• Tuberculosis and Respiratory Diseases
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• v.84 no.3
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• pp.226-236
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• 2021

Background: Although the Quidel Sofia rapid influenza fluorescent immunoassay (FIA) is widely used to identify influenza A and B, the diagnostic accuracy of this test remains unclear. Thus, the objective of this study was to determine the diagnostic performance of this test compared to reverse transcriptase-polymerase chain reaction. Methods: A systematic literature search was performed using MEDLINE, EMBASE, and the Cochrane Central Register. Pooled sensitivity, specificity, diagnostic odds ratio (DOR), and a hierarchical summary receiver-operating characteristic curve (HSROC) of this test for identifying influenza A and B were determined using meta-analysis. A sensitivity subgroup analysis was performed to identify potential sources of heterogeneity within selected studies. Results: We identified 17 studies involving 8,334 patients. Pooled sensitivity, specificity, and DOR of the Quidel Sofia rapid influenza FIA for identifying influenza A were 0.78 (95% confidence interval [CI], 0.71-0.83), 0.99 (95% CI, 0.98-0.99), and 251.26 (95% CI, 139.39-452.89), respectively. Pooled sensitivity, specificity, and DOR of this test for identifying influenza B were 0.72 (95% CI, 0.60-0.82), 0.98 (95% CI, 0.96-0.99), and 140.20 (95% CI, 55.92-351.54), respectively. The area under the HSROC for this test for identifying influenza A was similar to that for identifying influenza B. Age was considered a probable source of heterogeneity. Conclusion: Pooled sensitivities of the Quidel Sofia rapid influenza FIA for identifying influenza A and B did not quite meet the target level (≥80%). Thus, caution is needed when interpreting data of this study due to substantial betweenstudy heterogeneity.

• Korean Journal of Radiology
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• v.24 no.2
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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.

• Proceedings of the PSK Conference
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• 2003.04a
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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)

• Parasites, Hosts and Diseases
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• v.51 no.6
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• pp.751-754
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• 2013

Neurognathostomiasis is a severe form of human gnathostomiasis which can lead to disease and death. Diagnosis of neurognathostomiasis is made presumptively by using clinical manifestations. Immunoblotting, which recognizes antigenic components of molecular mass 21 kDa and 24 kDa in larval extracts of Gnathostoma spinigerum (Gs 21/24), has high sensitivity and specificity for diagnosis of neurognathostomiasis. However, only very small amounts of the Gs 21/24 antigens can be prepared from parasites harvested from natural or experimental animals. To overcome this problem, we recently produced a recombinant matrix metalloproteinase (rMMP) protein from G. spinigerum. In this study, we evaluated this rMMP alongside the Gs 21/24 antigens for serodiagnosis of human neurognathostomiasis. We studied sera from 40 patients from Srinagarind Hospital, Khon Kaen University, Thailand, with clinical criteria consistent with those of neurognathostomiasis, and sera from 30 healthy control adults from Thailand. All sera were tested for specific IgG antibodies against both G. spinigerum crude larval extract and rMMP protein using immunoblot analysis. The sensitivity and specificity for both antigenic preparations were all 100%. These results show that G. spinigerum rMMP protein can be used as an alternative diagnostic antigen, in place of larval extract, for serodiagnosis of neurognathostomiasis.

• 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 agricultural medicine and community health
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• v.31 no.2
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• pp.157-164
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• 2006

Objectives: Early diagnosis and treatment is the most important strategy to control malaria effectively. Microscopic examination of blood films is a traditional and standard method for diagnosing malaria, which takes a long time and needs expertise, Therefore, the alternative method, rapid diagnostic kit has been used for quick diagnosis in some counties, a highly infectious region by P. vivax. The purpose of this study was to evaluate the utility of malaria rapid diagnostic kit in Ganghwa county. Methods: The utility was evaluated by mean diagnosis time and sensitivity and specificity. For monitoring mean diagnosis time, 942 cases which were diagnosed for P. vivax were collected between 1998 and 2005, And for calculating sensitivity and specificity, 434 whole bloods in EDTA which were presented for P. vivax by microscopy and rapid diagnostic kit were collected between 2004 and 2005. Results: After malaria rapid diagnostic kit was used in 2003, mean diagnosis time has decreased to 3.36-3.14 day. The sensitivity and specificity of the rapid diagnostic kit was 98.2% and 98,5% and comparable to that of microscopic examination. Conclusions: The malaria rapid diagnostic kit is useful tool in a highly infectious region like Ganghwa county.

• Journal of Gastric Cancer
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• v.3 no.4
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• pp.182-185
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• 2003

Purpose: Preoperative staging of gastric cancer is crucial because the treatment modality and the prognosis depend upon the stage of gastric cancer. Current treatment modalities for early gastric cancer have focused on the quality of life. Endoscopic ultrasonography (EUS) and abdominal computed tomography (CT) are commonly used diagnostic tools to evaluate the invasiveness (T stage) of the primary tumor. The purpose of this paper is to evaluate the sensitivity and the specificity of preoperative EUS and CT in comparison with postoperative pathology. Materials and Methods: From October 2001 to October 2002, EUS and abdominal CT were performed simultaneously on 75 patients who underwent radical gastric surgery for the treatment of gastric cancer. Through analyzing the clinical T stage and the pathologic T stage, We evaluated the diagnostic sensitivities and specificities of endoscopic ultrasonography and abdominal computed tomography. Results: The male-to-female sex ratio was 1 : 0.6 (males: 47, females: 28). The mean age was 55.4 years in males (range: $28\~81$) and 54.4 years in females (range: $23\∼77$). The clinical T stage based on EUS included 22 T1mm, 7 T1sm, 22 T2, and 24 T3. The clinical T stage based on CT included 20 Tx, 23 T2, and 32 T3. The permanent pathologic report confirmed 23 T1mm, 10 T1sm, 17 T2, 24 T3, and 1 T4. The sensitivity and specificity of EUS were $84.2\%\;and\;94.7\%$, respectively. However, the sensitivity and specificity of abdominal CT were $53.3\%\;and\;77.0\%$, respectively. Conclusion: Our data suggest that EUS is a very useful diagnostic tool for evaluating the T stage of gastric cancer because EUS has higher specificity than abdominal CT. Therefore, EUS may have a significant role as a preoperative diagnostic modality in patients undergoing minimally invasive surgery.

• Journal of Veterinary Clinics
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• v.18 no.4
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• pp.329-333
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• 2001

Evaluation on the diagnostic performances of urease test and polymerase chain reaction (PCR) for detection of Helicobacter species infection in dogs has rarely been performed in research with site-specific situations, although assessing diagnostic tests is an essential part prior to its practical use in a variety of clinical settings. The clinical value of a diagnostic test may be misjudged and comparisons between different tests may yield misleading conclusions when high within-patient correlations are present. We applied a conceptually simple statistical approach to estimate the sensitivity and specificity of urease test and PCR for detection of Helicobacter species infection in dogs. This approach assumes that responses from three different sampling sites within an animal are correlated where unit for statistical analysis is the site rather than the animal. The sensitivity and specificity of urease test was 0.74% (95% confidence interval, 0.64-0.84) and 0.87 (95% CI, 0.67-1.00), respectively. For PCR, the sensitivity was 0.95(95% CI, 0.89-1.00) and specificity 0.90 (95% CI, 0.70-1.00). Two tests were almost equally specific. Urease test, however, has a lower diagnostic accuracy and thus should only be used after careful validation in terms of sensitivity.

• The Journal of Korean Orthopaedic Ultrasound Society
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• v.6 no.2
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• pp.53-59
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• 2013

Purpose: The aim of this study wasto evaluate the comparison of CT arthrography and ultrasonography, confirmed by the arthroscopic finding in patients with rotator cuff disease. Materials and Methods: We evaluated fifty seven patients with rotator cuff disease underwent CTA and arthroscopy, and twenty eight patients had taken ultrasonographyadditionally. The diagnostic value and prediction for tear size between CTA and ultrasonography were evaluated, as compared to arthroscopic findings. Results: CTA showed a sensitivity of 86.2% and a specificity of 100% in full thickness tear ofsupraspinatus, a sensitivity of 58.3% and a specificity of 87.8% in partial-thickness tear. CTA demonstrated good diagnostic value for full thickness tear, but there was relatively lower value for partial-thickness tear. Ultrasonography showed a sensitivity of 84.6% and a specificity of 86.7% for diagnosing in full thickness tear, a sensitivity of 84.6% and a specificity of 73.3% in partial-thickness tear. Ultrasonography provided good diagnostic value, but, there is lesser accurate result for prediction of tear size. Conclusion: CTA showedgood diagnostic tool of detection full-thickness tear of rotator cuff disease and predicting of tear size. Comparing with ultrasonography, CTA was inferior for detection of partial-thickness tear, but, provided better estimation for tear size.

• Korean Journal of Agricultural Science
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• v.47 no.1
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• pp.173-182
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• 2020

Human Astrovirus (HuAstV), known as a waterborne virus, is a group IV positive-sense single-stranded RNA that belongs to Astroviridae. The first outbreak of HuAstV was reported in England in 1975. HuAstV can exist not only among clinical patients but also in various water environments, such as water for agriculture and vegetables. For diagnosis of HuAstV from water samples, a polymerase chain reaction (PCR) system has been developed. However, the PCR-based diagnostic method has problems in field application, such as reaction time, sensitivity and specificity. For this reason, in this study we developed the loop-mediated isothermal amplification assay (LAMP) system, aimed specifically at HuAstV. Three prepared LAMP primer sets were tested by specificity, non-specificity and sensitivity; one LAMP primer set was selected with optimum reaction temperature. The developed LAMP primer set reaction conditions were confirmed at 62℃, and detection sensitivity was 1 fg/μL. In addition, restriction enzyme HaeIII (GG/CC) was introduced to confirm that the LAMP reaction was positive. As a result, selected LAMP primer set was 100 - 1000 times more specific, rapid, and sensitive than conventional-nested PCR methods. For verification of the developed LAMP assay, twenty samples of cDNA from groundwater samples were tested. We expect that the developed LAMP assay will be used to diagnose HuAstV from various samples.