Analysis of the Effects of the Implementation of Transfusion-Related Education for Nurses at Medical Institutions / 대한수혈학회지

Background@#Nurses play a central role in the process of blood transfusion because they have the closest interactions with patients. Providing nurses with the appropriate knowledge and competency through education can help ensure transfusion safety. This study investigated the effectiveness of the first nationwide transfusion-related education for nurses by analyzing questionnaires for a self-assessment of competency on transfusion-related knowledge before and after the education and general evaluation for the educational program. @*Methods@#The education program was composed of four lectures and was conducted in seven regions in South Korea. One hundred and ninety-two nurses participated, and the questionnaires for 170 nurses were analyzed. @*Results@#The participants consisted of 90 nurses (53.0%) from tertiary hospitals, 23 (13.5%) from general hospitals, and 57 (33.5%) from other hospitals. The majority of the participants (103/170, 60.6%) were from hospitals with ≥500 beds, and 69.4% had a work period of ≥10 years. The scores for pre-/post-education self-assessment of competency were as follows: blood components, 3.03/3.73; pretransfusion testing, 2.86/3.64; management of transfusion, 3.18/3.84; and transfusion reactions, 3.11/3.78. In all categories, there was a significant increase in the score after the education program. The majority of participants (99.4%) provided a positive response regarding the necessity of a transfusion-related education program. @*Conclusion@#South Korea’s first attempt at transfusion-related education for nurses showed a strong positive effect by improving participants’ transfusion-related competency. Considering the important role of nurses in blood transfusion, the educational program should continue and be expanded in the future.

Analysis of the Effects of the Implementation of Transfusion-Related Education for Nurses at Medical Institutions / 대한수혈학회지

Background@#Nurses play a central role in the process of blood transfusion because they have the closest interactions with patients. Providing nurses with the appropriate knowledge and competency through education can help ensure transfusion safety. This study investigated the effectiveness of the first nationwide transfusion-related education for nurses by analyzing questionnaires for a self-assessment of competency on transfusion-related knowledge before and after the education and general evaluation for the educational program. @*Methods@#The education program was composed of four lectures and was conducted in seven regions in South Korea. One hundred and ninety-two nurses participated, and the questionnaires for 170 nurses were analyzed. @*Results@#The participants consisted of 90 nurses (53.0%) from tertiary hospitals, 23 (13.5%) from general hospitals, and 57 (33.5%) from other hospitals. The majority of the participants (103/170, 60.6%) were from hospitals with ≥500 beds, and 69.4% had a work period of ≥10 years. The scores for pre-/post-education self-assessment of competency were as follows: blood components, 3.03/3.73; pretransfusion testing, 2.86/3.64; management of transfusion, 3.18/3.84; and transfusion reactions, 3.11/3.78. In all categories, there was a significant increase in the score after the education program. The majority of participants (99.4%) provided a positive response regarding the necessity of a transfusion-related education program. @*Conclusion@#South Korea’s first attempt at transfusion-related education for nurses showed a strong positive effect by improving participants’ transfusion-related competency. Considering the important role of nurses in blood transfusion, the educational program should continue and be expanded in the future.

Performance Evaluation of the CRE2 Reagent from Siemens for Serum Creatinine Measurement

BACKGROUND: For creatinine measurement, the enzymatic method is known to be more accurate than the Jaffe method; however, the latter is still widely used. We evaluated the performance of the CRE2 reagent (Siemens Healthcare Diagnostics Inc., USA), which uses a modified Jaffe method. METHODS: Three quality control standards were used for precision evaluations of CRE2 on Dimension VISTA 500 instrument (Siemens). Moreover, the linearity and carryover characteristics were assessed. Sixty-eight creatinine results obtained using the CRE2 and ECREA (enzymatic) reagents (Siemens) were compared with those obtained using the L-CRE (enzymatic) reagent (Shinyang Diagnostics, Korea). The accuracy of CRE2, ECREA, and L-CRE was evaluated using a standard reference material. RESULTS: The CV of within-run (0.7–2.4%), between-run (0.4–1.7%), between-day precision (0.7–0.9%) for three standards, and total CV for medium (1.6%) and high levels (1.3%) satisfied the analytical goal. The linearity for CRE2 was excellent (R2=0.999). Comparisons of CRE2 and ECREA to L-CRE were well correlated (r=0.996 and 0.997, respectively). In comparison with L-CRE, 5 CRE2 results and 15 ECREA results exceeded minimum bias goal (5.1%) in samples with creatinine levels of >1 mg/dL. The carryover rate was −0.04%. In terms of accuracy, the percent bias values of CRE2, ECREA, and L-CRE were 7.4, −6.4, and −3.4, respectively, for low level; and 3.9, −1.5, and 0.7, respectively, for high level. CONCLUSIONS: For creatinine measurements, the CRE2 reagent showed good performance. It can be used in the diagnosis, treatment monitoring, and risk assessment of kidney diseases.

Comparison of Red Blood Cell, White Blood Cell and Differential Counts between UF-5000 System and Manual Method

BACKGROUND: Analysis of body fluids provides important information for assessing various medical conditions. We aimed to validate the analytical and diagnostic performance of the Sysmex UF-5000 (Sysmex, Japan) system for the analysis of different body fluids. METHODS: Eighty body fluid samples were analyzed using the UF-5000 system in the body fluid mode and light microscopy. Body fluids included ascitic, pleural, and cerebrospinal fluid (CSF), as well as other fluid samples. RESULTS: A comparison between the UF-5000 system and manual counting demonstrated good correlations with regard to red (r=0.6555) and white blood cell (r=0.9666) counts. The UF-5000 system also demonstrated good performance for differential cell counting (r=0.9028). CSF particularly showed a good correlation. CONCLUSIONS: The use of the UF-5000 system for cell counting and differential analysis of body fluid samples might be an effective and automated alternative to chamber counting in laboratory routine analysis, thereby enhancing laboratory workflow and clinical effectiveness.

Evaluation of the Automated Cross-Matching Instrument, ORTHO VISION, for Use in Blood Banks

BACKGROUND: Automated systems are used widely for pre-transfusion tests in blood banks, in an attempt to reduce effort and human error. We evaluated the clinical performance of an automated blood bank system, ORTHO VISION (Ortho-Clinical Diagnostics, Switzerland), for blood cross-matching. METHODS: Saline cross-matching was performed for 93 tests using 56 samples. Coombs cross-matching was performed for 400 tests using 166 samples. Saline cross-matching was compared for the automated ORTHO VISION and manual tube methods. Coombs cross-matching was compared for the automated ORTHO VISION and manual column agglutination technique (CAT) methods. The evaluation of 32 antibody-positive samples using the automated ORTHO VISION and manual CAT methods was compared by performing 97 cross-matching tests. Additionally, the ORTHO VISION efficiency and carryover were evaluated. RESULTS: The concordance rate of the saline cross-matching results between the manual method and automated ORTHO VISION was 100%. The concordance rate of coombs cross-matching results between manual CAT and automated ORTHO VISION was 97.9%. The concordance rate of cross-matching for antibody positive samples between manual CAT and the automated ORTHO VISION was 97.9%. Coombs cross-matching was efficient using ORTHO VISION, whereas saline cross-matching was efficient using the tube manual method. CONCLUSIONS: ORTHO VISION showed reliable results for cross-matching and was more efficient than manual CAT for coombs cross-matching. Thus, ORTHO VISION can be used for pre-transfusion tests in blood banks.

The prognostic impact of lymphocyte subsets in newly diagnosed acute myeloid leukemia

BACKGROUND: Tumor-infiltrating lymphocytes, which form a part of the host immune system, affect the development and progression of cancer. This study investigated whether subsets of lymphocytes reflecting host-tumor immunologic interactions are related to the prognosis of patients with acute myeloid leukemia (AML). METHODS: Lymphocyte subsets in the peripheral blood of 88 patients who were newly diagnosed with AML were analyzed by quantitative flow cytometry. The relationships of lymphocyte subsets with AML subtypes, genetic risk, and clinical courses were analyzed. RESULTS: The percentages of T and NK cells differed between patients with acute promyelocytic leukemia (APL) and those with AML with myelodysplasia-related changes. In non-APL, a high proportion of NK cells (>16.6%) was associated with a higher rate of death before remission (P=0.0438), whereas a low proportion of NK cells (≤9.4%) was associated with higher rates of adverse genetic abnormalities (P=0.0244) and relapse (P=0.0567). A multivariate analysis showed that the lymphocyte subsets were not independent predictors of survival. CONCLUSION: Lymphocyte subsets at diagnosis differ between patients with different specific subtypes of AML. A low proportion of NK cells is associated with adverse genetic abnormalities, whereas a high proportion is related to death before remission. However, the proportion of NK cells may not show independent correlations with survival.

Report on the External Quality Assessment Scheme for Blood Gas (Central Laboratory and Point-of-Care Testing) and Glucose (Point-of-Care Testing) Analysis in Korea (2016–2017)

In the 2016 and 2017 programs for blood gas analysis (BGA) in central laboratory and by point-of-care testing (POCT), and glucose analysis by POCT, external quality assessment of 9, 3, and 1 analytes, respectively, was performed each year. The materials used were commercially available quality control materials, and three levels were used per trial. Based on the information and results from each participating laboratory, statistical analysis was carried out. Results were provided to each laboratory through individual and comprehensive reports. The mean response rates were 96.6%, 96.5%, and 95.6% for BGA in central laboratory, BGA (POCT), and glucose (POCT), respectively. The number of participating laboratories in BGA (central laboratory and POCT) in 2017 was not significantly different from that in 2016. However, in the glucose (POCT) program, the number of registered instruments sharply increased in 2017 as the allowable number of registered instruments was increased from 5 to 30. The coefficient of variation (CV) did not show any significant differences in pH, sodium, chloride, and ionized calcium of BGA. However, the differences of CV were found to be relative large between instruments in other analytes of BGA and glucose POCT.

Assessment of Medical Trainnees' Knowledge and Their Educational Needs on Transfusion Medicine / 대한수혈학회지

BACKGROUND: Transfusion is one of the most important treatments in patient care. It has been known that there is a lack of transfusion medicine knowledge of doctors in other countries, however it has not been investigated yet in Korea. In this study, we assessed the educational need and the knowledge on transfusion medicine for trainees to provide basic raw data for future education in transfusion medicine. METHODS: Transfusion is one of the most important treatments in patient care. It has been known that there is a lack of transfusion medicine knowledge of doctors in other countries, however it has not been investigated yet in Korea. In this study, we assessed the educational need and the knowledge on transfusion medicine for trainees to provide basic raw data for future education in transfusion medicine. RESULTS: Among trainees, 89.9% said they received more than one hour of transfusion medicine education at medical schools, but 57.3% did not receive transfusion medicine education after finishing medical school. Moreover, 76.4% and 86.5% of respondents stated that additional transfusion medicine education was needed during and after medical school respectively. Among respondents, 43.5%, 53.9%, and 28.1% reported their knowledge on blood products, pretransfusion testing, and transfusion reactions as low or very low. In the assessment of knowledge of transfusion medicine, the mean percentage of correct answers was 65.2%. The rates of correct answers (average) ranged from 25.8% to 80.9% (58.2%), 49.4% to 94.4% (75.7%) 70.8% to 89.9% (80.2%) in case of blood products, pretransfusion testing, and transfusion reactions respectively. CONCLUSION: Transfusion medicine education among trainees after finishing medical school was found to be insufficient, and additional education for transfusion medicine is demanded by trainees.

Evaluation of the Automated Blood Bank Systems IH-500 and VISION Max for ABO-RhD Blood Typing and Unexpected Antibody Screening

BACKGROUND: The use of automated systems for pre-transfusion tests is increasing in an attempt to reduce workload and the impact of human errors in blood banks. We evaluated the clinical performance of the automated blood bank systems IH-500 (Bio-Rad Laboratories, Switzerland) and VISION Max (Ortho-Clinical Diagnostics, USA) for ABO-RhD blood typing and unexpected antibody screening. METHODS: ABO-RhD blood typing was performed for 410 samples, and antibody screening was performed for 332 samples, including 15 antibody-positive samples. The results obtained from the two automated instruments were compared with those obtained using manual methods for ABO-RhD blood typing and a semiautomated method (DiaMed-ID system) for antibody screening. Additionally, both instruments were evaluated in terms of concordance rates, sensitivity, and carryover. RESULTS: The concordance rate of the ABO-RhD blood typing results between the manual methods and the two automated instruments was 100%. For antibody screening tests, the concordance rates between the semiautomated method (DiaMed-ID system) and the automated methods were 100% and 99.7% for the IH-500 and VISION Max instruments, respectively. The sole discrepant result was obtained for a sample identified as antibody-positive only on the VISION Max; the antibody was identified as anti-Le(a). The overall sensitivity of the two automated instruments was the same as or higher than that of the semiautomated method. Carryover was not observed in antibody screening. CONCLUSIONS: The IH-500 and VISION Max instruments showed reliable results for ABO-RhD blood typing and unexpected antibody screening, and can be used clinically, with confidence, for pre-transfusion tests in the blood bank.

Current Status of Pretransfusion Tests and Equipments in Small and Medium Sized Hospitals in Korea / 대한수혈학회지

BACKGROUND: The appropriate procedures and equipment for the pretransfusion test are fundamental to a safe blood transfusion. The present study aimed to assess the current status of procedures and equipment for pretransfusion tests at small- and medium-sized medical institutions, as well as to use this basic raw data to better manage blood transfusions at these institutions. METHODS: Offline and online questionnaire surveys were performed at institutions that used between 24 and 1,000 units of blood products in 2014. A total of 338 institutions participated, and the survey results were subsequently analyzed. RESULTS: Among 307 institutions where on-site ABO blood typing was performed, 15.0%, 2.1%, and 43.5% did not conduct ABO serum typing, RhD typing, and irregular antibody screening tests, respectively, and 12.8% only conducted the saline phase for crossmatching. Moreover, among 338 institutions, only 66.7% of blood banks had centrifuges, 84.5% had 37℃ incubators, 41.1% had slide view boxes; in addition, 66.1% and 18.6% had refrigerators and deep freezers, respectively, for blood storage. CONCLUSION: Certain small- and medium-sized institutions did not have the essential equipment required to operate as blood banks. Moreover, they also needed to improve their testing procedures. To address these issues, the initiation of systematic training programs and the employment of institutional strategies are necessary to enhance testing procedures and equipment, respectively.

External Quality Assessment of Institutions and Instruments Using a Linear Mixed Model

BACKGROUND: External quality assessment (EQA) uses a standard deviation index (SDI), based on a peer group, to evaluate laboratory performance. However, evaluations using peer group SDIs often have limited applicability, because they are not statistically valid unless the number of institutions in the same peer group is large. The present study proposes a statistical model for simultaneously evaluating the performance of all participating institutions, as well as the performance of instruments on the market. METHODS: By assuming that proficiency test results were affected by the manufacturer, the instrument, and the institution, the effects of those factors were estimated using a linear mixed model. We used these effect estimates to calculate manufacturer, instrument, and institution SDIs. Using simulation, we evaluated the false positive rates and efficiencies of the proposed linear mixed model. RESULTS: Simulations showed that the linear mixed model empirical type I error rates preserved the nominal significance level. This model was also more statistically efficient than the peer group SDI. Rates of unacceptability were lower when using institution SDI than they were when using peer group SDI. Additional outliers that could not be evaluated using the current system were detected by the institution SDI statistic. The instrument SDI statistic detected outliers among different instrument groups. CONCLUSIONS: Institution and instrument SDIs are robust and efficient tools for EQA, and they can replace the currently used system of peer group SDI.

A Case of Pentasomy 21 With Two Isochromosome 21s in Acute Megakaryoblastic Leukemia Associated With Down Syndrome

No abstract available.

A Case of Acute Promyelocytic Leukemia Concomitant with Plasma Cell Myeloma

No abstract available.

Diagnostic Utility of the URiSCAN 2 ACR Strip as a Point-of-care Test for Estimating Urine Albumin-Creatinine Ratios

BACKGROUND: Diagnosing albuminuria by measuring the urinary albumin-creatinine ratios (UACR) is important for the early detection of kidney diseases in patients with diabetes or hypertension. Currently, a few point-of-care testing (POCT) systems exist for estimating the UACR. Here, we evaluated the performance characteristics of two semi-quantitative UACR POCT assays. METHODS: Albumin and creatinine levels were quantified for 219 randomly acquired urine samples with the Toshiba TBA-200FR NEO analyzer, and the UACR were calculated. The results were compared to UACR measured using the CLINITEK Microalbumin 2 Strip (Siemens, USA) and URiSCAN 2 ACR Strip (YD diagnostics, Korea) POCT assays. RESULTS: Semi-quantitative results from the CLINITEK and URiSCAN UACR assays showed that the sensitivity and specificity of each test were, respectively, 96.7% and 62.7%, and 45.9% and 84.8%. Positive and negative predictive values of the CLINITEK and URiSCAN tests were, respectively, 50.0% and 98.0%, and 53.8% and 80.2%. The rate of agreement between URiSCAN test and CLINITEK test was 91.1% in the normal UACR range ( or =30 mg/g). CONCLUSIONS: The URiSCAN test showed higher specificity than did the CLINITEK test owing to the lower false positive results. However, the high rate of false negatives for the URiSCAN test significantly lowered its sensitivity and negative predictive values. Therefore, the sensitivity of the URiSCAN device in detecting urine albumin needs to be improved before its adoption as a reliable rule-out testing system.

Performance Evaluation of the Syva EMIT Methotrexate Assay on the Toshiba 200FR NEO

BACKGROUND: Methotrexate (MTX) is an antifolate antagonist that is widely used for treating various malignancies and non-malignant diseases. MTX levels should be monitored when used in high concentration to determine when to start leucovorin rescue. In this study, we evaluated the analytical performance of the EMIT Methotrexate Assay on a 200FR NEO Chemistry Analyzer (Toshiba Medical System Co., Japan) and compared it with Viva-E Drug Testing System (Siemens Healthcare, Germany). METHODS: According to the Clinical Laboratory and Standards Institute (CLSI) Evaluation Protocol (EP) 5-A2, three concentrations of the Liquichek Therapeutic Drug Monitoring Control (Bio-Rad Laboratories, USA) were analyzed twice a day for 20 days to monitor assay precision. The 200FR NEO and Viva-E instruments were compared using 40 patients' sera, according to CLSI EP9-A2. The linearity and carry-over rate were also evaluated. RESULTS: Between-run CVs for low-, medium-, and high-level controls were 4.9%, 0.9%, and 2.0%, respectively, whereas between-day CVs for low-, medium-, and high-level controls were 8.1%, 1.3%, and 3.5%, respectively. In the linearity test, the coefficient of determination (R2) was 0.98 (0.06-1.92 micromol/L). In the comparison study, R2 was 0.955, showing good correlation between the 200FR NEO and Viva-E instruments. The carry-over rate was 0.9%. CONCLUSIONS: The EMIT assay showed good precision, linearity, and carry-over rate on the Toshiba 200FR. An excellent correlation was observed when comparing results obtained using the Toshiba and Viva-E instruments. In conclusion, the Syva EMIT MTX assay can be readily used for MTX monitoring on the Toshiba 200FR NEO.

Quantitation of T-lymphocyte Subsets Using the CELL-DYN Sapphire Automated Haematology Analyser / 임상검사와정도관리

BACKGROUND: Quantitative analysis of T-lymphocyte subsets is used to assess immune competency. Traditionally, T-lymphocyte subset analysis has been performed using flow cytometry, which requires complex instrumentation and relatively skilled manual operation. We evaluated the performance of an automated haematology analyser, the CELL-DYN Sapphire (CD Sapphire; Abbott Laboratories, USA) for T-lymphocyte subset analysis. METHODS: The precision and linearity obtained using the CD Sapphire was evaluated. T-lymphocyte subsets in blood samples from 120 patients were quantified using CD Sapphire and flow cytometry (Cytomics FC 500; Beckman-Coulter, France). The time required for complete T cell subset analysis using both methods was also evaluated. RESULTS: Results of CD Sapphire-based quantitation of CD3+, CD3+CD4+, and CD3+CD8+ cells showed intra-assay CV of less than 5% for precision and displayed linearity in the ranges of 84 to 5364, 41 to 2615, and 44 to 2800 cells/microL, respectively. There was good correlation among the CD3+, CD3+CD4+, and CD3+CD8+ cell counts as well as in the CD4/CD8 ratio (r=0.987, 0.982, 0.982, and 0.980, respectively) using CD Sapphire and flow cytometry. The mean turnaround time for the CD Sapphire (10.0+/-0.5 minutes) was significantly less than that for flow cytometry (111.8+/-8.4 minutes, P<0.001). CONCLUSIONS: T cell subset analysis using the CD Sapphire gives excellent performance and consistent results that correlate well with those obtained by flow cytometry. We conclude that this time-efficient method can replace conventional flow cytometric methods used for measuring T cell subsets.

The Genetic Characteristics of Multidrug-resistant Acinetobacter baumannii Coproducing 16S rRNA Methylase armA and Carbapenemase OXA-23

Acinetobacter baumannii is a gram-negative organism reported worldwide as a cause of health-care associated infections. Due to its increasing drug resistance, several studies on coproduction of armA and carbapenemase in South Korea and other parts of the world were reported, which can pose significant therapeutic threat. The aim of this study was to investigate genetic characteristics of multidrug-resistant A. baumannii coproducing armA and carbapenemase and its epidemiological relatedness. Forty-five multidrug resistant (MDR) A. baumannii clinical isolates were collected. Antimicrobial susceptibility was determined by agar dilution, Etest and VITEK 2 system. The presence of 16S rRNA methylase and carbapenemase were analyzed by polymerase chain reaction (PCR) and sequencing. Repetitive element palindromic (REP)-PCR was also performed for epidemiologic investigation. All of A. baumannii isolates harbored blaOXA-51 -like gene and 10 isolates showed an upstream ISAba1. 36 isolates (80%) showed amplification of OXA-23, all of which except one had an upstream ISAba1. 16S rRNA methylase armA was found in 44 isolates with high level resistance to aminoglycosides. The rate of coproduction was found in 36 isolates (80%). All isolates showed dominant two patterns in REP-PCR profile. The prevalence of MDR A. baumannii coproducing OXA-23 and armA was high, which the rate of blaOXA-23 coproduction was also high.

Performance Evaluation of the Automated Coagulation Analyzer Coapresta 2000 / 임상검사와정도관리

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.

Evaluation of the Performance of ARKRAY ADAMS HA-8180 HbA1c Analyzer

BACKGROUND: Hemoglobin (Hb)-A1c is routinely used for the management of diabetes. In 2010, HbA1c was included into the diagnostic criteria for diabetes by the American Diabetes Association. A newly developed HbA1c analyzer, ARKRAY ADAMS HA-8180 (ARKRAY KDK, Japan) was introduced. In this study, we evaluated the analytical performance of ARKRAY ADAMS HA-8180 HbA1c analyzer and compared it with the previously used Variant II Turbo (Bio-Rad Laboratories, USA), which is a National Glycohemoglobin Standardization Program (NGSP) certified analyzer. METHODS: According to Clinical Laboratory and Standards Institute (CLSI) evaluation protocol (EP) 5-A, Lyphochek Diabetes Controls (Bio-Rad Laboratories, USA) are used for precision. Two (low and high) levels of quality control materials were analyzed twice a day for 20 days, after which the mean, total standard deviation (SD) and total coefficient of variation (CV), including the between-run CV and between-day CV were calculated. ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo were compared with 150 samples according to CLSI EP9-A2. In addition, the linearity and carry over rate were evaluated. RESULTS: Between-run CVs for low and high level quality control materials were 0.0% and 0.3%, respectively, whereas between-day CVs for low and high level quality control materials were 0.3% and 0.2%, respectively. In the linearity test, the coefficient of determination (R2) was 0.99 (range, 3.1-19.3%). Thus, a good correlation was observed between ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo (R2=0.994). The carry over rate was 0.0%. CONCLUSIONS: The ARKRAY ADAMS HA-8180 HbA1c analyzer showed excellent precision, linearity, and carryover rate. It also showed excellent correlation with the NGSP certified Variant II Turbo. In conclusion, the ARKRAY ADAMS HA-8180 HbA1c analyzer is a reliable high-performance liquid chromatography (HPLC) analyzer for HbA1c analysis and could be very useful for the diagnosis, treatment, monitoring, and risk assessment of diabetes.

Evaluation of the Performance of ARKRAY ADAMS HA-8180 HbA1c Analyzer

BACKGROUND: Hemoglobin (Hb)-A1c is routinely used for the management of diabetes. In 2010, HbA1c was included into the diagnostic criteria for diabetes by the American Diabetes Association. A newly developed HbA1c analyzer, ARKRAY ADAMS HA-8180 (ARKRAY KDK, Japan) was introduced. In this study, we evaluated the analytical performance of ARKRAY ADAMS HA-8180 HbA1c analyzer and compared it with the previously used Variant II Turbo (Bio-Rad Laboratories, USA), which is a National Glycohemoglobin Standardization Program (NGSP) certified analyzer. METHODS: According to Clinical Laboratory and Standards Institute (CLSI) evaluation protocol (EP) 5-A, Lyphochek Diabetes Controls (Bio-Rad Laboratories, USA) are used for precision. Two (low and high) levels of quality control materials were analyzed twice a day for 20 days, after which the mean, total standard deviation (SD) and total coefficient of variation (CV), including the between-run CV and between-day CV were calculated. ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo were compared with 150 samples according to CLSI EP9-A2. In addition, the linearity and carry over rate were evaluated. RESULTS: Between-run CVs for low and high level quality control materials were 0.0% and 0.3%, respectively, whereas between-day CVs for low and high level quality control materials were 0.3% and 0.2%, respectively. In the linearity test, the coefficient of determination (R2) was 0.99 (range, 3.1-19.3%). Thus, a good correlation was observed between ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo (R2=0.994). The carry over rate was 0.0%. CONCLUSIONS: The ARKRAY ADAMS HA-8180 HbA1c analyzer showed excellent precision, linearity, and carryover rate. It also showed excellent correlation with the NGSP certified Variant II Turbo. In conclusion, the ARKRAY ADAMS HA-8180 HbA1c analyzer is a reliable high-performance liquid chromatography (HPLC) analyzer for HbA1c analysis and could be very useful for the diagnosis, treatment, monitoring, and risk assessment of diabetes.