• Parasites, Hosts and Diseases
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• 제58권2호
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• pp.147-152
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• 2020

Malaria is a potent burden on public healthcare worldwide due to requiring rapid diagnosis and treatment. Nowadays, prompt diagnosis with rapid diagnostic tests (RDTs) has been widely accepted as an effective diagnostic technique in malaria-endemic countries, primarily due to their easy operation, fast output, and straightforward interpretation. The global availability and use of RDTs have gradually grown over recent decades as field-applicable diagnostic tests for the reliable confirmation of malaria infection and proper case management. This study was conducted to evaluate diagnostic performance of 3 commercially available malaria RDT kits : BIOCREDIT^TM Malaria Ag Pf(pLDH), Malaria Ag Pf(pLDH/pHRPII), and Malaria Ag Pf/Pv(pLDH/pLDH) (where pLDH and pHRPII stand for plasmodium lactate dehydrogenase and histidine-rich protein 2, respectively) for the specific detection of Plasmodium falciparum. A total of 1,129 blood samples including 95 blood samples, confirmed as vivax malaria infection by microscopic examinations and a nested-PCR method, were tested for falciparum malaria infection. The overall sensitivity and specificity of Malaria Ag Pf(pLDH/pHRPII), Malaria Ag Pf/Pv(pLDH/pLDH), and Pf(pLDH) for P. falciparum were 99.0% and 100%, 95.8% and 100%, and 100% and 100%, respectively. It is proposed that the 3 RDT kits perform reliable level of diagnostic accuracy of detection for P. falciparum parasites.

• Asian Pacific Journal of Cancer Prevention
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• 제13권11호
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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.

• 대한수의학회지
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• 제44권4호
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• pp.669-676
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• 2004

To evaluate the diagnostic accuracy of two commercial ELISA tests (Allied- and CSL-ELISA) for the diagnosis of Mycobacterium paratuberculosis in cattle, Meta-analysis using English language papers published during 1990-2001 was performed. Diagnostic odds ratios (DOR) were analyzed using regression analysis together with summary receiver operating characteristic (ROC) curves. The difference in diagnostic performance between the two ELISA systems was evaluated by using linear regression. Publication bias was assessed by funnel plot and linear regression. The pooled sensitivity and specificity were 44% (95% CI, 38 to 51) and 98% (95% CI, 96 to 99) for the random-effect model. The DOR between studies was heterogeneous. The area under the fitted ROC curve (AUC) was 0.72 for the unweighted and 0.77 for the weighted model. Maximum joint sensitivity and specificity for the unweighted and weighted model from their summary ROC curve were 70% and 75%, respectively. Based on the fitted model, at a specificity of 95%, sensitivity was estimated to be 52% for the unweighted and 57% for the weighted model. From the final multivariable model study characteristic, the country was the only significant variable with an explained component variance of 13.3%. There were no significant differences in discriminatory power, sensitivity, and specificity between the two ELISA tests. The overall diagnostic accuracy of two commercial ELISA tests was moderate, as judged by the AUC, maximum joint sensitivity and specificity, and estimates from the fitted model and clinical usefulness of the tests for screening program is limited because of low sensitivity and heterogeneous of DOR. It is, therefore, recommended to use ELISA tests as a parallel testing with other diagnostic tests together to increase test sensitivity in the screening program.

• Korean Journal of Radiology
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• 제20권1호
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• pp.158-165
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• 2019

Objective: Recent studies demonstrated that core needle biopsy (CNB) can effectively reduce the possibility of inconclusive results and prevent unnecessary diagnostic surgery. However, the effectiveness of CNB in patients with suspicious thyroid nodules has not been fully evaluated. This prospective study aimed to determine the potential of CNB to assess thyroid nodules with suspicious ultrasound (US) features. Materials and Methods: Patients undergoing CNB for thyroid nodules with suspicious features on US were enrolled between May and August 2016. Diagnostic performance and the incidence of non-diagnostic results, inconclusive results, conclusive results, malignancy, unnecessary surgery, and complications were analyzed. Subgroup analysis according to nodule size was performed. The risk factors associated with inconclusive results were evaluated using multivariate logistic regression analysis. Results: A total of 93 patients (102 thyroid nodules) were evaluated. All samples obtained from CNB were adequate for diagnosis. Inconclusive results were seen in 12.7% of cases. The diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value for diagnosis of malignancy were 93.8%, 100%, 100%, 78.9%, and 95%, respectively. None of the patients underwent unnecessary surgery. The diagnostic performance was not significantly different according to nodule size. On multivariate logistic regression analysis, larger nodule size and shorter needle length were independent risk factors associated with inconclusive results. Conclusion: Samples obtained by CNB were sufficient for diagnosis in all cases and resulted in high diagnostic values and conclusive results in the evaluation of suspicious thyroid nodules. These findings indicated that CNB is a promising diagnostic tool for suspicious thyroid nodules.

• Korean Journal of Radiology
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• 제24권2호
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• pp.155-165
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• 2023

Objective: Little is known about the effects of using different expert-determined reference standards when evaluating the performance of deep learning-based automatic detection (DLAD) models and their added value to radiologists. We assessed the concordance of expert-determined standards with a clinical gold standard (herein, pathological confirmation) and the effects of different expert-determined reference standards on the estimates of radiologists' diagnostic performance to detect malignant pulmonary nodules on chest radiographs with and without the assistance of a DLAD model. Materials and Methods: This study included chest radiographs from 50 patients with pathologically proven lung cancer and 50 controls. Five expert-determined standards were constructed using the interpretations of 10 experts: individual judgment by the most experienced expert, majority vote, consensus judgments of two and three experts, and a latent class analysis (LCA) model. In separate reader tests, additional 10 radiologists independently interpreted the radiographs and then assisted with the DLAD model. Their diagnostic performance was estimated using the clinical gold standard and various expert-determined standards as the reference standard, and the results were compared using the t test with Bonferroni correction. Results: The LCA model (sensitivity, 72.6%; specificity, 100%) was most similar to the clinical gold standard. When expert-determined standards were used, the sensitivities of radiologists and DLAD model alone were overestimated, and their specificities were underestimated (all p-values < 0.05). DLAD assistance diminished the overestimation of sensitivity but exaggerated the underestimation of specificity (all p-values < 0.001). The DLAD model improved sensitivity and specificity to a greater extent when using the clinical gold standard than when using the expert-determined standards (all p-values < 0.001), except for sensitivity with the LCA model (p = 0.094). Conclusion: The LCA model was most similar to the clinical gold standard for malignant pulmonary nodule detection on chest radiographs. Expert-determined standards caused bias in measuring the diagnostic performance of the artificial intelligence model.

• 한국통계학회:학술대회논문집
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• 한국통계학회 2000년도 추계학술발표회 논문집
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• pp.173-179
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• 2000

Genetic algorithm(GA) is applied for detecting multiple outliers. GA is a heuristic optimization tool solving for near optimal solution. We compare the performance of GA and the other diagnostic measures commonly used for detecting outliers in regression model. The results show that GA seems to have better performance than the others for the detection of multiple outliers.

• 대한방사선협회지
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• 제28권1호
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• pp.120-144
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• 2002

Purpose The quality assurance in a computed tomography gives a definition to be all the activity so as to optimize the performance of the device and keep an invariable quality of image, and it is to raise a high diagnostic efficiency to obtain a much info

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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• pp.291.1-291.1
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• 2003

The purpose of this study is to provide KFDA's guidance for premarket notification submission and labeling for prescription use drugs of abuse in vitro diagnostic devices. To evaluate in vitro diagnostic devices the following performance characteristics should be described in detail within the submission: analytical sensitivity or minimum detection limit, cutoff concentration, specificity and cross reactivity, interference, precision, method comparison and stability. (omitted)

• Korean Journal of Radiology
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• 제22권12호
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• pp.2026-2033
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• 2021

Objective: The aim of this study was to compare the diagnostic performances of digital tomosynthesis (DTS) and conventional radiography in detecting osteonecrosis of the femoral head (ONFH) using computed tomography (CT), as the reference standard and evaluate the diagnostic reproducibility of DTS. Materials and Methods: Forty-five patients (24 male and 21 female; age range, 25-77 years) with clinically suspected ONFH underwent anteroposterior radiography, DTS, and CT. Two musculoskeletal radiologists independently evaluated the presence and type of ONFH. The diagnostic performance of radiography and DTS in detecting the presence of ONFH and determining the types of ONFH were evaluated. The interobserver and intraobserver reliabilities of each imaging modality were analyzed using Cohen's kappa. Results: DTS had higher sensitivity (89.4%-100% vs. 74.5%-76.6%) and specificity (97.3%-100% vs. 78.4%-83.8%) for ONFH detection than radiography. DTS showed higher performance than radiography in identifying the subtypes of ONFH with statistical significance in one reader (type 1, 100% vs. 30.8%, p = 0.004; type II, 97.1% vs. 73.5%, p = 0.008). The interobserver agreement was excellent for DTS and moderate for radiography (kappa of 0.86 vs. 0.57, respectively). The intraobserver agreement for DTS was higher than that of radiography (kappa of 0.96 vs. 0.69, respectively). Conclusion: DTS showed higher diagnostic performance and reproducibility than radiography in detecting ONFH. DTS may be used as a first-line diagnostic modality instead of radiography for patients suspected of having ONFH.

• Korean Journal of Radiology
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• 제24권8호
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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.