Peformance Evaluation of Bioporto Diagnostics' Neutrophil Gelatinase-associated Lipocalin Assay on Automated Clinical Chemistry Analyzer Hitachi 7600 / 임상검사와정도관리

BACKGROUND: Neutrophil gelatinase-associated lipocalin (NGAL) is known to be one of the ideal biomarkers for acute kidney injury providing early information on damage to the kidney. METHODS: We evaluated the performance for precision and the reportable range of the automated NGAL Test (Bioporto Diagnostics, Denmark) assay and compared the values of these tests with widely used point of care test. The reference interval of NGAL was established in Korean adults. RESULTS: Within run percent coefficient of variation (%CV) and total precision %CV for 2 levels were all within 5%. The reportable range was found to be acceptable for the range of 57.0 - 3182.0 ng/mL (r=0.999). The method comparison was made between Biosite's assay and Bioporto Diagnostics' (Passing and Bablok fit, y=1.94x - 5.29; x, Biosite; y, Bioporto; n=31; y range, 250 to 1,308 ng/mL; r2=0.959). The correlation was linear within the limit of 1,500 ng/mL, but not beyond this limit. The 2.5 and 97.5 percentile of the reference range for the samples were 43.2 ng/mL and 124.8 ng/mL, respectively. CONCLUSIONS: Since NGAL Test can be used in automated chemical analyzer, it can not only reduce the man power and time consumed in but also displayed excellent precision and linearity.

Evaluation of ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip / 임상검사와정도관리

BACKGROUND: Self-monitoring of blood glucose levels is recommended for all diabetic patients who receive insulin treatment, because such monitoring of glucose levels may aid in achieving better control in type II diabetes. Further, the use of point-of-care (POC) blood glucose testing in hospitals has increased substantially. In the present study, we validated the performance of ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip (Roche Diagnostics, Germany). METHODS: We evaluated the precision, accuracy, and maltose interference of the ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip. Further, precision was evaluated using dedicated quality control (QC) and Bio-Rad Whole Blood (WB) QC materials (Meter Trax(TM) Control; Bio-Rad, USA). Forty samples were used to compare the results obtained using the ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip with those obtained using the clinical chemistry analyzer Hitachi 7600 (Hitachi, Japan). Maltose interference was assessed at 2 glucose concentration levels at 3 maltose concentration levels. RESULTS: For each concentration level of control materials, within-run coefficient of variation (CV) and total CV obtained were less than 5%. Good correlation was obtained using the Hitachi 7600 (y = 1.02x - 0.18; r 2 = 0.996; N = 40). Effects of maltose interference were less than 10%. CONCLUSIONS: Thus, the ACCU-CHEK(R) systems show good precision and correlation with the routine clinical chemistry analyzer and allow only minimal effects of maltose interference.

Evaluation of the i-Smart 30 Point-of-Care Analyzer for Use in Clinical Laboratory Settings / 임상검사와정도관리

BACKGROUND: The i-Smart 30 point-of-care (POC) analyzer (i-SENS, Korea) is a compact and portable system used for the analysis of electrolytes (sodium, potassium, chloride) and hematocrit in whole blood samples. In this study, we evaluated the analytical performance of the i-Smart 30 analyzer. METHODS: Precision and sample-related percent carry-over were determined using the quality control materials. Comparison study was performed with the Stat Profile Critical Care Xpress (STP CCX; Nova Biomedical, USA) analyzer using venous whole blood samples. RESULTS: In the precision study, imprecision studies demonstrated within-run and total-run coefficients of variation within 0.5-3.9% and 0.7-4.4%, respectively, for all analytes. A good correlation was found between the i-Smart 30 analyzer and the STP CCX analyzer, except for chloride that showed high intercept. In the study of carry-over, sample-related carry-over for Na+, K+, Cl- and Hct were demonstrated as 0.84%, 0%, 0.86% and 1.56%, respectively. CONCLUSIONS: We conclude that the i-Smart 30 analyzer is suitable for routine use in clinical laboratories, especially where rapid test results are required such as emergency departments, intensive care units, and dialysis units. However, for Cl-, it is necessary that a significant correlation between this analyzer and a reference method should be demonstrated.

Evaluation of HbA1c on COBAS INTEGRA 800 Closed Tube System Compared with Variant II Turbo / 임상검사와정도관리

BACKGROUND: We evaluated the HbA1c assay on COBAS INTEGRA 800 Closed Tube System (Roche Diagnostics, USA). METHODS: Precision was determined following Clinical and Laboratory Standards Institute (CLSI) EP5-A2 using the Lyphochek Diabetes Control (Bio-Rad Laboratories, Canada). Two levels of QC materials were assayed in duplicates at two separate times per day for 20 days. The within-run, between-run and between-day precisions were evaluated. We compared the HbA1c of COBAS INTEGRA 800 Closed tube system using Tina quant Hemoglobin A1c Gen.2 (Roche Diagnostics, Germany) reagent with Variant II Turbo (Bio-Rad Laboratories, USA). Bias was determined following CLSI EP9-A2. RESULT: The HbA1c assay on COBAS INTEGRA 800 Closed Tube System showed excellent precision performance: at a level of 5.9%, total, between run, and between day CVs were 1.8%, 0.5%, and 1.6%, respectively. At a level of 9.6%, total, between run, and between day CVs were 1.4%, 0.3%, and 1.1%, respectively. The assay correlated well with the Variant II Turbo (y=0.9x+0.53, r2=0.9857). Mean bias against Variant II Turbo was -0.2%. Compared with Variant II Turbo, the estimate of the predicted bias at a given medical decision level (HbA1c at 6% and 9%) was -0.1% and -0.31%, respectively. CONCLUSIONS: The COBAS INTEGRA 800 Closed Tube System HbA1C assay was precise and equivalent to Variant II Turbo.

Annual Report on External Quality Assessment in Immunoassay in Korea (2009) / 임상검사와정도관리

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.

Performance Characteristics of the UniCel DxI 800 Immunoassay for the Maternal Serum Quadruple Test, Including Median Values for Each Week of Gestation, in Korean Women / 대한진단검사의학회지

BACKGROUND: Maternal serum prenatal quadruple screening includes testing for alpha-fetoprotein (AFP), human chorionic gonadotrophin (hCG), unconjugated estriol (uE3), and dimeric inhibin A (DIA). We evaluated quadruple screening using an automated platform and looked for any ethnic differences in the median values of each marker. METHODS: We measured the concentrations of each quadruple test analyte using the UniCel DxI 800 system (Beckman Coulter, USA) in 788 Korean mid-trimester maternal serum samples and calculated their median values using Benetech software (Benetech, Canada). We also compared the results with those obtained using the Immulite 2000 assay (Siemens Healthcare Diagnostics, USA) or ELISA (DSL, USA) in 442 samples. RESULTS: We obtained mid-trimester median values for each marker. The following are the comparative results for each test using the Immulite 2000 assay or ELISA (x) and the UniCel DxI 800 immunoassay (y): AFP, y=1.10x+0.01, r=0.925; uE3, y=0.28x+0.24, r=0.885; hCG, y=1.22x-3047.8, r=0.944; and DIA, y=0.86x+15.31, r=0.833. Assay results for each of the four markers showed good correlations. However, significant biases necessitated new median calculations of prenatal risk estimates in all four tests. CONCLUSIONS: We established gestational age-specific second-trimester median values for four markers in Korean samples using the UniCel DxI 800 immunoassay system. Despite significant bias, there were good correlations between the results obtained using the UniCel DxI 800 immunoassay and those obtained using the Immulite 2000 assay.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2008) / 임상검사와정도관리

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.

Differences in Hemoglobin Levels as Measured by Blood Gas and Auto Blood Cell Count Analyzers / 대한수혈학회지

BACKGROUND: While point-of-care testing is being used increasingly as a basis for making decisions about erythrocyte transfusion, no valid standards or guidelines have been developed concerning the accuracy of measuring hemoglobin concentration. METHODS: To compare results from blood gas and auto blood cell count analyzers with respect to hemoglobin, 40 patient blood residual samples which had been withdrawn into 4 mL sodium heparin and EDTA tubes, were analyzed twice by each devices. RESULTS: Passing-Bablok comparisons for hemoglobin (g/dL) with the Nova CCX (y) and Advia 2120 (x) were y=0.877x+2.471 (r=0.985). Additionally, hemoglobin levels from the blood gas analyzer were out of the calculated range at the clinical decision point. CONCLUSION: Blood gas analyzers as point-of care testing exhibited a slightly higher hemoglobin level than auto blood cell count analyzers. Some also produced values of hemoglobin out of the expected range at the clinical decision point. Therefore, the use of blood gas analyzers for hemoglobin levels is limited and it is recommended that the assessment of hemoglobin for transfusion should be determined using auto blood cell count analyzers.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2007) / 임상검사와정도관리

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.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2007) / 임상검사와정도관리

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.

Seven Cases of Decreased Serum Valproic Acid Concentration During Concomitant Use of Carbapenem Antibiotics / 대한진단검사의학회지

Valproic acid (VPA) is a commonly prescribed anticonvulsant drug for the treatment of various forms of epilepsy. Concomitant administration of VPA and carbapenem antibiotics such as panipenem/ betamipron and meropenem has been reported to decrease the serum level of VPA. We observed seven cases which showed a decrease in serum levels of VPA due to concomitant use of VPA and carbapenem from January 2002 to October 2006 in a 750-bed university hospital, the average decrease of 70.4% was observed. Carbapenem antibiotics administrated concomitantly with VPA were panipenem (1 case), meropenem (3 cases), and imipenem (2 cases), and in one other case imipenem and meropenem were used sequentially. We found the VPA serum levels were significantly decreased with meropenem (n=4) more than with other carbapenem antibiotics (n=4, 89.3% vs. 51.5% decrease, P=0.03). Clinicians should be aware of this potential interaction, pay attention to the failure of seizure control due to decreased serum VPA levels with concomitant use of carbapenem antibiotics, and monitor VPA serum levels for those cases.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2005) / 임상검사와정도관리

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.

Evaluation of the Extraction Method for the Cytotoxicity Testing of Latex Gloves

In this study, the cytotoxicity of medical latex gloves to cultured L-929 cells was determined using various extraction conditions. According to the extraction time and temperature, three types of extraction conditions were used: 1) 24 h at 37 degrees C; 2) 72 h at 37 degrees C; 3) 72 h at 50 degrees C. Also, four different extraction vehicles were used, namely, distilled water (DW), 9 g/l sodium chloride (saline) in DW, and culture media with or without serum. Under the above-mentioned conditions, the samples were extracted and then 2-fold serially diluted in the concentration range 3.13 - 50%. When extracted with either DW or saline for 24 h or 72 h at 37 degrees C, only 50% diluted samples showed distinct cytotoxicity to L-929 cells. Moreover, no cytotoxic potentials were observed when gloves were extracted with DW or saline at 50 degrees C for 72 h. Cytotoxicity was markedly greater when gloves were extracted with culture medium, irrespective of the presence of serum in the medium. These results suggest that optimal extraction conditions should be established for the cytotoxicity evaluations of biomaterials and medical devices.

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

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.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korea (2003) / 임상검사와정도관리

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.

Evaluation of Clinical Usefulness of PREG-Q(TM) as a Screening Test for Pregnancy / 임상검사와정도관리

BACKGROUND: Among the many methods estimating the quantity of beta-hCG for pregnancy testing in urine, immunochromatography is one of most widely used semi-quantitative detection method for its convenience to use and also for its rapid result reporting system. PREG-Q(TM) is a newly introduced semi-quantitative immunochromatography method for detecting b-hCG. Clinical usefulness of PREG-Q(TM) was evaluated as a screening test for early pregnancy detection. METHODS: Accuracy, detection limit, cross-reactivity with various glycoprotein hormones, interference study, and comparison study using total 100 urine samples from pregnant (50 samples) and non-pregnant women (50 samples) was evaluated. RESULTS: All the 50 urine samples of pregnant women showed positive results, and another 50 urine samples of non-pregnant women showed negative results with PREG-Q(TM). The lower detection limit of PREG-Q(TM) was 25 mIU/mL and the result was not affected by addition of glycoprotein hormones tested. Interfering substance causing false negative or false positive results enrolled didn't affect the test results in this study. CONCLUSIONS: We conclude PREG-Q(TM) is an excellent test kit for pregnancy test, and is valuable especially for detecting early pregnancy.

Adoptive Immunotherapy for Cytomegalovirus (CMV) Disease in Immunocompromised Patients

Cytomegalovirus (CMV) reactivation in immune compromised patients such as those undergoing hematopoietic progenitor cell transplantation (HPCT) and those with HIV infections can cause severe morbidity and mortality despite treatment with appropriate antiviral agents. The recovery of Cytomegalovirus (CMV) specific cytotoxic T lymphocytes (CTL) plays an important role in the reconstitution of CMV specific immunity in immunocompromised patients. Recent studies have reported that CMV reactivation can be successfully treated by adoptive transfer of CMV-specific T cell clones from CMV seropositive donors expanded in vitro with CMV infected fibroblasts or lysates of CMV infected cells. Other studies have used immune dominant CMV proteins or peptides to expand CMV-specific cytotoxic T lymphocytes. This review describes the clinical manifestations of CMV disease in immunocompromised patients, recent advances of antiviral therapy for CMV disease, the principals of the induction of cellular immune response to CMV, and the clinical application of CMV immunotherapy.

Correlation of N-Terminal Pro-Brain Type Natriuretic Peptide Level and Echocardiographic Parameters / 대한진단검사의학회지

BACKGROUND: N-terminal pro-brain type natriuretic peptide (NT-proBNP) has been identified as a promising biochemical marker for congestive heart failure (CHF). Recently, the NT-proBNP assay using electrochemiluminescence method has been developed. We evaluated clinical utilities of the NT-proBNP assay and its relationship with echocardiographic parameters. METHODS: The NT-proBNP was measured in eighty-four patients who experienced an echocardiographic examination. We compared the NT-proBNP level with several echocardiographic parameters for the left ventricular systolic function and cardiac chamber dimensions. RESULTS: The NT-proBNP level was significantly increased as with a decreasing left ventricular ejection fraction (LVEF). It was also positively correlated with the left ventricular mass, left ventricular mass index, left ventricular end diastolic dimension, and left ventricular end systolic dimension. In patients with left atrial and ventricular enlargement, the mean NT-proBNP level was 7418.4 +/-9937.7 pg/mL, which was significantly elevated compared with 354.3 +/-749.8 pg/mL in patients with normal cardiac chamber dimensions (P<0.001). CONCLUSIONS: The NT-proBNP showed a significant correlation with echocardiographic parameters, especially for the systolic function and chamber enlargement. Therefore, the NT-proBNP seemed to be a new and promising alternative biochemical marker for CHF.

Comparison of the Indocyanine Green Clearance Test Using Conventional Blood Sampling and Finger Monitoring Methods / 대한진단검사의학회지

BACKGROUND: The indocyanine green (ICG) finger monitoring method is a newly developed noninvasive method for the ICG clearance test. This study was performed to determine its clinical usefulness compared with the conventional blood sampling method. METHODS: The ICG clearance test was performed on 270 patients using both the conventional blood sampling method and the finger monitoring method simultaneously. The plasma disappearance rate of the ICG and the 15-minute retention ratio (ICG R15) were analyzed and compared with the conventional blood sampling method. RESULTS: The plasma disappearance rate using the finger monitoring method was slightly lower than that of the conventional blood sampling method with good correlation (r=0.840, P<0.001). ICG R15 using finger monitoring method was slightly higher than that of the conventional blood sampling method with good correlation (r=0.839, P<0.001). CONCLUSIONS: As there was a good correlation between the conventional blood sampling method and the finger monitoring method, the latter method seemed to be clinically useful due to its convenience and accuracy.

Annual Report on External Quality Assessment in Immunoassay in Korea (2002) / 임상검사와정도관리

Two trials of external quality assessment were performed in 2002. Thirteen test items of immunoassay with eight control materials were surveyed. The response rate of external quality assessment for Immunoassay Subcommitee were 94.3% and 94.5% in each trial. Eight control materials were consisted of 6 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 233 to 241 laboratories and the response rate were 94.3% and 94.5% in 2002. 2. Chemiluminiscence immunoassay autoanalyzer was 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 wide variations of the test results of the same control material. But, generally the quality of the participating laboratories seems to be thought being improved.