化学发光免疫分析法检测肝纤维化血清标志物的性能评价

Performance evaluation of chemiluminescence immunoassay detection for four serum items of liver fibrosis

目的：验证某化学发光免疫分析系统检测透明质酸（HA ）、层粘连蛋白（LN ）、Ⅲ型前胶原 N端肽（PⅢP N-P）、Ⅳ型胶原（C-Ⅳ）的分析性能。方法参照相关标准文件中的方法，分别对精密度、加样针携带污染率、准确度、线性范围和参考区间进行验证。结果批内精密度验证结果显示，HA低值为3．38％，高值为1．00％；LN低值为4．42％，高值为0．78％；PⅢP N-P低值为4．39％，高值为0．35％；C-Ⅳ低值为4．42％，高值为0．40％。批间精密度验证结果显示，HA低值为4．49％，高值为3．86％；LN为低值为5．68％，高值为3．60％；PⅢP N-P低值为5．98％，高值为4．05％；C-Ⅳ低值为5．44％，高值为3．53％。加样针携带污染率验证结果显示，HA为0．99‰， LN为-0．41‰，PⅢP N-P为0．28‰，C-Ⅳ为0．53‰。各指标质控品实测值与靶值的相对偏差分别为HA 0．45％、LN -1．65％、PⅢP N-P -0．24％、C-Ⅳ-0．70％。线性范围验证结果显示，HA为12．84～1897．76 ng/mL ，LN为20．98～960．59 ng/mL ，PⅢP N-P为10．72～1923．48 ng/mL ，C-Ⅳ为11．85～1964．49 ng/mL。参考区间验证结果为HA＜100 ng/mL、LN＜50 ng/mL、PⅢP N-P＜30 ng/mL、C-Ⅳ＜30 ng/mL。结论该化学发光免疫分析系统检测HA、LN、PⅢP N-P、C-Ⅳ的主要分析性能指标达到预期要求，厂家提供的参考区间可以接受。

Objective To validate the performance of chemiluminescence immunoassay system for the detec-tion of hyaluronic acid （HA） ,laminin （LN） ,type Ⅲ of collagen N-terminal peptide （PⅢP N-P） ,collagen Ⅳ （C-Ⅳ） . Methods Precision ,needle carry pollution rate ,accuracy ,linear range and reference range were validated according to the criterion of relative standard documents .Results The intra-patch precision of HA low value was 3 .38% ,of HA high value was 1 .00% ,of LN low value was 4 .42% ,of LN high value was 0 .78% ,of PⅢ P N-P low value was 4 .39% ,of PⅢP N-P high value was 0 .35% ,of C-Ⅳ low value was 4 .42% ,and that of C-Ⅳ high value was 0 .40% . The inter-batch precision of HA low value was 4 .49% ,of HA high value was 3 .86% ,of LN low value was 5 .68% , of LN high value was 3 .60% ,of PⅢP N-P low value was 5 .98% ,of PⅢP N-P high value was 4 .05% ,of C-Ⅳ low value was 5 .44% ,and that of C-Ⅳ high value was 3 .53% .Needle carry pollution rates of HA ,LN ,PⅢP N-P and C-Ⅳ were 0 .99‰ ,-0 .41‰ ,0 .28‰ and 0 .53‰ .Relative deviations between actual detected value and target value of quality controls of HA ,LN ,PⅢP N-P and C-Ⅳ were 0 .45% ,-1 .65% ,-0 .24% and -0 .70% .Linear ranges of HA ,LN ,PⅢP N-P and C-Ⅳ were 12 .84-1 897 .76 ,20 .98-960 .59 ,10 .72-1 923 .48 and 11 .85-1 964 .49 ng/mL respectively .Reference ranges of HA ,LN ,PⅢP N-P and C-Ⅳ were less than 100 ,50 ,30 and 30 ng/mL respectively . Conclusion The main performance of this chemiluminescence immunoassay system for determination of HA ,LN ,PⅢP N-P and C-Ⅳ could achieve the desired requirements ,and the reference range provided by manufacturer is acceptable .