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Difference of the Results of Two Visits in Down Syndrome Screening Test.

Sun E KIM ; Jong Woo KIM ; Ile Kyu PARK ; Jung Han LEE ; Jung Hye HWANG ; Seung Ryong KIM

Journal of Laboratory Medicine and Quality Assurance.2006;28(2):251-255.

INTRODUCTION: Estimation of the risk of Down syndrome pregnancy by the triple marker test is performed on women once at anytime during the 15-21 weeks of gestational age. The triple marker test is based on the distribution of the alpha-fetoprotein (AFP), chorionic gonadotropin (CG) and unconjugated estriol (uE3) of the different pregnancy. In spite of the logical excellencies, various factors can affect the result of the test in practical field. We compared differences of the risk of Down syndrome pregnancy based on the specimen obtained from two visits during the 15-21 weeks of gestational age. METHOD: We measured the AFP, CG and uE3 with Access (Beckman Coulter, USA) from the sera of 104 pregnant women who visited two times about 2 weeks of interval during 15-21 weeks of gestational age. We calculated log (MoM) of AFP, CG and uE3 of each marker between two visits, and compared differences of each biochemical marker and difference of risk of Down syndrome pregnancy between two visits. RESULT: Mean+/-SD of log (MoM) of AFP, CG, uE3 of the 1st visit were 0.019+/-0.156, -0.016+/-0.224, 0.002+/-0.138, respectively, and those of AFP, CG, uE3 of the 2nd visit were 0.010+/-0.140, -0.076+/-0.205, 0.057+/-0.138, respectively. CG and uE3 showed statistically significant difference (P<0.001, P<0.001, respectively) but AFP did not (P=0.328). Risk of Down syndrome pregnancy of the 1st visit was 8.017x10(-4)+/-1.6241x10(-3), and that of the 2nd visit was 5.667x10(-4)+/-1.6241x10(-3), with no significant difference statistically (P=0.094). CONCLUSION: The risk of Down syndrome based on the sera of woman who visited two times about 2 weeks of interval between 15-21 weeks of gestational age did not show significant difference. It is resonable that triple marker test is performed on women once at anytime during the 15-21 weeks of gestational age in practical base.
alpha-Fetoproteins ; Biomarkers ; Chorionic Gonadotropin ; Down Syndrome* ; Estriol ; Female ; Gestational Age ; Humans ; Logic ; Mass Screening* ; Pregnancy ; Pregnant Women

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The Analysis of the Effect of Mixing of Anticoagulant on Nucleic Acid Amplification Tests for Donated Blood.

Jae Sook LEE ; Quehn PARK ; Jae Won KANG ; Kwang HUH ; Deok Ja OH ; Dong Hee SEO

Journal of Laboratory Medicine and Quality Assurance.2006;28(2):245-249.

BACKGROUND: In the process of implementing the nucleic acid amplification tests (NAT) for the blood screening, it was needed to change plain tube to EDTA tube for the sampling. Because the sample is taken from the CPDA-1 anticoagulated whole blood, the EDTA of tube could be mixed with the CPDA-1. So, we studied the effect of the mixing of two anticoagulants on the NAT. METHODS: Using HIV-1 and HCV RNA standards, we made the qualitative and quantitative test panels for the EDTA anticoagulant and the EDTA/CPDA-1 anticoagulant containing blood. The reverse transcription-polymerase chain reaction of Roche and transcription-mediated amplification of Chiron were used for the RNA qualitative and quantitative test. RESULTS: On the qualitative HIV-1 and HCV RNA tests for the EDTA, CPDA-1 alone and the CPDA-1/EDTA mixture, false negative and false positive reactions were not observed. On quantitative test, viral loads were not different statistically. CONCLUSIONS: Since there were no statistically significant differences between CPDA-1 alone and EDTA/CPDA-1 mixture in both qualitative and quantitative tests for HIV-1 and HCV RNA, it was concluded that mixing of anticoagulants, EDTA and CPDA-1, would not cause an significant effect on the NAT for the donated blood.
Anticoagulants ; Edetic Acid ; False Positive Reactions ; HIV-1 ; Mass Screening ; Nucleic Acid Amplification Techniques* ; RNA ; Viral Load

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The Effect of Semen Contamination on the Urine Dipsticks.

Young Uk CHO ; Ha Sung LEE ; Tae Yong HONG ; In Sub CHOO ; Dong Keun OH ; Min Kyu CHOI

Journal of Laboratory Medicine and Quality Assurance.2005;27(2):233-236.

BACKGROUND: The dipstick methodology is the most fundamental urinalysis but interfered by many factors. We evaluated the effect of semen contamination on the urine dipsticks. METHODS: Thirty-two specimens for semen analysis were enrolled. After semen was directly applied on urine dipsticks, residual samples were diluted in pooled normal urine. Urine dipsticks were performed at each dilution titer. Seminal plasma separated by centrifugation of semen were also tested in the same manner. RESULTS: All semen showed positive results for blood, protein and leukocytes. The intensities of reaction for blood and leukocytes were correlated with sperm concentration. The negative conversion of blood and protein occurred at 1:100, and that of leukocytes occurred at 1:50. Seminal plasma showed nearly the same findings. CONCLUSIONS: Semen contamination of urine may cause false positive reaction especially for blood and protein on the urine dipsticks. It should therefore be considered when assessing unexplained, transient hematuria or proteinuria.
Centrifugation ; False Positive Reactions ; Hematuria ; Leukocytes ; Proteinuria ; Semen Analysis ; Semen* ; Spermatozoa ; Urinalysis

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Evaluation of C-peptide Test on Modular E170 Electrochemiluminescent Autoanalyzer.

Sook Young LEE ; Chang Bum HURH ; Eun Suk KANG

Journal of Laboratory Medicine and Quality Assurance.2005;27(2):227-232.

BACKGROUND: C-peptide is a useful marker to differentiate the cause of hypoglycemia and assessment of beta cell secretory capacity in diabetes mellitus. On Modular E170 (E170, Roche Diagnostics, US), an immunoassay autoanalyzer based on the electrochemiluminescence technology, we evaluated the performances of C-peptide measurement and established the normal reference range whether suitable to replace the conventional radioimmunoassay (RIA). METHODS: Control materials and patient sera were used for evaluation of precision and linearity and for comparison with RIA method. Reference range was determined with 130 adults chosen as a reference population. All procedures were done according to NCCLS guidelines. RESULTS: Within-run and total precision of C-peptide measurement in E170 with five different control materials were all below 2 %. The linearity was excellent up to 60.4 ng/mL. The Passing-Bablok linear regression analysis showed excellent correlation with conventional RIA method (R=0.9862). The reference range determined from a reference population was 0.75-2.30 ng/mL. CONCLUSIONS: C-peptide measurement with E170 had satisfactory performance and the results had excellent correlation with RIA results. Adopting new automated electrochemiluminescence immunoassay would improve the overall performance of laboratory in terms of precision, turnaround time and overcoming the drawbacks of a conventional RIA.
Adult ; C-Peptide* ; Diabetes Mellitus ; Humans ; Hypoglycemia ; Immunoassay ; Linear Models ; Radioimmunoassay ; Reference Values

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Evaluation of Immunochemical Autoanalyzer Modular Analytics(R).

Chong Rae CHO ; Tae Hyun UM

Journal of Laboratory Medicine and Quality Assurance.2005;27(2):219-225.

BACKGROUND: We evaluated the performance of Modular Analytics (Roche Diagnostics, Basel, Switzerland) which is combined with automated chemiluminescent immunoassay analyzer and automated chemical analyzer

in order to assess its utility for the improvement of efficiency of routine immuno-chemistry workstation. METHODS: Within- and between-day precision, linearity, and recovery rates were evaluated for 21 items (T3, T4, TSH, E2, LH, Testosterone, FSH, prolactin, AFP, CEA, CA125, CA19-9, total PSA, CRP, ASO, RF, Ig G, Ig M, Ig A, C3C, and C4). Commercialized controls(Roche Diagnostics, Basel, Switzerland) and patient sera for test specimens were used. Centaur(Bayer Diagnostic Division, New York, USA) and LX 2200(Eiken Chemical Co., Tokyo, Japan) were used as the control analyzers to evaluate the correlation. RESULTS: Within-day Coefficients of variation(CVs) was below 5% for all the analytes and between-day CVs was below 5.0% except ASO(8.01%). The linearity was excellent(r2>0.999; slope, 0.98-1.02; p<0.001). Recovery rates for all analytes were in the range of 95% to 103%. The correlation coefficients between modular and Centaur was exceeded 0.971, and between modular

and LX2200 exceeded 0.910, except RF(r=0.834). (P<0.05) CONCLUSION: The recently developed Modular Analytics proved to be highly precise and linear for quantitative analysis of hormones, tumor markers, and serum proteins in routine immuno-chemistry workstation. Correlations with Centaur and LX 2200 were thought to be good.
Blood Proteins ; Humans ; Immunoassay ; Prolactin ; Testosterone ; Biomarkers, Tumor

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Evaluation of VITROS(R) 5,1 FS Automated Chemistry Analyzer.

Kap Jun YOON ; Jae Kyun KIM ; Jae Yun JANG

Journal of Laboratory Medicine and Quality Assurance.2005;27(2):211-218.

BACKGROUND: VITROS(R) 5,1 FS (Ortho-Clinical Diagnostics, NY, USA) is a newly developed, fully automated analyzer that uses the dry slide type technology to process routine chemistry items, electrolytes, therapeutic drug monitoring and immunity items. We evaluated the usefulness of the VITROS(R) 5,1 FS in the aspect of precision, linearity, recovery rates and comparison. METHODS: We evaluated the analytical performance of the VITROS(R) 5,1 FS for sodium, potassium, chloride, total CO2, BUN, creatinine, glucose, amylase, total protein, albumin, ALT, AST, ALP, GGT, total bilirubin, unconjugated bilirubin, calcium and phosphorus. Commercialized quality control material, Performance Verifiers (Ortho-Clinical Diagnostics, NY, USA), chemTRAK(R).H (Medical Analysis Systems, California, USA) and patient' sera for evaluation of precision, linearity, recovery rates and comparison were used. MODULAR Systems (Roche Diagnostics, Switzerland) and CX3 (Beckman Coulter, California, USA) were used as a comparative analyzer to evaluate comparison study. RESULTS: Within-run and within-day coefficients of variation (CVs) of all items were below 5%. Between-day and total CVs were less than 5% in almost all items except of total CO2, amylase, ALT, AST, total bilirubin, unconjugated bilirubin and phosphorus. The linearities were statistically acceptable (R2>0.99) for all items (P<0.001). The recovery rates for all items were in the range of 96.20 to 111.45%. The comparison study indicated good correlation between VITROS(R) 5,1 FS and MODULAR Systems or CX3, and correlation coefficients of all items were above 0.975 except sodium (0.971) (P<0.01). CONCLUSIONS: VITROS(R) 5,1 FS showed satisfactory precision, linearity, recovery rates and comparison. Because it has features of one system with many capabilities, we recommend that VITROS(R) 5,1 FS would be used for the emergency laboratories in general hospitals with many examinations or in medium-sized laboratories with relatively small numbers of cases.
Amylases ; Bilirubin ; Calcium ; California ; Chemistry* ; Creatinine ; Drug Monitoring ; Electrolytes ; Emergencies ; Glucose ; Hospitals, General ; Phosphorus ; Potassium ; Quality Control ; Sodium

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Annual Report on External Quality Assessment in Immunoserology in Korea (2009).

Young Joo CHA ; So Yong KWON ; Think You KIM ; Jae Ryong KIM ; Hyon Suk KIM ; Myong Hee PARK ; Seong Hoon PARK ; Ae Ja PARK ; Jai Hoon BAI ; Han Chul SON ; Kye Sook LEE ; Seok Lae CHAE

Journal of Laboratory Medicine and Quality Assurance.2010;32(1):45-68.

The followings are the results for external quality assessment (EQA) in immunoserology for 2009: Evaluation of EQA was done in 2 trials in April and November, about 99% of laboratories participating average 7.4 items. The results were collected via internet and about 98% of laboratories have sent their results via internet. Control materials used in EQA were pooled sera including commercial controls, MASR Immunology Control from Medical Analysis Systems (Camarillo, CA, USA), which were delivered refrigerated for stability of control materials, being received within 48 hours after sending. Latex agglutination tests for rheumatoid factor (RF) showed frequently false positive or false negative results especially in commercial controls, possibly due to matrix effect. False negative and positive results were frequently found in the laboratories using immunochromatography assay (ICA) for anti-HCV and anti-HIV. More careful quality control should be required for ICA tests. New tests measuring non-treponemal and trponemal antibody such as turbidoimmunoassay (TIA) and chemiluminescence immunoassay (CLIA) were introduced. Standardization of instruments and reagents including calibrators for quantitative results should be required for the harmonization of results.
Hepatitis B Surface Antigens ; Immunoassay ; Immunochromatography ; Indicators and Reagents ; Internet ; Korea ; Latex Fixation Tests ; Luminescence ; Nephelometry and Turbidimetry ; Quality Control ; Rheumatoid Factor

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Annual Report on External Quality Assessment in Hematology in Korea (2009).

Gye Cheol KWON ; Ji Myung KIM ; Yeon Bo PARK ; Ji Young PARK ; Woon Heung SONG ; Soo Young YOON ; Young Kyung LEE ; Woo In LEE ; Yoon Hwan CHANG ; Mi Ok CHEI ; Chun Kyung HAM

Journal of Laboratory Medicine and Quality Assurance.2010;32(1):25-43.

Four trials of external quality assessment in diagnostic hematology were performed in 2009 with average 946 participating laboratories in Korea. We performed quality assessment for white blood cell count, hemoglobin, hematocrit, red blood cell count, platelet count, blood cell morphology, prothrombin time and activated partial thromboplastin time. The response rate was more than 98.2%. The coefficients of variation in hemoglobin, hematocrit and RBC count were stable but variable in platelet count and WBC count according to measuring cell counters. Test results of blood cell morphology showed variation among various cell morphologies.
Blood Cells ; Cell Count ; Erythrocyte Count ; Hematocrit ; Hematology ; Hemoglobins ; Korea ; Leukocyte Count ; Partial Thromboplastin Time ; Platelet Count ; Prothrombin Time

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Annual Report on External Quality Assessment in Clinical Microbiology Laboratory in Korea (2009).

Nam Yong LEE ; Myoung Sook KIM ; Mi Na KIM ; Min Joong KIM ; Sunjoo KIM ; Sung Il KIM ; Eui Chong KIM ; Jae Seok KIM ; Dongeun YONG ; Nam Surp YOON ; Jang Ho LEE ; Se Ik JOO

Journal of Laboratory Medicine and Quality Assurance.2010;32(1):11-24.

Two trials of external quality assessment for clinical microbiology laboratories were performed in 2009. A total of 16 specimens were distributed. Eight specimens were distributed to 339 laboratories with 322 (95.0%) returns in Trial I, and another eight specimens to 337 laboratories with 327 returns (97.0%) in Trial II. Two slide specimens for mycobacterium stain (AFB) were distributed in both Trial I and II. The acceptable percentages of Gram stain were relatively good for both stainability and morphology. The acceptable percentages of bacterial identification (correct answers to species level) on Sterotrophomonas maltophilia, Staphylococcus aureus, Streptococcus agalactiae, Micrococcus luteus, Vibrio parahemolyticus and Candida glabrata (Trial I) were 94.4%, 98.5%, 92.1%, 62.3%, 92.1% and 71.5%, respectively. The acceptable percentages of bacterial identification on Pseudomonas aeruginosa, Enterococcus faecalis, Candida albicans, Staphylococcus epidermidis, Moraxella catarrhalis and Enterobacter cloacae (Trial II) were 98.5%, 94.1%, 89.2%, 86.2%, 79.6% and 98.5%, respectively. The acceptable percentages for antimicrobial susceptibility tests on S. maltophilia and S. aureus (Trial I), and P. aeruginosa and E. faecalis(Trial II) were relatively good compared to data of the last year, except results using disk method for S. maltophilia. The acceptable percentages for AFB stain in Trial I and II were relatively high. In summary, the acceptable percentages of bacterial stain and identification were relatively good. However, it is still necessary that the quality assurance of the individual laboratories should be improved for antimicrobial susceptibility tests, and the selection of the most appropriate antimicrobial agents to test should be also considered.
Anti-Infective Agents ; Candida albicans ; Candida glabrata ; Enterobacter cloacae ; Enterococcus faecalis ; Korea ; Micrococcus luteus ; Moraxella (Branhamella) catarrhalis ; Mycobacterium ; Pseudomonas aeruginosa ; Staphylococcus aureus ; Staphylococcus epidermidis ; Streptococcus agalactiae ; Vibrio

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Annual Report on External Quality Assessment in Clinical Chemistry in Korea (2009).

Won Ki MIN ; Changha KO ; Kyung Dong KIM ; Young Kee KIM ; Jeong Ho KIM ; Jin Q KIM ; Tae Jin KIM ; Ile Kyu PARK ; Joonseok PARK ; Kwang Sup AHN ; Do Hoon LEE ; Soo Youn LEE ; Sail CHUN ; Tae Jin HAN ; Kisook HONG

Journal of Laboratory Medicine and Quality Assurance.2010;32(1):1-10.

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.
Bilirubin ; Calcium ; Chemistry, Clinical ; Cholesterol ; Creatinine ; Glucose ; Hydrogen-Ion Concentration ; Korea ; Peer Group ; Phosphorus ; Potassium ; Sodium ; Uric Acid

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