BACKGROUND: Anti-topoisomerase I antibodies (anti-topo-I) have been known to be a specific serologic marker for systemic sclerosis (SSc). However, anti-topo-I have also been detected fre-quently in the sera of patients with diagnosis other than SSc since the enzyme linked immunosor-bent assay (ELISA) has been used widely. In order to clarify the clinical significance of anti-topo-I on ELISA, we analyzed the clinical features of the patients positive for anti-topo-I. METHODS: Anti-topo-I and other antinuclear antibodies (ANA) were investigated by conventional ELISA methods. The clinical characteristics were analyzed in 38 patients positive for anti-topo-I and 28 patients with SLE but negative for anti-topo-I. RESULTS: Of 38 patients positive for anti-topo-I, 15 were SLE and eight SSc. The mean level of anti-topo-I in the patients with SSc was higher than that in the patients with SLE (P=0.015). Of 15 anti-topo-I positive patients with SLE, 14 had one or more other ANAs in their sera whereas only one of eight anti-topo-I positive patients with SSc did (P=0.000). There was no significant difference in clinical characteristics between anti-topo-I positive and negative patients with SLE. The preva-lences of restrictive lung disease in both groups with SLE were significantly lower than that in the anti-topo-I positive patients with SSc (P=0.008). CONCLUSIONS: Anti-topo-I is not exclusively specific for SSc and present in a considerable subset of SLE. As well as the level of anti-topo-I, the coexistence of other ANAs is helpful to discriminate SLE from SSc. The Anti-topo-I detected by ELISA does not seem to be a risk factor for restrictive lung disease in the patients with SLE, unlike those with SSc.
Antibodies* ; Antibodies, Antinuclear ; Diagnosis ; Enzyme-Linked Immunosorbent Assay* ; Humans ; Lung Diseases ; Risk Factors ; Scleroderma, Systemic

BACKGROUND: The prevalence of Hepatitis B virus (HBV) in Korea is still higher than that of devel-oped countries. Recently, the automated chemiluminescent microparticle immunoassay analyzer ARCHITECT i2000 (Abbott Laboratories, Abbott Park, IL USA) was introduced in Korea and we evaluated performance of the tests for serological markers for HBV infection. METHODS: We analyzed precision, agreement, sensitivity, specificity and throughput of the HBs antigen, anti-HBs and anti-HBc as well as linearity and compared with the AxSYM (Abbott Labora-tories, Abbott Park, IL USA) for anti-HBs. Precision, linearity and comparison were performed on the basis of the National Committee for Clinical Laboratory Standards guidelines. Random patients 'sera were used for this study. RESULTS: The coefficients of variations of precision were below 5% for anti-HBs and anti-HBc (total) except for the HBs antigen. The agreements, sensitivities and specificities for serologic mark-ers were more than 90%. The linearity and comparison for anti-HBs were statistically significant (P < 0.001). The throughput of ARCHITECT i2000 was 110 tests/hours and that was 2.8 times faster than that of the AxSYM. CONCLUSIONS: These results suggest that ARCHITECT i2000 can provide rapid and effective results for serologic markers for HBV infection. However, each laboratory should decide the utiliza-tion of this analyzer on the basis of volume of samples, other items tested concurrently, and the inter-face of existing facilities etc.
Hepatitis B virus ; Hepatitis B* ; Hepatitis* ; Humans ; Immunoassay* ; Korea ; Prevalence ; Sensitivity and Specificity

BACKGROUND: Identification of antibodies recognizing extractable nuclear antigens (ENAs) is use-ful in the diagnosis and characterization of a variety of connective tissue diseases. Recently, LG ENA Immunoblot (LGCI, Seoul, Korea) was introduced for detecting various autoantibodies to ENAs simultaneously. Performance of this kit was evaluated in this study. METHODS: Sera from 108 SLE patients and 103 RA patients were tested for the presence of spe-cific autoantibodies to ENAs by LG ENA Immunoblot and DID. Concordance rates in each autoan-tibody were obtained. After discordant results were resolved by EIA (ENA ELISA TEST SYSTEM, Zeus Scientific Inc., NJ, USA) and western blot (ANA Western Blot Immunoassay, IMMCO Diag-nostics Inc., NY, USA), sensitivity and specificity of LG ENA Immunoblot were evaluated. Between-day precision was also tested. RESULTS: Concordance rates in each autoantibody in two methods were as follows: anti-RNP (88.0%, 95/108; 100%, 103/103), anti-Sm (87.0%, 94/108; 97.1%, 100/103), anti-SSA (94.4%, 102/108; 99.0%, 102/103), anti-SSB (97.2%, 105/108; 98.1%, 101/103), anti-Scl70 (99.1%, 107/108; 100%, 103/103) in SLE and RA patients, respectively. Sensitivity and specificity of Immunoblot were 92.0% and 99.6% for anti-RNP, 100% and 99.6% for anti-Sm, 100% and 98.6% for anti-SSA, 90.0% and 98.5% for anti-SSB, and 100% and 100% for anti-Scl70, respectively. Between-day precisions were 100% in all anti-ENA antibodies. CONCLUSIONS: LG ENA Immunoblot showed good concordance rates with the conventional DID method and high sensitivity (>90%) and specificity (>98.5%) in detecting all kinds of anti-ENA autoantibodies. LG Immunoblot has another merit in that it can detect several autoantibodies simul-taneously. It is suggested that LG ENA Immunoblot can replace DID for anti-ENA detection without any problem.
Antibodies ; Antigens, Nuclear* ; Autoantibodies* ; Blotting, Western ; Connective Tissue Diseases ; Diagnosis ; Enzyme-Linked Immunosorbent Assay ; Humans ; Immunoassay ; Sensitivity and Specificity ; Seoul

Enterococcus gallinarum carrying both vanA and vanC1 genes were detected from a surveillance culture from a patient staying at the surgical intensive care unit for a few years. E. gallinarum, SI04, was highly resistant to vancomycin (MIC of >or=256ng/mL) and teicoplanin (MIC of >or=256ng/mL). Multiplex PCR for vanA, vanB, vanC1 and vanC2/3 genes revealed SI04 to be positive for both vanA and vanC1 genes. This finding supports the fact that genotyping is needed to classify vancomycin-resistant enterococci (VRE). This is the first report on VanC VRE accompanying vanA gene in Korea.
Enterococcus* ; Humans ; Critical Care ; Korea ; Multiplex Polymerase Chain Reaction ; Teicoplanin ; Vancomycin

BACKGROUND: V. parahaemolyticus O3:K6 strains responsible for the increase in the number of cases of diarrhea in Southeast Asia since 1995. We performed serotyping of V. parahaemolyticus isolated from different geographic areas in Korea since 1998. METHODS: A total of 45 V. parahaemolyticus strains were isolated from clinical specimens of pa-tients with diarrhea in different geographic areas of Seoul (Hanyang University Hospital, 16 cases), Incheon (Gachon Medical Center, 27 cases) and Gwangju (Chonnam University Hospital, 2 cases) from 1998 to 2000 in Korea. Serovar O3:K6 of V. parahaemolyticus was determined by slide and tube agglutination tests with specific antisera (Seiken, Japan). RESULTS: The twenty-eight (62%) of 45 samples were positive to specific antisera of V. parahae-molyticus O3:K6. The O3:K6 strains were detected 11/16 (69%) in Seoul, 15/27 (56%) in Incheon, and 2/2 (100%) in Gwangju. V. parahaemolyticus O3:K6 was detected 11/16 (69%) in 1998, 12/18 (67%) in 1999, and 5/11 (45%) in 2000, respectively. CONCLUSIONS: We report the epidemic emergence of V. parahaemolyticus O3:K6 in Korea, since 1998.
Agglutination Tests ; Asia, Southeastern ; Diarrhea ; Gwangju ; Immune Sera ; Incheon ; Korea* ; Seoul ; Serotyping ; Vibrio parahaemolyticus* ; Vibrio*

BACKGROUND: Because extended-spectrum -lactamase (ESBL) producing strains can frequent-ly cause therapeutic failure and infectious outbreaks in hospitals, rapid and accurate detection of these strains are important. We compared the Vitek ESBL test with the NCCLS ESBL phenotypic confirmatory test by disk diffusion (NCCLS ESBL test) and double disk synergy test (DDST). METHODS: For a total of 316 clinical isolates composed of Escherichia coli (184), Klebsiella pneu-moniae (120) and Klebsiella oxytoca (12), we performed the Vitek ESBL test and the NCCLS ESBL test. For sixty-eight ESBL producing isolates, the Vitek ESBL test was compared with the NCCLS ESBL test and the DDST. The ESBL producer was defined as an organism showing an increase in the inhibited zone diameter of >or=5 mm for either cefotaxime or ceftazidime in combination with clavu-lanic acid versus its single test. The DDST was performed with 20 mm and 30 mm for interdisk diam-eter. For seven false negative isolates in the Vitek ESBL test, the DDST of cefepime was performed. RESULTS: Compared with the NCCLS ESBL test, the Vitek ESBL test showed one false positive (specificity, 99.6%), seven false negatives (sensitivity, 89.7%) and 97.5% agreement. Seven false negative isolates of the Vitek ESBL test were the cefoxitin-resistant ESBL producer. In positivity for the NCCLS ESBL test of 68 ESBL producing isolates, cefotaxime-clavulanic acid and ceftazidime-clavulanic acid were 94% and 91%. Cefotaxime, ceftazidime, aztreonam and ceftriaxone showed 95/90%, 100/55%, 100/85% and 95/80% positivity in double-disk synergy with amoxicillin-clavulanic acid (AMC) for 20/30 mm of the interdisk diameter respectively. For seven false negative isolates of the Vitek ESBL test, cefepime showed a distinct synergic effect with AMC. CONCLUSIONS: The Vitek ESBL test may be a useful method for clinical laboratories due to its easy, rapid and sensitive method but its method was less sensitive to cefoxitin-resistant ESBL. For these cases, if the NCCLS ESBL test or DDST with cefepime are added, the detection rate of the ESBL pro-ducer can be augmented.
Amoxicillin-Potassium Clavulanate Combination ; Aztreonam ; Cefotaxime ; Ceftazidime ; Ceftriaxone ; Diffusion ; Disease Outbreaks ; Escherichia coli* ; Escherichia* ; Klebsiella oxytoca ; Klebsiella*

BACKGROUND: Recently, we noticed an increased isolation rate for Candida tropicalis from urine of the patients in the intensive care unit (ICU) of the neurosurgery department in our hospital. We inves-tigated the risk factors for funguria and performed randomly amplified polymorphic DNA (RAPD) analysis for the isolates. METHODS: A total of 27 strains including 12 strains of C. tropicalis from the urine of ICU patients collected during a one-month period, 13 strains from other wards than ICU, and 2 control strains were analyzed. RAPD analysis was performed using 2 primers (UBC78 and CD16S). Medical re-cords of the patients were reviewed to determine the risk factors for funguria by C. tropicalis. RESULTS: RAPD analysis showed an identical pattern for all strains of C. tropicalis from ICU patients and a heterogeneous pattern for the isolates from other wards. C. tropicalis funguria of these ICU patients was significantly associated with the use of an urinary catheter (100%, P < 0.001), previous surgery (44%, P < 0.05) and trachostomy (40%, P < 0.05), when compared with those of non-ICU patients. CONCLUSIONS: The identical RAPD pattern of all C. tropicalis strains from ICU patients indicates that they possibly originated from one clone. Through the investigation of risk factors, we can postulate that an urinary catheter might be a source for the outbreaks of urinary tract infections in the ICU. In addition, RAPD analysis might be a very useful test as one of the molecular epidemiologic tools for C. tropicalis funguria.
Candida tropicalis* ; Candida* ; Clone Cells ; Disease Outbreaks ; DNA* ; Epidemiologic Studies* ; Humans ; Intensive Care Units ; Neurosurgery ; Risk Factors* ; Urinary Catheters ; Urinary Tract Infections* ; Urinary Tract*

BACKGROUND: We evaluated the analytical performances of Diasys reagents manufactured by Diasys Diagnostic Systems (Holzheim, Germany) with Hitachi 747. METHODS: We evaluated AST, ALT, ALP, gamma-GT, calcium, and glucose. Only two tests were adapt-ed to different methods from the current ones: the photometric test using the arsenazo III for calci-um, the kinetic colorimetric test according to Szasz/Persijin using l-gamma-glutamyl-3-carboxy-4-nitranilide as a substrate for gamma-GT. Precision, interference, linearity, and method comparisons were evaluated by NCCLS guidelines. RESULTS: The coefficient of variation (CV) of total precision was less than 6.8% in all items. Preci-sions and linearities of all items were acceptable. Correlation coefficients were more than 0.9884 and all items showed excellent agreement compared to the current reagents in the reportable range. We could not find any significant interference for six test items up to 750 mg/dL triglyceride, 50 mg/dL hemoglobin, and 20 mg/dL bilirubin, except that the latter ALT showed a negative bias by more than 5 mg/dL of bilirubin. CONCLUSIONS: Diasys reagents showed high precision, linearity and correlation in comparison to the current reagents. So we conclude that these reagents are good for routine clinical use with Hitachi 747.
Arsenazo III ; Bias (Epidemiology) ; Bilirubin ; Calcium ; Glucose ; Indicators and Reagents* ; Triglycerides

BACKGROUND: There have been many reports that 1,5-Anhydroglucitol (1,5-AG) was a better marker than the hemoglobin A1c (HbA1c) or fructosamine for monitoring the control of glucose in patients with Diabetes Mellitus (DM). However, there was difficulty in performing the tests on the patient's samples in the hospital laboratory because the measurement was possible only with gas chromatog-raphy or high performance chromatography. Recently, a reagent that can measure 1,5-AG on the automatic chemistry analyzer was introduced. We evaluated the analytical and clinical characteris-tics of the reagent. METHODS: We measured the 1,5-AG with the Lana(TM) (Japan Chemistry Medicine, Tokyo, Japan) on the automatic chemistry analyzer, TBA-30FR (Toshiba, Otawara, Japan). We evaluated the pre-cision, the recovery rate, the lower detection limit, the reference value, and the correlation with other clinical markers for glucose control of the DM patient. RESULTS: The within-run precisions of abnormal and normal samples were 1.27% and 1.41%. The between-day precisions were 2.34% and 4.56%, respectively. The recovery rate was 100.1% and 100.7% in abnormal and normal samples, respectively. The lower detection limit was 0.05 mg/L. The reference value from the healthy people was from 12.7 to 50.9 mg/L. The correlation coefficients of the 1,5-AG with glucose and HbA1c were -0.45 and -0.63, respectively. CONCLUSIONS: The newly introduced reagent for 1,5-AG that could be applied with the automatic chemistry analyzer was enough to satisfy the analytical features and it showed better correlation with HbA1c than with the fasting blood glucose. We expect that the Lana(TM) can be used in hospital lab-oratories to monitor the blood glucose control of DM patients and more studies on the clinical value of the 1,5-AG can be done with the convenient reagent such as this.
Biomarkers ; Blood Glucose ; Chemistry ; Chromatography ; Diabetes Mellitus ; Fasting ; Fructosamine ; Glucose ; Humans ; Laboratories, Hospital ; Limit of Detection ; Reference Values

BACKGROUND: Sometimes we receive specimens collected several hours ahead, hemolyzed, or turbid. To decide to analyze the samples or not, the influence of storage time, hemolysis, and turbidi-ty on PT and PTT were studied. METHODS: Total of 198 cases for PT and 192 for aPTT were studied to clarify the effect of storage time on PT and aPTT. We performed the tests of PT and aPTT at 0, 2, 4, and 8 hours after collection of specimens. For the hemolysis effect study, we used 31 cases. Slightly, moderately, and severely hemolyzed plasma were obtained by adding hemolysate to plasma. For the turbidity effect study, we used 30 cases. Slightly, moderately, and severely turbid plasma were obtained by adding Intrali-pos (20% soybean oil) to plasma. RESULTS: Delayed test time affected the aPTT results after 8 hours. Hemolysis affected the PT and aPTT results. Turbidity did not affect the PT and aPTT results; however, the Coagrex-100s rejected to analyze the severely turbid samples. CONCLUSIONS: It is recommended that specimens be evaluated immediately or within 4 hours and that hemolysed or severely turbid specimens for PT and aPTT tests not be used.
Hemolysis* ; Plasma ; Soybeans