Minimally processed fresh frozen human reference sera: preparation, testing, and application to international external quality assurance

被引:19
作者
Henriksen, GM
Pedersen, MM
Norgaard, I
Blom, M
Blou, L
Blaabjerg, O
Uldall, A
机构
[1] Herlev Univ Hosp, DEKS, Danish Inst External Qual Assurance Labs Hlth Car, DK-2730 Herlev, Denmark
[2] Hjoerring Hosp, Dept Clin Biochem, Hjorring, Denmark
[3] Hjoerring Hosp, Blood Bank, Hjorring, Denmark
[4] Statens Serum Inst, Dept Plasma Fractionat, DK-2300 Copenhagen, Denmark
[5] Odense Univ Hosp, Dept Clin Biochem, DK-5000 Odense, Denmark
关键词
calibration; control; control material; homogeneity; preparation; reference; stability;
D O I
10.1080/00365510410006612
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
The preparation of unmodified or minimally processed fresh frozen human sera is described, as well as the previous use of such sera, e. g. in Nordic and international external quality assurance (EQA) activities. The unmodified serum is prepared from fresh donors' blood collected in dry bags and allowed to coagulate. The serum is collected "on the clot'', pooled, filtered, mixed, dispensed in polypropylene vials and frozen at -80degreesC without further processing. Some batches were slightly modified by spiking or dilution. Critical steps of the production and use of the sera are described and improvements are discussed. A total of 34 different batches have been prepared since 1985. Results from homogeneity and stability studies are presented. The studies cover 18 routine components in serum stored at +4degreesC to 37degreesC for up to 34 days. Good stability was observed for storage of all components, with the exception of triglyceride. Amylase, creatininium, glucose, gamma-glutamyltransferase, urate (and perhaps carbamide) showed deterioration after 13 days of incubation at 37degreesC. The long-term stability at -80degreesC is reviewed and new data are presented, e. g. as consensus values from EQA schemes, where the same serum has been sent out three times over 5 years, and from reference measurement procedure values that have been assigned twice with an interval of 5 years. Furthermore, a 10-year stability study has been started.
引用
收藏
页码:293 / 307
页数:15
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