PMID- 23315876
OWN - NLM
STAT- MEDLINE
DCOM- 20140212
LR  - 20130827
IS  - 1676-5680 (Electronic)
IS  - 1676-5680 (Linking)
VI  - 12
IP  - 3
DP  - 2013 Jul 24
TI  - Quantitative determination of activated coagulation factor XI as an impurity in 
      therapeutic immunoglobulins from Chinese blood fractionation companies.
PG  - 2556-61
LID - 10.4238/2013.January.4.17 [doi]
AB  - Residual activated coagulation factor XI (FXIa) has been suggested to play an 
      important role in thromboembolic events associated with the use of intravenous 
      immunoglobulin (IVIG) lots. This study investigated the predominant plasma 
      proteases in 42 IVIG lots from 4 Chinese manufacturers. In one-stage clotting 
      assays, the procoagulant activities of factors II, VII, IX, X, XI, and XII were 
      quantified. Non-activated partial thromboplastin time and a modified thrombin 
      generation test served as global and FXIa-specific clotting assays, respectively. 
      We found that coagulation factor clotting activities of the 42 IVIG lots were 
      below the detection limit of the assays, except for the products of manufacturer 
      B (lots of 2010), in which 0.030 to 0.032 IU/mL FXI:C were detected. The peak 
      time of thrombin using a thrombin generation test was greater than 35 min, the 
      relevant amount of FXIa was below 0.37 nM, and non-activated partial 
      thromboplastin time was greater than 200 s. Consequently, the 42 IVIG lots showed 
      non-significant procoagulant potential. Further study is required to determine 
      whether a program for FXIa determination in IVIG products should be launched in 
      China.
FAU - Ma, L
AU  - Ma L
AD  - Institute of Blood Transfusion, Chinese Academy of Medical Sciences, Chengdu, 
      Sichuan, China.
FAU - Sun, P
AU  - Sun P
FAU - Lin, F Z
AU  - Lin FZ
FAU - Diao, G
AU  - Diao G
FAU - Li, C Q
AU  - Li CQ
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20130724
PL  - Brazil
TA  - Genet Mol Res
JT  - Genetics and molecular research : GMR
JID - 101169387
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 9013-55-2 (Factor XI)
SB  - IM
MH  - China
MH  - *Drug Contamination
MH  - Drug Industry
MH  - Factor XI/*analysis
MH  - Humans
MH  - Immunoglobulins, Intravenous/*chemistry
EDAT- 2013/01/15 06:00
MHDA- 2014/02/13 06:00
CRDT- 2013/01/15 06:00
PHST- 2013/01/15 06:00 [entrez]
PHST- 2013/01/15 06:00 [pubmed]
PHST- 2014/02/13 06:00 [medline]
AID - gmr2130 [pii]
AID - 10.4238/2013.January.4.17 [doi]
PST - epublish
SO  - Genet Mol Res. 2013 Jul 24;12(3):2556-61. doi: 10.4238/2013.January.4.17.