Analytical Performance of INNOVANCE Free Protein S Antigen on Sysmex CS-5100.
- Author:
Sholhui PARK
1
;
Sanghee PARK
;
Jungsoo LEE
;
Jungwon HUH
Author Information
- Publication Type:Original Article
- Keywords: Protein S; Immunoturbidimetry; Performance
- MeSH: Delivery of Health Care; Female; Humans; Male; Mass Screening; Protein S Deficiency; Protein S*; Thrombophilia
- From:Laboratory Medicine Online 2019;9(1):1-5
- CountryRepublic of Korea
- Language:English
- Abstract: BACKGROUND: Protein S deficiency is a common cause of thrombophilia. Free protein S has been suggested as one of the best screening tests for this deficiency. We evaluated an immunoturbidimetric free protein S reagent, INNOVANCE Free Protein S Antigen (Free PS Ag; Siemens Healthcare Diagnostics, Germany), using a CS-5100 coagulation analyzer (Sysmex, Japan). METHODS: The performance of INNOVANCE Free PS Ag was evaluated according to the CLSI guidelines. Precision, linearity, and verification of reference intervals were examined. The INNOVANCE Free PS Ag was also compared by the STA-Liatest Free Protein S immunoturbidimetric assay (Diagnostica Stago, France). RESULTS: The repeatability and within-laboratory imprecision of INNOVANCE Free PS Ag were 0.8% CV and 2.0% CV at the normal level, and 1.3% CV and 2.3% CV at the abnormally low level, respectively. This assay showed linearity from 4.0% to 151.9% (correlation coefficient r=1, P < 0.0001). Reference intervals for males and females were verified as acceptable. INNOVANCE Free PS Ag was comparable with STA-Liatest Free Protein S with a very high correlation (r=0.935, P < 0.0001). The results for the INNOVANCE antigen were higher. CONCLUSIONS: The INNOVANCE Free PS Ag on a Sysmex CS-5100 coagulation analyzer has excellent analytical performance and is comparable with the STA-Liatest Free Protein S assay.
