Analytical Performance of INNOVANCE Free Protein S Antigen on Sysmex CS-5100
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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.
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.
참고문헌 (19)
- Ohga S, "Protein C deficiency as the major cause of thrombophilias in childhood", Pediatr Int, 55, pp.267~271 (2013)
- Martinelli I, "Different risks of thrombosis in four coagulation defects associated with inherited thrombophilia : a study of 150 families", Blood, 92, pp.2353~2358 (1998)
- Kitchens CS, "Consultative hemostasis and thrombosis", pp.212~ (2013), Saunders
- Lee SY, "The prevalence and clinical manifestation of hereditary thrombophilia in Korean patients with unprovoked venous thromboembolisms", PLoS ONE, 12, pp.e0185785~ (2017)
- Crowley MP, "Venous thromboembolism and thrombophilia testing", Medicine, 45, pp.233~238 (2017)
- Connors JM, "Thrombophilia Testing and Venous Thrombosis", N Engl J Med, 377, pp.1177~1187 (2017)
- Stevens SM, "Guidance for the evaluation and treatment of hereditary and acquired thrombophilia", J Thromb Thrombolysis, 41, pp.154~164 (2016)
- Marlar RA, "Protein S abnormalities : a diagnostic nightmare", Am J Hematol, 86, pp.418~421 (2011)
- Johnston AM, "Use of a functional assay to diagnose protein S deficiency; inappropriate testing yields equivocal results", Intern Med J, 37, pp.409~411 (2007)
- Cunningham MT, "External quality assurance of antithrombin, protein C, and protein s assays : results of the College of American Pathologists proficiency testing program in thrombophilia", Arch Pathol Lab Med, 135, pp.227~232 (2011)
- Clinical and Laboratory Standards Institute, "User verification of precision and estimation of bias; approved guideline—third ed. EP15-A3", Clinical and Laboratory Standards Institute, ~ (2014)
- Clinical and Laboratory Standards Institute, "Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline. EP6-A", Clinical and Laboratory Standards Institute, ~ (2003)
- Clinical and Laboratory Standards Institute, "Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline—third ed. EP28-A3c", Clinical and Laboratory Standards Institute, ~ (2010)
- Clinical and Laboratory Standards Institute, "Measurement procedure comparison and bias estimation using patient samples; approved guideline—third ed. EP09-A3", Clinical and Laboratory Standards Institute, ~ (2013)
- Taylor R, "Interpretation of the correlation coefficient : a basic review", J Diagn Med Sonogr, 6, pp.35~39 (1990)
- Mou E, "Magnitude of potentially inappropriate thrombophilia testing in the inpatient hospital setting", J Hosp Med, 12, pp.735~738 (2017)
- De Maat MP, "Biological variation of hemostasis variables in thrombosis and bleeding : consequences for performance specifications", Clin Chem, 62, pp.1639~1646 (2016)
- Lijfering WM, "Clinical relevance of decreased free protein S levels : results from a retrospective family cohort study involving 1143 relatives", Blood, 113, pp.1225~1230 (2009)
- Pintao MC, "Protein S levels and the risk of venous thrombosis : results from the MEGA case-control study", Blood, 122, pp.3210~3219 (2013)