy or thoracotomy. The purpose of this study was to compare the sensitivity and specificity of FNA and other diagnostic tests in diagnosing lung lesions. Materials and Methods: The population included all patients undergoing FNA for lung lesions at Meir Medical Center from 2006 through 2010. Information regarding additional tissue tests was derived from the electronic archives of the Department of Pathology, patient records and files from the Department of Oncology. Sensitivity, specificity, diagnostic accuracy, and positive and negative predictive values were calculated for each test. Results: FNA was carried out in 245 patients. Malignant tumors were diagnosed in 190 cases (78%). They included adenocarcinoma (43%), squamous cell carcinoma (15%), non-small cell carcinoma, not otherwise specified (19%), neurondocrine tumors (7%), metastases (9%) and lymphoma (3%). The specificity of FNA for lung neoplasms was 100%; sensitivity and diagnostic accuracy were 87%. Conclusions: FNA is the most sensitive procedure for establishing tissue diagnoses of lung cancer. Combination with core needle biopsy increases the sensitivity. Factors related to the lesion (nature, degenerative changes, location) and to performance of all stages of test affect the ability to establish a diagnosis.