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Diagnostic Performance of the Anti-Cyclic Citrullinated Peptide Antibodies and Rheumatoid Factor Isotypes in Rheumatoid Arthritis.

Kyung Hee KIM ; Jung Ah KWON ; Young Kee KIM

Journal of Laboratory Medicine and Quality Assurance.2005;27(1):195-202.

BACKGROUND: The rheumatoid factor (RF) is the only serological marker in American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis (RA), but its specificity is not satisfactory for the diagnosis of RA. We evaluated the diagnostic performance of a new anti-cyclic citrullinated peptide antibodies (anti-CCP) test with those of RF isotypes for the diagnosis of RA. METHODS: Anti-CCP was determined in 186 serum samples: 110 from RA patients, 30 from non-RA patients(rheumatic diseases other than RA), and 46 normal individuals. IgM RF by latex fixation test and IgA RF by ELISA were also assayed in each samples, and the results were compared to anti-CCP for sensitivity and specificity by the receiver-operating characteristic curve on optimal cut-off values. RESULTS: The sensitivity of anti-CCP was highest (80.0%) and the sensitivities of IgM RF, IgA RF were 71.8%, 45.5%, respectively. The sensitivity increased (from 80.0% to 88.2%) especially in the combination of anti-CCP with IgM RF. The specificity of IgA RF by ELISA were highest (96.0 %) and the specificity of anti-CCP (94.7%) was higher than that of IgM RF (71.4%). Anti-CCP was positive in 58.1% in 31 RA patients with negative IgM RF. CONCLUSIONS: The results said that the combination test of anti-CCP with IgM RF might be useful for the diagnosis of RA because of its higher sensitivity and specificity than IgM RF alone.
Antibodies* ; Arthritis, Rheumatoid* ; Diagnosis ; Enzyme-Linked Immunosorbent Assay ; Humans ; Immunoglobulin A ; Immunoglobulin M ; Latex Fixation Tests ; Rheumatoid Factor* ; Rheumatology ; Sensitivity and Specificity

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Comparisons of Bayer ADVIA Centaur BNP Assay with Biosite Triage BNP Assay.

Kap Jun YOON ; Ki Jin OH ; Sung Ja IM

Journal of Laboratory Medicine and Quality Assurance.2005;27(1):189-193.

BACKGROUND: B-type natriuretic peptide (BNP) has been useful as a diagnostic tool to define heart failure. Recently, the BNP assay was used on an automated immunochemistry platform. Studies included precision, analytical correlation between the Biosite Triage BNP assay and Bayer ADVIA Centaur BNP assay. METHODS: Between February 22, 2005 and March 4, 2005, 66 cases were anal-yzed. For the BNP measurement, 3 mL blood samples were collected in plastic tubes containing EDTA. Precision was analyzed with 20 repeat tests in 3 different control levels. RESULTS: The ADVIA Centaur assay had between-run precision (CV) of 3.9%, 3.7%, and 3.7% at BNP concentrations of 41.39, 420.08, and 1671.73 ng/L, respectively. The correlation between the ADVIA Centaur and Triage was as follows: ADVIA Centaur=0.753(Triage)-21.888 ng/L (r=0.94). At a cutoff of 100 ng/L, however, the diagnostic agreement was 89.4%. CONCLUSIONS: The ADVIA Centaur BNP assay is the first commercially available BNP assay using an automated immunochemistry platform. This assay has good analytical and clinical performances and agreement with the Biosite Triage BNP Assay.
Edetic Acid ; Heart Failure ; Immunochemistry ; Natriuretic Peptide, Brain ; Plastics ; Triage*

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Evaluation of the Usefulness of Anti-Cyclic Citrullinated Peptide Antibodies Measured by an Automated Enzyme Immunoassay.

Hye Ran KIM ; Jeong Whan SHIN ; Jeong Nyeo LEE

Journal of Laboratory Medicine and Quality Assurance.2005;27(1):183-188.

BACKGROUND: Rheumatoid arthritis (RA) is the most common autoimmune rheumatic disease, but sensitive and specific test for its diagnosis is lack. This study evaluated the analytical performance and diagnostic role of a new automated ELISA anti-cyclic citrullinated peptide (anti-CCP) antibody test. METHODS: Anti-CCP antibody test was done with the enzyme-linked immunosorbent assay (ELISA) in serum samples from 49 RA patients and 104 non-RA patients, and 51 healthy subjects. Serum pools were used to determine its precision and linearity. The optimal cut-off values were determined by the receiver-operator characteristics (ROC) curve. The rheumatoid factor (RF) by turbidimetry was also assayed in every samle and the results were compared to anti-CCP for sensitivity and specificity. RESULTS: The total imprecision (CV%) was 4.8%, 7.6% for serum pools with low (mean concentration: 2.7 U/mL) and high (mean concentration :82.2 U/mL) concentration, respectively. Linearity data were acceptable (R2=0.9907). At each optimal cut-off value, the sensitivity of anti-CCP was higher than that of RF (81.6 % vs 69.4%), but statistical significance was not defined. Specificity of anti-CCP was higher than that of RF (95.5% vs 75.5%, p<0.001). A combination of anti-CCP and RF increased sensitivity and specificity to 87.7%, 98.0%, respectively. Nine of 15 (60.0%) sera from RF negative RA patients were positive for anti-CCP. CONCLUSIONS: Anti-CCP ELISA antibody test, we examined on a fully automated enzyme immunoassay, is easy to assay in routine laboratory, and showed good analytical performance. And anti-CCP antibody test also showed higher diagnostic specificity than RF. So, anti-CCP antibody may be useful serologic marker for diagnosis and monitoring of RA, if performed concomitantly with RF assay.
Antibodies* ; Arthritis, Rheumatoid ; Diagnosis ; Enzyme-Linked Immunosorbent Assay ; Humans ; Immunoenzyme Techniques* ; Nephelometry and Turbidimetry ; Rheumatic Diseases ; Rheumatoid Factor ; Sensitivity and Specificity

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Reference Intervals in Healthy Adults using Automatic Cell Counter Beckman Coulter LH 750.

Tae Eun JEONG ; Kee Su NA ; Kye Chul KWON ; Sun Hoe KOO ; Chi Seon KO ; Jong Woo PARK

Journal of Laboratory Medicine and Quality Assurance.2005;27(1):173-181.

BACKGROUND: Our aim was to set reference intervals of healthy adults using Beckman Coulter LH 750 by gender and age. METHODS: The specimens were obtained from a total of 705 healthy adults (male 484, female 221), who took part in annual health-check at Chungnam National University Hospital, analyzed in total 22 parameters and compared using SPSS V10.0 program. RESULTS: Totally 16 parameters showed the Gaussian distribution with 12 in parametric method and 4 in logarithmically transformed parametric method. All acquired reference intervals were showed in Table 3, 4, 5 and 6. There were statistical significances between genders in RBC, Hgb, Hct, MCV, MCH, WBC, EO%, LY#, MO#, EO#, MPV, PDW (P<0.001), BA% (P=0.001), NE% (P=0.016), BA# (P=0.019), MO% (P=0.021) and NE# (P=0.039), between age decades in RBC, Hgb, Hct, MCV, MCH, NE%, LY% (P<0.001), LY# (P=0.002), EO%, NE# (P=0.003) and Pct (P=0.033) as well as between genders and age decades in RBC, Hct (P=0.001), Hgb (P=0.004), LY# (P=0.005), Plt (P=0.014) and MO% (P=0.017). CONCLUSIONS: This study suggested that the reference intervals of RBC and Hgb ought to be set by both genders and age decades, WBC by gender and the others by total study populations. Moreover, it need to be set the reference intervals by each laboratory for itself and to be monitored with periodic review.
Adult* ; Cell Count* ; Chungcheongnam-do ; Female ; Humans ; Normal Distribution

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Evaluation of Serologic Markers for HBV Infection Using Roche Modular Analytics E170.

Sue Hyun OH ; Suk Jin CHOI ; Sun Young PARK ; Chang Seok KI

Journal of Laboratory Medicine and Quality Assurance.2005;27(1):167-172.

BACKGROUND: Hepatitis B virus (HBV) infection is the leading cause of liver disease in Korea and, is usually diagnosed with serologic testings. The automated immunoassay analyzer, Roche Modular Analytics E170 (Roche Diagnostics, Mannheim, Germany; E170) tests HBV serologic markers based on electrochemiluminescence (ECL) method. We would like to evaluate analytical performances of E170 for HBV serologic markers. METHODS: We evaluated the precision of E170 for 6 serologic markers (HBsAg, anti-HBs, HBeAg, anti-HBe, IgG anti-HBc, IgM anti-HBc) with positive pooled serum. A comparison study with the AxSym immuoassay analyzer (Abbott Laboratories, Abbott Park, IL USA) was performed using patient's sera. HBsAg confirm test was evaluated using the specimens with cutoff index (COI) between 1 and 10 for HBsAg. RESULTS: The total coefficients of variations were below 5% for all of the 6 serologic markers. Method comparisons between E170 and AxSYM showed a good concordance rate; the rates of positive and negative agreements were more than 90% for almost all the serologic markers. HBsAg confirm tests for 84 samples with COI between 1 and 10 revealed that only 36 samples (43%) were true positive for HBsAg. Among 36 true positive samples, 9 samples (25%) were anti-HBs positive concurrently, but these showed low antibody titer (<50 IU/L). CONCLUSIONS: The E170 showed good precision for all HBV serologic markers and a high concordance rate with the AxSYM. Therefore, E170 can be used as a routine immunoassay analyzer for the testing of HBV serologic markers. In addition, HBsAg confirmatory test might be useful to confirm the true positivity when a specimen has low cut-off index (1-10).
Germany ; Hepatitis B e Antigens ; Hepatitis B Surface Antigens ; Hepatitis B virus ; Immunoassay ; Immunoglobulin G ; Immunoglobulin M ; Korea ; Liver Diseases ; Serologic Tests

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Annual Report on External Quality Assessment in Diagnostic Genetics in Korea (2004).

Sun Hee KIM ; Jong Won KIM ; Suiyon PARK ; Eun Hae CHO ; Eun Ji KIM ; Sung Sup PARK ; Jae Seok KIM ; You Kyung LEE ; Chang Seok KI ; Seung Jung KEE ; Sun Young KONG ; Sunghee HAN ; Eul Ju SEO ; Hyoun Chan CHO

Journal of Laboratory Medicine and Quality Assurance.2005;27(1):141-165.

The importance of quality control for dramatically growing genetic tests continues to be emphasized with increasing clinical demands. Diagnostic genetics subcommitee of KSQACP performed two trials for cytogenetic study in 2004. Cytogenetic surveys were performed by 36 laboratories and answered correctly in most laboratories except some problems in karyotype nomenclature, interpretation of FISH test results and the detection of complex cytogenetic abnormalities in hematologic neoplasias. The molecular genetic test surveys included may kinds of tests like M. tuberculosis, HBV, HCV, HPV, leukemias/lymphomas, ApoE genotyping, MTHFR genotyping, BRCA1 & BRCA2, Duchenne muscular dystrophy, and Huntington disease. Each molecular test for HCV, MTHFR genotyping, BRCA1 & BRCA2 analysis and Huntington disease was the first challenge in 2004. Molecular genetic surveys showed excellent results in most of participants. External quality assessment program for genetic analysis in 2004 was proved to be helpful in continuous education and evaluation of quality improvement.
Apolipoproteins E ; Chromosome Aberrations ; Cytogenetics ; Education ; Genetics* ; Huntington Disease ; Karyotype ; Korea* ; Molecular Biology ; Muscular Dystrophy, Duchenne ; Quality Control ; Quality Improvement ; Tuberculosis

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Annual Report on External Quality Assessment in Inborn Error of Metabolism in Korea (2004).

Junghan SONG ; Kye Chol KWON ; Jeong Ho KIM ; Jong Won KIM ; Won Ki MIN ; Soo Youn LEE ; Eun Hee LEE ; Sun Hee JUN ; Tae Yoon CHOI

Journal of Laboratory Medicine and Quality Assurance.2005;27(1):125-140.

The trial of external quality assessment for inborn error of metabolism was performed twice in 2004. Total 10 specimens for the conventional newborn screening tests were distributed to 43 laboratories. The response rates were 90.7%(39/43) in first trial and 90%(36/40) in second trial. All the control materials were sent as filter paper forms. Each laboratory replied the test results as the screening items they were doing as a routine test at the reception of the specimen among PKU screening, TSH, T4 (total/free), galactosemia screen, maple syrup urine disease screen, homocytinuria screen and histidinemia screen. The mean, SD, CV, median and range were analyzed. From this trial, pilot proficiency test for newborn screening using tandem mass spectrometry (MS/MS) was also performed. Total 8 blood spots were distributed to 7 laboratories performing newborn screening using MS/MS. Participants results for amino acids & acylcarnitine and their cutoff values were analyzed.
Amino Acids ; Galactosemias ; Humans ; Infant, Newborn ; Korea* ; Maple Syrup Urine Disease ; Mass Screening ; Metabolism* ; Tandem Mass Spectrometry

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Annual Report on External Quality Assessment in Therapeutic Drug Monitoring in Korea (2004).

Jeong Ho KIM ; Byung Kwang KIM ; Soo Youn LEE ; Sail CHUN ; Gye Cheol KWON ; Yeomin YOON ; Jong Baeck LIM ; Dong Hoon SHIN ; Kyung Eun SONG ; Kyung Ryul LEE ; Soon Pal SUH ; Jin Q KIM

Journal of Laboratory Medicine and Quality Assurance.2005;27(1):111-124.

Two trials of external quality assessment for Therapeutic Drug Monitoring (TDM) Subcommittee of Korean Association of Quality Assurance for Clinical Pathology (KAQACP) were performed in 2004. Number of participating laboratories were increased to 89, by 11.3% increase comparing with the previous year. Response rates were 100.0% for both trials just like the previous year. Two kinds of control materials were requested to be tested in each trial so that each institution could know the possible systematic error. In both trials, 20 test items were responded at least from one laboratory. The average drug item was 6.8 per institution, which was elevated slightly from 6.5 in recent 5 years. The most common test items were valproic acid, digoxin, phenytoin, carbamazepine, theophylline, and phenobarbital which were peformed in more than 71% of participating laboratories, followed by cyclosporine, lithium, tacrolimus, vancomycin, methotrexate, amikacin, gentamycin, salicylate, tobramycin, acetaminophen, primidone, free phenytoin, and amitryptyline. The most widely used TDM analyzer was Abbott TDx/TDxFLx (41.6%), followed by Roche Cobas Integra (21.3%), and Abbott AxSym (20.2%). The inter-laboratory coefficients of variations were not greatly improved comparing with previous years. We also determined cyclosporine and tacrolimus with reference method using liquid chromatography-tandem mass spectrometry. In conclusion, the TDM external quality assessment of 2004 showed grossly similar pattern comparing with those of previous year, except the 11.3% increase of participating laboratories.
Acetaminophen ; Amikacin ; Carbamazepine ; Cyclosporine ; Digoxin ; Drug Monitoring* ; Gentamicins ; Korea* ; Lithium ; Mass Spectrometry ; Methotrexate ; Pathology, Clinical ; Phenobarbital ; Phenytoin ; Primidone ; Tacrolimus ; Theophylline ; Tobramycin ; Valproic Acid ; Vancomycin

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Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2004).

Hyon Suk KIM ; Hwan Sub LIM ; Young Ran KIM ; Han Soo CHO ; Hea Sun CHUN ; Seob SHIN ; Young Soon JUNG ; Oh Hun KWON ; Deog An KIM ; Young Kee KIM ; Jin Q KIM ; Young Kyu SUN

Journal of Laboratory Medicine and Quality Assurance.2005;27(1):91-110.

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.
Immunoassay* ; Quality Control

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Annual Report on External Quality Assessment in Blood Bank Tests in Korea (2004).

Seog Woon KWON ; Dae Won KIM ; Kyu Sup HAN ; Hyun Ok KIM ; Jang Soo SEO ; Young Ju CHA ; Dong Seok JEON ; Dong Wook RYANG ; Hyun Jun PARK ; Young Ae LIM ; Kye Chul KWON ; Seon Ho LEE

Journal of Laboratory Medicine and Quality Assurance.2005;27(1):85-90.

We report here the results of surveys for external quality assessment of blood bank tests performed in 2004. Response rates for the 1st, 2nd and 3rd trial were 96.4%, 96.8%, and 96.8%, respectively. Test items for the surveys were ABO grouping, Rh(D) typing, crossmatching, direct antiglobulin test, antibody screening and identification test. The average accuracy rates of ABO grouping and Rh typing were in the range of 100% and 100%, respectively. In crossmatching test, the accuracy rates were 96.2-97.8% for the compatible samples, 75.5-90.6% for the incompatible samples, and 75.5-90.6% for the samples which could be detected as incompatible only by antiglobulin method. The accuracy rates of direct antiglobulin test were 98.8-100% for negative samples and 87.3-98.8% for positive samples. The correct results were reported by 98.8-100% of the surveyed institutions for antibody screening test and 100% for identification test. Forty six institutions gave repeatedly incorrect answers for crossmatching. Nine institutions out of them gave incorrect answers for all the test specimens sent out 3 times last year.
Blood Banks* ; Coombs Test ; Korea* ; Mass Screening

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