Lab Med Online.  2016 Jan;6(1):19-24. 10.3343/lmo.2016.6.1.19.

Performance Evaluation of the ichroma SMART Analyzer in Measuring C-reactive Protein and Procalcitonin Levels

Affiliations
  • 1Department of Laboratory Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea. jhyooken@gmail.com
  • 2Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 3Department of Laboratory Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Korea.

Abstract

BACKGROUND
For monitoring infection and inflammation episodes, biomarkers of host response, such as C-reactive protein (CRP) and procalcitonin (PCT), are now being recognized as useful tools in the diagnostic process. We aimed at evaluating the analytical performance of the recently developed semi-automated ichroma SMART system (Boditech Med Inc., Korea), which allows measurements of both CRP and PCT.
METHODS
We evaluated the analytical performance of the ichroma SMART system and the agreement between its results and the laboratory standards for CRP and PCT measurements. The precision and linearity as well as the method of measurement were compared to the DxC 800 (Beckman Coulter, USA) for CRP and to the VIDAS (bioMerieux SA, France) for PCT, according to corresponding CLSI guidelines. Additionally, we evaluated the carryover rates between specimens.
RESULTS
The total precision (% CV) of the ichroma SMART system in measuring low, middle, and high level controls (level 1, 2, 3) was 6.32%, 5.75%, and 3.56% for CRP, and 8.07%, 6.24%, and 6.53% for PCT. In the linearity test, R2 was 0.9997 and 0.9982 for CRP (0.1-336.8 mg/L) and PCT (0.05-60.91 ng/mL), respectively. Good correlation was observed between ichroma SMART and DxC 800 for CRP (r=0.997), and between ichroma SMART and VIDAS for PCT (r=0.992). Carry-over effect was 0.02% for CRP and 0.04% for PCT.
CONCLUSIONS
The ichroma SMART system showed an adequate performance and appeared to be a suitable clinical analyzer with a simple operating procedure for the measurement of CRP and PCT.

Keyword

C-reactive protein; Procalcitonin; ichroma SMART
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