Abstract
Patients with congenital protein S (PS) deficiency show a hereditary predisposition for thrombosis, and PS deficiency is prevalent among Japanese populations. Diagnosis is based on symptoms of thrombosis and reduced PS activity. Three reagents that use different measurement principles for determining PS activity are available in Japan. This study aimed to confirm the possibility of harmonization of these three reagents to establish a universal standard for PS activity in Japanese populations. Commercial normal plasma and plasma samples obtained from healthy individuals and healthy pregnant women were tested at three facilities using three reagents for measuring PS: STA-Staclot Protein S (STA-PS), HemosIL Protein S (Clotting) (IL-PS), and a total PS assay (SNT-PS). The within-run precision of each reagent was good, as each had a coefficient of variation of ≤ 3.8%. The dilution linearity for each reagent was also good. The correlation coefficient was 0.94 for STA-PS vs. IL-PS, 0.93 for SNT-PS vs. STA-PS, and 0.90 for SNT-PS vs. IL-PS, indicating a good correlation. Although the three reagents available in Japan for measuring PS activity use different measurement methods, each showed good performance, and large differences were not observed between the obtained values. Harmonization among them appears possible.
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Acknowledgements
We thank Hiroko Juraku and Kyoko Kumagai for helping with the PS activity measurements. We also thank Yayoi Ishida for the administrative support in writing the manuscript. The manuscript was proofread for language usage by Enago (www.enago.jp) before submission.
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The authors did not receive support from any organization for the submitted work.
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MI conceived the study, provided research guidance, and wrote the manuscript. EM, HT, and DK interpreted the data and critically revised the manuscript. Data analysis was performed by MI, TH, and TA. Testing was done by SN, MY, TH, KW, and ST. Patient enrolment was done by KO, NT, and TA. All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
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This study was approved by the Ethics Committee of the School of Dentistry at the Health Sciences University of Hokkaido (No. 148 and 192) and the Medical Ethics Committee of the Aiiku Maternal and Child Health Center (No. 152).
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Ieko, M., Hotta, T., Watanabe, K. et al. Comparative evaluation of reagents for measuring protein S activity: possibility of harmonization. Int J Hematol 113, 530–536 (2021). https://doi.org/10.1007/s12185-020-03049-8
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DOI: https://doi.org/10.1007/s12185-020-03049-8