Lab Med Online.  2015 Apr;5(2):57-62. 10.3343/lmo.2015.5.2.57.

Evaluation of i-STAT CHEM8+ Point-of-Care Chemistry Analyzer

Affiliations
  • 1Department of Laboratory Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. jlim@yuhs.ac

Abstract

BACKGROUND
We evaluated the analytical performance of the Abbott i-STAT CHEM8+, a point-of-care testing system that measures 8 basic chemical analytes, namely, sodium, potassium, chloride, total carbon dioxide, BUN, creatinine, glucose, and ionized calcium.
METHODS
The precision and linearity of 8 analytes were evaluated according to the CLSI guidelines EP15-A and EP6-A, respectively, using standard material provided by the manufacturer. i-STAT CHEM8+ and other primary methods (e.g. Hitachi Clinical Analyzer 7600 for 7 analytes, Nova CCX for ionized calcium) were also compared according to the CLSI guideline EP9-A2, using 113 patient samples.
RESULTS
The standard deviation (SD) of within-run and total precision of 7 analytes except chloride was within the claimed SD or within the verification value. The coefficient of variation of total precision of 7 analytes except creatinine was within 2%. With regard to linearity, all 8 analytes showed first-order equation or at least no statistical difference with the first-order equation. We observed that the efficiency of i-STAT CHEM8+ was comparable to that of primary methods, and that this method has potential applications in the clinical laboratory.
CONCLUSIONS
i-STAT CHEM8+ showed good precision and linearity, and an efficiency comparable to that shown by routine chemistry analyzers; thus, it has potential applications in the clinical laboratory. It can provide much faster results and relatively accurate value to clinicians in need of immediate results, such as in an emergency unit or in the intensive care unit.

Keyword

Clinical chemistry tests; Evaluation studies; Point of care systems; Verification
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