BACKGROUND: The purpose of this study was to evaluate the performance and agreement among HbA(1c) values measured using selected analyzers certified by the National Glycohemoglobin Standardization Program (NGSP) and standardized by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). METHODS: HbA(1c) determined using D-10 (Bio-Rad, USA), Variant II Turbo (Turbo; Bio-Rad, USA), Cobas Integra 800 (Integra; Roche, Switzerland) and Afinion AS100 (Afinion; Axis-Shield, Norway) were compared with each other. Precision and method comparisons with Deming regression were evaluated according to CLSI recommendations. We also compared the HbA(1c) values obtained with each analyzer using either IFCC or NGSP methods by correlation analysis and kappa statistics. RESULTS: The repeatability and method/device precisions of D-10 and Afinion were acceptable. The correlation coefficients of HbA(1c) were 0.986 for D-10 vs. Afinion, 0.997 for D-10 vs. Turbo, 0.988 for D-10 vs. Integra, and 0.991 for Integra vs. Afinion. The average biases of HbA(1c) Afinion (IFCC) and HbA(1c) Integra (IFCC) against HbA(1c) D-10 (NGSP) were -1.90% and -1.79%, respectively. Kappa agreement statistics for the three diabetic control group HbA(1c) values of "less than 6.5%," "6.5%-7.5%," and "greater than 7.5%" for D-10 vs. Turbo, D-10 vs. Integra, and D-10 vs. Afinion were 0.872, 0.836, and 0.833, respectively. CONCLUSIONS: The strong correlations and good clinical agreements of HbA(1c) between each analyzer expressed in terms of either NGSP or IFCC-derived NGSP indicate that these analyzers can be used interchangeably.
Blood Chemical Analysis/instrumentation/methods/standards ; Diabetes Mellitus/therapy ; Hemoglobin A, Glycosylated/*analysis/standards ; Humans ; Reproducibility of Results

BACKGROUND: Commutable reference materials (RMs) are suitable for end-users for evaluating the metrological traceability of values obtained using routine measurement systems. We assessed the performance of 6 routine measurement systems with validated secondary RMs. METHODS: We tested the homogeneity, stability, and commutability of 5 minimally processed human serum pools according to the standard guidelines. The serum pools were assigned values as per the reference procedure of the United States Centers for Disease Control and were used to evaluate the trueness of results from 6 commercial measurement systems based on enzymatic methods: 3 glucose oxidase (GOD) and 3 hexokinase (HK) methods. RESULTS: The prepared RMs were validated to be sufficiently homogenous, stable, and commutable with the patient samples. Method bias varied for different systems: GOD01, -0.17 to 2.88%; GOD02, 1.66 to 4.58%; GOD03, -0.17 to 3.14%; HK01, -3.48 to -0.85%; HK02, -3.83 to -0.11%, and HK03, -1.82 to -0.27%. CONCLUSIONS: We observed that the prepared serum glucose RMs were qualified for trueness assessment. Most of the measurement systems met the minimal quality specifications.
Blood Chemical Analysis/instrumentation/*standards ; Blood Glucose/*analysis ; Glucose Oxidase/metabolism ; Hexokinase/metabolism ; Humans ; Reagent Kits, Diagnostic ; Reference Standards ; Regression Analysis

No abstract available.
Adult ; Aged ; Aged, 80 and over ; Blood Chemical Analysis/instrumentation ; Blood Platelets/*cytology/physiology ; Female ; Flow Cytometry/*instrumentation/standards ; Humans ; Male ; Middle Aged ; Platelet Count/*instrumentation/standards ; Reference Values ; Republic of Korea ; Young Adult

BACKGROUND: Hemolysis, icterus, and lipemia (HIL) cause preanalytical interference and vary unpredictably with different analytical equipments and measurement methods. We developed an integrated reporting system for verifying HIL status in order to identify the extent of interference by HIL on clinical chemistry results. METHODS: HIL interference data from 30 chemical analytes were provided by the manufacturers and were used to generate a table of clinically relevant interference values that indicated the extent of bias at specific index values (alert index values). The HIL results generated by the Vista 1500 system (Siemens Healthcare Diagnostics, USA), Advia 2400 system (Siemens Healthcare Diagnostics), and Modular DPE system (Roche Diagnostics, Switzerland) were analyzed and displayed on physicians' personal computers. RESULTS: Analytes 11 and 29 among the 30 chemical analytes were affected by interference due to hemolysis, when measured using the Vista and Modular systems, respectively. The hemolysis alert indices for the Vista and Modular systems were 0.1-25.8% and 0.1-64.7%, respectively. The alert indices for icterus and lipemia were <1.4% and 0.7% in the Vista system and 0.7% and 1.0% in the Modular system, respectively. CONCLUSIONS: The HIL alert index values for chemical analytes varied depending on the chemistry analyzer. This integrated HIL reporting system provides an effective screening tool for verifying specimen quality with regard to HIL and simplifies the laboratory workflow.
Blood Chemical Analysis/instrumentation/*methods/standards ; Female ; Hemoglobins/analysis ; *Hemolysis ; Humans ; Hyperlipidemias/metabolism/*pathology ; Jaundice/metabolism/*pathology ; Male ; Quality Control ; Reproducibility of Results

In human medicine, diagnosis of diabetic ketoacidosis (DKA) is usually based on measurement of capillary 3-beta-hydroxybutyrate (3-HB) with a hand held ketone sensor. This study was conducted to determine if measurement of capillary 3-HB could be useful for the diagnosis and monitoring of canine DKA. Fifteen dogs with diabetic ketosis and 10 with DKA were evaluated. Paired measurements of 3-HB of capillary and venous blood samples were analysed by the electrochemical sensor and reference method. Use of capillary 3-HB measurement during DKA management was then evaluated through simultaneous measurements of capillary 3-HB, urinary AcAc and venous blood gas analysis. Good agreement between capillary and venous 3-HB measurement was detected by the electrochemical sensor and reference method. Monitoring treatment of DKA revealed a significant correlation between capillary 3-HB and acidosis markers, while no significant correlation was observed between AcAc and acidosis markers. A cut-off value of capillary blood 3-HB >3.8 mmol/L for diagnosis of DKA resulted in 70% and 92% sensitivity and specificity. The electrochemical sensor accurately measures 3-HB concentration in both capillary and venous blood samples, is accurate in diagnosing canine DKA, and appears to reflect the patient's metabolic status during DKA treatment.
3-Hydroxybutyric Acid/blood/*diagnostic use ; Animals ; Blood Chemical Analysis/standards/*veterinary ; Blood Specimen Collection/instrumentation/*veterinary ; Capillaries/chemistry ; Diabetic Ketoacidosis/diagnosis/therapy/*veterinary ; Dog Diseases/*diagnosis/therapy ; Dogs ; Electrochemical Techniques/instrumentation/*veterinary

BACKGROUND: Point-of-care (POC) tests are used increasingly due to fast results and simple test procedures, which enables rapid diagnosis and therapeutic monitoring. We evaluated the performance of the Piccolo xpress Chemistry Analyzer (Abaxis, USA) a POC chemistry analyzer. METHODS: Fourteen analytes, Na+, K+, Cl-, Ca2+, total carbon dioxide, AST, ALT, total bilirubin, alkaline phosphatase, blood urea nitrogen, creatinine, albumin, total protein, and glucose; were measured simultaneously with a 100 microliter of whole blood sample using a Comprehensive Metabolic Reagent disk. Within-run and total precision and linearity were evaluated according to CLSI EP15-A and EP6-A guidelines, respectively. Comparison with a central laboratory chemistry analyzer was performed using 144 patient samples. RESULTS: The coefficients of variations of within-run and total precision were all within 5% for three levels except for total carbon dioxide, ALT, alkaline phosphatase, total bilirubin, and creatinine in low level, and creatinine in middle level. The results of 14 analytes were linear within a commonly encountered range in clinical samples (r2> or =0.98). More than 10% of samples in Na+, AST, ALT, glucose, BUN did not satisfy CLIA analytical quality requirement. CONCLUSIONS: The Piccolo xpress Chemistry Analyzer can analyze multiple analytes with a minimal amount of whole blood in a short time. It showed an acceptable performance for precision, linearity and comparison with central laboratory analyzer. It can be useful as a screening tests modality in mobile clinics, ambulances, and field clinics for military use, and for pediatric patients from whom enough sample volume is difficult to obtain.
Alanine Transaminase/blood ; Alkaline Phosphatase/blood ; Aspartate Aminotransferases/blood ; Bilirubin/blood ; Blood Chemical Analysis/*instrumentation/methods/*standards ; Blood Glucose/analysis ; Calcium/blood ; Carbon Dioxide/blood ; Chlorides/blood ; Creatinine/blood ; Humans ; *Point-of-Care Systems ; Potassium/blood ; Quality Control ; Reproducibility of Results ; Serum Albumin/analysis ; Sodium/blood