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Abstract
Background
We evaluated the analytical performance of Wako assays for albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), complement C3 and C4, calcium, creatine kinase (CK), C-reactive protein (CRP), direct bilirubin (DBIL), iron, gamma-glutamyl transferase (GGT), HDL cholesterol (HDLC), inorganic phosphorus (IP), LDL cholesterol (LDLC), total bilirubin (TBIL), total protein (TP), and uric acid (UA), as well as the performance of Sekisui assays for albumin, BUN, calcium, CRP, HDLC, IP, LDLC, TP, and UA by using Hitachi LABOSPECT 008 (Hitachi High-Tech Co., Japan).
Methods
Liquid Assayed Multiqual Control (Bio-Rad Laboratories, USA) and pooled patients' sera were analyzed for 20 days. Wako linearity material (Wako Pure Chemical Industries, Ltd., Japan) and Sysmex Interference Check A Plus kit (Sysmex Co., Japan) were used to test linearity and interference, respectively. Concentrations of the target analytes were measured using Hitachi LABOSPECT 008 in 100 residual patient specimens and compared to those in Pureauto S series reagent (Sekisui Medical, Japan), which were measured using Hitachi 7600 (Hitachi High-Tech Co., Japan).
Results
Total coefficients of variation (CVs) for the tested analytes were 0.91-9.26% in Wako and 1.04-7.46% in Sekisui assays. Linearity was demonstrated up to the highest concentration within the analytical range in all the assays except for Wako albumin and Sekisui TP. Wako and Sekisui albumin, BUN, CRP, HDLC, and LDLC assays, and in Wako C3, C4, calcium, and UA assays showed no interference with the test concentrations used. All the tested assays, except for Wako AST, LDLC, and TP, and Sekisui calcium and TP, demonstrated comparability with comparative method for at least one medical decision level.
Figures and Tables
 | Fig. 1Method comparison of Wako or Sekisui assays on Hitachi LABOSPECT 008 and Pureauto S assays on Hitachi 7600.
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 | Fig. 2Interference of common potential interfering substances in Wako and Sekisui assays on Hitachi LABOSPECT 008.
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Table 1
Precision of Wako and Sekisui assays on Hitachi LABOSPECT 008 with control materials and pooled patients' sera
*Minimum specifications for imprecision derived from intra- and inter-individual biologic variations.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; C3, complement 3; C4, complement 4; CK, creatine kinase; CRP, C-reactive protein; GGT, gamma glutamyl transpeptidase; HDL, high density lipoprotein; LDL, low density lipoprotein.
Table 3
Method comparison of the Wako and Sekisui assay on Hitachi LABOSPECT 008 against Pureauto S on Hitachi 7600
*Minimum specifications for bias derived from intra- and inter-individual biological variations; †Medical decision levels from "Westgard QC website"[8]; ‡Reference interval from "Interpretation of Diagnostic Tests"[7]; §Reference interval from "Tietz Textbook of Clinical Chemistry and Molecular Diagnostics"[6]; ∥ATP III classification of total, LDL, and HDL cholesterol from "Tietz Textbook of Clinical Chemistry and Molecular Diagnostics"[6].
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; C3, complement 3; C4, complement 4; CK, creatine kinase; CRP, C-reactive protein; GGT, gamma glutamyl transpeptidase; HDL, high density lipoprotein; LDL, low density lipoprotein.MDL, medical decision level; CI, confidence interval.
References
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