Lab Med Online.  2019 Jul;9(3):133-145. 10.3343/lmo.2019.9.3.133.

Evaluation of the Analytical Performance of Atellica CH 930 Automated Chemistry Analyzer

• Kim D
• Cho Y
• Cho J
• Kim SH
• Lee SG
• Kim JH

• KMID: 2450838
• DOI: http://doi.org/10.3343/lmo.2019.9.3.133

Abstract

BACKGROUND
Recently, a new automated chemistry analyzer, Atellica CH930 (Siemens, Germany), was introduced. It automatically measures internal quality control (QC) materials according to a pre-determined schedule. For this purpose, the instrument has space for storage of QC materials. We evaluated the analytical performance of chemistry items by using the Atellica system.
METHODS
The precision of 29 items was evaluated with three levels of QC materials with two storage methods. We stored the QC materials in the dedicated storage space in the instrument during the precision evaluation period. In addition, we aliquoted and stored the materials in the refrigerator, and then loaded the material in a timely manner. Linearity, carry-over, and agreement with current methods were also evaluated.
RESULTS
The within-laboratory coefficient of variation (CV) of most items, except for total CO2 (tCO2), was within 5.0% in both QC storage methods without significant differences in CV between storage methods. The CV of tCO2 was 5.2%, 5.8%, and 5.1% at three different levels when the QC materials were stored in a dedicated space in the instrument. The linearity was acceptable, showing <5% nonlinearity. Although good agreement was observed for most items, some items, such as calcium, total bilirubin, aspartate transaminase, and chloride, showed unequivalent results.
CONCLUSIONS
Atellica CH930 showed acceptable precision, linearity, and agreement in routine chemistry items. The automatic QC function using the storage device has no problem with stability or precision. It can reduce the manual process, allowing technicians to focus on reviewing the QC results and reporting reliable results.

Keyword

Atellica CH 930 Analyzer; Performance evaluation; Automated QC function

MeSH Terms

Appointments and Schedules
Aspartate Aminotransferases
Bilirubin
Calcium
Chemistry*
Quality Control
Aspartate Aminotransferases
Bilirubin
Calcium

Figure

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  Fig. 1. Precision of the Siemens Atellica CH 930 Analyzer. Within-laboratory precision (A) and repeatability (B) of 29 analytes were calculated according to the CLSI guideline EP05-A3. QC materials used were supplied either by conventional manual loading after warming up to room temperature from refrigerator storage (black) or by automatic loading from the inner storage/supply system of the instrument (red). Mean CV value and the 95% confidence interval of each analyte are denoted as rectangles and flanking lines, respectively.

• 

  Fig. 2. Agreement and correlation of 28 chemical analytes between the Atellica CH 930 analyzer (Y axis) and Hitachi 7600 analyzer (X axis).

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  Fig. 3. Agreement and correlation of 25 chemical analytes between the Atellica CH 930 analyzer (Y axis) and Cobas c702 (X axis).

Reference

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