J Lab Med Qual Assur.  2005 Dec;27(2):219-225.

Evaluation of Immunochemical Autoanalyzer Modular Analytics(R)

• Cho CR
• Um TH

Abstract

BACKGROUND: We evaluated the performance of Modular Analytics (Roche Diagnostics, Basel, Switzerland) which is combined with automated chemiluminescent immunoassay analyzer and automated chemical analyzer

in order to assess its utility for the improvement of efficiency of routine immuno-chemistry workstation.
METHODS
Within- and between-day precision, linearity, and recovery rates were evaluated for 21 items (T3, T4, TSH, E2, LH, Testosterone, FSH, prolactin, AFP, CEA, CA125, CA19-9, total PSA, CRP, ASO, RF, Ig G, Ig M, Ig A, C3C, and C4). Commercialized controls(Roche Diagnostics, Basel, Switzerland) and patient sera for test specimens were used. Centaur(Bayer Diagnostic Division, New York, USA) and LX 2200(Eiken Chemical Co., Tokyo, Japan) were used as the control analyzers to evaluate the correlation.
RESULTS
Within-day Coefficients of variation(CVs) was below 5% for all the analytes and between-day CVs was below 5.0% except ASO(8.01%). The linearity was excellent(r2>0.999; slope, 0.98-1.02; p<0.001). Recovery rates for all analytes were in the range of 95% to 103%. The correlation coefficients between modular and Centaur was exceeded 0.971, and between modular

and LX2200 exceeded 0.910, except RF(r=0.834). (P<0.05)
CONCLUSION
The recently developed Modular Analytics proved to be highly precise and linear for quantitative analysis of hormones, tumor markers, and serum proteins in routine immuno-chemistry workstation. Correlations with Centaur and LX 2200 were thought to be good.

Keyword

Modular Analytics ; precision; linearity; recovery rate; correlation

MeSH Terms

Blood Proteins
Humans
Immunoassay
Prolactin
Testosterone
Biomarkers, Tumor
Blood Proteins
Prolactin
Testosterone