Performance Evaluation of the Hitachi 7600-110 Chemistry Autoanalyzer / 대한임상병리학회지

BACKGROUND: Hitachi 7600-110 (Hitachi, Tokyo, Japan) is an automated chemistry analyzer introduced in 1999. It consists of one dispensing type plus one pipetting type module and one electrolyte analyzer. We evaluated the performance of the analyzer in order to access the utility of the Hitachi 7600-110 autoanalyzer for the efficiency of routine chemistry work. METHODS: Within-day and between-day precision, accuracy, linearity, and recovery rates for albumin, ALP, ALT, AST, BUN, Ca, cholesterol, creatinine, r-GT, glucose, phosphorus, total bilirubin, TG, total protein, uric acid, CK, direct bilirubin, Fe, HDL-cholesterol, LD, Mg, Cl, K, and Na (24 items) were evaluated. Commercialized quality control material, Lyphochek (Bio-Rad, CA, USA) and patient sera for test specimens were used. Vitros 750 (Johnson & Johnson, Rochester, USA) was used as a control analyzer to evaluate the correlation. RESULTS: The within-day coefficients of variations (CVs) of almost all items were less than 3.0% except for direct bilirubin (7.71%), Mg (6.65%), and Fe (5.83%). The between-day CVs of almost all items were less than 5% except the direct bilirubin (13.16%). All items showed good linearity in the performance range (r>0.99, slope, 0.97-1.0). The results of ALT, AST, BUN, creatinine, glucose, CK, LD, Cl, K, and Na between Hitachi 7600-110 and the Vitros 750 revealed good correlation (r> or = 0.975) except Na and Cl. Hitachi data of Na and Cl showed significantly lower results (P<0.05) than did the Vitros 750 data. The recovery rates for BUN, creatinine, glucose, and uric acid were in the range of 100.00 to 101.78%. CONCLUSIONS: Hitachi 7600-110 showed acceptable performance in the "within-day" and "between-day" precision, linearity, and accuracy. The Hitachi 7600-110 that combines dispensing and pipetting modules can improve the speed and the efficiency of the workflow and can minimize the reagent consumption and the cost of system management. Therefore, it can be used both in large laboratories in general hospitals with many examinations and in small laboratories with relatively small numbers of cases.

Evaluation of Hitachi 7600-110(R) for Quantitative Analysis of C-Reactive Protein / 대한임상병리학회지

BACKGROUND: The C-reactive protein(CRP) is one of the "acute phase" proteins and it is known to be the most sensitive indicator of the inflammatory and/or necrotic process. Traditional methods for measuring CRP are capillary precipitation assay and latex agglutination assay. However, these methods have low sensitivity and provide only qualitative results. Recently the development of specific and very sensitive assays for CRP using highly specific monoclonal antibodies for CRP have done, including radioimmunoassay, nephelometric assay(NA), and turbidimetric immunoassay(TIA). We evaluated the Hitachi 7600-110(R)(Hitachi Co., Japan) using TIA in the measurement of CRP and compared its results to those of the the LX-M(R)(Eiken Chemical Co., Japan) using NA in order to replace the Hitachi 7600-110(R) for quantitative analysis of CRP. METHODS: CRP were measured by the Hitachi 7600-110(R) using TIA and the LX-M(R) using NA in the sera from 106 patients. The relationship between results of Hitachi 7600-110(R) and LX-M(R). By performing 20 repetitive assays at three levels of CRP control serum and pooled sera, within-run, within-day, and between-day precision of the Hitachi 7600-110(R) were established. RESULTS: When the CRP value of 4.60 +/- 5.65 mg/dL by the Hitachi 7600-110(R) was compared with that of 3.71 +/- 4.32 mg/dL by the LX-M(R), coefficients of correlation of 0.994 was obtained. The regression equation was Y(Hitachi 7600-110(R)) = 1.298 X(LX-M(R)) - 0.211(r=0.994, n=106). CVs of CRP measured by Hitachi 7600-110(R) were 5.45% at 0.82 mg/dL, 1.32% at 2.39 mg/dL, and 2.37% at 4.62 mg/dL. The precision was excellent in each group. The linearity was acceptable, and sample to sample carry-over was 0.8%. CONCLUSIONS: The Hitachi 7600-110(R) using TIA, compared with the LX-M(R) using NA, showed good coefficient of correlation and excellent precision. Therefore the Hitachi 7600-110(R) can replace the LX-M for quantitative analysis of CRP.