• Tuberculosis and Respiratory Diseases
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• v.51 no.6
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• pp.559-569
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• 2001

Background : Pleural effusion is one of the most common clinical manifestations associated with a variety of pulmonary diseases such as malignancy, tuberculosis, and pneumonia. However, there are no useful laboratory tests to determine the specific cause of pleural effusion. Therefore, an attempt was made to analyze the various types of pleural effusion and search for useful laboratory tests for pleural effusion in order to differentiate between the diseases, especially between a malignant pleural effusion and a non-malignant pleural effusion. Methods : 93 patients with a pleural effusion, who visited the Severance hospital from January 1998 to August 1999, were enrolled in this study. Ultrasound-guided thoracentesis was done and a confirmational diagnosis was made by a gram stain, bacterial culture, Ziehl-Neelsen stain, a mycobacterial culture, a pleural biopsy and cytology. Results : The male to female ratio was 56 : 37 and the average age was $47.1{\pm}21.8$ years. There were 16 cases with a malignant effusion, 12 cases with a para-malignant effusion, 36 cases with tuberculosis, 22 cases with a para-pneumonic effusion, and 7 cases with transudate. The LDH2 fraction was significantly higher in the para-malignant effusion group compared to the para-pneumonic effusion group [$30.6{\pm}6.4%$ and $20.2{\pm}7.5%$, respectively (p<0.05)] and both the LDH1 and LDH2 fraction was significantly in the para-malignant effusion group compared to those with tuberculosis [$16.4{\pm}7.2%$ vs. $7.6{\pm}4.7%$, and $30.6{\pm}6.4%$ vs.$17.6{\pm}6.3%$, respectively (p<0.05)]. The pleural effusion/serum LDH4 fraction ratio was significantly lower in the malignant effusion group compared to those with tuberculosis [$1.5{\pm}0.8$ vs. $2.1{\pm}0.6$, respectively (p<0.05)]. The LDH4 fraction and the pleural effusion/serum LDH4 fraction ratio was significantly lower in the para-malignant effusion group compared to those with tuberculosis [$17.0{\pm}5.8%$ vs. $23.5{\pm}4.6%$ and $1.3{\pm}0.4$ vs. $2.1{\pm}0.6$, respectively (p<0.05)]. Conclusion : These results suggest that the LDH isoenzyme was the only useful biochemical test for a differential diagnosis of the various diseases. In particular, the most useful test was the pleural effusion/serum LDH4 fraction ratio to distinguish between a para-malignant effusion and a tuberculous effusion.

• Pediatric Infection and Vaccine
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• v.14 no.1
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• pp.91-96
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• 2007

Purpose : This study was performed to evaluate a new rapid diagnostic kit (BIOLINE $RSV^{TM}$; Standard Diagnostics Inc., Yongin, Korea), a lateral-flow immunoassay, in the detection of respiratory syncytial virus (RSV) from the nasopharyngeal aspirates (NPA) of children with lower respiratory tract infections (LRTIs) in comparison with other diagnostic methods. Methods : Three hundred and nineteen NPAs were selected from a large pool of NPAs that had been obtained from children with LRTIs. All specimens had already been tested for RSV by culture and immunofluorescent (IF) test, and had been kept frozen. Tests with BIOLINE $RSV^{TM}$ were performed at least twice. All who conducted the experiments or interpreted the test results were blinded to the results of both culture and IF tests. Results : One hundred seven (97.3%) of 110 specimens that were positive for RSV by both culture and IF test, 29 (87.9%) of 33 that were positive by IF test only, 20 (76.9%) of 26 that were positive by culture only, and 140 (93.3%) of 150 that were negative by both methods were negative for RSV by BIOLINE $RSV^{TM}$. By combining the above results, the following 5 diagnostic values of BIOLINE $RSV^{TM}$ were determined in comparison with viral culture or IF test; sensitivity, 92.3% (156/169, 95% confidence interval [CI], 87.1-97.5%); specificity, 93.3% (140/150, 95% CI, 88.4-98.2%); positive predictive value, 94.0% (156/166, 95% CI, 89.5-98.5%); negative predictive value, 91.5% (140/143, 95% CI, 86.0-97.0%); and agreement, 95.9% (306/319, 95% CI, 92.1-99.7%), respectively. Conclusion : This study revealed that BIOLINE $RSV^{TM}$ demonstrated good sensitivity and specificity for the detection of RSV antigen from NPAs of children with LRTIs. Because of simple methods and quick results, this test may be useful for the diagnosis of RSV infection during the epidemic periods.

• The Korean Journal of Nuclear Medicine
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• v.35 no.1
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• pp.61-68
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• 2001

Purpose: The C-14 urea breath test (C-14 UBT) is the most specific noninvasive method to detect Helicobacter (H) pylori infection. We investigated if the C-14 UBT can reflect the presence and degree of H. pylori detected by gastroduodenoscopic biopsies (GBx). Materials and methods: One hundred fifty patients (M:F=83:67, age $48.6{\pm}11.2$ yrs) underwent C-14 UBT, rapid urease test (CLO test) and GBx on the same day. For the C-14 UBT, a single breath sample was collected at 10 minutes after ingestion of C-14 urea (137 KBq) capsule and counting was done in a liquid scintillation counter for 1 minute, and the results were classified as positive (${\geq}200dpm$), Intermediate ($50{\sim}199dpm$) or negative (<50 dpm). The results of CLO tests were classified as positive or negative according to color change. The results of GBx on giemsa stain were graded 0 (normal) to 4 (diffuse) according to the distribution of H. pylori by the Wyatt method. We compared C-14 UBT results with GBx grade as a gold standard. Results: In the assessment of the presence of H. pylori infection, the C-14 UBT global performance yielded sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 92.5%, 88.4%, 97.1%, 88.4% and 91.3%, respectively. However, the CLO test had sensitivity, specificity, PPV, NPV and accuracy of 83.2%, 81.4%, 91.8%, 81.4% and 82.7%, respectively. The quantitative values of the C-14 UBT were $45{\pm}27$ dpm in grade 0, $707{\pm}584dpm$ in grade 1, $1558{\pm}584dpm$ in grade 2, $1851{\pm}604dpm$ in grade 3, and $2719{\pm}892dpm$ in grade 4. A significant correlation (r=0.848, p<0.01) was found between C-14 UBT and the grade of distribution of H. pylori infection on GBx with giemsa stain. Conclusion: We conclude that the C-14 UBT is a highly accurate, simple and noninvasive method for the diagnosis of ongoing H. pylori infection and reflects the degree of bacterial distribution.

• Pediatric Infection and Vaccine
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• v.12 no.2
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• pp.124-134
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• 2005

Purpose : It has been known that the diagnostic confirmation of group A streptococcal pharyngitis is accompanied with the results of throat culture and/or rapid antigen detection test(RADT). This study was designed to evaluate the usefulness and cost benefits of the RADT in patients with a sore throat compared the empirical antibiotic treated group without using RADT or throat culture with the antibiotic treated group according to the results of RADT test and/or throat culture. Methods : From April 2003 to August 2003, total 369 patients were enrolled this study. They were redistributed into two groups. In one group, the RADT test and throat culture were used and the patients received antibiotic treatment according to the results of test and in the other group, no diagnostic examinations were used and the patients were treated with antibiotics which were chosen empirically. The flow sheet with questionnaire was drawing up and obtained the clinical symptoms, signs and the name of antibiotics that were administered. Results : A total of 244 patients were treated after the throat culture and/or RADT, and 125 patients were treated empirically. The prevalence of bacteriologically confirmed group A streptococcal pharyngitis was 20.1%. The sensitivity and specificity of RADT were 89.8% and 86.1%, respectively. Positive predictive value and negative predictive value were 62.0% and 97.1%, respectively. The rate of antibiotic use was high in both groups. Because the physician used the antibiotics even if the result of RADT was negative. So about 37% of reduction of antibiotics use might be possible if we used antibiotics according to the results of RADT. There were no cost differences between the RADT applied group and the empirically treated antibiotic group if we could reduce the price of RADT to 63% of the current price. Conclusion : The RADT could be applied for the easy and rapid diagnosis and prompt treatment for group A streptococcal pharyngitis, and RADT could reduced the number of antibiotics used if the price of RADT was reduced to 63% of current price. For accurate evaluation of efficacy and cost effect, further controlled study is needed.

• Clinical and Experimental Pediatrics
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• v.49 no.4
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• pp.381-387
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• 2006

Purpose : Neonatal lupus is characterized by congenital complete heart block(CCHB), cutaneous rash, and laboratory abnormalities in infants born to mothers with systemic lupus erythematosus(SLE). This study aims to examine the incidence of CCHB and clinical outcome in neonates born to mothers with SLE. Methods : The study group consisted of 49 neonates, born from 57 pregnancies of 55 women with SLE, diagnosed at Hanyang University Hospital for the period between January 1997 and January 2005. Clinical and laboratory data were retrospectively identified from medical record. Results : There were 5(8.8 percent) spontaneous abortions and one(1.8 percent) still births among 57 pregnancies of 55 mothers. Of 49 live births, 15(26.3 percent) were premature and eight(12.3 percent) were small for their gestational age. There was one(1.8 percent) CCHB suspected during pregnancy on fetal echocardiograpy in a fetus of mother with systemic lupus erythematosus and the fetus was not born by artificial abortion because of mother. There was no CCHB among EKG findings of 49 newborns. Laboratory testing showed hematologic abnormalities among 25.6 percent(10/39) of the babies. 5.1 percent(2/39) and 7.7 percent(3/39) of them were diagnosed as neutropenia, and thrombocytopenia was seen respectively. Anti-SSA(Ro) and antiphospholipid antibodies were predictive factors for prematurity(P=0.003, P=0.049). Anticardiolipin antibodies were predictive factors for ventilatory care(P=0.018). Conclusion : The incidence of CCHB among neonates born to mothers with SLE, which was measured in this study, was lower than that in earlier studies. A high incidence of hematologic abnormalities was found in our study. It is suggested that careful examination should be made of skin for the diagnosis of neonatal lupus.

• Journal of Gastric Cancer
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• v.9 no.4
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• pp.172-176
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• 2009

Purpose: The rapid urease test is a rapid and reliable method for diagnosing Helicobacter pylori infection. However it requires gastric mucosal biopsies during endoscopy, and the test is not covered by national health insurance for patients with gastric cancer. So, we introduced an alternative method for a rapid urease test using back-table gastric mucosal biopsies from gastrectomy specimen. Materials and Methods: Ninety gastric cancer patients underwent an anti H. pylori IgG ELISA test and gastrectomy. Just after gastrectomy, two gastric mucosal biopsies from the prepyloric antrum and lower body of the gastrectomy specimen were taken from the back table in the operative room, and these were fixed immediately with the rapid urease test kit, and the color change was monitored for up to 24 hours. In this study, H. pylori infection was defined as positive when the serology or rapid urease test showed positive results. Results: The positive rate of the rapid urease test and serology was 91.1% and 77.8%, respectively. The sensitivity, specificity, positive predictive value and negative predictive value of the rapid urease test and serology were 94.3 and 80.5%, 100 and 100%, 100 and 100%, and 37.5 and 15%, respectively. The accuracy of the rapid urease test was higher than that of serology (94.4 vs. 81.1%, respectively). The rapid urease test showed a higher rate of detecting H. pylori infection than that of serology (McNemar's test, P=0.019). Conclusion: The result of the rapid urease test using back-table gastric mucosal biopsies from a gastrectomy specimen is comparable to the reference data of the conventional rapid urease test using gastric mucosal endoscopic biopsies. Therefore, it can be an alternative diagnostic method for H. pylori infection.

• Journal of Gastric Cancer
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• v.9 no.3
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• pp.110-116
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• 2009

Purpose: The aim of this study was to examine the usefulness of positron emission tomography (PET)-computed tomography (CT) in the pre-operative staging of gastric cancer. Materials and Methods: Between February 2006 and August 2008, PET-CT and CT were performed on 70 patients diagnosed with gastric cancer by gastrofiberscopic biopsy. The sensitivities, specificities, Positive predictive value (PPV), and negative predictive value (NPV) of PET-CT and CT imaging for the detection of gastric cancer TNM staging were compared. Results: The detection rates for the primary tumor were as follows: PET-CT, 81.4% (57/70); and CT, 42.9% (30/70). For both early gastric cancer (EGC) and advanced gastric cancer (AGC), PET-CT was more accurate than CT in detecting the lesions. As the size of the tumor exceeded 3 cm, the detection rate increased. The sensitivities, specificities, PPV, and NPV of PET-CT for lymph node staging were 55.6%, 81%, 86.2%, and 45.9%, while the sensitivities, specificities, PPV, and NPV of CT were 40.0%, 85.7%, 85.7% and 40%, respectively. One case of multiple liver metastasis and two cases of dual primary cancer (rectal and pancreatic cancers) were detected by PET-CT. PET-CT also had a higher detection rate for all histologic types of primary tumors. PET-CT was more accurate than CT in detecting primary gastric cancer lesions. The detection of nodal metastasis by PET-CT was similar to CT; small-sized tumors or EGC detection rates were not high. However, PET-CT provided additional information to detect distant metastases and dual primary cancers and reduced unnecessary laparotomies to detect peritoneal seeding or carcinomatosis. Conclusion: It would be useful to make a pre-operative diagnosis of gastric cancer and determine treatment if PET-CT were added to other routine pre-operative studies.

• Tuberculosis and Respiratory Diseases
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• v.54 no.3
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• pp.330-337
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• 2003

Background : Low spirometric forced vital capacity(FVC) in conjunction with a normal or high ratio of the forced expiratory volume at 1 second to the forced vital capacity($FEV_1$/FVC%) has traditionally been classified as a restrictive abnormality. However, the gold-standard diagnosis of a restrictive pulmonary impairment requires a measurement of the total lung capacity (TLC). This study was performed to determine the predictive value of spirometric measurements of the FVC for diagnosing a restrictive pulmonary abnormality. Methods : Test results from 1,371 adult patients who undertook both spirometry and lung volume measurements on the same visit from January 1999 to December 2000 were enrolled in this study. The test values for the FVC, the TLC that was below 80% of predicted value, and a $FEV_1$/FVC% that was below 70%, were classified as being abnormal. Results : Of the 1,371 patients, 353 patients had a reduced a FVC. Of these patients, 186 patients had a reduced TLC. Therefore, the positive predictive value was 52.7%. Of the 196 patients with a normal $FEV_1$/FVC% and a reduced FVC, 148(75.5%) patients had a lower TLC. Thirty eight (24.2%) patients out of 157 patients with a low $FEV_1$/FVC% and a low FVC showed a restrictive defect. Conclusion : Spirometry is useful to rule out a restrictive pulmonary abnormality, but a restrictive pattern on the spirometry dose not mean there is a true restrictive disease. For the patients with a low FVC, TLC measurements are essential for diagnosing a restrictive pulmonary impairment.

• Childhood Kidney Diseases
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• v.12 no.1
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• pp.54-61
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• 2008

Purpose: This study was performed to assess necessity of voiding cystourethrography (VCUG) for infants with urinary tract infection (UTI) who had both normal renal sonography and normal DMSA renal scans. Methods: We reviewed 117 infants hospitalized for UTI between February 2002 and July 2007 at Sanggye Paik Hospital. The diagnosis of UTI was made by culture from a urine specimen obtained by suprapubic puncture(n=57), catheterization(n=58), or collection bag method (n=2, twice positive culture of the same organism). All patients had undergone renal sonography, DMSA renal scan and VCUG. Children with both normal renal sonography and normal DMSA renal scans were evaluated for the presence or severity of vesicoureteral reflux (VUR). Results: Of the 117 patients, 96 were boys and 21 were girls. 28 patients(23.9%) had VUR. 59(50.4%) showed both normal renal sonography and normal DMSA renal scans. Among these 59 patients, 7(11.9%) showed VUR. Three of them had grade I-II reflux, two grade III reflux, and the other two grade IV reflux. One of them showed bilateral VUR, grade IV reflux on the right and grade III on the left. Conclusion: Although the negative predictive value of both normal renal sonography and normal DMSA renal scan for VUR was 88.1%, 7 patients had VUR and two of them had high grade reflux(grade IV). So, we suggest that VCUG should be performed in infants with UTI despite both normal renal sonography and normal DMSA renal scans.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.85-124
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• 2016

The Human gene testing act (GenDG) in Germany starts from the characteristic features of gene testing, i.e. dualisting structure consisted of anlaysis on the one side and the interpretation on the other side. The linguistic distincion of 'testing', 'anlaysis' and 'judgment' in the act is a fine example. Another important basis of the regulation is the ideological purpose of the law, that is information autonomy. The normative texts as such and the founding principle are the basis of the classification of testing types. Especially in the case of gene testing for medical purpose is classified into testing for diagnostic purpose and predictive purpose. However, those two types are not always clearly differentiated because the predictive value of testing is common in both types. In the legal regulation of gene testing it is therefore important to manage the uncertainty and subjectivity which are inherent in the gene-analysis and the judgment. In GenDG the system ensuring the quality of analysis is set up and GEKO(Commity for gene tisting) based on the section 23 of GenDG concretes the criterium of validity through guidelines. It is also very important in the case of gene testing for medical purpose to set up the system for ensurement of procedural rationality of the interpretation. The interpretation of the results of analysis has a wide spectrum because of the consistent development of technology on the one side and different understandings of different subjects who performs gene testings. Therefore the process should include the communication process for patients in oder that he or she could understand the meaning of gene testing and make plans of life. In GenDG the process of genetic counselling and GEKO concretes the regulation very precisely. The regulation as such in GenDG seems to be very suggestive to Korean legal polic concerning the gene testing.