Preparation of the mixed serum calibrators for C-reactive protein
10.3760/cma.j.issn.1009-9158.2014.11.009
- VernacularTitle:C 反应蛋白冰冻混合人血清定值校准品的制备研究
- Author:
Yazhe FANG
;
Huaian MA
;
Nan GUO
;
Baoping LI
;
Ying LIN
;
Ximing YANG
- Publication Type:Journal Article
- Keywords:
C-reactive protein;
Reference standards;
Reference values;
Reproducibility of results
- From:
Chinese Journal of Laboratory Medicine
2014;(11):832-835
- CountryChina
- Language:Chinese
-
Abstract:
Objective To prepare serum calibrators for CRP measurement.Methods Fresh serum without infectious diseases , hemolysis, lipemia and choloplania were collected and divided into 3 groups, low, medium, and high, according to the CRP concentration.Each serum pool was mixed , filtered, sterilized and aliquoted.The materials were tested for homogeneity and stability.The values of the CRP was assigned by particle enhanced immunonephelpmetry , and calibrated with international reference materials.The expanded uncertainty was evaluated.Results The materials were tested to be homogeneous (Ubb﹤Ur, P>0.05) with Ubb values being 0, 0.125, 0, Ur values being 0.046, 0.213, 0.785, and F values being 0.803, 1.686, 0.966 in CL, CM, CH groups respectively.Stability study, where F values are 0.609, 0.259, and 1.557 at 22-25℃, 1.217, 4.583, and 0.893 at 2-8℃(P>0.05), showed that the materials were stable for at least 3 days at 22-25 ℃or 30 days at 2-8 ℃, respectively.The certified values of the 3 levels materials for CRP were ( 2.64 ±0.14 ) , ( 31.17 ±0.63 ) , ( 73.85 ±1.74 ) mg/L, respectively.Conclusion The calibrators prepared for serum CRP measurement were homogeneous , stable and accurately assigned and can be used to calibrate the CRP measure system.
