Analytical Performance of INNOVANCE Free Protein S Antigen on Sysmex CS-5100
Laboratory Medicine Online
;
: 1-5, 2019.
Article
in English
| WPRIM
| ID: wpr-719669
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Mass Screening
/
Protein S
/
Protein S Deficiency
/
Thrombophilia
/
Delivery of Health Care
Type of study:
Practice guideline
/
Screening study
Limits:
Female
/
Humans
/
Male
Language:
English
Journal:
Laboratory Medicine Online
Year:
2019
Type:
Article
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