ABSTRACT
Lung disease caused by nontuberculous mycobacteria (NTM) represents an increasing proportion of all mycobacterial diseases. We investigated recent occurrences of NTM and evaluated the clinical significance of NTM isolates from 752 respiratory specimens collected from patients at National Health Insurance Service Ilsan Hospital between January 2007 and May 2011. Specimens were incubated on solid and liquid media (BACTEC MGIT 960, BD, USA) for 6-8 weeks, and PCR and reverse blot hybridization were performed (REBA Myco-ID, Molecules & Diagnostics, Korea). Clinical features of the patients were reviewed through medical records. The most frequently isolated organism was Mycobacterium avium (46.7%), followed by M. intracellulare (14.8%), M. fortuitum (7.2%), and M. abscessus (6.6%). The most common mycobacteria among definitive cases of NTM lung disease were M. avium (42/351, 12.0%), M. intracellulare (19/111, 17.1%), M. abscessus (11/50, 22.0%), M. massiliense (4/13, 30.8%), and M. fortuitum (4/54, 7.4%). Clinically significant cases of NTM lung disease increased from 4 patients in 2007 to 32 in 2011. The mean patient age was 64 yr (range: 35-88 yr), and 58 (64%) patients were women. Patients suffered from cough, productive sputum, and hemoptysis. In summary, the most common mycobacteria causing NTM lung disease were M. avium and M. intracellulare; however, cases of M. massiliense and M. abscessus infection are on the rise in Korea.
Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Bronchoalveolar Lavage Fluid/microbiology , DNA, Bacterial/analysis , Hospitals, General/standards , Lung Diseases/diagnosis , Mycobacterium Infections, Nontuberculous/diagnosis , Nontuberculous Mycobacteria/genetics , Nucleic Acid Hybridization , Polymerase Chain Reaction , Reagent Kits, Diagnostic , Republic of Korea , Sputum/microbiologyABSTRACT
BACKGROUND: Analyzing large numbers of specimens in a short time and generating accurate results while minimizing costs are critical to laboratory tests. The CS-6400 (Dong-A Dirui, China), an automated chemistry analyzer, has been recently developed in China in collaboration with domestic corporations. To assess the performance and usability of the analyzer, we evaluated its analytical performance and clinical usefulness including accuracy and linearity of electrolytes and chemistry tests using HiSens reagent (HBI Co., Korea) with protocols provided by the Clinical and Laboratory Standards Institute, and compared these results with those of the formerly used DXC800 (Beckman Coulter, USA), and Vista500 (Siemens, Germany). METHODS: The accuracy, linearity, recovery factor, and sample carryover of the CS-6400 using HiSens reagent were determined for 29 tests-aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (ALP), lactate dehydrogenase (LDH), gamma glutamyl transferase, glucose, total cholesterol, triglyceride (TG), amylase, lipase, creatine kinase (CK), blood urea nitrogen, creatinine, uric acid, total protein, albumin, total bilirubin (TB), direct bilirubin (DB), calcium, inorganic phosphorus, magnesium (MG), HDL cholesterol, rheumatoid factor (RF), LDL cholesterol, C-reactive protein, anti-streptolysin O, sodium, potassium, and chloride and the results were compared with the values obtained from the DXC800 and Vista500 to set reference intervals for each test. Serum samples obtained from 128 healthy adults were used for the reference intervals. and values obtained from DXC800 and Vista500 were used to make comparison on and to set reference intervals for each routine. Serum specimens obtained from a total of 128 healthy adults were used for the reference intervals. RESULTS: The coefficient of variation showed excellent values of or =5%). The coefficient of determination (R2) was > or =0.993 with linearity between 0.928 and 1.078 within the useful clinical span. In addition, the recovery factor values of the tests were 84% to 108%, and correlation comparisons were 0.975 except for albumin (0.9516), RF (0.7617), and LDL cholesterol (0.9709). We evaluated whether the CS-6400 contributed to the attempt to minimize the test's cost and running time. Developed in China, the CS-6400 has been approved by the Food and Drug Administration and uses indirect ion selective electrodes for electrolytes and colorimetry and turbidimetry for general and specific chemistry items. The tests showed excellent linearity of > or =0.993 using commercial certified linearity material. The recovery factor values of the tests were 93% to 108%, except for LDL cholesterol (84%). Except for the minimum values, percentage sample carryover values for CK and LDH were < or =1% (0.00% and 0.07%, respectively), suggesting that the results of the tests were not affected by sample carryover, and reference interval was present based on sex. CONCLUSIONS: The CS-6400 with HiSens showed excellent analytical performance (precision, linearity, and accuracy). Furthermore, results from the CS-6400 were highly correlated with those obtained from similar tests performed on DXC800 and Vista500. Therefore, the CS-6400 is appropriate for tertiary care hospitals where large volumes of test samples must be processed within a short period with minimal cost.
Subject(s)
Adult , Humans , Alanine Transaminase , Alkaline Phosphatase , Amylases , Bilirubin , Blood Urea Nitrogen , C-Reactive Protein , Calcium , China , Cholesterol , Cholesterol, HDL , Cholesterol, LDL , Colorimetry , Cooperative Behavior , Creatine Kinase , Creatinine , Electrolytes , Glucose , Ion-Selective Electrodes , L-Lactate Dehydrogenase , Lipase , Magnesium , Nephelometry and Turbidimetry , Phosphorus , Potassium , Rheumatoid Factor , Running , Sodium , Tertiary Healthcare , Transferases , United States Food and Drug Administration , Uric AcidABSTRACT
BACKGROUND: The aim of this study was to investigate alterations in homocysteine levels with delays in the initiation time of centrifugation. Attempts were made to improve the processing of samples by analyzing the homocysteine levels of patients from a health promotion center, where delays in the initiation of sample centrifugation were expected because of the nature of the workload and operational procedures. METHODS: Forty healthy adults were selected for the measurement of homocysteine levels. The two samples those were obtained from each individual simultaneously and separately were designated as group A (centrifugation initiation time or =2 hours). The degree of deviation from the homocysteine reference interval was also evaluated with samples from 1,134 adults who had medical check-up at a health promotion center from August 1, 2009 to July 31, 2010. RESULTS: The mean serum homocysteine level in group B was significantly higher than that of group A (12.4 vs. 10.6 micromol/L, P<0.0001). Homocysteine level increased with a mean of 19.4% when the initiation of centrifugation was delayed over 2 hours. In the 1,134 adults who had medical check-up, the numbers outside the reference interval were 334 (29.5%). Abnormal samples with homocysteine levels out of the reference interval were reduced to about 7% in July 2011 through improving sample processing to minimize delays in centrifugation initiation time. CONCLUSIONS: Homocysteine levels rapidly increase as blood sample centrifugation is delayed. Therefore, in order to provide accurate test results immediate centrifugation of blood samples is critical.
Subject(s)
Adult , Humans , Centrifugation , Health Promotion , HomocysteineABSTRACT
Two trials with 15 test items of external quality assessment survey were performed in 2009. The test items were constituted three immunoassay categories, i.e., tumor markers, thyroid hormones and immunoproteins (IgG, IgM, IgA, C3 and C4). Fifteen test items commonly used in clinical laboratories and performed by immunoassay method were surveyed as scheduled. The number of participated laboratory of external quality assessment for Immunoassay Subcommittee were 494 institutions in the first trial survey and 519 institutions in the second survey. All of the fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (Liquimmune(R), Liquid Assayed Immunoassay Control, Microgenics Co, USA) were used for the two trials in 2009 survey. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 494 and 519 laboratories and the response rate were 97.6% and 98.3% in 2009. 2. Chemiluminiscence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories for detecting tumor markers and hormones. 3. Stability tests of home-made control materials were performed and confirmed the CV values were in acceptable ranges. 4. Workshops titled "National health examination for tumors" and "Standardization and harmonization of laboratory tests" were held on September 4, 2009 and December 16, 2009 in cooperation with Annual Autumn Academic Conferences of Clinical Laboratory and Quality Control, and Immunoserology Subcommittee, respectively. The quality of the participating laboratories seems to be continuously improved. And, this year, new sixty eight laboratories were participated to our Immunoassay Subcommittee.
Subject(s)
Congresses as Topic , Immunoassay , Immunoglobulin A , Immunoglobulin M , Immunoproteins , Korea , Quality Control , Thyroid Hormones , Biomarkers, TumorABSTRACT
Two trials of external quality assessment were performed in 2008. The first and the second trials assessed by three test categories, i.e., tumor markers, thyroid hormones and immunoproteins (IgG, IgM, IgA, C3 and C4). Fifteen test items using immunoassay method were surveyed as scheduled. The number of participated laboratory of external quality assessment for Immunoassay Subcommittee were 437 institutions in the first trial survey and 476 institutions in the second survey.Fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (Liquimmune(R), Liquid Assayed Immunoassay Control, Microgenics Co, USA) were used. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 437 and 476 laboratories and the response rate were 94.6% and 98.7% in 2008. 2. Chemiluminiscence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories for detecting tumor markers and hormones. 3. Some analyzers of a few test items showed variations of the test results of the same control material probably due to personal factors of the institution. 4. Workshops titled "Quality control of Immunoassay" and " Quality control of tumor markers" were held on September 5, 2008 and December 3, 2008 in cooperation with Annual Autumn Academic Conferences of Clinical laboratory and Quality Control and Immunoserology Subcommittee. The quality of the participating laboratories seems to be thought being continuously improved. And, this year, about 51 laboratories are newly participated to our Immunoassay Subcommittee.
Subject(s)
Humans , Congresses as Topic , Immunoassay , Immunoglobulin A , Immunoglobulin M , Immunoproteins , Quality Control , Thyroid Hormones , Biomarkers, TumorABSTRACT
Two trials of external quality assessment were performed in 2007. The first and the second trials assessed by three test categories, tumor markers, thyroid hormones and immunoproteins(IgG, IgM, IgA, C3 and C4). All of fifteen test items using immunoassay method were surveyed. The response rates of external quality assessment for Immunoassay Subcommittee were 98.3%in first trial and 98.8% in second trial in 2007. Fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (LyphoCheck, BioRad, USA) were used for external survey. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 400 laboratories and the response rates were 95.4% and 98.8% in 2007. 2. Recently chemiluminescence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories. 3. Still some test items show big variations of the test results of the same control material according to reagents and autoanalyzers. 4. A workshop for "Quality control practices of Immunoassay" was held on September 7th, 2007 in cooperation with Annual Autumn Academic Conferences of Clinical Laboratory and Quality Control. The quality of the participating laboratories seems to be continuously improved. And, this year, many laboratories are newly participated to Immunoassay Subcommittee. A new surveillance system for the individual laboratory according to its performance by method and analyzer is on scheduling for special performance-based QC.
Subject(s)
Congresses as Topic , Immunoassay , Immunoglobulin A , Immunoglobulin M , Indicators and Reagents , Luminescence , Quality Control , Thyroid Hormones , Biomarkers, TumorABSTRACT
Two trials of external quality assessment were performed in 2007. The first and the second trials assessed by three test categories, tumor markers, thyroid hormones and immunoproteins(IgG, IgM, IgA, C3 and C4). All of fifteen test items using immunoassay method were surveyed. The response rates of external quality assessment for Immunoassay Subcommittee were 98.3%in first trial and 98.8% in second trial in 2007. Fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (LyphoCheck, BioRad, USA) were used for external survey. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 400 laboratories and the response rates were 95.4% and 98.8% in 2007. 2. Recently chemiluminescence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories. 3. Still some test items show big variations of the test results of the same control material according to reagents and autoanalyzers. 4. A workshop for "Quality control practices of Immunoassay" was held on September 7th, 2007 in cooperation with Annual Autumn Academic Conferences of Clinical Laboratory and Quality Control. The quality of the participating laboratories seems to be continuously improved. And, this year, many laboratories are newly participated to Immunoassay Subcommittee. A new surveillance system for the individual laboratory according to its performance by method and analyzer is on scheduling for special performance-based QC.
Subject(s)
Congresses as Topic , Immunoassay , Immunoglobulin A , Immunoglobulin M , Indicators and Reagents , Luminescence , Quality Control , Thyroid Hormones , Biomarkers, TumorABSTRACT
BACKGROUND: Metabolic syndrome is a combination of disorders that increase the risk of cardiovascular disease and type 2 diabetes. The aim of this study was to evaluate the influence of waist circumference index of metabolic syndrome on the establishment of reference intervals. METHODS: We selected 2,442 adults (1,324 men and 1,118 women) samples who took medical check-up at our hospital health promotion center from January 1, 2008 to May 20, 2008. Study groups were divided into two subgroups by waist circumference. The data was statistically analyzed using SAS 8.2 for Gaussian distribution and t-test. RESULTS: Leukocyte counts, erythrocyte counts, platelet counts, and hs-CRP showed difference in reference intervals, but no significant differences were observed between the two groups (P>0.05). In most of routine chemistry items, reference intervals were significantly different between the two groups (P<0.05). CONCLUSIONS: Because waist circumference is measured exactly by physician, use of waist circumference for prior sampling in setting of reference intervals would be very useful for selection of healthy person.
Subject(s)
Adult , Humans , Male , Cardiovascular Diseases , Erythrocyte Count , Health Promotion , Leukocyte Count , Phenothiazines , Platelet Count , Waist CircumferenceABSTRACT
Clonorchis sinensis infection is one of the most common parasitic infections that is widely distributed in Southern Korea as well as China, Japan, Taiwan, Hong kong, and Vietnam and countries in Eastern Asia. The disease is caused by the ingestion of infected raw or under- processed freshwater fish. The clinical manifestations depend on the number of flukes in a patient, the period of infestation, and the complications. We experienced a 10-year-old boy who had a history of ingestion of raw fresh-water Chinese mitten crab preserved in soy sauce and presented with chronic urticaria. The causal organism, Clonorchis sinensis, was found by the identification of parasite ova in stool. We report a rare case of chronic urticaria related to Clonorchis sinensis that was successfully treated with praziquantel and review the pertinent literature.
Subject(s)
Child , Humans , Male , Asian People , China , Clonorchis sinensis , Eating , Asia, Eastern , Fresh Water , Hong Kong , Japan , Korea , Ovum , Parasites , Praziquantel , Soy Foods , Taiwan , Trematoda , Urticaria , VietnamABSTRACT
Three trials of external quality assessment were performed in 2005. The first and the second trials were assessed by 14 test items including tumor markers, hormones and immunoproteins and the third trial was intended only for five items of immunoproteins, i.e. Immunoglobulin G (IgG), IgM, IgA, Complement 3 (C3) and C4. Fourteen test items of immunoassay method including 5 tumor markers, 4 hormones and 5 imunoproteins were surveyed. The response rate of external quality assessment for Immunoassay Subcommittee were 94.4% ~ 95.0% in this year. Ten control materials of the first and second trials were consisted of 8 home-made pooled sera and 2 commercial control sera (LyphoCheck, BioRad, USA and Randox, Randox Ltd., UK). And, for the third trial we used the 05-S-4 specimen of the Immunoserology Subcommittee control material. The results are summarized as follows. 1. Laboratories participating in external quality control program of Immunoassay Subcommittee were 305 laboratories and the response rate were 94.4% and 95.0% in 2005. 2. Autoanalyzers based on enhanced or improved enzyme/chemiluminiscence imunoassay were mostly used in the field of immunoassay testing. 3. A new reporting system which uses the internet web site was introduced in this year from the second trial of external quality survey. 4. Some test items show big variations of the test results of the same control material according to autoanalyzer and reagents. The quality of the participating laboratories seems to be improved step by step. And, the new methods of reporting system and statistic analyses introduced this year were considered to get a good reputation from the member institutes for the surveillance systems.
Subject(s)
Academies and Institutes , Complement C3 , Immunoassay , Immunoglobulin A , Immunoglobulin G , Immunoglobulin M , Immunoproteins , Indicators and Reagents , Internet , Quality Control , Biomarkers, TumorABSTRACT
Two trials of external quality assessment were performed in 2004 as previous year. Thirteen test items of immunoassay with ten control materials were surveyed. The response rate of external quality assessment for Immunoassay Subcommittee were 94.4% and 98.6%. Ten control materials were consisted of 8 home-made pooled sera and 2 commercial control sera (LyphoCheck, BioRad, USA). The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 259 laboratories and the response rate were 94.4% and 98.6% in 2004. 2. Chemiluminiscence immunoassay autoanalyzers were most widely used in the field of immunoassay testing. 3. A new test item CA125 was introduced in this year from the second trial of external quality survey. 4. Still some test items show big variations of the test results of the same control material according to autoanalyzers. The quality of the participating laboratories seems to be thought being continuously improved. And, some new methods of the statistic analysis and some standardization protocols were considered to be introduced in the surveillance systems.
Subject(s)
Immunoassay , Quality ControlABSTRACT
Two trials of external quality assessment were performed in 2003. Thirteen test items of immunoassay with ten control materials were surveyed. The response rate of external quality assessment for Immunoassay Subcommittee were 93.8% and 92.8%. Ten control materials were consisted of 8 home-made pooled sera and 2 commercial control sera. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 259 laboratories and the response rate were 93.8% and 92.8% in 2003. 2. Chemiluminiscence immunoassay autoanalyzer was now widely introduced comparing to previous years and now it is the most popular analyzer in the field of immunoassay testing. 3. Still some test items show big variations of the test results of the same control material according to autoanalyzer. Generally the quality of the participating laboratories seems to be thought being improved. And in the following years, new planning of the statistic analysis and some standardization protocols could be introduced.
Subject(s)
Immunoassay , Korea , Quality ControlABSTRACT
BACKGROUND: Newly developed ACL9000 automatic coagulation analyzer was evaluated in measurement of prothrombin time(PT), activated partial thromboplastin time(aPTT) and fibrinogen. METHODS: We studied precision including withtin-run and between-day precision. Normal reference ranges for PT, aPTT and fibrinogen were obtained in 60 healthy normal controls. The heparin sensitivity for aPTT and heparin interference for PT and fibrinogen were also determined. Lastly ACL9000 was compared with another coagulation analyzer, MLA Electra 1600. RESULTS: Precision of PT, aPTT and fibrinogen were acceptable, mostly. The normal reference ranges were as followings: 10.7-12.4 sec for PT, 28.7-40.8 sec for aPTT and 165-468 mg/dL for fibrinogen. The ranges of aPTT were from 49.8 sec to 84.7 sec in therapeutic heparin concentration(0.2-0.4 IU/mL) and heparin interfered determination of PT and fibrinogen in high concentrations. The comparability between ACL9000 and MLA Electra 1600 was good in determinations of PT and fibrinogen but not in determination of aPTT. CONCLUSIONS: We concluded that the performance of ACL9000 was acceptable and ACL9000 would be a useful analyzer for routine coagulation tests.
Subject(s)
Fibrinogen , Heparin , Partial Thromboplastin Time , Prothrombin , Prothrombin Time , Reference Values , ThromboplastinABSTRACT
BACKGROUND: The analytical performance of the Vitros ECi(R) Immunodiagnostic System on the thyroid stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4) and estradiol (E2) assays, which are based on electrochemical luminescence to replace the radioimmunoassay was evaluated. METHODS: The precision as measured by the NCCLS protocol and a comparison of the method were done for each TSH, FT3, FT4, and E2 assay. The functional sensitivity and linearity tests were performed for both TSH and E2. The free hormone validity test was performed for both the FT3 and FT4. RESULTS: All four analytes showed an acceptable precision. The functional sensitivities of TSH and E2 were 0.007 mIU/L, and 87 pmol/L, respectively. TSH and E2 showed excellent linearity up to 78 mIU/mL, and up to 7,700 pmol/L, respectively. The free hormone validity test showed acceptable results demonstrating accurate free hormone determination. The E2 showed a significant proportion-al bias requiring an adjustment of the reference range, However, the other analytes showed good agreement with a slight proportional bias. CONCLUSIONS: The TSH, FT3, FT4, and E2 assay by Vitros ECi(R) exhibited excellent performance overcoming the drawbacks of a conventional radioimmunoassay.
Subject(s)
Bias , Estradiol , Luminescence , Radioimmunoassay , Reference Values , Thyrotropin , Thyroxine , TriiodothyronineABSTRACT
BACKGROUND: Urinary tract is the most common site of nosocomial infections, accounting for 35% of all nosocomial infections. About 80-90% of these urinary tract infections are associated with urethral catheter insertion. Recently, we experienced an outbreak of nosocomial UTI (urinary tract infection) caused by Candida spp. in the surgical ICU (SICU) and we investigated the cause of UTI outbreak. METHODS: We collected data from clinical records and observed the current methods of care of urethral catheters in the SlCU. During the outbreak, we investigated the current procedures and maintenance care of urethral catheter insertion and educated the staff on the correct methods of the catheter insertion and care. We performed surveillance cultures of unused new urine bags, RESULTS: Between May 2000 and June 2000, 17 Candida spp. strains were isolated from urines of 17 patients hospitalized in the SICU of National Health Insurance Corporation Ilsan Hospital. All infections were attributed to the care of urethral catheter insertion and contaminated bags. We identified that routine bladder irrigation and emptying urine to a common urinal have been done incorrectly during the outbreak period. Rodotorula spp. was isolated from 4 urine bags (50% contamination rate) out of 8 unused new urine bags by surveillance cultures. CONCLUSION: The causes of the UTI outbreak caused by Candida spp. was terminated by outbreak investigation and change of contaminated urine bag.
Subject(s)
Humans , Candida , Catheters , Cross Infection , National Health Programs , Urinary Bladder , Urinary Catheters , Urinary Tract Infections , Urinary TractABSTRACT
BACKGROUND: Recently malaria infection became one of the most important parasitic diseases in Korea. After the re-emergence of malaria in a young soldier in 1993 near the De-Militarized Zone (DMZ), three to four thousand people have been infected per year in the last few years and the cases of infection have been increasing threefold each year. Microscopic examination of a thick blood smear is a conventional and confirmatory method for diagnosis. However, it requires labor-intensive procedures and its interpretation is quite subjective. Faster and more reliable methods are needed for the diagnosis of malaria. METHODS: We evaluated 155 patients who were diagnosed as malaria. We performed point-of-care rapid diagnostic methods recently introduced: two antibody detection tests manufactured by Korean companies and one antigen (Plasmodium lactate dehydrogenase, pLDH) detection test. The results were compared with those of microscopic examinations of thick blood smears. RESULTS: Sensitivities of two antibody detection assays and one antigen detection assay in acute attacks of malaria were 64.7%, 72.5%, and 96.1%; and, specificities were 88.5%, 89.4%, and 95.1%, respectively. Overall accuracy for all samples were 80.6%, 83.9%, and 95.5%, respectively. CONCLUSIONS: Antibody detection tests for malaria have limitations in sensitivity and accuracy to replace microscopic examination of blood film. Antigen tests detecting pLDH could replace conventional microscopic examinations of blood film, especially in emergency situations in cases that require prompt medication.