检验医学与临床
檢驗醫學與臨床
검험의학여림상
JOURNAL OF LABORATORY MEDICINE AND CLINICAL SCIENCES
2014年
3期
304-306,309
,共4页
化学发光免疫分析%透明质酸%层粘连蛋白%Ⅲ型前胶原N端肽%Ⅳ型胶原%性能验证
化學髮光免疫分析%透明質痠%層粘連蛋白%Ⅲ型前膠原N耑肽%Ⅳ型膠原%性能驗證
화학발광면역분석%투명질산%층점련단백%Ⅲ형전효원N단태%Ⅳ형효원%성능험증
chemiluminescence immunoassay%hyaluronic acid%laminin%type Ⅲ of collagen N-terminal peptide%collagen Ⅳ%performance verification
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。
目的：驗證某化學髮光免疫分析繫統檢測透明質痠（HA ）、層粘連蛋白（LN ）、Ⅲ型前膠原 N耑肽（PⅢP N-P）、Ⅳ型膠原（C-Ⅳ）的分析性能。方法參照相關標準文件中的方法，分彆對精密度、加樣針攜帶汙染率、準確度、線性範圍和參攷區間進行驗證。結果批內精密度驗證結果顯示，HA低值為3．38％，高值為1．00％；LN低值為4．42％，高值為0．78％；PⅢP N-P低值為4．39％，高值為0．35％；C-Ⅳ低值為4．42％，高值為0．40％。批間精密度驗證結果顯示，HA低值為4．49％，高值為3．86％；LN為低值為5．68％，高值為3．60％；PⅢP N-P低值為5．98％，高值為4．05％；C-Ⅳ低值為5．44％，高值為3．53％。加樣針攜帶汙染率驗證結果顯示，HA為0．99‰， LN為-0．41‰，PⅢP N-P為0．28‰，C-Ⅳ為0．53‰。各指標質控品實測值與靶值的相對偏差分彆為HA 0．45％、LN -1．65％、PⅢP N-P -0．24％、C-Ⅳ-0．70％。線性範圍驗證結果顯示，HA為12．84～1897．76 ng/mL ，LN為20．98～960．59 ng/mL ，PⅢP N-P為10．72～1923．48 ng/mL ，C-Ⅳ為11．85～1964．49 ng/mL。參攷區間驗證結果為HA＜100 ng/mL、LN＜50 ng/mL、PⅢP N-P＜30 ng/mL、C-Ⅳ＜30 ng/mL。結論該化學髮光免疫分析繫統檢測HA、LN、PⅢP N-P、C-Ⅳ的主要分析性能指標達到預期要求，廠傢提供的參攷區間可以接受。
목적：험증모화학발광면역분석계통검측투명질산（HA ）、층점련단백（LN ）、Ⅲ형전효원 N단태（PⅢP N-P）、Ⅳ형효원（C-Ⅳ）적분석성능。방법삼조상관표준문건중적방법，분별대정밀도、가양침휴대오염솔、준학도、선성범위화삼고구간진행험증。결과비내정밀도험증결과현시，HA저치위3．38％，고치위1．00％；LN저치위4．42％，고치위0．78％；PⅢP N-P저치위4．39％，고치위0．35％；C-Ⅳ저치위4．42％，고치위0．40％。비간정밀도험증결과현시，HA저치위4．49％，고치위3．86％；LN위저치위5．68％，고치위3．60％；PⅢP N-P저치위5．98％，고치위4．05％；C-Ⅳ저치위5．44％，고치위3．53％。가양침휴대오염솔험증결과현시，HA위0．99‰， LN위-0．41‰，PⅢP N-P위0．28‰，C-Ⅳ위0．53‰。각지표질공품실측치여파치적상대편차분별위HA 0．45％、LN -1．65％、PⅢP N-P -0．24％、C-Ⅳ-0．70％。선성범위험증결과현시，HA위12．84～1897．76 ng/mL ，LN위20．98～960．59 ng/mL ，PⅢP N-P위10．72～1923．48 ng/mL ，C-Ⅳ위11．85～1964．49 ng/mL。삼고구간험증결과위HA＜100 ng/mL、LN＜50 ng/mL、PⅢP N-P＜30 ng/mL、C-Ⅳ＜30 ng/mL。결론해화학발광면역분석계통검측HA、LN、PⅢP N-P、C-Ⅳ적주요분석성능지표체도예기요구，엄가제공적삼고구간가이접수。
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 .
