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Application of Middleware to Automated Hematology Analyzers.

Jae Ok LEE ; Sung Ran CHO ; Il Joong PARK ; Young Ae LIM

Journal of Laboratory Medicine and Quality Assurance.2013;35(1):56-59.

BACKGROUND: Test results in a laboratory are simply relayed to the laboratory information system through the interface. Middleware facilitates and manages the interaction between applications across heterogeneous computing platforms. We applied middleware to automated hematology analyzers in a clinical laboratory. METHODS: We used HemLink (Beckman Coulter Korea, Korea) as middleware between the laboratory information system and hematology analyzers. It provides quality control programs including the Westgard multirule chart and moving averages. RESULTS: Unlike the previous system, middleware does not require manual input of the quality control results. Amendment of quality control, if necessary, could be done without the help of hospital information teams. Identification of abnormal results with patient information could be achieved with moving averages. Morphology flags and system flags are checked at remote computers. CONCLUSIONS: Management of quality control results of hematology analyzers was easy via middleware. Thus, middleware could be useful to connect proficiency testing programs with HemLink and to compare results from laboratories using the same middleware.
Clinical Laboratory Information Systems ; Hematology ; Humans ; Korea ; Quality Control

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Evaluation on the Stability of Pooled Sera for External Quality Assessment of Tumor Marker Assays.

Yongjung PARK ; Young Ran KIM ; Mi Seon HWANG ; Hyon Suk KIM

Journal of Laboratory Medicine and Quality Assurance.2013;35(1):47-55.

BACKGROUND: Specimens for the external quality assessment (EQA) need to be highly stable during the EQA process. Therefore, we evaluated the stability of pooled sera (PS) for tumor markers including alpha fetoprotein (AFP), carcinoembryonic antigen (CEA), carbohydrate antigen 125 (CA 125), and carbohydrate antigen 19-9 (CA 19-9). METHODS: PS with 2 different levels (high and low) of each of the 4 tumor markers were collected and stored at -20degrees C, 4degrees C, and room temperature (RT). The concentration of each tumor marker was then measured after storage under these different conditions at baseline and on days 1, 3, 7, 14, 30, 90, and 181. Internal quality control (QC) results during the evaluation period were also analyzed. RESULTS: Irrespective of storage conditions, coefficients of variation (CVs) of AFP and CA 125 levels in the PS during the evaluation period ranged from 3.3% to 7.5% in EQA assays and were similar to the CVs of QC assays. However, the levels of CEA detected in PS stored at -20degrees C, and 4degrees C, showed higher variability, with CVs ranging from 4.0% to 10.4%, and samples stored at RT showed especially high CVs, i.e., >8.3%. Samples for CA 19-9 testing stored at RT also showed lower stability than the QC samples as well as samples stored at -20degrees C, after 3 days. CONCLUSIONS: CEA and CA 19-9 levels in PS showed higher variability than AFP and CA 125, especially when stored at RT. These results indicate that all EQA specimens for tumor marker assays need to be tested as soon as possible and not stored at RT for longer than 3 days during the EQA process.
alpha-Fetoproteins ; Carcinoembryonic Antigen ; Quality Control ; Biomarkers, Tumor

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Evaluation of the CS-6400 Automated Chemistry Analyzer.

Hyo Jun AHN ; Hye Ryun KIM ; Young Kyu SUN

Journal of Laboratory Medicine and Quality Assurance.2013;35(1):36-46.

BACKGROUND: Analyzing large numbers of specimens in a short time and generating accurate results while minimizing costs are critical to laboratory tests. The CS-6400 (Dong-A Dirui, China), an automated chemistry analyzer, has been recently developed in China in collaboration with domestic corporations. To assess the performance and usability of the analyzer, we evaluated its analytical performance and clinical usefulness including accuracy and linearity of electrolytes and chemistry tests using HiSens reagent (HBI Co., Korea) with protocols provided by the Clinical and Laboratory Standards Institute, and compared these results with those of the formerly used DXC800 (Beckman Coulter, USA), and Vista500 (Siemens, Germany). METHODS: The accuracy, linearity, recovery factor, and sample carryover of the CS-6400 using HiSens reagent were determined for 29 tests-aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (ALP), lactate dehydrogenase (LDH), gamma glutamyl transferase, glucose, total cholesterol, triglyceride (TG), amylase, lipase, creatine kinase (CK), blood urea nitrogen, creatinine, uric acid, total protein, albumin, total bilirubin (TB), direct bilirubin (DB), calcium, inorganic phosphorus, magnesium (MG), HDL cholesterol, rheumatoid factor (RF), LDL cholesterol, C-reactive protein, anti-streptolysin O, sodium, potassium, and chloride and the results were compared with the values obtained from the DXC800 and Vista500 to set reference intervals for each test. Serum samples obtained from 128 healthy adults were used for the reference intervals. and values obtained from DXC800 and Vista500 were used to make comparison on and to set reference intervals for each routine. Serum specimens obtained from a total of 128 healthy adults were used for the reference intervals. RESULTS: The coefficient of variation showed excellent values of < or =5% for all tests except ALP, DB, MG, RF, TB, and TG (> or =5%). The coefficient of determination (R2) was > or =0.993 with linearity between 0.928 and 1.078 within the useful clinical span. In addition, the recovery factor values of the tests were 84% to 108%, and correlation comparisons were 0.975 except for albumin (0.9516), RF (0.7617), and LDL cholesterol (0.9709). We evaluated whether the CS-6400 contributed to the attempt to minimize the test's cost and running time. Developed in China, the CS-6400 has been approved by the Food and Drug Administration and uses indirect ion selective electrodes for electrolytes and colorimetry and turbidimetry for general and specific chemistry items. The tests showed excellent linearity of > or =0.993 using commercial certified linearity material. The recovery factor values of the tests were 93% to 108%, except for LDL cholesterol (84%). Except for the minimum values, percentage sample carryover values for CK and LDH were < or =1% (0.00% and 0.07%, respectively), suggesting that the results of the tests were not affected by sample carryover, and reference interval was present based on sex. CONCLUSIONS: The CS-6400 with HiSens showed excellent analytical performance (precision, linearity, and accuracy). Furthermore, results from the CS-6400 were highly correlated with those obtained from similar tests performed on DXC800 and Vista500. Therefore, the CS-6400 is appropriate for tertiary care hospitals where large volumes of test samples must be processed within a short period with minimal cost.
Adult ; Alanine Transaminase ; Alkaline Phosphatase ; Amylases ; Bilirubin ; Blood Urea Nitrogen ; C-Reactive Protein ; Calcium ; China ; Cholesterol ; Cholesterol, HDL ; Cholesterol, LDL ; Colorimetry ; Cooperative Behavior ; Creatine Kinase ; Creatinine ; Electrolytes ; Glucose ; Humans ; Ion-Selective Electrodes ; L-Lactate Dehydrogenase ; Lipase ; Magnesium ; Nephelometry and Turbidimetry ; Phosphorus ; Potassium ; Rheumatoid Factor ; Running ; Sodium ; Tertiary Healthcare ; Transferases ; United States Food and Drug Administration ; Uric Acid

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Performance Evaluation of CareSens PRO Glucose Monitoring System.

Borahm KIM ; Ji Young SEO ; Hye In WOO ; Soo Youn LEE ; Hyung Doo PARK

Journal of Laboratory Medicine and Quality Assurance.2013;35(1):29-35.

BACKGROUND: Point-of-care testing (POCT) glucometers are widely used for the management of diabetic patients. We evaluated the analytical performance of the recently developed glucometer CareSens PRO (i-SENS Inc., Korea). METHODS: Linearity, precision, and correlation were evaluated according to the Clinical and Laboratory Standards Institute guidelines. Five levels of glucose obtained from patient samples were used to determine the linearity of the device response. Control materials with low, medium, and high levels of glucose were evaluated with two different CareSens PRO glucometers to determine their precision. Correlations were evaluated between venous plasma analyzed with Synchron CX3 Delta (Beckman Coulter Inc., USA) and capillary whole blood analyzed with CareSens PRO, and between venous whole blood analyzed with ADAMS GA-1171 (Arkray, Inc., Japan) and venous whole blood analyzed with CareSens PRO, respectively. The effect of hematocrit was assessed. RESULTS: The linearity in the glucose range of 25.5 to 535.0 mg/dL was R2=0.9988. The coefficients of variations (CVs) of within-run precision were 2.06 to 3.47% and the CVs of total precision were 2.99 to 5.38%. The correlations were as follows: r=0.9660 in the range of 68.0 to 404.0 mg/dL with Synchron CX3 Delta and r=0.9886 in the range of 20.5 to 511.0 mg/dL with ADAMS GA-1171. In the specimens containing glucose above 75 mg/dL, 91.2% and 98.9% of CareSens PRO results were within +/- 20% of the results by Synchron CX3 Delta and ADAMS GA-1171, respectively. Hematocrit influenced the glucose concentration. CONCLUSIONS: CareSens PRO displayed acceptable linearity and precision. For clinical application, it is necessary for the improvement of comparable analytical performance and careful interpretation according to hematocrit concentration.
Capillaries ; Glucose ; Hematocrit ; Humans ; Plasma

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

Youkyung SEO ; Woonhyoung LEE ; Oh Hun KWON

Journal of Laboratory Medicine and Quality Assurance.2013;35(1):23-28.

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.
Acute Kidney Injury ; Biomarkers ; Chemistry, Clinical ; Immunoassay ; Lipocalins ; Nephelometry and Turbidimetry ; Neutrophils ; Reference Values

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A Comparative Study to Determine the Most Suitable Fixative for Immunocytochemical Staining of Cytospin Slides.

Sang Hyuk PARK ; Hyun Sook CHI ; Dahae WON ; Young Uk CHO ; Seongsoo JANG ; Chan Jeoung PARK

Journal of Laboratory Medicine and Quality Assurance.2013;35(1):13-22.

BACKGROUND: Fixation of cells is a critical procedure that can determine the success of immunocytochemical staining (ICC) of cytospin slides. In this study, we evaluated the efficacy of a number of fixatives to determine the ideal fixative for ICC of cytospin slides. METHODS: Sixteen patients with metastatic neoplasm in the body cavity were enrolled. Cytospin slides were prepared from each patient using 5 different fixatives (cold acetone, 95% ethanol, 1:1 methanol:ethanol, 3.7% formalin, and 3:1 methanol:acetone), and the suitability of each for use with Wright's stain was compared. For 4 of the samples, appropriate ICCs were performed using all 5 fixatives and the results were compared, while for 11 samples, only the first 3 fixatives were used for ICC. RESULTS: Using Wright stain, cold acetone, 95% ethanol, and 1:1 methanol:ethanol fixatives all showed similar efficacy when compared to the conventional methanol fixation method. However, the stain quality using 3.7% formalin or 3:1 methanol:acetone fixatives was poor due to deterioration of cell adhesion and distortion of cell morphology. Using ICC, cold acetone fixative showed stronger and more tumor-specific stainability than the 95% ethanol (decreased stainability in 6 stained slides, false positive staining of histiocytes/neutrophils in 4 stained slides, no staining of CD3 and terminal deoxynucleotidyl transferase [TdT]) and 1:1 methanol:ethanol fixatives (decreased stainability in 3 stained slides, false positive staining of histiocytes/neutrophils in 2 stained slides, no staining of CD3 and TdT). CONCLUSIONS: Cold acetone fixative was the most efficacious among the 5 fixatives tested in this study; therefore, it is the most appropriate fixative in the preparation of cytospin slides for ICC.
Acetone ; Cell Adhesion ; Cold Temperature ; DNA Nucleotidylexotransferase ; Ethanol ; Fixatives ; Formaldehyde ; Humans ; Immunohistochemistry ; Methanol

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Performance Evaluation of the Automated Coagulation Analyzer Coapresta 2000.

Yeong Chun PARK ; Jinsook LIM ; Yong Hyun KO ; Ji Myung KIM ; Sun Hoe KOO ; Kye Chul KWON

Journal of Laboratory Medicine and Quality Assurance.2013;35(1):8-12.

BACKGROUND: The Coapresta 2000 (Sekisui Medical Co., Japan) is a newly developed, fully automated coagulation analyzer that can perform clotting time assays using the synthetic substrate method and the latex turbidimetric method. In this study, we evaluated the analytical performance of the Coapresta 2000 for measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT), and compared the results to those of the CA-7000 (Sysmex Co., Japan) and ACL-9000 (Instrumentation Laboratory, USA) analyzers. METHODS: The Coapresta 2000 was evaluated for its precision at measuring PT and aPTT in fresh normal plasma and fresh abnormal plasma. Three hundred venous blood specimens were collected in 3.2% sodium citrate tubes, and PT and aPTT results were compared among the Coapresta 2000, ACL-9000, and CA-7000 analyzers. RESULTS: The coefficients of variation of both intra- and inter-assays for the Coapresta 2000 were <5% for PT and aPTT in the normal and pathological ranges. The results obtained using the Coapresta 2000 analyzer correlated well with those obtained using the ACL-9000 analyzer (r in the range of 0.9799-0.9886) except for aPTT (r=0.7626) and with those obtained using the CA-7000 analyzer (r in the range of 0.8258 - 0.9735). CONCLUSIONS: The Coapresta 2000 provided satisfactory precision, and the results obtained correlated well with those obtained using the existing CA-7000 and ACL-9000 coagulation analyzers. We conclude that the Coapresta 2000 would be a useful analyzer for routine coagulation tests.
Citrates ; Citric Acid ; Latex ; Partial Thromboplastin Time ; Plasma ; Prothrombin Time ; Sodium

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Serum Hepcidin Level as an Early Marker of Hematopoietic Activity after Allogeneic Peripheral Blood Stem Cell Transplantation.

Jimyung KIM ; Kye Chul KWON ; Sun Hoe KOO

Journal of Laboratory Medicine and Quality Assurance.2013;35(1):1-7.

BACKGROUND: Hepcidin plays a central role in the regulation of iron metabolism, and hepatic iron production is stimulated by iron load and inflammation. Recent animal studies have shown that hepcidin levels increase when hematopoiesis is blocked. We aimed to monitor pre- and post-stem cell transplantation hepcidin levels and evaluate its association with hematologic recovery. METHODS: The study group comprised 12 patients with hematologic malignancies (7 with AML, 4 with ALL, and 1 with refractory anemia with excess blasts-2) undergoing allogeneic peripheral blood stem cell transplantation (PBSCT). One day before and 3 days, 1 week, 2 weeks, 4 weeks, and 8 weeks after PBSCT, reticulocyte count and levels of Hb, ferritin, and C-reactive protein were monitored; serum hepcidin-25 was measured by ELISA. RESULTS: The median serum hepcidin-25 levels (ng/mL) were significantly higher until 1 week after PBSCT (103.6, 103.3, and 96.5) than those at 2, 4, and 8 weeks after PBSCT (63.9, 53.9, and 56.6, respectively). The reticulocyte count also significantly increased from 2 weeks after PBSCT. The hepcidin level showed an inverse correlation with reticulocyte count (r=-0.56, P<0.001) and a weak positive correlation with ferritin (r=0.27, P=0.02). At 2 weeks, patients with high hepcidin levels (> or =63.9) tended to demonstrate lower Hb recovery at 8 weeks than patients with low hepcidin levels did (P=0.15), but without any differences in the incidence of complications. CONCLUSIONS: These findings indicate that hepcidin production is associated with erythropoietic activity and that hepcidin level may be used as an early marker of hematopoietic recovery in PBSCT.
Anemia, Refractory ; Animals ; Antimicrobial Cationic Peptides ; C-Reactive Protein ; Cell Transplantation ; Ferritins ; Hematologic Neoplasms ; Hematopoiesis ; Humans ; Incidence ; Inflammation ; Iron ; Organothiophosphorus Compounds ; Peripheral Blood Stem Cell Transplantation ; Reticulocyte Count ; Stem Cell Transplantation ; Transplants

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Evaluation of the Effectiveness of NK Vue Gold Kit in Patients with Chronic Hepatitis B.

Young Ae LIM ; Soon Sun KIM ; Sung Won CHO ; Jae Youn CHEONG

Journal of Laboratory Medicine and Quality Assurance.2016;38(3):151-158. doi:10.15263/jlmqa.2016.38.3.151

BACKGROUND: The associations between hepatitis B virus (HBV) infection and natural killer cell activity (NKA) have been studied. However, there have been no studies on detection of NKA in HBV patients using NK Vue Gold kit (ATGen Co., Korea), which has been developed in Korea and can easily detect NKA in whole blood. METHODS: A patient group of 40 patients diagnosed with hepatitis B antigen-positive chronic hepatitis B and a control group of 40 people eligible for blood donation were selected for this study. Whole blood (1 mL) was collected in special tubes for analysis with NK Vue Gold kit. The concentration of interferon-γ (IFN-γ) was measured and considered to represent NKA. RESULTS: There was no significant difference in the median (value, range) of concentration of IFN-γ between the patient (2,000, 89–2,000 pg/mL) and control groups (1,786, 333–2,000 pg/mL). The concentration of IFN-γ was inversely correlated with leukocyte count in both patient (r=–0.390, P=0.022) and control (r=–0.339, P=0.032) groups. The concentration of IFN-γ in the patient group was inversely correlated with concentrations of alanine aminotransferase (r=–0.363, P=0.021), aspartate aminotransferase (r=–0.336, P=0.037), and bilirubin (r=–0.376, P=0.020). CONCLUSIONS: There was no significant difference in NKA between the patient and control group. Caution should be practiced when interpreting results of NKA, because leukocyte count can affect concentration of IFN-γ.
Alanine Transaminase ; Aspartate Aminotransferases ; Bilirubin ; Blood Donors ; Hepatitis B ; Hepatitis B virus ; Hepatitis B, Chronic* ; Hepatitis, Chronic* ; Humans ; Interferon-gamma ; Killer Cells, Natural ; Korea ; Leukocyte Count

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Survey of Fungal Cultures and the Identification Tests Used by Diagnostic Laboratories in Korea.

Seungok LEE ; Gyong Gi YU ; Kang Hoon PARK ; Seong Yeoun LEE ; Dong Wook JEKARL ; Nam Surp YOON ; Mi Na KIM

Journal of Laboratory Medicine and Quality Assurance.2016;38(3):143-150. doi:10.15263/jlmqa.2016.38.3.143

BACKGROUND: The aim of this study was to investigate the current status of fungal cultures and the identification tests used by diagnostic laboratories in Korea. METHODS: From 22 October to 30 November 2013, we surveyed 76 laboratories, participating in the regular proficiency survey program of The Korean Association of Quality Assurance for Clinical Laboratory, with a questionnaire on fungal cultures and their identification tests. In March 2014, five mold were distributed to ninety-one participating laboratories, as an educational challenge. RESULTS: Fifty-six (73.7%) out of seventy-six laboratories replied to the survey questionnaire. Yeast was identified using commercial kits in all laboratories and to species level in 82.1% of the laboratories, whereas moulds were mainly identified by morphological examinations, to species level in 41.1% of the laboratories. The response rate to the five proficiency specimens was 67.0%–71.1%. The percentage of correctly identified dermatophytes was lower than that of Aspergillus species. CONCLUSIONS: An improvement is required in the mould culturing and identification techniques used in diagnostic laboratories in Korea.
Arthrodermataceae ; Aspergillus ; Fungi ; Korea* ; Surveys and Questionnaires ; Yeasts

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