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1.
Journal of Laboratory Medicine and Quality Assurance ; : 43-49, 2012.
Article in English | WPRIM | ID: wpr-207567

ABSTRACT

BACKGROUND: In 2010, the Clinical and Laboratory Standards Institute (CLSI) revised the minimum inhibitory concentration (MIC) breakpoints of cephalosporins and aztreonam to exempt extended-spectrum beta-lactamase (ESBL) confirmatory tests for Enterobacteriaceae. However, the CLSI did not change the MIC breakpoint of cefepime. Here, a proficiency survey of a strain of ESBL-producing Klebsiella pneumoniae was analyzed for MIC distribution and interpretation of cephalosporins and aztreonam. METHODS: The survey strain, K. pneumoniae, which produced SHV-18, was distributed to 170 clinical laboratories as 1 of 5 presumptive clinical specimens through the proficiency survey of the clinical microbiology division of the Korean Association of Quality Assurance for Clinical Laboratories (KAQACL). MIC, zone diameter of inhibition (ZDI), and interpretation of tested antimicrobials, methods of antimicrobial susceptibility testing (AST), and ESBL confirmatory results were collected. RESULTS: According to the revised breakpoints of the 2010 CLSI guidelines, MIC results indicated resistance to aztreonam in 100%, cefepime in 5.5%, cefotaxime in 20%, ceftazidime in 100%, and ceftriaxone in 100% of samples by broth microdilution methods. ZDI results also indicated resistance to aztreonam in 75%, cefepime in 0%, cefotaxime in 66.7%, ceftazidime in 100%, and ceftriaxone in 80% of samples by disk diffusion method. Ninety (75.6%) participants performed an ESBL confirmatory test, and 89 (98.9%) reported ESBL-positive tests. Of the 55 laboratories that tested the susceptibility of cefepime, 50 (90.9%) self-reported to be "resistant" because of ESBL-positive results. CONCLUSIONS: In conclusion, susceptibility testing of ESBL producers against certain cephalosporins is not reliable enough to apply the revised breakpoints presented in the 2010 CLSI guidelines. It is therefore necessary to reach a consensus for interpretation of ASTs of ESBL producers in Korea. Ideally, clinicians should be provided two interpretations based on both the revised breakpoints and ESBL confirmatory testing.


Subject(s)
Aztreonam , beta-Lactamases , Cefotaxime , Ceftazidime , Ceftriaxone , Cephalosporins , Consensus , Diffusion , Enterobacteriaceae , Klebsiella , Klebsiella pneumoniae , Korea , Microbial Sensitivity Tests , Pneumonia , Sprains and Strains
2.
Korean Journal of Blood Transfusion ; : 38-47, 2012.
Article in Korean | WPRIM | ID: wpr-76695

ABSTRACT

BACKGROUND: To ensure safety of blood transfusion, accuracy in performance of blood grouping tests (BGT) is essential. External proficiency testing (PT) for BGT has not been conducted in Korea. The first PT for BGT in domestic blood centers was conducted in order to evaluate the domestic status of accuracy of BGT in blood centers and to aid in improving the quality of blood centers. METHODS: Whole blood survey specimens consisting of three panels for ABO grouping and two panels for Rh typing were sent to 81 blood centers. Evaluation criteria for BGT were as follows: 'Good' for answers with 100% referee consensus, 'Acceptable' for correct answers other than those of the referee, and 'Unacceptable' for answers other than those of 'Good+acceptable' as correct answers. RESULTS: Rates of correct answers on three panels for ABO grouping were all 100%; however, that of cell typing for the panel with BW was 61.7%, and 31 blood centers incorrectly reported normal 'B' type as an answer. The rate of correct answers for the Rh negative panel was 100%; however, that for the weak D panel was 84%, and 13 blood centers incorrectly reported Rh negative type as an answer. CONCLUSION: Findings from this study demonstrated that some hospital blood centers were not able to correctly detect blood groups with weak antigens. Therefore, to improve the quality of blood centers, intensive education for blood center staff and continued PT for BGT should be required.


Subject(s)
Blood Group Antigens , Blood Grouping and Crossmatching , Blood Transfusion , Consensus , Dietary Sucrose , Korea
3.
The Korean Journal of Laboratory Medicine ; : 22-29, 2011.
Article in English | WPRIM | ID: wpr-30866

ABSTRACT

BACKGROUND: Insulin assays are affected by varying degrees of interference from anti-insulin antibodies (IAs) and by cross-reactivity with recombinant insulin analogues. We evaluated the usefulness of the E170 insulin assay by assessing IA effects and cross-reactivity with 2 analogues. METHODS: Sera were obtained from 59 type 2 diabetes patients receiving continuous subcutaneous insulin infusion and 18 healthy controls. Insulin levels were determined using an E170 analyzer. To investigate the effects of IAs, we performed IA radioimmunoassays, and analyzed the differences between directly measured insulin (direct insulin) and polyethylene glycol (PEG)-treated insulins (free, IA-unbound; total, IA-bound and unbound insulin). We performed in-vitro cross-reactivity tests with insulin aspart and insulin glulisine. RESULTS: In IA-positive patients, E170 free insulin levels measured using the E170 analyzer were significantly lower than the direct insulin levels. The mean value of the direct/free insulin ratio and IA-bound insulin, which were calculated as the difference between total and free insulin, increased significantly as endogenous IA levels increased. The E170 insulin assay showed low cross-reactivities with both analogues (< 0.7%). CONCLUSIONS: IAs interfered with E170 insulin assay, and the extent of interference correlated with the IA levels, which may be attributable to the increase in IA-bound insulin, and not to an error in the assay. The E170 insulin assay may measure only endogenous insulin since cross-reactivity is low. Our results suggest that the measurement of free insulin after PEG pre-treatment could be useful for beta cell function assessment in diabetic patients undergoing insulin therapy.


Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Cross Reactions , Diabetes Mellitus, Type 2/blood , Infusions, Subcutaneous , Insulin/analogs & derivatives , Insulin Antibodies/blood , Polyethylene Glycols/chemistry , Radioimmunoassay/instrumentation , Recombinant Proteins/analysis
4.
The Korean Journal of Laboratory Medicine ; : 250-256, 2011.
Article in English | WPRIM | ID: wpr-164053

ABSTRACT

BACKGROUND: We evaluated the performance of multiplex tandem mass spectrometry (MS/MS) in newborn screening for detection of 6 lysosomal storage disorders (LSDs), namely, Niemann-Pick A/B, Krabbe, Gaucher, Fabry, and Pompe diseases and Hurler syndrome. METHODS: We revised the conditions and procedures of multiplex enzyme assay for the MS/MS analysis and determined the precision of our enzyme assay and the effects of sample amounts and incubation time on the results. We also measured the degree of correlation between the enzyme activities in the dried blood spots (DBSs) and those in the leukocytes. DBSs of 211 normal newborns and 13 newborns with various LSDs were analyzed using our revised methods. RESULTS: The intra- and inter-assay precisions were 2.9-18.7% and 8.1-18.1%, respectively. The amount of product obtained was proportional to the DBS eluate volume, but a slight flattening was observed in the product vs. sample volume curve at higher sample volumes. For each enzyme assay, the amount of product obtained increased linearly with the incubation period (range, 0-24 hr). Passing and Bablok regression analysis revealed that the enzyme activities in the DBSs and those in the leukocytes were favorably correlated. The enzyme activities measured in the DBSs were consistently lower in patients with LSDs than in normal newborns. CONCLUSIONS: The performance of our revised techniques for MS/MS detection and enzyme assays was of the generally acceptable standard. To our knowledge, this is the first report on the use of MS/MS for newborn screening of LSDs in an Asian population.


Subject(s)
Humans , Infant, Newborn , Dried Blood Spot Testing , Enzyme Assays , Enzymes/blood , Leukocytes/enzymology , Lysosomal Storage Diseases/diagnosis , Republic of Korea , Tandem Mass Spectrometry/methods , Time Factors
5.
Journal of Laboratory Medicine and Quality Assurance ; : 217-223, 2010.
Article in Korean | WPRIM | ID: wpr-22074

ABSTRACT

BACKGROUND: Hemoglobin A1c (HbA1c) is widely used for the monitoring of glycemic control in diabetes mellitus patients. Various methods are applied for the determination of HbA1c levels. Recently, a novel National Glycohemoglobin Standardization Program (NGSP)-certificated reagent (AutoLab HbA1c, IVD-LAB, Korea) was introduced for use in an automated chemistry analyzer. We evaluated the analytical performance of this immunoturbidimetry reagent and compared it with the ion-exchange high performance liquid chromatography (Variant II Turbo, Bio-Rad Laboratories, Inc., USA) and immunoassay (Cobas Integra 800, Roche Diagnostics, Germany) methods. METHODS: Toshiba 200FR NEO (Toshiba Medical Systems Co., Japan) with the AutoLab reagent was evaluated for precision, linearity, carryover and compared with Cobas Integra and Variant II Turbo. RESULTS: Coefficients of variation (CVs) of within-run imprecision for low and high level were 1.8% and 0.7%, respectively. CVs of within-laboratory imprecision for low and high level were 2.4% and 1.0%, respectively. The linearity was excellent with R2 = 0.99 in the range of 3.05-15.50%. It was well correlated with Variant II Turbo (R=0.9904) and Cobas Integra 800 (R=0.9992). The carryover rate was 0.4%. CONCLUSIONS: The Toshiba 200FR NEO with the AutoLab reagent showed excellent precision and linearity and minimal carryover rate. It was well correlated with the other widely used methodological instruments. It may be used for the diagnosis and the treatment monitoring of diabetes.


Subject(s)
Humans , Chromatography, Liquid , Diabetes Mellitus , Hemoglobins , Immunoassay
6.
The Korean Journal of Laboratory Medicine ; : 51-57, 2010.
Article in English | WPRIM | ID: wpr-82768

ABSTRACT

BACKGROUND: The Lewis histo-blood group system consists of 2 major antigens-Lea and Leb-and a sialyl Lewis antigen-carbohydrate antigen (CA) 19-9. We investigated the distribution of Lewis genotypes and evaluated the relationship between the Lewis/Secretor genotypes and the serum level of CA 19-9 in a Korean population to identify whether the serum CA 19-9 levels are influenced by the Lewis/Secretor genotypes. METHODS: The study included 242 individuals who had no malignancies. Lewis genotyping was performed for the 59T>G, 508G>A and 1067T>A polymorphic sites. The Secretor genotype was determined through analysis of the 357C>T and 385A>T polymorphic sites and the fusion gene. Serum CA 19-9 level was analyzed using an electrochemiluminescence immunoassay. RESULTS: Individuals carrying the 3 common genotypes-Le/Le, Le/le(59,508), and Le/le(59,1067)-accounted for 95% of the study population. In the Korean population, the allelic frequencies of Le, Le(59), le(59,508), and le(59,1067) were 0.731, 0.010, 0.223, and 0.035, respectively. We found a significant difference in serum CA 19-9 concentrations among the 9 Lewis/Secretor genotype groups (P<0.001). The serum CA 19-9 levels in subjects with genotype groups 1 and 2 (Le/- and se/se) were higher than those with genotype groups 3-6 (Le/- and Se/-; 15.63 vs 6.64 kU/L, P<0.001). CONCLUSIONS: Le/Le, Le/le(59,508), and Le/le(59,1067) are frequent Lewis genotypes in Koreans. Because serum CA 19-9 levels are significantly influenced by the Lewis/Secretor genotypes, caution is suggested when interpreting the serum CA 19-9 levels.


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Alleles , Asian People/genetics , CA-19-9 Antigen/blood , Luminescent Measurements/methods , Gene Frequency , Genotype , Immunoassay/methods , Lewis Blood Group Antigens/genetics , Phenotype , Polymorphism, Genetic , Republic of Korea
7.
Journal of Laboratory Medicine and Quality Assurance ; : 69-93, 2010.
Article in Korean | WPRIM | ID: wpr-10375

ABSTRACT

Three external quality assesment trials which composed of 16 control materials(12 chemical materials and four sets of microscopic photograph of urinary sediment) for interlaboratory quality control assesment in urinalysis were performed with 796, 823, and 841 participants, in each, in the year of 2009. The response rate were 97.1% (796/820), 95.5% (823/862) and 97.1% (841/866), in the first, the second and the third trials, in each. The test items include pH, glucose, protein, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte estrase, specific gravity and four microscopic photographs of urinary sediment. The survey results are summarized as follows: 1. The chemical quality control test in urinalysis revealed generally good concordance. 2. The percentage of using urinalysis analyzer was slightly decreased as 82.3% and the distribution of using reagent strip was similar to the previous year. 3. The percentage of response rate of microscopic photographs of urinary sediment was 83.5% (702/841) and the percentage of good performance of these tests ware 83.6% to 99.1%.


Subject(s)
Bilirubin , Equidae , Glucose , Hydrogen-Ion Concentration , Korea , Leukocytes , Quality Control , Reagent Strips , Specific Gravity , Urinalysis , Urobilinogen
8.
Journal of Laboratory Medicine and Quality Assurance ; : 103-114, 2010.
Article in Korean | WPRIM | ID: wpr-10373

ABSTRACT

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, Tumor
9.
Journal of Laboratory Medicine and Quality Assurance ; : 115-130, 2010.
Article in Korean | WPRIM | ID: wpr-10372

ABSTRACT

We performed two trials of external quality assessment for Therapeutic Drug Monitoring (TDM) subcommittee of Korean Association of Quality Assurance for Clinical Laboratory (KAQACL) in 2009. The number of participating laboratories were 110, which is similar with that of previous 3 years. Average response rates were 97.8% in both trials, similar to those of previous years. Two kinds of control materials were requested to be tested in each trial so that each institution could find the possible systematic errors. The average drug item responded was 6.2 per institution, which was decreased slightly from 6.5 in recent 5 years. The most common test items were valproic acid, digoxin, carbamazepine, phenytoin, and theophylline which were peformed in more than 63.8% of participating laboratories, followed by phenobarbital, cyclosporine, tacrolimus, vancomycin, lithium, methotrexate, amikacin, gentamicin, acetaminophen, tobramycin, salicylate, free phenytoin, amitryptyline, ethosuximide, and primidone. The widely used TDM analyzers were Abbott AxSym (26.9%), followed by Abbott TDx/TDxFLx (24.8%), Roche Cobas Integra (15.1%), Siemens Diagnostics Viva-E (5.5%), Roche cobas c501 (5.1%), Siemens Diagnostics Dimension (3.4%), and many other analyzers. The inter-laboratory coefficients of variations showed similar tendency comparing with those of the previous years. The number of participating laboratories for drug of abuse (DOA) tests were 19, which was slightly increased compared to that of the previous year. Average DOA items were 3.8~4.2. We found the good performance of participating laboratories for DOA. In conclusion, the TDM and DOA external quality assessment of 2009 showed similar performance comparing with that of the recent 3 years.


Subject(s)
Acetaminophen , Amikacin , Carbamazepine , Cyclosporine , Digoxin , Drug Monitoring , Ethosuximide , Gentamicins , Korea , Lithium , Methotrexate , Phenobarbital , Phenytoin , Primidone , Tacrolimus , Theophylline , Tobramycin , Valproic Acid , Vancomycin
10.
The Korean Journal of Laboratory Medicine ; : 477-484, 2010.
Article in English | WPRIM | ID: wpr-120817

ABSTRACT

BACKGROUND: Carbohydrate-deficient transferrin (CDT) levels have rarely been determined in an Asian population. We evaluated the analytical performance of a test for measuring CDT levels by using capillary electrophoresis (EP). METHODS: We determined the precision of CDT measurement by using capillary EP and nephelometry and compared the CDT values obtained using both the methods. We included healthy control subjects, abstinent patients with liver disease, and individuals consuming varying amounts of alcohol. RESULTS: The CDT measurement by using capillary EP were correlated well with those CDT measurement by using nephelometry, N Latex CDT assay, Y=0.5706X+1.581, R=0.930. The results obtained from both methods showed good qualitative agreement with each other (kappa coefficient=0.61). Genetic variants of transferrin isoforms were detected in 4.1% of the tested population. Both the CDT and gamma-glutamyl transpeptidase (GGT) levels in the abstinent patients with liver disease were significantly higher than those in healthy abstinent individuals (0.9% vs. 0.5%, 109.5 mg/dL vs. 28.5 mg/dL, respectively), but the difference in CDT values in the 2 groups was less pronounced for the CDT values. Individuals who had a mean daily alcohol intake of more than 60 g/day showed significantly higher CDT levels than those who had a mean daily alcohol intake of less than 60 g/day (1.9% vs. 0.7%, P=0.03). CONCLUSIONS: The CDT test using capillary EP showed good performance, and this method has several advantages such as automation and detection of variant forms. Thus, CDT can be a more useful marker than GGT for monitoring alcohol abstinence, especially in patients with liver disease.


Subject(s)
Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Automation , Electrophoresis, Capillary/methods , Gene Frequency , Liver Diseases, Alcoholic/diagnosis , Nephelometry and Turbidimetry/methods , Protein Isoforms/analysis , ROC Curve , Republic of Korea , Transferrin/analogs & derivatives , gamma-Glutamyltransferase/analysis
11.
Korean Journal of Blood Transfusion ; : 201-209, 2010.
Article in Korean | WPRIM | ID: wpr-199583

ABSTRACT

BACKGROUND: To prevent blood-borne infections and guarantee safe transfusion, we proposed a quality assurance program for donor screening tests, such as hepatitis B surface antigen (HBsAg) and anti-hepatitis C virus antibody (anti-HCV), by introducing external proficiency testing for the laboratories that perform donor screening tests. METHODS: The materials for external proficiency testing (PT) were prepared from the HBsAg Standard Panels and anti-HCV Reference Panels provided by the Korea Food and Drug Administration (KFDA), and the normal Human Serum was provided by the Serum Bank of the Korea National Research Resource Center. The external PT materials were sent to 83 laboratories that performed donor screening tests after evaluating their quality. RESULTS: The results of evaluating the quality of the PT materials were acceptable. All the laboratories receiving the materials answered with a 100% response rate. All the laboratories answered that they obtained positive results for the HBsAg Standard Panel E, H, I and J; however, one laboratory answered in the gray-zone and that lab had negative results for HBsAg Standard Panel C and G. Seventy laboratories (84%) and 42 laboratories (51%) among the total 83 laboratories answered they had positive results for HBsAg Standard Panel B and D, suggesting that many laboratories could not detect a low level of HBsAg. All 83 laboratories answered that they had concordant results for the external PT for anti-HCV. CONCLUSION: Donor screening laboratories can detect low levels of HBsAg and anti-HCV without any errors and the performance of the laboratories that could not detect low levels of HBsAg remains to be improved. Quality assurance program using external PT with materials that contain various genotypes and mutants should be conducted to maintain the quality of donor screening tests.


Subject(s)
Humans , Blood Donors , Donor Selection , Genotype , Hepatitis B Surface Antigens , Korea , Mass Screening , Pyridines , Thiazoles , United States Food and Drug Administration , Viruses
12.
Journal of Laboratory Medicine and Quality Assurance ; : 1-10, 2010.
Article in Korean | WPRIM | ID: wpr-96806

ABSTRACT

Six trials with 3 samples for each trial for external quality assessment of general chemistry and blood gas were performed in 2009. All the control materials were sent in specifically-made boxes at the same time. The response rates were 87.5% in general chemistry and 89.3% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2008), change of the methods of analysis was not remarkable. The peer group coefficient of variation and the VIS scores of general chemistry items were slightly improved.


Subject(s)
Bilirubin , Calcium , Chemistry, Clinical , Cholesterol , Creatinine , Glucose , Hydrogen-Ion Concentration , Korea , Peer Group , Phosphorus , Potassium , Sodium , Uric Acid
13.
Journal of Laboratory Medicine and Quality Assurance ; : 229-232, 2009.
Article in Korean | WPRIM | ID: wpr-228391

ABSTRACT

No abstract available.


Subject(s)
Toxicology
14.
Journal of Laboratory Medicine and Quality Assurance ; : 1-12, 2009.
Article in Korean | WPRIM | ID: wpr-54353

ABSTRACT

Six trials with 3 samples for each trial for external quality assessment of general chemistry and blood gas were performed in 2008. All the control materials were sent in specifically-made boxes at the same time. The response rates were 93.5% in general chemistry and 88.1% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2007), change of the methods of analysis and the peer group coefficient of variation was not remarkable and the VIS scores of general chemistry items were slightly improved.


Subject(s)
Bilirubin , Calcium , Chemistry, Clinical , Cholesterol , Creatinine , Glucose , Hydrogen-Ion Concentration , Korea , Peer Group , Phosphorus , Potassium , Sodium , Uric Acid
15.
Journal of Laboratory Medicine and Quality Assurance ; : 73-98, 2009.
Article in Korean | WPRIM | ID: wpr-54349

ABSTRACT

Three external quality assesment trials which composed of 16 control materials (12 chemical materials and four sets of microscopic photograph of urinary sediment) for interlaboratory quality control assesment in urinalysis were performed with 699, 718, and 732 participants, in each, in the year of 2008. The response rate were 95.4% (699/733), 96.6% (718/743) and 95.3% (732/767), in the first, the second and the third trials, in each. The test items include pH, glucose, protein, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte estrase, specific gravity and four microscopic photographs of urinary sediment. The survey results are summarized as follows: 1. The chemical quality control test in urinalysis revealed generally good concordance. 2. The percentage of using urinalysis analyzer was slightly decreased as 83.0% and the distribution of using reagent strip was similar to the previous year. 3. The percentage of response rate of microscopic photographs of urinary sediment was 81.3% (571/732) and the percentage of good performance of these tests ware 32.9% to 80.5%.


Subject(s)
Bilirubin , Equidae , Glucose , Hydrogen-Ion Concentration , Korea , Leukocytes , Quality Control , Reagent Strips , Specific Gravity , Urinalysis , Urobilinogen
16.
Journal of Laboratory Medicine and Quality Assurance ; : 105-124, 2009.
Article in Korean | WPRIM | ID: wpr-54347

ABSTRACT

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, Tumor
17.
Journal of Laboratory Medicine and Quality Assurance ; : 125-141, 2009.
Article in Korean | WPRIM | ID: wpr-54346

ABSTRACT

Two trials of external quality assessment for Therapeutic Drug Monitoring (TDM) subcommittee of Korean Association of Quality Assurance for Clinical Laboratory (KAQACL) were performed in 2008. The number of participating laboratories were 114, which is similar with that of the previous year. Average response rates were 97.8% in both trials slightly lower than that of the previous year. Two kinds of control materials were requested to be tested in each trial so that each laboratory could know the possible systematic error. The average drug item was 6.3 per laboratory, which was decreased slightly from 6.8 in recent 5 years, and the maximum was 18 items. The most common test items were valproic acid, digoxin, carbamazepine, theophylline, phenytoin, and phenobarbital which were peformed in more than 52.1% of participating laboratories, followed by cyclosporine, vancomycin, tacrolimus, lithium, methotrexate, amikacin, tobramycin, gentamycin, acetaminophen, salicylate, free phenytoin, primidone, and amitryptyline. The widely used TDM analyzers were Abbott TDx/TDxFLx (35.3%), followed by Abbott AxSym (26.5%) and Roche Cobas Integra (17.3%), Abbott IMx (3.3%), and Siemens Viva E (3.0%). The inter-laboratory coefficients of variations showed similar tendency comparing with those of the previous years. The number of participating laboratories for drug of abuse tests were 17, which is similar to that of the previous year. Average drug item were 3.7 for the 1st trial. We found the relatively good performance as we got the correct answers for all laboratories except 2 laboratories. In conclusion, the TDM external quality assessment of 2008 showed grossly similar pattern comparing with that of previous year.


Subject(s)
Acetaminophen , Amikacin , Carbamazepine , Cyclosporine , Digoxin , Drug Monitoring , Gentamicins , Korea , Lithium , Methotrexate , Phenobarbital , Phenytoin , Primidone , Tacrolimus , Theophylline , Tobramycin , Valproic Acid , Vancomycin
18.
The Korean Journal of Laboratory Medicine ; : 430-438, 2009.
Article in Korean | WPRIM | ID: wpr-170202

ABSTRACT

BACKGROUND: Point-of-care (POC) tests are used increasingly due to fast results and simple test procedures, which enables rapid diagnosis and therapeutic monitoring. We evaluated the performance of the Piccolo xpress Chemistry Analyzer (Abaxis, USA) a POC chemistry analyzer. METHODS: Fourteen analytes, Na+, K+, Cl-, Ca2+, total carbon dioxide, AST, ALT, total bilirubin, alkaline phosphatase, blood urea nitrogen, creatinine, albumin, total protein, and glucose; were measured simultaneously with a 100 microliter of whole blood sample using a Comprehensive Metabolic Reagent disk. Within-run and total precision and linearity were evaluated according to CLSI EP15-A and EP6-A guidelines, respectively. Comparison with a central laboratory chemistry analyzer was performed using 144 patient samples. RESULTS: The coefficients of variations of within-run and total precision were all within 5% for three levels except for total carbon dioxide, ALT, alkaline phosphatase, total bilirubin, and creatinine in low level, and creatinine in middle level. The results of 14 analytes were linear within a commonly encountered range in clinical samples (r2> or =0.98). More than 10% of samples in Na+, AST, ALT, glucose, BUN did not satisfy CLIA analytical quality requirement. CONCLUSIONS: The Piccolo xpress Chemistry Analyzer can analyze multiple analytes with a minimal amount of whole blood in a short time. It showed an acceptable performance for precision, linearity and comparison with central laboratory analyzer. It can be useful as a screening tests modality in mobile clinics, ambulances, and field clinics for military use, and for pediatric patients from whom enough sample volume is difficult to obtain.


Subject(s)
Humans , Alanine Transaminase/blood , Alkaline Phosphatase/blood , Aspartate Aminotransferases/blood , Bilirubin/blood , Blood Chemical Analysis/instrumentation , Blood Glucose/analysis , Calcium/blood , Carbon Dioxide/blood , Chlorides/blood , Creatinine/blood , Point-of-Care Systems , Potassium/blood , Quality Control , Reproducibility of Results , Serum Albumin/analysis , Sodium/blood
19.
Journal of Laboratory Medicine and Quality Assurance ; : 1-12, 2008.
Article in Korean | WPRIM | ID: wpr-75522

ABSTRACT

Six trials with 3 samples for each of external quality assessment for general chemistry and blood gas were performed in 2007. All the control materials were sent in specifically-made boxes at the same time. The response rates were 92.0% in general chemistry and 95.5% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2006), the methods of analysis were slightly changed and the coefficient of variation and VIS scores of general chemistry items were not significantly changed.


Subject(s)
Bilirubin , Calcium , Chemistry, Clinical , Cholesterol , Creatinine , Glucose , Hydrogen-Ion Concentration , Korea , Phosphorus , Potassium , Sodium , Uric Acid
20.
Journal of Laboratory Medicine and Quality Assurance ; : 243-247, 2008.
Article in Korean | WPRIM | ID: wpr-42697

ABSTRACT

No abstract available.


Subject(s)
Drug Monitoring , Mycophenolic Acid
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