中华实验和临床病毒学杂志
中華實驗和臨床病毒學雜誌
중화실험화림상병독학잡지
CHINESE JOURNAL OF EXPERIMENTAL AND CLINICAL VIROLOGY
2013年
4期
307-309
,共3页
蒋郁青%谢志贤%方雯丹%刘添翼
蔣鬱青%謝誌賢%方雯丹%劉添翼
장욱청%사지현%방문단%류첨익
梅毒%梅毒血清诊断%化学发光%酶联免疫吸附测定
梅毒%梅毒血清診斷%化學髮光%酶聯免疫吸附測定
매독%매독혈청진단%화학발광%매련면역흡부측정
Syphilis%Syphilis serodiagnosis%Chemiluminescence%Enzyme-linked immunosorbent assay
目的 对国产化学发光法试剂盒检测梅毒螺旋体抗体的检测进行临床评价.方法 收集来自卫生部北京医院的血清样品共1200例,包括经临床确诊的梅毒患者血清300例,正常人血清900例.对标本分别用国产化学发光法试剂盒和国产酶联免疫吸附实验试剂盒同时测定梅毒螺旋体抗体,对结果进行统计学处理和分析,计算两种方法的特异性、灵敏度和临床符合率.结果 对临床确诊的血清样品检测结果表明,该试剂盒检测梅毒螺旋体抗体敏感度为99.3％,特异度为99.9％,阳性结果预测值为99.7％,阴性结果预测值100％.与ELISA法比较,两者阳性符合率98.7％,阴性符合率99.8％.总符合(有效)率为99.5％.结论 国产CLIA试剂盒与ELISA试剂盒的临床符合率达到临床检测要求,可用于临床检测.
目的 對國產化學髮光法試劑盒檢測梅毒螺鏇體抗體的檢測進行臨床評價.方法 收集來自衛生部北京醫院的血清樣品共1200例,包括經臨床確診的梅毒患者血清300例,正常人血清900例.對標本分彆用國產化學髮光法試劑盒和國產酶聯免疫吸附實驗試劑盒同時測定梅毒螺鏇體抗體,對結果進行統計學處理和分析,計算兩種方法的特異性、靈敏度和臨床符閤率.結果 對臨床確診的血清樣品檢測結果錶明,該試劑盒檢測梅毒螺鏇體抗體敏感度為99.3％,特異度為99.9％,暘性結果預測值為99.7％,陰性結果預測值100％.與ELISA法比較,兩者暘性符閤率98.7％,陰性符閤率99.8％.總符閤(有效)率為99.5％.結論 國產CLIA試劑盒與ELISA試劑盒的臨床符閤率達到臨床檢測要求,可用于臨床檢測.
목적 대국산화학발광법시제합검측매독라선체항체적검측진행림상평개.방법 수집래자위생부북경의원적혈청양품공1200례,포괄경림상학진적매독환자혈청300례,정상인혈청900례.대표본분별용국산화학발광법시제합화국산매련면역흡부실험시제합동시측정매독라선체항체,대결과진행통계학처리화분석,계산량충방법적특이성、령민도화림상부합솔.결과 대림상학진적혈청양품검측결과표명,해시제합검측매독라선체항체민감도위99.3％,특이도위99.9％,양성결과예측치위99.7％,음성결과예측치100％.여ELISA법비교,량자양성부합솔98.7％,음성부합솔99.8％.총부합(유효)솔위99.5％.결론 국산CLIA시제합여ELISA시제합적림상부합솔체도림상검측요구,가용우림상검측.
Objective To analyze the clinical performance of TP antibody detection by CLIA kits and evaluate whether the CLIA kits made in China is suitable for clinical use.Methods 1200 samples were collected from Beijing Hospital including 300 samples with confirmed TP infection and 900 healthy control samples.To detect the TP antibody of the 1200 sanples separately by the CLIA kits and the ELISA kits at the same time.The test results were analyzed with statistical methods.Results The sensitivity and specificity of the CLIA kits were 99.3％ and 99.9％ respectively,and positive predictive value of 99.7％,negative predictive value of 100％.With the ELISA method,the positive coincidence rate was 98.7％,the negative coincidence rate was 99.8％,and the total coincidence rate was 99.5％.Conclusion The CLIA kits showed good clinical performance and the agreement rate with the ELISA kits was.The CLIA kits are suitable for clinical use.
