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Management of Clinical Laboratory Staffs in Korea (II).

In Bum SUH ; Kyung Ran MA ; Seung Moo LEE ; Jung Ah KWON ; Sook Young BAE ; Soo Young YOON ; Chae Seung LIM ; Kap No LEE

Journal of Laboratory Medicine and Quality Assurance.2002;24(2):237-242.

BACKGROUND: For the efficient management of clinical pathology laboratory, not only the economic side but also the quality of test should be considered. Therefore, the authors investigated the status of laboratory in the management point including the status of technical personnel by survey and tried to find out the fundamental status of work environment, laboratory automation, computerization, and to evaluate the efficiency of management of clinical pathology laboratories in Korea. METHOD: The questionnaires included those for investigating laboratory management status, qualities of laboratory personnels, workloads, test items and numbers of tests performed annually. It contained 22 items with 32 detailed sub-questionnaires for laboratory personnel survey, and 9 items with 106 detailed sub-questionnaires for facilities. We sent those three times to 400 laboratories that were participating in the National External Quality Assessment Scheme in Korea and analysed the answers by descriptive statistics, ANOVA, t-test and correlation analysis. RESULTS: The replies were from 96 laboratories and 326 technical personnels. Among the 96 laboratories, there were 71 full time employed clinical pathologists. The annually performed number of tests were increased with the increased the size of laboratory, that was classified by number of personnels. As the laboratory size was increased, part time personnels, cases of test per technical personnel, automation and computerization, satisfaction for their work (58,2%) were increased but decreased satisfaction of salaries. CONCLUSIONS: We surveyed the present employee status of laboratory personnels and status of laboratory and offered fundamental data of clinical laboratory management in Korea.
Automation ; Automation, Laboratory ; Humans ; Korea* ; Laboratory Personnel ; Pathology, Clinical ; Surveys and Questionnaires ; Salaries and Fringe Benefits

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Detection and Occurrence of Extended-Spectrum beta-Lactamase-Producing Citrobacter freundii, Enterobacter spp., Proteus spp., and Serratia marcescens Isolates.

Wonkeun SONG ; Tae Jae LEE ; Taek Kyung KIM ; Jae Seok KIM ; Min Jeong PARK ; Kyu Man LEE

Journal of Laboratory Medicine and Quality Assurance.2002;24(2):231-235.

BACKGROUND: The occurrence of extended-spectrum beta-lactamases (ESBLs) in enterobacteria that possess inducible Bush group 1 chromosomal beta-lactamases is being increasingly reported worldwide. The current National Committee for Clinical Laboratory Standards documents do not indicate the tests that should be used for the detection of ESBLs in Enterobacteriaceae except Klebsiella spp. and Escherichia coli. We determined the occurrence and detection of ESBL-producing Enterobacteriaceae isolates. METHODS: One hundred fifty-six consecutive, non-repeated isolates of Citrobacter freundii, Enterobacter spp., Proteus spp., and Serratia marcescens were collected. These isolates were performed broth microdilution antimicrobial susceptibility test, Vitek ESBL detection test, and double disk synergy (DDS) test. All the DDS-positive strains were tested PCR amplification of the blaTEM and blaSHV alleles. RESULTS: S. marcescens (27.3%) was the most frequently isolated ESBL producers followed by E. cloacae (23.8%), E. aerogenes (18.2%), C. freundii (13.3%), and P. mirabilis (8.3%). Among the total of 30 isolates that were considered ESBL producers, the Vitek ESBL detection test was positive for 26 (86.7%) strains. The genotypes of ESBLs were predominently SHV type (10 isolates) followed by others (8 isolates), SHV and TEM (7 isolates), and TEM type (5 isolates). CONCLUSIONS: Our findings indicate that 19.2% of all Enterobacteriaceae except E. coli and Klebsiella spp. tested produced ESBLs. The Vitek ESBL detection test seems to be a useful test to identify ESBL-producing strains of C. freundii, Enterobacter spp., Proteus spp., and S. marcescens isolates.
Alleles ; beta-Lactamases ; Citrobacter freundii* ; Citrobacter* ; Cloaca ; Enterobacter* ; Enterobacteriaceae ; Escherichia coli ; Genotype ; Klebsiella ; Mirabilis ; Polymerase Chain Reaction ; Proteus* ; Serratia marcescens* ; Serratia*

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Antimicrobial Susceptibilities of Viridans Streptococci Isolated from Blood Cultures during Recent Period.

Young UH ; Gyu Yul HWANG ; In Ho JANG ; Kap Jun YOON ; Hyo Youl KIM

Journal of Laboratory Medicine and Quality Assurance.2002;24(2):225-230.

BACKGROUND: Viridans group streptococci (VGS) are being increasingly reported as pathogens causing septicemia in neutropenic and other immunocompromised patients since 1980s. In the past, VGS were nearly uniformly susceptible to beta-lactam antimicrobial agents, aminoglycosides, tetracyclines, and macrolides. Several recent published studies, however, indicate that antimicrobial resistance may be emerging as a problem with VGS. The purpose of this study was to determine the antimicrobial susceptibility of VGS strains isolated from blood cultures in recent period. METHODS: A total of 45 consecutive strains of VGS isolated from blood cultures between May 2001 and March 2002 at Wonju Christian Hospital were tested for antimicrobial susceptibility. Identification of VGS were performed by API Strep 32(bioMerieux sa, Marcy-l'Etoile, France) commercial kit. Antimicrobial susceptibility tests were done by NCCLS recommended disk diffusion method and penicillin MICs were determined by E test. RESULTS: Among the 45 VGS strains, frequently isolated organisms were Streptococcus mitis (31.1%), Streptococcus oralis (17.8%), Streptococcus constellatus (11.1%), and Streptococcus anginosus (8.9%). Overall intermediate-and resistant rates to antimicrobial agents of VGS were as follows: penicillin; 26.7% and 8.9%, erythromycin; 4.4% and 28.9%, clindamycin 2.2% and 22.2%, and ceftriaxone; 4.4% and 6.7%, respectively. Resistant rates of Streptococcus mitis and Streptococcus oralis were as follows: penicillin; 50% vs 50%, erythromycin 43% vs 37%, clindamycin 21% vs 37%, and ceftriaxone 7% vs 25%, respectively. CONCLUSIONS: These results indicate the species-related variability of susceptibility among VGS isolated from blood in recent period. In addition to S. mitis, S. oralis also displayed high rates of resistance to penicillin, macrolides, and ceftriaxone. The difference in susceptibilities between species of VGS indicates the importance of accurate identification and the need for continuing monitoring of antimicrobial resistance.
Aminoglycosides ; Anti-Infective Agents ; Ceftriaxone ; Clindamycin ; Diffusion ; Erythromycin ; Gangwon-do ; Immunocompromised Host ; Macrolides ; Penicillin Resistance ; Penicillins ; Sepsis ; Streptococcus anginosus ; Streptococcus constellatus ; Streptococcus mitis ; Streptococcus oralis ; Tetracyclines ; Viridans Streptococci*

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Evaluation of the HM-JACK Automatic Analyzer for Fecal Occult Blood Test.

Seung Bok HONG ; Hyun Soo KIM ; Hyo Soon PARK ; Do Hoon LEE

Journal of Laboratory Medicine and Quality Assurance.2002;24(2):221-224.

BACKGROUND: Fecal occult blood test is a useful method for mass screening of colorectal cancer. HM-JACK is automatic analyzer for detecting fecal occult blood with latex agglutination methods. We evaluated its apparatus for compatibility for clinical testing. METHODS: The linearity, precision and effect of temperature and container in stool storage were evaluated. The comparison study with OC-Hemodia and prozone phenomenon were evaluated. RESULTS: The linearity was good(R(2)=0.997) and coeffiecinet variation(CV) of within-day precision were 4.6% and 2.6% in low concentration and high concentration. The CV of between-day precision were 4.8% and 3.5%. The hemoglobin concentration of 0.1 g/dL(1x10(6) ng/mL) was measured to 651 ng/mL for Antigen excess zone. The hemoglobin were more decreased in room temperature storage and usual container storage than in low temperature storage and HM-JACK container storage. The concordance rate between HM-JACK and OC-Hemodia was 90%. CONCLUSION: HM-JACK showed good performance for linearity, precision and comparison study. Therefore, it can be used effectively in clinical laboratory due to convenience, and possibility of quantitation and fast reporting.
Agglutination ; Colorectal Neoplasms ; Latex ; Mass Screening ; Occult Blood*

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Antinuclear Antibodies in Patients on Medication with Cardiovascular Drugs and Antihyperglycemic Agents.

Pil Whan PARK ; Think You KIM

Journal of Laboratory Medicine and Quality Assurance.2002;24(2):215-220.

BACKGROUND: This study was set to determine the antinuclear antibody (ANA) frequency and fluorescence pattern, as well as the incidence of drug-induced lupus (DIL) in patients on long term medications with cardiovascular drugs and antihyperglycemic agents. METHODS: Sera from 301 patients on medications with cardiovascular drugs or antihyperglycemic agents for at least 6 months and 105 serum samples from healthy controls were tested by indirect immunofluorescence on immunotype (IT)-1 cells, and the medical records were retrospectively reviewed. The patients included 39 on digoxin, 38 on theophylline, 8 on theophylline and digoxin, 26 on captopril, 15 on diltiazem, and 182 on antihyperlycemic agents. RESULTS: ANA was positive in 3 of the 105 normal controls (3%). Thirty four percent of patients on medication with digoxin, 29% on theophylline, 31% on captopril, 7% on diltiazem, and 8% on antihyperglycemic agents were positive for ANA. The prominent ANA pattern was cytoplasmic type in patients on digoxin and theophylline, and the speckled type in captopril, however, most of them showed low titers. CONCLUSIONS: Long-term ingestion of theophylline, digoxin, captopril were shown to influence ANA, but not for diltiazem and antihyperglycemics. Therefore, patients on long-term medications with theophylline, digoxin, captopril should be regularly tested for ANA.
Antibodies, Antinuclear* ; Captopril ; Cardiovascular Agents* ; Cytoplasm ; Digoxin ; Diltiazem ; Eating ; Fluorescence ; Fluorescent Antibody Technique, Indirect ; Humans ; Hypoglycemic Agents* ; Incidence ; Medical Records ; Retrospective Studies ; Theophylline

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The Experience of HLA-B27 Test Using Flowcytometry.

Bo Moon SHIN

Journal of Laboratory Medicine and Quality Assurance.2002;24(2):209-213.

BACKGROUND: HLA-B27 is associated with an increased incidence of specific spondyloarthropathies(SpA), most notably ankylosing spondylitis(AS). I evaluated the cases referred for HLA-B27 antigen using flowcytometry (FCM) to find the clinical characteristics of the patients and the diagnostic utilities of median fluorescence intensity (MFI) in HLA-B27 program. METHODS: I evaluated 443 subjects of HLA-B27 cases using FACScan flowcytometry, consisted with software for automated calibration and analysis, calibration beads, and the anti-HLA- B27 fluorescein isothiocyanate (FITC)/anti-CD3 phycoerythrin (PE) monoclonal antibodies (all from Becton Dickinson, San Jose, CA). RESULTS: Of the total 443 cases, the positive rate in male cases was 44% (132/300) and it was higher than that of female cases (22.4%, 32/143). The gating procedure was failed in one sample of 443 (0.23%). The positive rates in each diagnostic criteria were as follows; AS 61.6%, gout 20.0%, herniated intervertebral disc 20%, lower back pain 25.6%, polyarthritis 16.0%, psoriatic arthritis 20.0%, rheumatoid arthritis 28.3%, reactive arthritis 26.9%, SpA, undifferentiated 31.8% and uveitis/iritis 23.8%. In AS group, 89 cases (95.7%) showed MFI values higher than 150. CONCLUSION: About 62% of AS group showed HLA-B27 positivity using FCM and the positive rates of other diseases group in SpA categories were around 20-30%. If we considered MFI value 150 as differential value, about 95% of HLA-B27 positive AS cases might not need further confirmatory study to differentiate HLA-B7.
Antibodies, Monoclonal ; Arthritis ; Arthritis, Psoriatic ; Arthritis, Reactive ; Arthritis, Rheumatoid ; Calibration ; Female ; Fluorescein ; Fluorescence ; Gout ; HLA-B27 Antigen* ; HLA-B7 Antigen ; Humans ; Incidence ; Intervertebral Disc ; Low Back Pain ; Male ; Phycoerythrin ; Spondylarthropathies ; Spondylitis, Ankylosing

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Measurement of PT, aPTT, and Fibrinogen by Automatic Coagulation Analyzer, ACL9000.

Young Ah KIM ; Young Kyu SUN

Journal of Laboratory Medicine and Quality Assurance.2002;24(2):201-207.

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.
Fibrinogen* ; Heparin ; Partial Thromboplastin Time ; Prothrombin ; Prothrombin Time ; Reference Values ; Thromboplastin

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The Clinical Implications of Antiplatelet Antibody.

Hyoun Chan CHO ; Young Kyung LEE ; Sung Ha KANG ; Young Chul KIM ; Young Chul OH ; Dong Hee SEO

Journal of Laboratory Medicine and Quality Assurance.2002;24(2):197-200.

BACKGROUND: Antiplatelet antibody test is the most important tool for the diagnosis of immune mediated thrombocytopenia. But antiplatelet antibody can occur in various diseases and the detection rates of antiplatelet antibody differ among investigators. In this study we investigated the prevalence of antiplatelet antibody in thrombocytopenic patients with various clinical conditions and analyzed the clinical significance of antiplatelet antibody in thrombocytopenia. METHODS: We tested 130 thrombocytopenic patients from 1999 January to 2000 October. The clinical diagnosis of the patients were 30 idiopathic thrombocytopenic purpura (ITP), 12 hematological diseases, 29 sepsis, 17 liver diseases, 11 pregnancy, 8 solid tumor, 2 malaria and 21 unclassified disorders. Antiplatelet antibody was detected by means of indirect immunofluorescence test. RESULTS: Antiplatelet antibody was detected in 6.2% of total patients (8/130) ; ITP 10% (3/30), malaria infection 50%(1/2), sepsis 3.5%(1/29), liver diseases 5.9%(1/17), solid tumors 12.5%(1/8), other unclassified disorders 4.8%(1/21). Antiplatelet antibody was negative in three drug induced thrombocytopenic patients. CONCLUSIONS: The positive rate of indirect immunofluorescent antiplatelet antibody was unexpectedly low in immune mediated thrombocytopenia. The positive results of non-immune mediated thrombocytopenia may be related to various conditions such as past platelet transfusions.
Diagnosis ; Fluorescent Antibody Technique, Indirect ; Hematologic Diseases ; Humans ; Liver Diseases ; Malaria ; Platelet Transfusion ; Pregnancy ; Prevalence ; Purpura, Thrombocytopenic, Idiopathic ; Research Personnel ; Sepsis ; Thrombocytopenia

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Standardization of Reference Values among Laboratories of Korean Association of Health Promotion.

Kap No LEE ; Jong Hyun YOON ; Young Hee CHOI ; Han Ik CHO ; Ki Woong BAE ; Cheong Ha YOON ; Sang In KIM

Journal of Laboratory Medicine and Quality Assurance.2002;24(2):185-195.

BACKGROUND: All fifteen laboratories of Korean Association of Health Promotion were used to use different reference ranges that were mostly adapted from the published data or the recommended data by the reagent companies supplied as inserts. These created problems such as inadequate interpretation, inability of exchangeable patient data, and subsequent confusion, and all the data stored became useless particularly in the respect of health statistics. The purpose of this study was to solve such problems through defining commonly acceptable reference ranges. METHODS: All the results performed during October 1, 2000 through September 31, 2001 were collected in preferably 'Excel' file format. All the data included the necessary information such as age and sex. The age was grouped in six; baby (0-3y), children (4-12y), adolescent (13-18y), adult (19-64y), younger elderly (65-79y), old elderly (over 80y), with references of statistics in medical informatics and WHO classification. The data were statistically analyzed with SAS 6.04 for Gaussian distribution. None of the tests showed Gaussian distribution. These procedures had been repeated twice or three times after trimming out the results lying outside three standard deviations. Though, all the tests showed non-Gaussian distribution. Subsequently, the reference ranges were defined in the range from the point of lower 2.5% to the point of higher 97.5%. And in case the lower range could be "0", the reference ranges were defined in the range of 0 to 95%. RESULTS: The reference ranges of 56 test items were newly assigned. Among these there were eight tests that needed reference ranges by the age groups and nine tests by the sex. CONCLUSIONS: All 15 laboratories of Korean Association of Health Promotion now have the same reference ranges that were statistically derived from their own data. This means the patient data and reference values can be exchangeable among their laboratories.
Adolescent ; Adult ; Aged ; Child ; Classification ; Deception ; Health Promotion* ; Humans ; Medical Informatics ; Reference Values*

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Performance Evaluation of the VISTA 500.

Dae Hyun KO ; Eun Jung CHO ; Woochang LEE ; Sail CHUN ; Won Ki MIN

Journal of Laboratory Medicine and Quality Assurance.2016;38(1):52-57. doi:10.15263/jlmqa.2016.38.1.52

In this study, we evaluated the performance of a recently developed immunoassay analyser, the VISTA 500 (Siemens, Germany). Precision, linearity, and comparison studies were performed according to the Clinical and Laboratory Standards Institute guidelines. The test items evaluated included IgG, IgA, IgM, C3, C4, ceruloplasmin, prealbumin, transferrin, haptoglobin, rheumatoid factor, anti-streptolysin O, and cystatin C. Commercial control materials (BioRad Laboratories, USA), commercial linearity validation materials (Maine Standards, USA), and patient samples were used for the evaluation. For the correlation study, analysis with a BN-II nephelometer (Siemens) was used as a comparative method. Total coefficients of variation of analytes were found to be between 1.9% and 5.5%. Results of the linearity evaluation were also acceptable for the range tested. Correlations with comparative methods were acceptable. The VISTA 500 analyser showed satisfactory analytical performance with respect to precision, linearity, and comparison. We conclude that the VISTA 500 is likely a good candidate as an immunology analyser.
Allergy and Immunology ; Ceruloplasmin ; Cystatin C ; Evaluation Studies as Topic ; Haptoglobins ; Humans ; Immunoassay ; Immunoglobulin A ; Immunoglobulin G ; Immunoglobulin M ; Prealbumin ; Rheumatoid Factor ; Statistics as Topic ; Transferrin

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