Acquired hemophilia is a rare acquired bleeding disorder. It occurs most frequently in elderly patients and in patients with associated underlying diseases such as autoimmune disorders, rheumatoid arthritis, malignancies, and so on. It is caused by autoantibodies to factor VIII which deplete circulating factor VIII. We report a 78-year-old man with acquired hemophilia A who underwent subtotal gastrectomy for stomach cancer 7 years ago with no current evidence of recurrence. He has no bleeding tendency in the past nor family history for bleeding. On admission he had blood clots in both renal pelvis and sustaining hematuria. Laboratory tests revealed prolonged activated partial thromboplastin time(aPTT), decreased activity of factor VIII and evidence of factor VIII inhibitor.
Aged ; Arthritis, Rheumatoid ; Autoantibodies ; Factor VIII ; Gastrectomy ; Hematuria ; Hemophilia A* ; Hemorrhage ; Humans ; Kidney Pelvis ; Partial Thromboplastin Time ; Recurrence ; Stomach Neoplasms ; Thromboplastin

BACKGROUND: We evaluated the performance and analysis time of HLC-723 G7 (Tosoh corp. Tokyo, Japan) hemoglobin (Hb) A1c autoanalyzer. It utilizes cation exchange high performance liquid chromatography (HPLC) method and has a reduced analysis time compared with that of an earlier model HLC-723GHb V A1c 2.2(TM) (HLC-723GHb V, Tosoh corp. Tokyo, Japan). METHODS: We evaluated linearity, precision and comparison with HLC-723GHb V following NCCLS guidelines and counted the number of tests per hour to estimate analysis time. RESULTS: Linearity through the range from 5.8% to 13.9% was good (r2=0.9930, relative nonlinearity <2.5%). The within-run coefficients of variation (CVs) for groups of low, middle, and high level were 1.09%, 0.76%, and 0.68% and total CVs for each group were 1.60%, 0.91%, and 1.00%, respectively. Correlation equation between HLC-723 G7 and HLC-723GHb V was HLC-723 G7=1.0308 (HLC-723GHb V)-0.2896 %Hb A1c (r=0.9992, P<0.0001). Analysis time of HLC-723 G7 was 1.2 minutes per test compared with 2.1 minutes of HLC-723GHb V. CONCLUSIONS: HLC-723 G7 showed the acceptable performance and shortening analysis time therefore, it was suitable for reducing turn around time of Hb A1c assay.
Chromatography, Liquid ; Hemoglobin A, Glycosylated

BACKGROUND: The Dimension(R) RxL (Dade Behring Inc., Illinois) is a newly developed, high-throughput and versatile automated chemistry analyzer with continuous and random-access features for routine chemistry tests, enzymes, electrolytes, therapeutic drug monitoring, cardiac markers, and hormones. We evaluated the usefulness of Dimension(R) RxL in the aspect of precision, linearity, and comparison. METHODS: We evaluated the analytical performance of the Dimension(R) RxL for aspartate aminotransferase, alanine aminotransferase, high density lipoprotein cholesterol, blood urea nitrogen, creatinine, glucose, total bilirubin, total iron binding capacity, sodium, potassium, chloride, total CO2, digoxin, phenytoin, valporic acid, CK-MB, myoglobin and cardiac troponin-I. We used control materials for linearity and precision evaluation and random patients sera for comparison study with Hitachi 747 (Hitachi LTD., Tokyo, Japan), TDxFLx(TM) (Abbott Diagnotistics, Chicago) and ACS: Centaur(TM) (Bayer Diagnotistics, New York) according to NCCLS guidelines. RESULTS: In the precision study, within-run and total CVs of most items were below 5% except CK-MB and cardiac troponin-I. The linearities were maintained well in the range of medically significant levels and were statistically acceptable (P<0.001). The comparison study indicated good correlation with the central laboratory analyzer and correlation coefficients were above 0.975 (P<0.01). CONCLUSIONS: Dimension(R) RxL showed satisfactory precision, linearity, and good correlation compared with other analyzers. Because it has features of one system with many capabilities, we recommend that Dimension(R) RxL would be used for the routine chemistry setting or stat test settings at medium- to large-sized hospitals.
Alanine Transaminase ; Aspartate Aminotransferases ; Bilirubin ; Blood Urea Nitrogen ; Chemistry* ; Cholesterol, HDL ; Creatinine ; Digoxin ; Drug Monitoring ; Electrolytes ; Glucose ; Humans ; Iron ; Myoglobin ; Phenytoin ; Potassium ; Sodium ; Troponin I

BACKGROUND: In hospital laboratory using Microscan, the search for an isolate or the analysis for antimicrobial susceptibility rates were obtained by the Data Management System (DMS) software. However, it is hard to convert DMS database to other file formats in addition to some limitation in using the database. We applied BacLink 2 and WHONET 5.1 softwares to convert and analyse DMS database for the utilization of the isolate profiles and the antimicrobial resistance rates. METHODS: Specimen and microbial data were printed as 'Short report form', an ASCII text file, from Microscan DMS. BacLink 2 software was used to convert the printed file to dBASE format file. Statistical analyses were performed using WHONET 5.1 software. RESULTS: Data of isolates were obtained as 'Short report form' in one month intervals. This file could be converted to other database file using BacLink 2 software. The antimicrobial resistant profiles were obtained, and the susceptibility, intermediate resistant, and resistant rates for each isolates could be analyzed. CONCLUSIONS: In this study, BacLink 2 and WHONET 5.1 software were successfully applied for the conversion of the database. Analysis of isolate profiles and antimicrobial resistant rates could be performed in other personal computer systems. The database management by BacLink 2 and WHONET 5.1 software could be applicable for the convenient statistical analysis in microbiology laboratories using Microscan.
Laboratories, Hospital ; Microcomputers

BACKGROUND: Serum separator tubes were introduced 25 years ago and are widely used in the clinical laboratory for collection of blood. Recently, the plastic serum separator tube has become available for blood collection for lightening and flexibility and suitability for automation. However few studies have been reported on stability of the common analytes in this tube. METHODS: We evaluated the concentrations of seventeencommonly ordered analytes: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total protein, albumin, sodium, chloride, calcium, phosphorus, triglyceride, low density lipoprotein (LDL)-cholesterol, potassium, uric acid, blood urea nitrogen (BUN), total cholesterol, glucose, creatinine in sera separated in plain glass tubes (no gel) and in sera separated in the plastic Greiner Bio-One Vacuette tubes containing serum separator gel (Greiner Bio-One, Kremsm?nster, Austria) by Toshiba 200-FR Neo. RESULTS: Results were analyzed using two-tailed paired t-tests and Bland-Altman plots. Results from 9 common analytes (glucose, total cholesterol, BUN, potassium, LDL-cholesterol, inorganic phosphorus, calcium, sodium, chloride) were statistically different between glass tube and plastic Greiner Bio-One Vacuette tube, but the differences were not considered to be clinically significant. CONCLUSIONS: We conclude that the plastic Greiner Bio-One Vacuette tubes are suitable for collection of blood and storage of serum for common analytes.
Alanine Transaminase ; Alkaline Phosphatase ; Aspartate Aminotransferases ; Automation ; Blood Urea Nitrogen ; Calcium ; Calcium Chloride ; Chemistry, Clinical* ; Cholesterol ; Creatinine ; Glass* ; Glucose ; Lipoproteins ; Phosphorus ; Plastics ; Pliability ; Potassium ; Sodium ; Triglycerides ; Uric Acid

BACKGROUND: There is room for doubt that the reference intervals currently used in many hospitals or health institutions in Korea are appropriate, because some scientists do not agree that the selections of reference individuals were valid universally. If we adopt the inappropriate reference intervals in the decision making of examinees' health status, we are liable to lead to false-negatives or false-positives. METHODS: We selected 555 healthy and 2,134 unhealthy adult samples who took medical check-up at an institution between 2000 and 2004 through semi-stratified random sampling method. Disease groups were divided into 7 subgroups: hepatic, gastrointestinal, obesity, circulatory, endocrine, urogenital and others. RESULTS: Through parametric and non-parametric methods, we produced new reference intervals and compared the newly developed intervals with current ones. Some reference values should be adjusted newly; ALT-male < or =33 IU/L, ALT-female < or =22 IU/L, AST < or =28 IU/L, cholesterol < or =198 mg/dL, triglyceride-male < or =172 mg/dL, triglyceride-female < or =133 mg/dL, fasting blood sugar 65-101 mg/dL. CONCLUSIONS: In order to reduce the rate of false-positives or false-negatives, we suggest that reference ranges of some items might be reestablished or adjusted according to gender through the further studies on current reference ranges.
Adult* ; Blood Glucose ; Cholesterol ; Decision Making ; Fasting ; Humans ; Korea ; Obesity ; Reference Values*

BACKGROUND Coagulation assays can be easily affected by preanalytical variables, including the factors associated with the blood collection tube. Recently the Sekisui Trank Insepack (Sekisui Chemical Co., Ltd, Osaka, Japan; Insepack) blood collection tubes were introduced into Korea. The aim of this study was to compare the results of routine coagulation assays using the Insepack with those using BD Vacutainer (BD, Franklin Lakes, NJ, USA; Vacutainer) tubes, which are most widely used in Korea. METHODS: Paired blood samples from 64 patients were drawn into Insepack and Vacutainer 3.2% citrate tubes. The results of prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, and fibrin/fibrinogen degradation product (FDP) were determined in parallel. RESULTS: No statistically significant differences were observed between Insepack and Vacutainer tubes for PT, fibrinogen, and FDP tests. For APTT which showed the significant differences between the results in the two tubes the mean difference was small (0.8 seconds), and it was not considered clinically significant. CONCLUSIONS: The results of this study suggest that Insepack tubes can be used in place of Vacutainer tubes for routine coagulation assays.
Citric Acid* ; Fibrinogen ; Humans ; Japan ; Korea ; Lakes ; Partial Thromboplastin Time ; Plastics* ; Prothrombin Time

BACKGROUND: Recent advances of hematology analyzers have improved performance of leukocyte differential counts and have reduced work load of clinical hematology laboratories. We evaluated CELL-DYN Sapphire (Abbott Diagnostics, Santa Clara, CA, USA) performance on leukocyte differential counts according to Clinical and Laboratory Standards Institute (CLSI) document H20-A. METHODS: We evaluated imprecision (short term imprecision from duplication of 147 patients' sample and long term imprecision from three level commercial controls) and accuracy (n=462) of leukocyte differential counts of CELL-DYN Sapphire and compared with those of Sysmex XE-2100 (TOA Medical Electronics Co., Kobe, Japan), ADVIA 120 (Bayer Diagnostics, Tarrytown, NY, USA) and Beckman Coulter LH 750 (Beckman Coulter, Miami, FL, USA). RESULTS: The imprecision of CELL-DYN Sapphire for neutrophils and lymphocytes differentials was low with coefficients of variation (CV) from 1.4 to 6.2%, but the imprecision for basophils was high with CV from 34.7 to 79.6%. The correlation with manual count was good in samples without flags (n=314), with the exception of basophils (r: neutrophils, 0.921; lymphocytes, 0.921; monocytes, 0.653; eosinophils, 0.869; basophils 0.272). The correlation with other hematology analyzers was high except basophils (r: neutrophils, 0.969-0.986; lymphocytes, 0.986-0.990; monocytes, 0.787-0.887; eosinophils, 0.881-0.962; basophils 0.086-0.327). CONCLUSION: The performance on leukocyte differential counts of CELL-DYN Sapphire is comparable to Sysmex XE-2100, ADVIA 120 and Beckman Coulter LH 750. In regards of enumeration of basophils, the comparison with manual counts and other hematology analyzers shows poor agreement.
Aluminum Oxide* ; Basophils ; Electronics, Medical ; Eosinophils ; Hematology* ; Leukocytes* ; Lymphocytes ; Monocytes ; Neutrophils

BACKGROUND: Detection of antiphospholipid antibodies (aPL) can be considered problematic due to assay variability and reagent sensitivity, high false-positive and false-negative rates, and lack of assay standardization. Therefore, utilizing an automated system can improve reproducibility and reduce interlaboratory variation. Here, we evaluated the analytical performance of the new automated ACL AcuStar chemiluminescence assay (Instrumentation Laboratory, USA). This was compared to the results of a panel analyzed with the QUANTA Lite ELISA (INOVA Diagnostics Inc., USA). METHODS: We evaluated the inter-assay precision, linearity, and carry-over between the two methods, ACL and ELISA. A reference range study for each of the anticardiolipin (aCL) and anti-beta2 glycoprotein-I (abeta2GPI) IgG and IgM antibodies were performed using 135 healthy patient samples, which served as controls. We then compared the accuracy among the AcuStar and ELISA systems via four aPL tests. For this comparison, 69 patient samples suspected of an autoimmune disorder were used as the experimental panel. RESULTS: The AcuStar analyzer showed excellent precision, linearity, and carry-over for all four assays. The calculated cutoff values were 20.3 U/mL for aCL IgG, 20.3 U/mL for aCL IgM, 26.3 U/mL for abeta2GPI IgG, and 11.9 U/mL for abeta2GPI IgM. The consensus between AcuStar and ELISA results were generally comparable. Total agreement varied between 82.6% and 95.7%, and kappa values showed moderate to good agreement. CONCLUSIONS: Our study demonstrates that the new AcuStar chemiluminescence assay showed better performance. This automated system leads to improved reproducibility and reduces interlaboratory variability.
Antibodies ; Antibodies, Anticardiolipin ; Antibodies, Antiphospholipid* ; Antiphospholipid Syndrome ; Automation ; Consensus ; Enzyme-Linked Immunosorbent Assay ; Humans ; Immunoglobulin G ; Immunoglobulin M ; Luminescence* ; Reference Values

As Immunoserology Subcommittee of the Korean Association of External Quality Assessment Service, we organized two trials on the external quality assessment of viral markers and serological tests for syphilis (STS) in 2014. For this purpose, we delivered three kinds of pooled sera specimens for external proficiency testing to 1,060 and 1,064 institutions for the first and second trials, respectively. Pooled sera were checked for their homogeneity and stability by using more than three other methods between the day of their manufacture and 3 days after despatching. The numbers of participating laboratories were 1,053 (99.3%) and 1,046 (99.3%) in the first and second trials, respectively. The most commonly tested items were hepatitis B surface antigen, followed by antibody to hepatitis B surface antigen, anti-human immunodeficiency virus, anti-hepatitis C virus, STS, and anti-hepatitis B core. The most frequently used methods for detecting viral markers were the chemiluminescence immunoassay (CLIA) and the electrochemiluminescence immunoassay, which generated few false positive results. In contrast, false negative results were frequently found through the immunochromatography assay, the use of which for detecting viral markers has been steadily increasing in recent years. Furthermore, the use of turbidoimmunoassay and CLIA, which are new tests recently introduced for the measurement of non-treponemal and treponemal antibodies, is also increasing.
Antibodies ; Biomarkers* ; Hepatitis B ; Hepatitis B Surface Antigens ; Hepatitis C ; HIV ; Immunoassay ; Immunochromatography ; Korea* ; Laboratory Proficiency Testing ; Luminescence ; Serologic Tests* ; Syphilis*