中华流行病学杂志
中華流行病學雜誌
중화류행병학잡지
CHINESE JOURNAL OF EPIDEMIOLOGY
2009年
8期
841-844
,共4页
辜文洁%黄维金%周诚%吴星%蓝海云%姚昕%林京香%李河民%梁争论%庄辉
辜文潔%黃維金%週誠%吳星%藍海雲%姚昕%林京香%李河民%樑爭論%莊輝
고문길%황유금%주성%오성%람해운%요흔%림경향%리하민%량쟁론%장휘
乙型肝炎病毒%酶联免疫试验%灵敏度%血清型
乙型肝炎病毒%酶聯免疫試驗%靈敏度%血清型
을형간염병독%매련면역시험%령민도%혈청형
Hepatitis B virus%Enzyme immunoassay%Sensitivity%Serotype
目的 评价乙型肝炎病毒表面抗原(HBsAg)酶联免疫(EIA)试剂盒的分析灵敏度.方法 对2007年6月至2008年6月申报批批检验的31种HBsAg EIA试剂盒,应用国家参考品进行检测,并用国家参考品中的灵敏度标准品,建立浓度和吸光度(A)值双对数曲线,将各试剂盒的Cut-off值代入曲线方程,计算其分析灵敏度,然后进行比较.结果 对27个国内厂家(351批)和4个国外厂家(27批)HBsAg EIA试剂盒进行分析,其中2个批次国产试剂盒的灵敏度低于国家要求的质量标准,总符合率为99.43%(349/351).国产试剂盒对adr、adw、ay血清型的分析灵敏度均值分别为0.307、0.419、0.513 ng/ml,差异有统计学意义(F=97.30,P<0.01);进口试剂盒的分析灵敏度均值分别为0.054、0.066、0.050 ng/ml,差异无统计学意义(F=0.65,P>0.05).进口试剂盒各血清型分析灵敏度均高于国产试剂盒(P<0.01).部分国产试剂盒与进口试剂盒对相同血清型的分析灵敏度差异有统计学意义.同一厂家试剂盒加酶后孵育30min和60min,其血清型分析灵敏度差异无统计学意义(P>0.05);同一厂家生产的试剂盒显色10 min和15 min,其血清型分析灵敏度的差异有统计学意义(P<0.01).结论 国产试剂盒应提高分析灵敏度,特别是对adw和ay血清型.
目的 評價乙型肝炎病毒錶麵抗原(HBsAg)酶聯免疫(EIA)試劑盒的分析靈敏度.方法 對2007年6月至2008年6月申報批批檢驗的31種HBsAg EIA試劑盒,應用國傢參攷品進行檢測,併用國傢參攷品中的靈敏度標準品,建立濃度和吸光度(A)值雙對數麯線,將各試劑盒的Cut-off值代入麯線方程,計算其分析靈敏度,然後進行比較.結果 對27箇國內廠傢(351批)和4箇國外廠傢(27批)HBsAg EIA試劑盒進行分析,其中2箇批次國產試劑盒的靈敏度低于國傢要求的質量標準,總符閤率為99.43%(349/351).國產試劑盒對adr、adw、ay血清型的分析靈敏度均值分彆為0.307、0.419、0.513 ng/ml,差異有統計學意義(F=97.30,P<0.01);進口試劑盒的分析靈敏度均值分彆為0.054、0.066、0.050 ng/ml,差異無統計學意義(F=0.65,P>0.05).進口試劑盒各血清型分析靈敏度均高于國產試劑盒(P<0.01).部分國產試劑盒與進口試劑盒對相同血清型的分析靈敏度差異有統計學意義.同一廠傢試劑盒加酶後孵育30min和60min,其血清型分析靈敏度差異無統計學意義(P>0.05);同一廠傢生產的試劑盒顯色10 min和15 min,其血清型分析靈敏度的差異有統計學意義(P<0.01).結論 國產試劑盒應提高分析靈敏度,特彆是對adw和ay血清型.
목적 평개을형간염병독표면항원(HBsAg)매련면역(EIA)시제합적분석령민도.방법 대2007년6월지2008년6월신보비비검험적31충HBsAg EIA시제합,응용국가삼고품진행검측,병용국가삼고품중적령민도표준품,건립농도화흡광도(A)치쌍대수곡선,장각시제합적Cut-off치대입곡선방정,계산기분석령민도,연후진행비교.결과 대27개국내엄가(351비)화4개국외엄가(27비)HBsAg EIA시제합진행분석,기중2개비차국산시제합적령민도저우국가요구적질량표준,총부합솔위99.43%(349/351).국산시제합대adr、adw、ay혈청형적분석령민도균치분별위0.307、0.419、0.513 ng/ml,차이유통계학의의(F=97.30,P<0.01);진구시제합적분석령민도균치분별위0.054、0.066、0.050 ng/ml,차이무통계학의의(F=0.65,P>0.05).진구시제합각혈청형분석령민도균고우국산시제합(P<0.01).부분국산시제합여진구시제합대상동혈청형적분석령민도차이유통계학의의.동일엄가시제합가매후부육30min화60min,기혈청형분석령민도차이무통계학의의(P>0.05);동일엄가생산적시제합현색10 min화15 min,기혈청형분석령민도적차이유통계학의의(P<0.01).결론 국산시제합응제고분석령민도,특별시대adw화ay혈청형.
Objective To study the analytical sensitivity on 31 HBsAg enzyme immunoassy (EIA) test kits.Methotis Thirty one HBsAg EIA kits produced by domestic or overseas manufactories and applied for approval during May 2007 to May 2008,were evaluated using the national reference panels.The hyperbolic curve of the log A value and log concentration for the national sensitivity standards was established.The cut-off value of each kit was substituted into the curvilinear equation to determine the analytical sensitivity which was compared between different HBsAg EIA kits.Results Twenty seven(351 lots) domestic and 4(27 lots) overseas kits were compared.Among 378 lots of the 31 HBsAg EIA kits,only 2 lots of the domestic kits had a lower sensitivity when tested with the national HBsAg reference panels,with an average approvalr ate of 99.43%(349/351).The mean analytical sensitivity of the domestic kits for adr,adw,ay serotypes were 0.307,0.419,0.513 ng/ml,respectively.There was a significant difierence between serotypes (F=97.30,P<0.01).The mean analytical sensitivity of the overseas kits for adr,adw,ay serotypes were 0.054,0.066,0.050 ng/ml respectively,with no significant difference between serotypes(F=0.65,P>0.05).The analytical sensitivity of the overseas kits for all the three serotypes was higher than that of the domestic kits(P<0.01).There was no significant difference found between the analytical sensitivities of the kits produced by the same manufactory using 30- or 60- minute incubation of detection(P>0.05).In contrast,there was significant diffefence noticed between the analytical sensitivities of the kits produced by the same manufactory when tested for 10 or 15- minute coloration of the results(P<0.01).Conclusion Analytical sensitivity of the HBsAg EIA domestic kits should be further improved,especiatry for detecting adw and ay serotypes.
