Variability in combinations of APTT reagent and substrate plasma for a one-stage clotting assay to measure factor VIII products

被引：1

作者：

Suzuki, Atsuo ^{[1
]}

Suzuki, Nobuaki ^{[2
]}

Kanematsu, Takeshi ^{[3
]}

Okamoto, Shuichi ^{[4
]}

Suzuki, Naruko ^{[5
]}

Tamura, Shogo ^{[6
]}

Kikuchi, Ryosuke ^{[7
]}

Katsumi, Akira ^{[8
]}

Kojima, Tetsuhito ^{[4
,9
]}

Matsushita, Tadashi ^{[2
,3
]}

机构：

[1] Nagoya Univ Hosp, Dept Med Tech, Nagoya, Japan

[2] Nagoya Univ Hosp, Dept Transfus Med, 65 Tsurumai Cho,Showa Ku, Nagoya, Aichi 4668560, Japan

[3] Nagoya Univ Hosp, Dept Clin Lab, Nagoya, Japan

[4] Nagoya Univ, Grad Sch Med, Dept Integrated Hlth Sci, Div Cellular & Genet Sci, Nagoya, Japan

[5] Nagoya Univ, Grad Sch Med, Dept Haematol Oncol, Nagoya, Japan

[6] Hokkaido Univ, Grad Sch Hlth Sci, Sapporo, Japan

[7] Gifu Univ Hosp, Div Clin Lab, Gifu, Japan

[8] Natl Ctr Geriatr & Gerontol, Dept Haematol, Obu, Japan

[9] Aichi Hlth Promot Fdn, Nagoya, Japan

来源：

INTERNATIONAL JOURNAL OF LABORATORY HEMATOLOGY | 2024年 / 46卷 / 04期

关键词：

factor VIII; FVIII-deficient plasma; one-stage clotting assay; RECOMBINANT FACTOR-VIII; EXTENDED HALF-LIFE; FACTOR-IX; ACTIVATION; AFSTYLA;

D O I：

10.1111/ijlh.14258

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction: An investigation of the suitability of reagents for measuring FVIII products in a one-stage clotting assay (OSA) showed variations in their FVIII activity (FVIII:C). Most studies have focused on the activated partial thromboplastin time (APTT) reagent rather than FVIII-deficient plasma (F8DP), even though the APTT-based OSA is comprised of APTT reagents and factor-deficient plasma. Aim: A single-centre study was conducted to clarify variations in measurements of FVIII products in an OSA using a total of 12 reagent combinations, including four APTT reagents and three types of F8DP. Methods: FVIII:C in nine types of FVIII product-spiked plasma was measured using an OSA with four different APTT reagents and three types of F8DP. ResultsF8DP-dependent variations were found in addition to differences derived from APTT reagents. Variations in target recovery (TR) were observed for NovoEight (R), Eloctate (R), and Jivi (R). Reduced TR for Jivi was found only for Pathromtin SL in combination with congenital F8DP (F8DP-3). This lower TR was not observed with alternative manufacturing lots of F8DP-3. The reduced TR for Jivi might be related to impaired contact activation due to lower factor XI activity in F8DP-3. Conclusion: In addition to APTT reagents, variations in F8DPs used for OSAs can also affect FVIII:C results. F8DPs as well as the APTT reagent used for OSA should be chosen with caution, and laboratories should evaluate reagents for F8DPs as they currently do for APTT reagents, especially when lot changes occur.

引用

页码：705 / 713

页数：9

共 38 条

[1]

BARROWCLIFFE TW, 1993, THROMB HAEMOSTASIS, V70, P433

[2]

Behring CSL., Full Prescribing Information Afstyla Antihemophilic Factor (Recombinant), Single Chain

[3]

2016

[4] The coagulation laboratory monitoring of Afstyla single-chain FVIII concentrate [J].