中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2013年
10期
903-907
,共5页
欧阳金鸣%韩晓旭%吉阳涛%王亚男%尚红
歐暘金鳴%韓曉旭%吉暘濤%王亞男%尚紅
구양금명%한효욱%길양도%왕아남%상홍
HIV感染%HIV%电化学%酶联免疫吸附测定%指示剂和试剂%试剂盒,诊断%对比研究
HIV感染%HIV%電化學%酶聯免疫吸附測定%指示劑和試劑%試劑盒,診斷%對比研究
HIV감염%HIV%전화학%매련면역흡부측정%지시제화시제%시제합,진단%대비연구
HIV infections%HIV%Electrochemistry%Enzyme-linked immunosorbent assay%Indicators and reagents%Reagent kits,diagnostic%Comparative study
目的 比较3种HIV第4代抗原/抗体联合诊断试剂针对HIV早期感染者标本、国际血清盘标本及临床常规标本的检测性能.方法 横断面研究.收集2009至2011年沈阳市男男同性恋人群随访中发现的HIV早期感染者标本37份、4套美国BBI公司、NABI公司和英国NIBSC的不同类型国际血清盘标本66份以及703份中国医科大学附属第一医院2011年10月间常规就诊患者的HIV筛查标本,分别采用化学发光试验(CLIA)、电化学发光试验(ECLIA)和酶联免疫吸附试验(ELISA)3种HIV第4代血清学诊断试剂进行检测,比较3种试剂的检测敏感度和特异度,通过x2检验进行统计学分析.结果 37份早期HIV-1感染者标本及22份HIV-1阳转血清盘标本中,ECLIA和CLIA试剂的敏感性均为96.61％ (95％ CI 91.5％ ～ 100.0％),高于ELISA试剂的敏感性83.93％(95％ CI 75.0％ ～92.9％)(x2=5.341,P＜0.05)；3种试剂对12份不同亚型的抗体血清盘标本的敏感性:ECLIA试剂＞ELISA试剂＞CLIA试剂；3种试剂对25份不同亚型的病毒裂解物血清盘标本的敏感性:CLIA试剂＞ECLIA试剂＞ELISA试剂；3种试剂对7份P24抗原定量血清盘标本的检出下限分别为:CLIA试剂0.705 IU/ml,ECLIA试剂0.843 IU/ml,ELISA试剂6.691 IU/ml;703份临床常规筛查标本中,3种试剂的特异性分别为100％ (CLIA)、99.86％ (ECLIA)和99.71％ (ELISA),差异无统计学意义(P=0.914).结论 HIV第4代CLIA和ECLIA血清学诊断试剂的检测敏感性优于ELISA试剂,其检测特异性未受到临床常见干扰因素的影响,两者更适用于临床常规筛查以及高危人群的HIV早期感染的筛查.
目的 比較3種HIV第4代抗原/抗體聯閤診斷試劑針對HIV早期感染者標本、國際血清盤標本及臨床常規標本的檢測性能.方法 橫斷麵研究.收集2009至2011年瀋暘市男男同性戀人群隨訪中髮現的HIV早期感染者標本37份、4套美國BBI公司、NABI公司和英國NIBSC的不同類型國際血清盤標本66份以及703份中國醫科大學附屬第一醫院2011年10月間常規就診患者的HIV篩查標本,分彆採用化學髮光試驗(CLIA)、電化學髮光試驗(ECLIA)和酶聯免疫吸附試驗(ELISA)3種HIV第4代血清學診斷試劑進行檢測,比較3種試劑的檢測敏感度和特異度,通過x2檢驗進行統計學分析.結果 37份早期HIV-1感染者標本及22份HIV-1暘轉血清盤標本中,ECLIA和CLIA試劑的敏感性均為96.61％ (95％ CI 91.5％ ～ 100.0％),高于ELISA試劑的敏感性83.93％(95％ CI 75.0％ ～92.9％)(x2=5.341,P＜0.05)；3種試劑對12份不同亞型的抗體血清盤標本的敏感性:ECLIA試劑＞ELISA試劑＞CLIA試劑；3種試劑對25份不同亞型的病毒裂解物血清盤標本的敏感性:CLIA試劑＞ECLIA試劑＞ELISA試劑；3種試劑對7份P24抗原定量血清盤標本的檢齣下限分彆為:CLIA試劑0.705 IU/ml,ECLIA試劑0.843 IU/ml,ELISA試劑6.691 IU/ml;703份臨床常規篩查標本中,3種試劑的特異性分彆為100％ (CLIA)、99.86％ (ECLIA)和99.71％ (ELISA),差異無統計學意義(P=0.914).結論 HIV第4代CLIA和ECLIA血清學診斷試劑的檢測敏感性優于ELISA試劑,其檢測特異性未受到臨床常見榦擾因素的影響,兩者更適用于臨床常規篩查以及高危人群的HIV早期感染的篩查.
목적 비교3충HIV제4대항원/항체연합진단시제침대HIV조기감염자표본、국제혈청반표본급림상상규표본적검측성능.방법 횡단면연구.수집2009지2011년침양시남남동성련인군수방중발현적HIV조기감염자표본37빈、4투미국BBI공사、NABI공사화영국NIBSC적불동류형국제혈청반표본66빈이급703빈중국의과대학부속제일의원2011년10월간상규취진환자적HIV사사표본,분별채용화학발광시험(CLIA)、전화학발광시험(ECLIA)화매련면역흡부시험(ELISA)3충HIV제4대혈청학진단시제진행검측,비교3충시제적검측민감도화특이도,통과x2검험진행통계학분석.결과 37빈조기HIV-1감염자표본급22빈HIV-1양전혈청반표본중,ECLIA화CLIA시제적민감성균위96.61％ (95％ CI 91.5％ ～ 100.0％),고우ELISA시제적민감성83.93％(95％ CI 75.0％ ～92.9％)(x2=5.341,P＜0.05)；3충시제대12빈불동아형적항체혈청반표본적민감성:ECLIA시제＞ELISA시제＞CLIA시제；3충시제대25빈불동아형적병독렬해물혈청반표본적민감성:CLIA시제＞ECLIA시제＞ELISA시제；3충시제대7빈P24항원정량혈청반표본적검출하한분별위:CLIA시제0.705 IU/ml,ECLIA시제0.843 IU/ml,ELISA시제6.691 IU/ml;703빈림상상규사사표본중,3충시제적특이성분별위100％ (CLIA)、99.86％ (ECLIA)화99.71％ (ELISA),차이무통계학의의(P=0.914).결론 HIV제4대CLIA화ECLIA혈청학진단시제적검측민감성우우ELISA시제,기검측특이성미수도림상상견간우인소적영향,량자경괄용우림상상규사사이급고위인군적HIV조기감염적사사.
Objective To compare the performance of fourth generation HIV antigen/antibody combined detection reagents for HIV early infection samples,international HIV seroconversion panel samples and routine clinical screening samples.Methods Thirty seven early HIV infected samples from the followup gays in Shen Yang between 2009 and 2011,66 seroconversion panel samples from BBI company (U.S.A),NABI company(U.S.A) and NIBSC company(U.K) and 703 routine HIV screening samples in the first hospital of China medical university in October 2010 were collected.All kinds of samples were tested by three diagnostic reagents based on chemiluminescence assay (CLIA),electrochemiluminescence assay (ECLIA) and enzyme-linked immunosorbent assay (ELISA) respectively.The detection sensitivity and specificity of these assays were analyzed.Results For 59 early infected and seroconversion samples,the sensitivities of both ECLIA and CLIA reagent were 96.61％ (95％ CI 91.5％-100.0％),higher than that of the ELISA kit (95％ CI 75.0％-92.9％) (x2 =5.341,P ＜ 0.05),which is 83.93％ ; Comparison among the three reagents for different subtypes of the antibody seroconversion samples showed that ECLIA had the highest sensitivity while CLIA was the lowest ; Detection sensitivity of the three reagents for the P24 antigen is CLIA ＞ ECLIA ＞ ELISA; With detection of 703 clinical routine screening samples,the specificities of three reagents were 100％ (CLIA),99.86％ (ECLIA) and 99.71％ (ELISA) respectively.Conclusions For the sensitivity of the fourth HIV diagnostic reagents CLIA and ECLIA are better than ELISA.The former two reagents are more suitable for identifying earlier HIV infection in clinic.
