• Title/Summary/Keyword: sensitivity and specificity

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Urinary Tract Infections in Febrile Infants under Three Months of Age (3개월 이하 영아기 열성 요로감염증에 대한 임상적 관찰)

  • Eun, Byung Wook;Chung, Yoo Mi;Kang, Hee Gyung;Ha, Il Soo;Cheong, Hae Il;Lee, Hoan Jong;Choi, Yong
    • Clinical and Experimental Pediatrics
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    • v.46 no.3
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    • pp.265-270
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    • 2003
  • Purpose : To characterize the infants under 3 months of age with urinary tract infections(UTIs), and especially patients with bacteremia or meningitis Methods : Hospital records of all the infants under 3 months of age discharged from our hospital for 69 consecutive months with the diagnosis of initial episode of UTI were reviewed. UTI was defined when patients had fever with pyuria, and had urine culture results of ${\geq}10^5$ colony forming units/mL from a bag specimen. Patients with previously known urologic abnormality or immunodeficiency were excluded. Nosocomial infections were also excluded from the study. Results : The male:female ratio was 35 : 6. Of the urine cultures, 40(97.6%) yielded single pathogen, one yielded two pathogens. Escherichia coli was the predominant isolate from the urine. Five patients(12%) also had bacteremia. Pathogens isolated from the blood cultures were E. coli(4) and Enterococcus faecalis(1). No patient had culture-positive meningitis or cerebrospinal fluid pleocytosis. Clinical or laboratory findings between patients with and without bacteremia were not different significantly. The rate of vesicoureteral reflux(VUR) was 44%. The sensitivity of ultrasound for detection of VUR was 38%; specificity was 50%. Conclusion : Clinical and laboratory data were not helpful for identifying patients with bacteremia at the time of presentation. Consequently, blood cultures need to be obtained from all febrile infants under 3 months of age with UTIs. A large-scale study including the indication of lumbar puncture for infants with a febrile UTI and study of evaluation and treatment of infants under 3 months of age with UTIs are required.

Clinical Significance of Tumor Markers in Gastric Cancer Patients after Curative Resection (근치적 절제술을 시행한 위암 환자에서 종양 표지자의 임상적 의미)

  • Kim, Sa-Young;Ha, Tae-Kyung;Kwon, Sung-Joon
    • Journal of Gastric Cancer
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    • v.9 no.3
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    • pp.136-142
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    • 2009
  • Purpose: This clinical study was conducted to evaluate the predictive value of tumor markers for recurrence and the clinical significance of false positive findings after curative gastrectomy in patients with gastric cancer. Materials and Methods: Two hundred ninety patients with gastric cancer who underwent gastrectomy with curative intent were evaluated retrospectively. We analyzed the correlations between changes in tumor markers (CEA, CA 19-9, AFP, and CA-125) and clinicopathologic data, and basis for changes in tumor markers without recurrence during the follow-up period. Results: The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of tumor markers for recurrence were 75.0%, 64.6%, 23.1%, 94.8%, and 65.9% respectively. Among 36 patients with recurrences, 10 patients (27.8%) had elevated tumor markers prior to positive findings on imaging studies, while 13 patients (36.1%) had concomitant elevation in tumor markers. At least 1 of the 4 tumor markers increased in 90 of 290 patients during the follow-up period; however, there was no evidence of tumor recurrence. Twenty patients had persistently elevated tumor markers, while the tumor marker levels in 70 patients returned to normal level within $9.08\pm7.2$ months. The patients with pulmonary disease, hepatobiliary disease, diabetes, hypertension, or herbal medication users had elevated tumor markers more frequently than patients without disease (P<0.001). Conclusion: Although detecting recurrence of gastric cancer with tumor markers may be useful, false positive findings of tumor markers are common, so surgeons should consider other chronic benign diseases and medical conditions when tumor markers increase without evidence of recurrence.

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Real-Time RT-PCR for Validation of Reovirus Type 3 Safety During the Manufacture of Mammalian Cell Culture-Derived Biopharmaceuticals (세포배양 유래 생물의약품 생산 공정에서 Reovirus Type 3 안전성 검증을 위한 Real-Time RT-PCR)

  • Lee, Dong-Hyuck;Jeong, Hyo-Sun;Kim, Tae-Eun;Oh, Seon-Hwan;Lee, Jung-Suk;Kim, In-Seop
    • Korean Journal of Microbiology
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    • v.44 no.3
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    • pp.228-236
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    • 2008
  • Validation of viral safety is essential in ensuring the safety of mammalian cell culture-derived biopharmaceuticals, because numerous adventitious viruses have been contaminated during the manufacture of the products. Mammalian cells are highly susceptible to Reovirus type 3 (Reo-3), and there are several reports of Reo-3 contamination during the manufacture of biopharmaceuticals. In order to establish the validation system for the Reo-3 safety, a real-time RT-PCR method was developed for quantitative detection of Reo-3 in cell lines, raw materials, manufacturing processes, and final products as well as Reo-3 clearance validation. Specific primers for amplification of Reo-3 RNA was selected, and Reo-3 RNA was quantified by use of SYBR Green I. The sensitivity of the assay was calculated to be $3.2{\times}10^0\;TCID_{50}/ml$. The real-time RT-PCR method was proven to be reproducible and very specific to Reo-3. The established real-time RT-PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with Reo-3. Reo-3 RNA could be quantified in CHO cell as well as culture supernatant. When the real-time RT-PCR assay was applied to the validation of virus removal during a virus filtration process, the result was similar to that of virus infectivity assay. Therefore, it was concluded that this rapid, specific, sensitive, and robust assay could replace infectivity assay for detection and clearance validation of Reo-3.

Usefulness of Serum Thymidine Kinase 1 as a Biomarker for Aggressive Clinical Behavior in B-cell Lymphoma (B세포림프종의 임상적 악성도 표지자로서 혈청 Thymidine Kinase 1의 유용성)

  • Kim, Heyjin;Kang, Hye Jin;Lee, Jin Kyung;Hong, Young Jun;Hong, Seok-Il;Chang, Yoon Hwan
    • Laboratory Medicine Online
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    • v.6 no.1
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    • pp.25-30
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    • 2016
  • Background: The cell cycle-dependent enzyme thymidine kinase 1 (TK1) is known to increase during cancer cell proliferation and has been reported as a prognostic marker for various hematologic malignancies and solid tumors. This study aimed to determine the reference interval in Korean healthy controls and to evaluate the usefulness of TK1 as a biomarker for aggressive clinical behavior in B-cell lymphoma patients. Methods: We enrolled 72 previously untreated patients with B-cell lymphoma and 143 healthy controls. Serum TK1 levels were measured by chemiluminescence immunoassay ($Liaison^{(R)}$, DiaSorin, USA). We established the reference intervals in healthy controls. The diagnostic performance of serum TK1 was studied using receiver operating characteristic (ROC) analysis, and the correlation between the cutoff level for serum TK1 and clinical characteristics of B-cell lymphoma was evaluated. Results: The reference range (95th percentile) of serum TK1 in healthy controls was 5.4-21.8 U/L. There was a clear difference in TK1 levels between patients with B-cell lymphoma and healthy controls ($40.6{\pm}68.5$ vs. $11.8{\pm}4.4U/L$, P <0.001). The area under the curve of serum TK1 for the diagnosis of B-cell lymphoma was 0.73 (cutoff, 15.2 U/L; sensitivity, 59.7%; specificity, 83.2%). An increased TK1 level (${\geq}15.2U/L$) correlated with the advanced clinical stage (P <0.001), bone marrow involvement (P =0.013), international prognostic index score (P =0.001), lactate dehydrogenase level (P =0.001), low Hb level (<12 g/dL) (P =0.028), and lymphocyte count (P =0.023). Conclusions: The serum TK1 level could serve as a useful biomarker for aggressive clinical behavior in B-cell lymphoma patients.

Diagnostic Value of CYFRA 21-1 Measurement in Fine-Needle Aspiration Washouts for Detection of Axillary Recurrence in Postoperative Breast Cancer Patients (유방암 수술 후 액와림프절 재발 진단에 있어서의 미세침세척액 CYFRA 21-1의 진단적 가치)

  • So Yeon Won;Eun-Kyung Kim;Hee Jung Moon;Jung Hyun Yoon;Vivian Youngjean Park;Min Jung Kim
    • Journal of the Korean Society of Radiology
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    • v.81 no.1
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    • pp.147-156
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    • 2020
  • Purpose The objective of this study was to evaluate the diagnostic value and threshold levels of cytokeratin fragment 21-1 (CYFRA 21-1) in fine-needle aspiration (FNA) washouts for detection of lymph node (LN) recurrence in postoperative breast cancer patients. Materials and Methods FNA cytological assessments and CYFRA 21-1 measurement in FNA washouts were performed for 64 axillary LNs suspicious for recurrence in 64 post-operative breast cancer patients. Final diagnosis was made on the basis of FNA cytology and follow-up data over at least 2 years. The concentration of CYFRA 21-1 was compared between recurrent LNs and benign LNs. Diagnostic performance and cut-off value were evaluated using a receiver operating characteristic curve. Results Regardless of the non-diagnostic results, the median concentration of CYFRA 21-1 in recurrent LNs was significantly higher than that in benign LNs (p < 0.001). The optimal diagnostic cut-off value was 1.6 ng/mL. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of CYFRA 21-1 for LN recurrence were 90.9%, 100%, 100%, 98.1%, and 98.4%, respectively. Conclusion Measurement of CYFRA 21-1 concentration from ultrasound-guided FNA biopsy aspirates showed excellent diagnostic performance with a cut-off value of 1.6 ng/mL. These results indicate that measurement of CYFRA 21-1 concentration in FNA washouts is useful for the diagnosis of axillary LN recurrence in post-operative breast cancer patients.

The Change of Squamous Cell Cancer Antigen (SCC Ag) Level as A Tumor Marker in Squamous Cell Lung Cancer (편평세포 폐암환자에서 Squamous Cell Cancer Antigen(SCC 항원)의 변화)

  • Kim, Young-Jun;Park, In-Won;Choi, Byung-Whui;Hue, Sung-Ho
    • Tuberculosis and Respiratory Diseases
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    • v.39 no.5
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    • pp.400-406
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    • 1992
  • Background: It has been known that see antigen was used in diagnosis of uterine cervical cancer and also known to be higher in squamous cell lung cancer. There has been no report about see antigen in squamous cell lung cancer in Korea. This study was designed to evaluate the usefulness of see antigen as a diagnostic tool and index for follow up after treatment. Method: The serum level of see antigen was measured in 12 cases with squamous cell lung carcinoma, 9 patients with other types of lung cancer, 7 patients with benign lung disease and 7 normal subjects by radioimmunoassay with Abott see Riabeap radioimmunoassay kit. We also measured see antigen after treatment in 6 patients who had received chemotherapy or sugery. Result: 1) The level of see antigen ($mean{\pm}1$ SD) was $2.27{\pm}1.53$, $0.67{\pm}0.38$, $0.62{\pm}0.53$, $0.53{\pm}0.36\;ng/ml$ respectively. 2) The see antigen activity in squamous cell lung carcinoma according to stage were as gollows. I; $2.07{\pm}1.56$, $III_a$; $5.04{\pm}0.53$ $III_b$; $1.94{\pm}0.7$ IV; $1.07{\pm}0.64$ (ng/ml). 3) In squamous cell lung cancer, 5 of 12 (42%) cases was shown more than 2.0 ng/ml see antigen. (sensitivity; 42%), but there was no case in any other type of lung cancer, benign lung disease, and in control groups (specificity; 100%). 4) The serum sec antigen level after treatment was significantly decreased in patients with partial or complete remission (p<0.01). Conclusion; It was suggested that see antigen might be used as a useful tumor marker for the response of treatment and assessment of prognosis in squamous cell lung cancer, but further study should be performed for the clinical use of see antigen.

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The Clinical Utility of Polymerase Chain Reaction in the Bronchoalveolar Lavage Fluid for the Detection of Mycobacteria (객담 도말 음성인 환자에서 기관지폐포 세척액 결핵균 중합 효소 연쇄반응 검사의 유용성)

  • Mo, Eun-Kyung;Kyung, Tae-Young;Kim, Dong-Gyu;Park, Myung-Jae;Lee, Myung-Goo;Hyun, In-Gyu;Jung, Ki-Suck;Lee, Kyung-Wha
    • Tuberculosis and Respiratory Diseases
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    • v.45 no.3
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    • pp.519-528
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    • 1998
  • Background: Diagnosis of pulmonary tuberculosis is not easy when the sputum smear for Mycobacterium tuberculosis(M. Tb) is negative. We evaluated the clinical utility of polymerase chain reaction(PCR) for detecting M. Tb in bronchoalveolar lavage(BAL) samples. Methods: We recruited 84 patients whose sputum smear for M. Tb were negative or not available due to no production of sputum. We performed bronchoalveolar lavage for acid-fast stain, culture of mycobacteria, and PCR assay of BAL fluid. We analyzed the results of microbiologic examination. Results: The sensitivity of BAL fluid smear, culture, and PCR were 20%, 38%, and 40%, respectively. The specificity of BAL fluid PCR was 95%. The positive predictive value of PCR was 89%. The smear of BAL fluid was positive in 17%. The PCR of BAL fluid was the only diagnostic test in 17%. Therefore, the BAL fluid analysis including smear and PCR was diagnostic in 34 % within 24 hours. The BAL fluid analysis including smear, PCR, and culture was diagnostic in 55% within 2 month. Conclusion: The BAL fluid PCR was valuable method in the diagnosis of pulmonary tuberculosis in patients whose sputa were not available or reveal negative smear.

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Prediction of Improvement of Hibernating Myocardium after Coronary Artery Bypass Grafting -The role of dobutamine stress echocardiography- (동면심근을 가진 관상동맥 환자의 수술 후 기능회복의 예측에 대한 임상적 고찰 - Dobutamine 심초음파의 역할 -)

  • 유경종;강면식;이교준;김대준;임세중;정남식
    • Journal of Chest Surgery
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    • v.31 no.8
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    • pp.776-780
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    • 1998
  • Background: In patients with coronary artery disease, dysfunctional hypoperfused myocardium at rest may represent either nonviable or viable hibernating myocardium. Two-dimensional echocardiography can detect regional wall motion abnormalities resulting from myocardial ischemia by dobutamine infusion. The purpose of the present study was to identify the prediction of improvement of regional left ventricular(LV) function after surgical revascularization. Materials and methods: Sixteen patients with chronic regional LV dysfunction underwent dobutamine stress echocardiography(DSE) (dobutamine: baseline, 5, 10, 20$\mu$g/kg/min) before coronary artery bypass grafting(CABG) and underwent echocardiography at least 2 months after CABG. Results: All patients were male with mean age of 58 years ranging from 42 to 73 years. The mean LV ejection fraction was 41.8% with a range from 19% to 55%. During DSE, there were no complications, also, there were no operative morbidities or mortalities. Improvement of wall motion within the dysfunctional myocardium was found in 8(50%) of 16 patients in DSE. Among them, 6 patients(75%) showed functional recovery after CABG. Another 8 patients did not show improvement of wall motion in DSE. But among them, 3 patients(38%) showed functional recovery after CABG. 84 dysfunctional segments were found in 256 segments of 16 patients. Improvement of wall motion was found in 34 of 84 segments in DSE. Among them, 23 segments(74%) showed functional recovery after CABG. Another 53 segments did not show improvement of wall motion in DSE. But among them, 12 segments(23%) showed functional recovery after CABG. The sensitivity and specificity of DSE for the prediction of postoperative improvement of segmental wall motion were 66% and 84%, respectively. The positive and negative predictive value of DSE were 74% and 77%, respectively. In patients with chronic regional LV dysfunction, think that DSE is a good predictor of the improvement of dysfunctional segments after CABG.

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Comparison of Ultrasound-guided Suprapubic Aspiration with Urethral Catheterization in Infants (영유아에서 초음파 감시하 치골상부 방광천자와 도뇨관 채뇨의 비교)

  • Lee, Jung-Won;Lee, Seung-Joo
    • Childhood Kidney Diseases
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    • v.11 no.1
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    • pp.59-64
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    • 2007
  • Purpose : Suprapubic aspiration(SPA) has been considered the "gold standard" for obtaining urine in non-toilet trained infants. Ultrasound(US)-guided SPA improves the success rate of the procedure and reduces the complications. However, many physicians perceive SPA as invasive and prefer the use of urethral catheterization (Ucat). We compared the success rate, complications and accuracy of US-guided SPA and Ucat. Methods : 121 infants who visited Ewha Womans University Mokdong Hospital with suspected urinary tract infection(UTI) were investigated. For the first study, the study infants were randomly assigned to either the US-guided SPA(n=32) or Ucat(n=32) groups. The success rate and complications of both procedures were compared. For the second study, US-guided SPA and Ucat were performed simultaneously(n=57). The accuracy of urethral catheterization was subsequently analyzed. The criteria for success was defined as the collection of more than 0.5 mL of urine. UTI was diagnosed by the presence of uropathogens over 105 colony-forming units (CFU)/mL. Results : The overall success rate of the US-guided SPA was 96.9%(71.9% in first attempts, 25.0% in second attempts) which was not significantly different compared to 96.9%(90.6% in first attempts, 6.3% in second attempts) in the Ucat(P>0.05) group. The aspirated urine volume was $7.4{\pm}3.7mL$ in the US-guided SPA group, which was not significantly different to $4.5{\pm}2.6mL$ in the Ucat(P>0.05) group. The accuracy of Ucat in comparison to the US guided SPA was low with sensitivity 59.5%, specificity 86.6%, false-positive rate 13.3% and false-negative rate 40.5%. Conclusion : US-guided SPA should be encouraged as the best method to collect the urine in non-toilet trained infants with UTI.

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N-terminal Pro-B-type Natriuretic Peptide as a Predictive Risk Factor in Fontan Operation (Fontan 수술시 위험 예측인자로서의 N-Terminal Pro-B-type Natriuretic Peptide의 유용성)

  • Jang, Gi Young;Lee, Jae Young;Kim, Soo Jin;Shim, Woo Sup
    • Clinical and Experimental Pediatrics
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    • v.48 no.12
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    • pp.1362-1369
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    • 2005
  • Purpose : This study aimed to investigate the correlation between the plasma level of N-terminal pro-B-type natriuretic peptide(pro-BNP) and several known risk factors influencing outcomes after Fontan operations, and to assess whether pro-BNP levels can be used as predictive risk factors in Fontan operations. Methods : Plasma pro-BNP concentrations were measured in 35 patients with complex cardiac anomalies before catheterization. Cardiac catheterization was performed in all subjects. Mean right atrium pressure, mean pulmonary artery pressure(PAP), and ventricular end-diastolic pressure(EDP) were obtained. Cardiac output and pulmonary vascular resistance were calculated by Fick method. Results : Plasma pro-BNP levels exhibited statistically significant positive correlations with mean PAP(r=0.70, P<0.001), pulmonary vascular resistance(r=0.57, P<0.001), RVEDP(r=0.63, P<0.001), LVEDP(r=0.74, P<0.001), and cardiothoracic ratio(r=0.71, P<0.001). The area under the ROC curve using pro-BNP level to differentiate risk groups in Fontan operations was high : 0.868(95 percent CI, 0.712-1.023, P<0.01). The cutoff value of pro-BNP concentrations for the detection of risk groups in Fontan operations was determined to be 332.4 pg/mL(sensitivity 83.3 percent, specificity 82.7 percent). Conclusion : These data suggest that plasma pro-BNP levels may be used as a predictive risk factor in Fontan operations, and as a guide to determine the mode of therapy during follow-up after Fontan operations.