• Title/Summary/Keyword: test specificity

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Clinical Significance of PCR-Based Rapid Detection of Mycobacterium tuberculosis DNA in Peripheral Blood (결핵 환자에서 말초혈액 결핵균 중합효소 연쇄반응 양성의 임상적 의의)

  • Kim, Gyu-Won;Lee, Jae-Myung;Kang, Min-Jong;Son, Jee-Woong;Lee, Seung-Joon;Kim, Dong-Gyu;Lee, Myung-Goo;Hyun, In-Gyu;Jung, Ki-Suck;Lee, Young-Kyung;Lee, Kyung-Wha
    • Tuberculosis and Respiratory Diseases
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    • v.50 no.5
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    • pp.599-606
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    • 2001
  • Background : Since the advent of AIDS, tuberculosis has become a major public health problem in the western society. Therefore, it is essential that pulmonary tuberculosis be rapidly diagnosed. Light microscopic detection of acid-fast organisms in sputum has traditionally been used for rapidly diagnosing tuberculosis. However positive smears are only observed in about one-half to three-quarters of cases. Studies using PCR for diagnosing pulmonary tuberculosis disclosed several shortcomings suggesting an inability to distinguish between active and treated or inactive tuberculosis. In this study, the clinical significance of a PCR-based rapid technique for detecting Mycobacterium tuberculosis DNA in peripheral blood was investigated. Materials and Methods : From July 1, 1998 through to August 30, 1999, 59 patients with presumed tuberculosis, who had no previous history of anti-tuberculosis medication use within one year prior to this study were recruited and followed up for more than 3 months. AFB stain and culture in the sputum and/or pleural fluids and biopsies when needed were performed. Blood samples from each of the 59 patients were obtained in order to identify Mycobacterium Tuberculosis DNA by a PCR test. Results : 1) Forty five out of 59 patients had a final diagnosis of tuberculosis ; Twenty eight were confirmed as having active pulmonary tuberculosis by culture or biopsy. Four were clinically diagnosed with pulmonary tuberculosis. The other 13 patients were diagnosed as having tuberculous pleurisy (9) and extrapulmonary tuberculosis (4). 2) Fourteen patients showed a positive blood PCR test. The PCR assay correctly identified active tuberculosis in 13 out of 14 patients. The overall sensitivity and specificity of this blood peR assay for diagnosing tuberculosis were 29% and 93%, respectively. The positive predictive value was 93%, the negative predictive value was 29% and the diagnostic accuracy was 44%.3) Six out of 14(43%) patients with blood PCR positive tuberculosis were immunologically compromised hosts. 4) A simple chest radiograph in blood PCR positive tuberculosis patients showed variable and inconsistent findings. Conclusion : A peripheral blood PCR assay for Mycobacterium tuberculosis is not recommended as a screening method for diagnosing active tuberculosis. However, it was suggested that the blood PCR assay could contribute to an early diagnostic rate due to its high positive predictive value.

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Diagnostic Significance of the Serologic Test Using Antigen of Mycobacterium Tuberculosis for Antibody Detection by ELISA (결핵항원에 대한 혈청학적 검사와 진단적 유용성)

  • Park, Jae-Min;Park, Yeon-Soo;Chang, Yeon-Soo;Kim, Young-Sam;Ahn, Kang-Hyun;Kim, Se-Kyu;Chang, Joon;Kim, Sung-Kyu;Lee, Won-Young;Cho, Shang-Rae
    • Tuberculosis and Respiratory Diseases
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    • v.45 no.2
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    • pp.271-279
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    • 1998
  • Background: Diagnosis by direct microscopy and/or by culture of the Mycobacterium tuberculosis from body fluids or biopsy specimens is "Gold standard". However, the sensitivity of direct microscopy after Ziehl-Neelsen staining is relatively low and culture of mycobacteria is time consuming. Detection of mycobacterial DNA in clinical samples by the polymerase chain reaction is highly sensitive but laborious and expensive. Therefore, rapid, sensitive and readily applicable new tests need to be developed. So we had evaluated the clinical significance of serologic detection of antibody to 38 kDa antigen, which is known as the most specific to the M. tuberculosis complex, and culture filtrate antigen by ELISA in sputum AFB smear negative patients. Method: In this study, culture tests for acid fast bacilli with sputa or bronchial washing fluids of 183 consecutive patients who were negative of sputum AFB smear were performed. Simultaneously serum antibodies to 38 kDa antigen and unheated culture filtrate of M. tuberculosis were detected by an ELISA method. Results: The optical densities of ELISA test with 38 kDa and culture filtrate antigen were significantly higher in active pulmonary tuberculosis cases than in non tuberculous pulmonary diseases (p<0.05), but in patients with active pulmonary tuberculosis, those of the sputum culture positive patients for M. tuberculosis were not significantly different from those of the sputum culture negative cases(p>0.05). In the smear-negative active pulmonary tuberculosis patients, the sensitivity of the ELISA using 38 kDa antigen and culture filtrate was 20.0% and 31.4%. respectively. The specificity was 95.3% and 93.9%. respectively. Conclusion : In active pulmonary tuberculosis but smear negative, the serologic detection of antibody to 38 kDa antigen and culture filtrate by ELISA cannot substitute traditional diagnostic tests and does not have clinically significant role to differenciate the patient with active pulmonary tuberculosis from other with non-tuberculous pulmonary diseases.

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A cost-benefit analysis on tandem mass spectrometry of inherited metabolic diseases in Korea (한국에서의 유전성 대사 질환에 대한 탄뎀 매스 검사의 경제성 분석)

  • Ryu, Hyoung-Ock;Lee, Dong-Hwan;Choi, Tae-Youn;Yoon, Hye-Ran
    • Journal of Genetic Medicine
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    • v.4 no.1
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    • pp.53-63
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    • 2007
  • Purpose : Tandem mass spectrometry (MS/MS) is effective screening test for inherited metabolic diseases. In this study, we estimate potential costs and benefits of using tandem mass spectrometry (MS/MS) to screen new borns for inherited metabolic diseases (phenylketonuria, BH4 deficiency, citrullinemia, maple syrup urine disease, propionic aciduria, isovaleric aciduria, glutaric aciduria type 1, LCHAD deficiency) in Korea. Methods : From April 2001 to March 2004, 79,179 new borns were screened for amino acid disorders, organic acid disorders, and fatty acid oxidative disorders. Twenty-eight new borns were diagnosed with one of the metabolic disorder and the collective estimated prevalence amounted to 1 in 2,800 with a sensitivity of 97.67%, a specificity of 99.28%, a recall rate of 0.05%, and a positive preditive value of 6.38%. We calculated and compared the total costs in case when neonatal screening on pheny lketonuria, BH4 deficiency, citrullinemia, maple syrup urine disease, propionic aciduria, isovaleric aciduria, glutaric aciduria type 1, LCHAD deficiency is implemented, and when not. Results : If the neonatal screening on pheny lketonuria, BH4 deficiency, citrullinemia, maple syrup urine disease, propionic aciduria, isovaleric aciduria, glutaric aciduria type 1, LCHAD deficiency is implemented, total benefits far exceed costs at a ratio of 1.40:1. Conclusion : Although, this study only concerns the monetary aspects of the neonatal screening, tandem mass spcetrometry for neonatal screening is cost-effective compared with not screening. The study appears to support the introduction of tandem mass spectrometry into a Korea neonatal screening programme for inherited metabolic diseases.

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Clinical Findings of Mycoplasma pneumoniae pneumonia under 3 Year-Old Children (3세 이하 Mycoplasma pneumoniae 폐렴환자의 임상적 고찰)

  • Lee, Sung-Soo;Youn, Kyung-Lim;Kang, Hyeon-Ho;Cho, Byoung-Soo;Cha, Sung-Ho
    • Pediatric Infection and Vaccine
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    • v.6 no.1
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    • pp.78-85
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    • 1999
  • Purpose : Mycoplasma pneumoniae pneumonia has been to be developed frequently in school age children and adolescence and hard to see under 3 year-old children. But it seems to be increased in number of patients with Mycoplasma pneumoniae pneumonia under 3-year old in clinical practice in these days. We have aimed to examine the characteristics of clinical findings of Mycoplasma pneumonia under 3 year-old children. Methods : We had performed retrospective review of medical records of 30 patients with Mycoplasmal pneumonia under 3-year old children who admitted to Department of Pediatrics, Kyunghee University Hospital from Jan. 1994 to Dec. 1997. The diagnostic criteriae was Cold agglutinin titer>1:64 or Mycoplasma antibody titer>1:80. Results : Mycoplasmal pneumonia was 30 out of 235 cases(12.7%) of total pneumonia under 3 year old children. Male female ratio was 1.3 : 1 and age distributions were 0~1y : 0, 1~2y : 8, 2~3y : 22 cases. Clinical symptoms and signs were cough(100.0%), sputum(83.3%), fever(80.0%) rhinorrhea(33.3%), vomiting(33.3%), moist rale(86.7%), decreased breathing sound(26.7%), wheezing(20.0%), and pharyngeal injection(30.0%). Thirteen out of 30 cases(43.3%) had unilateral infiltration, 10 cases(33.4%) had bilateral infiltration, 1 case(3.3%) had pleural effusion, and 6 cases(20.0%) had negative findings on chest radiography and there was no cases of atelectasis. On laboratory findings, 6 out of 30 cases(20.0%) had leukocytosis, 1 case(3.3%) had neutrophilia, 10 cases(30.0%) had eosinophilia, 17 cases(56.7%) had increased ESR, and 18 cases(60.6%) had positive CRP. Positive cold agglutinin titers(>1 : 64) were 19 cases(63.3%), and positive mycoplasma antibody(M-ab) titers(>1 : 80) were 27 cases(93.3%). Mycoplasma antibody test was more valuable than cold agglutinin test for the diagnosis of Mycoplasmal pneumonia and there was no correlation between cold agglutinin titer and mycoplasma antibody titer. Mycoplasma-polymerase chain reaction(M-PCR) was done with 13 cases, 12 out of 13 cases(92.3%) were positive. M-PCR test was valuable to the diagnosis of Mycoplasmal pneumonia but it will be needed to further study for their clinical application. Among 30 cases, 5 cases(16.7%) had complications, 3 cases(10.0%) had skin rash, 1 case(3.3%) had pleural effusion, 1 case(3.3%) had arthralgia, but all complications were mild and recovered without residual sequelae. Conclusion : The occurrence of Mycoplasmal pneumonia under 3 year-old children was not rare from this study. Clinical characteristics of Mycoplasmal pneumonia under 3-year old were normal radiologic findings in many cases, low complication rate, mild clinical course, and tend to rapid recovery compared with general manifestations of Mycoplasmal infectionsin children and adolescence. There were likely to be missed patients with Mycoplasmal pneumonia which did not diagnose by conventional serologic tests that had low sensitivity and specificity. We have to pay attention to the Mycoplasmal infection of the young children with pneumonia during epidemic periods of Mycoplasmal infection.

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Evaluation of Enzyme-linked Immunosorbent Assay in Serological Diagnosis of Human Neurocysticercosis using paired Samples of Serum and Cerebrospinal Fluid (면역효소측정법을 이용한 뇌낭미충증의 혈청학적 진단의 평가)

  • 조승열;김석일
    • Parasites, Hosts and Diseases
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    • v.24 no.1
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    • pp.25-41
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    • 1986
  • The applicability of micro-ELISA was evaluated in human neuro-cysticercosis using paired samples of serum and CSF. A total of 355 cases who were mostly neurologic patients was subjected. Cystic fluid of C. cellulosae was used as antigen in protein concentration of $2.5{\;}{\mu}g/ml$. Serum was diluted to 1 : 100 and CSF was undiluted in the assay for the specific IgG antibody level. The differential criterion of the positive reaction was the abs. of o. 18 in both samples. The results were summarized as follows: 1. The overall sensitivity of the micro-ELISA in 71 confirmed neurocysticercosis was 90.1% ; the sensitivity by serum was 77.5% and that by CSF was 83.1%. CSF was a more sensitive and valuable material. Most of the false negative cases of neuro-cysticercosis showed far lower level of abs. rather than marginal. 2. The overall specificity of the micro-ELISA in 52 confirmed other neurologic diseases was 88.5%; the specificities by serum and by CSF were 94.2% respectively. Cases of other neurologic diseases did not show false positive reactions in both samples. 3. When serum was assayed, taeniasis(2/18), sparganosis(2/20), paragonimiasis(1/56), clonorchiasis(1/15) and fascioliasis(1/1) cases showed cross reactions. When CSF was assayed, 2 ot 10 neuro-sparganosis showed cross reactions while none of 9 neuro-paragonimiasis showed it. Out of 71 confirmed neuro-cysticercosis cases, 6 and 11 showed cross reactions by serum and CSF to crude extract antigen of sparganum; but no case did show it to crude extract antigen of Paragonimus westermani. 4. Ventricular CSF showed low or negative levels of IgG antibody than lumbar CSF unless the lesion was at the lateral ventricle itself. 5. Out of 4 racemose cysticercosis cases, 3 showed positive reaction in serum while all of 3 examined CSF were positive. The above results indicated that the serological test for detecting the specific IgG antibody by micro-ELISA using paired samples of serum and CSF was very helpful for clinical differentiation of neuro-cysticercosis from neurologic diseases of other causes.

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A Study on the Risk Factors for Maternal and Child Health Care Program with Emphasis on Developing the Risk Score System (모자건강관리를 위한 위험요인별 감별평점분류기준 개발에 관한 연구)

  • 이광옥
    • Journal of Korean Academy of Nursing
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    • v.13 no.1
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    • pp.7-21
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    • 1983
  • For the flexible and rational distribution of limited existing health resources based on measurements of individual risk, the socalled Risk Approach is being proposed by the World Health Organization as a managerial tool in maternal and child health care program. This approach, in principle, puts us under the necessity of developing a technique by which we will be able to measure the degree of risk or to discriminate the future outcomes of pregnancy on the basis of prior information obtainable at prenatal care delivery settings. Numerous recent studies have focussed on the identification of relevant risk factors as the Prior infer mation and on defining the adverse outcomes of pregnancy to be dicriminated, and also have tried on how to develope scoring system of risk factors for the quantitative assessment of the factors as the determinant of pregnancy outcomes. Once the scoring system is established the technique of classifying the patients into with normal and with adverse outcomes will be easily de veloped. The scoring system should be developed to meet the following four basic requirements. 1) Easy to construct 2) Easy to use 3) To be theoretically sound 4) To be valid In searching for a feasible methodology which will meet these requirements, the author has attempted to apply the“Likelihood Method”, one of the well known principles in statistical analysis, to develop such scoring system according to the process as follows. Step 1. Classify the patients into four groups: Group $A_1$: With adverse outcomes on fetal (neonatal) side only. Group $A_2$: With adverse outcomes on maternal side only. Group $A_3$: With adverse outcome on both maternal and fetal (neonatal) sides. Group B: With normal outcomes. Step 2. Construct the marginal tabulation on the distribution of risk factors for each group. Step 3. For the calculation of risk score, take logarithmic transformation of relative proport-ions of the distribution and round them off to integers. Step 4. Test the validity of the score chart. h total of 2, 282 maternity records registered during the period of January 1, 1982-December 31, 1982 at Ewha Womans University Hospital were used for this study and the“Questionnaire for Maternity Record for Prenatal and Intrapartum High Risk Screening”developed by the Korean Institute for Population and Health was used to rearrange the information on the records into an easy analytic form. The findings of the study are summarized as follows. 1) The risk score chart constructed on the basis of“Likelihood Method”ispresented in Table 4 in the main text. 2) From the analysis of the risk score chart it was observed that a total of 24 risk factors could be identified as having significant predicting power for the discrimination of pregnancy outcomes into four groups as defined above. They are: (1) age (2) marital status (3) age at first pregnancy (4) medical insurance (5) number of pregnancies (6) history of Cesarean sections (7). number of living child (8) history of premature infants (9) history of over weighted new born (10) history of congenital anomalies (11) history of multiple pregnancies (12) history of abnormal presentation (13) history of obstetric abnormalities (14) past illness (15) hemoglobin level (16) blood pressure (17) heart status (18) general appearance (19) edema status (20) result of abdominal examination (21) cervix status (22) pelvis status (23) chief complaints (24) Reasons for examination 3) The validity of the score chart turned out to be as follows: a) Sensitivity: Group $A_1$: 0.75 Group $A_2$: 0.78 Group $A_3$: 0.92 All combined : 0.85 b) Specificity : 0.68 4) The diagnosabilities of the“score chart”for a set of hypothetical prevalence of adverse outcomes were calculated as follows (the sensitivity“for all combined”was used). Hypothetidal Prevalence : 5% 10% 20% 30% 40% 50% 60% Diagnosability : 12% 23% 40% 53% 64% 75% 80%.

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A VALIDITY STUDY OF PARENT BEHAVIORAL RATING SCALES AS DIAGNOSTIC TOOLS OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (주의력결핍/과잉운동장애(ADHD) 아동의 진단도구로서 부모용 행동 평가지의 타당도 연구 - 한국아동인성검사와 아동 ${\cdot}$ 청소년 행동평가척도를 중심으로 -)

  • Kim, Ji-Hae;So, Yoo-Kyung;Jung, Yoo-Sook;Lee, Im-Soon;Hong, Sung-Do
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.11 no.2
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    • pp.282-289
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    • 2000
  • This study was designed to examine the validity of HPR subscale in Korean Personality Inventory for Children(KPI-C) and Attention Problems subscale in Korean Child Behavior Checklist(K-CBCL) as diagnostic tool for Attention-Deficit/Hyperactivity Disorder(ADHD). Nineteen ADHD-1 type, twenty-three ADHD-H type, sixteen Neurosis, and fifteen normal children with the age from 6 to12 were selected based on DSM-IV, and their responses of the KPI-C and CBCL were analyzed. Omnibus F-test results showed that there were significant differences in the F scores of HPR and Attention Problems T scores(p<.05). But in Posthoc analysis, the HPR and AP scores in three clinical groups were significantly higher than in normal group, but there was no group difference among three clinical groups(p<.05). These results shows that HPR subscale and Attention Problems subscale may be useful tools for screening clinical groups(vs normal group) but there was a limit to the clinical validity of two subscales as diagnostic tools for the subtypes of ADHD.

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Effects of the Variability of Individual Data on the Group Results; an Acupuncture Study Using fMRI (기능적 자기공명영상을 이용한 침 연구에 있어서 개체 별 다양성이 그룹분석에 미치는 영향 연구)

  • Bae, Seong-In;Jahng, Geon-Ho;Ryu, Chang-Woo;Lim, Sabina
    • Progress in Medical Physics
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    • v.20 no.4
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    • pp.277-289
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    • 2009
  • Recently, functional MRI has been used to investigate the neurobiological mechanisms of acupuncture and the specificity of acupoint. The group data tend to be regarded as more important than the individual data in the most of previous studies. This study was designed to investigate the effect of the variability of individual data on the group results. A functional MRI (fMRI) of the whole brain was performed in fifteen healthy subjects during placebo and acupuncture stimulations at the ST36 acupoint. After remaining at rest for 30 seconds, the acupuncture was inserted and twisted at the rate of 2 Hz for 45 seconds and then the acupuncture was removed immediately. This process was repeated three times. Individual and group analyses were performed by voxel-based analyses using SPM2 software. Visual inspections of the activation and deactivation maps from individual sessions have shown the large variability across fifteen subjects. This means that the group data reflected the brain activation responses of only a few subjects. We suggest that the individual data should be presented to demonstrate the effect of acupuncture.

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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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Diagnostic Value of Cyfra 21-1 in Differential Diagnosis of Pleural Effusion (흉수의 감별 전단으로 Cyfra 21-1의 진단적 가치)

  • Lee, Hak-Jun;Lee, Kwan-Ho;Shin, Kyeong-Cheol;Shin, Chang-Jin;Park, Hye-Jung;Mun, Yeung-Chul;Lee, Kyung-Hee;Chung, Jin-Hong;Hyun, Myung-Soo;Lee, Hyun-Woo
    • Tuberculosis and Respiratory Diseases
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    • v.47 no.1
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    • pp.50-56
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    • 1999
  • Background : Pleural effusion is a common clinical problem and many clinical and laboratory evaluations, such as tumor marks, have been studied to discriminate malignant pleural fluid from benign pleural fluid. However their usefulness in the diagnosis of pleural effusion is still not established fully. We studied the diagnostic value of cyfra 21-1 in diagnosis of malignant pleural effusion. Methods: Pleural fluid was obtained from 45 patients with malignant diseases(32 lung cancer patients, 13 metastatic malignant diseases) and 47 patients with benign diseases. The level of cyfra 21-1 in the pleural fluid and serum were determined using a CYFRA 21-1 enzyme immunoassay kit(Cis-Bio International Co.). The t-test was used for comparison between two diseases groups and receiver operating characteristic(ROC) curves were constructed by calculating the sensitivities and specificities of the cyfra 21-1 at several points to determine the diagnostic accuracy of the cyfra 21-1. Results: In patients with primary lung cancer, the level of cyfra 21-1 in the pleural fluid was significantly higher than those of patients with benign diseases and had positive correlations between the level of cyfra 21-1 in the pleural fluid and serum levels. In the ROC curve analysis of the pleural fluid, the curve for primary lung cancer group was located closer to the left upper comer and the cut off value, sensitivity and specificity of the cyfra 21-1 of the primary lung cancer group was determined as 22.25ng/ml, 81.8% and 78.7% respectively. Conclusions: Our data indicates that the measurement of cyfra 21-1 level in pleural effusion has useful diagnostic value to discriminate malignant pleural effusion in primary lung cancer from benign pleural effusion.

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