J Lab Med Qual Assur.  2017 Dec;39(4):181-184. 10.15263/jlmqa.2017.39.4.181.

Performance Evaluation of STRATUS CS200 for Cardiac Markers

• Lee YW
• Kim JG

• KMID: 2401288
• DOI: http://doi.org/10.15263/jlmqa.2017.39.4.181

Abstract

The STRATUS CS200 (Siemens Healthcare Diagnostics Inc., USA) has recently been developed as an on-site diagnostic instrument for assaying several kinds of cardiac markers within a short duration. The precision, linearity, comparison, limit of quantification, and turnaround time (TAT) were evaluated for troponin I, creatine kinase-MB (CK-MB), N-terminal pro-brain natriuretic peptide (NT-proBNP), and myoglobin assays according to guidelines provided by the Clinical and Laboratory Standards Institute. The total coefficients of variation of the four items were between 1.90% and 4.25%. All markers showed a linearity that was ≥0.99, and the values were within the manufacturer's range. All items showed a close correlation with E170 (Roche Diagnostics, Germany). The limits of quantification for troponin I, CK-MB, myoglobin, and NT-proBNP were 0.03 ng/mL, 0.3 ng/mL, 1 ng/mL, and 15 pg/mL, respectively. The TAT was 14 minutes. The performance of the STRATUS CS200 for assaying cardiac markers was highly satisfactory in terms of the precision, linearity, limit of quantification, and TAT, and it showed a good correlation with the comparative method.

Keyword

Cardiac marker; Evaluation; STRATUS CS200

MeSH Terms

Creatine
Delivery of Health Care
Methods
Myoglobin
Troponin I
Creatine
Myoglobin
Troponin I