国际医学寄生虫病杂志
國際醫學寄生蟲病雜誌
국제의학기생충병잡지
INTERNATIONAL JOURNAL OF MEDICAL PARASITIC DISEASES
2013年
5期
257-261
,共5页
杨英超%张瑾%薄淑英%张影%王国柱%辛晓芳
楊英超%張瑾%薄淑英%張影%王國柱%辛曉芳
양영초%장근%박숙영%장영%왕국주%신효방
刚地弓形虫%亲和力%化学发光微粒子
剛地弓形蟲%親和力%化學髮光微粒子
강지궁형충%친화력%화학발광미입자
Toxoplasma gondii%Avidity%Chemiluminescent microparticle immunoassay
目的 对弓形虫IgG亲和力诊断试剂盒进行考核和验证. 方法 采用化学发光微粒子免疫检测法,用10份弓形虫IgG阳性血清及弓形虫IgG抗体检测血清国家参考品对三批弓形虫IgG亲和力测定试剂盒及质控品进行考核,计算符合率、精密度及加速稳定性等. 结果 试剂盒的符合率为100％,精密度变异系数(coefficient variation,CV)值均≤14％;经温度加速稳定性试验,其符合率与精密度无变化. 结论 经由化学发光微粒子免疫检测法制备的弓形虫IgG亲和力诊断试剂盒具有良好的符合率、精密度及稳定性,可用于临床检测.
目的 對弓形蟲IgG親和力診斷試劑盒進行攷覈和驗證. 方法 採用化學髮光微粒子免疫檢測法,用10份弓形蟲IgG暘性血清及弓形蟲IgG抗體檢測血清國傢參攷品對三批弓形蟲IgG親和力測定試劑盒及質控品進行攷覈,計算符閤率、精密度及加速穩定性等. 結果 試劑盒的符閤率為100％,精密度變異繫數(coefficient variation,CV)值均≤14％;經溫度加速穩定性試驗,其符閤率與精密度無變化. 結論 經由化學髮光微粒子免疫檢測法製備的弓形蟲IgG親和力診斷試劑盒具有良好的符閤率、精密度及穩定性,可用于臨床檢測.
목적 대궁형충IgG친화력진단시제합진행고핵화험증. 방법 채용화학발광미입자면역검측법,용10빈궁형충IgG양성혈청급궁형충IgG항체검측혈청국가삼고품대삼비궁형충IgG친화력측정시제합급질공품진행고핵,계산부합솔、정밀도급가속은정성등. 결과 시제합적부합솔위100％,정밀도변이계수(coefficient variation,CV)치균≤14％;경온도가속은정성시험,기부합솔여정밀도무변화. 결론 경유화학발광미입자면역검측법제비적궁형충IgG친화력진단시제합구유량호적부합솔、정밀도급은정성,가용우림상검측.
Objective To verify and assess ARCHITECT Toxo IgG Avidity Reagent kit.Methods Ten human IgG antibodies positive serum and national reference serum for IgG against Toxoplasma were used for the evaluation on three batches of kits and controls by chemiluminescent microparticle immunoassay method,their coincidence rate,precision and accelerated stability were calculated.Results The coincidence rate of the kit was 100％,coefficient variation (CV) of precision was less than or equal to 14％.In accelerated stability test,coincidence rate and precision were no change.Conclusion ARCHITECT Toxo IgG Avidity Reagent kit shows good performance in coincidence rate,precision and accelerated stability test.It can be used for clinical detection.
