377例泌尿生殖道标本支原体培养及药敏结果分析

目的了解本地区泌尿生殖道标本解脲支原体(Uu)和人型支原体(Mh)的感染状况及耐药性,指导临床合理用药。方法应用珠海市银科医学工程有限公司生产试剂盒,对2009年至2010年间377份泌尿生殖道标本进行支原体培养及药敏检测。结果 377例标本中支原体培养阳性142例,总阳性率37.7%,其中单纯Uu阳性76例(20.2%),Mh阳性10例(2.7%),Uu合并Mh阳性56例(14.8%)。药敏试验结果显示,Uu感染对抗菌药物敏感性较高的依次是克拉霉素、强力霉素、交沙霉素和美满霉素;Mh、Uu+Mh感染对抗菌药物敏感性较高的是强力霉素、美满霉素和交沙霉素。结论本地区支原体感染以Uu为主,其次是Uu+Mh混合感染和Mh感染;支原体对各种抗菌药物已产生一定的耐药性,临床治疗支原体感染可选择强力霉素、交沙霉素和美满霉素等敏感率高的抗菌药物。     

生殖道沙眼衣原体和支原体试剂盒的临床应用研究

目的探讨使用生殖道沙眼衣原体(CT)试剂盒和支原体培养鉴定药敏试剂盒对性传播疾病(STD)的诊断价值。方法对2006年7月至2007年6月临床疑为STD的患者,使用生殖道CT试剂盒和支原体培养鉴定药敏试剂盒并对照胶体金法检测生殖道CT、人型支原体(Mh)、解脲支原体(Uu)、Mh与Uu混合感染的阳性率。结果2006年7月至2007年6月使用胶体金法诊断生殖道CT、Mh、Uu及Mh与Uu混合感染的阳性率分别为4.50%、3.95%、19.14%、8.09%;2007年7月至2008年10月使用生殖道CT试剂盒和支原体培养鉴定药敏试剂盒诊断生殖道CT、Mh、Uu及Mh和Uu混合感染的阳性率分别为19.91%、3.18%、32.98%、6.84%。结论使用生殖道CT试剂盒和支原体培养鉴定药敏试剂盒后,生殖道CT、Uu阳性检出率差异有统计学意义(P0.05),而Mh、Mh与Uu混合感染的阳性检出率差异无统计学意义(P0.05)。在进行支原体药敏培养鉴定时,结果不受真菌影响。     

泌尿生殖系支原体感染299例中西药药敏分析

[目的]调查本地区泌尿生殖系支原体[解脲支原体（Uu）和人型支原体（Mh）]感染情况并进行中西药药敏分析,探讨其对临床治疗的指导意义.[方法]采用珠海银科支原体药敏试剂盒检测支原体,观察西药药敏结果.支原体阳性标本用中药煎剂作药敏实验,观察中药药敏结果.[结果]658例疑似非淋病性尿道炎（NGU）患者的标本共检出209例Uu阳性、26例Mh阳性、64例Uu与Mh合并感染,阳性率分别为31.76%、3.95%、9.73%.西药药敏实验中,单纯Uu感染和单纯Mh感染中以强力霉素、美满霉素最为敏感,Uu与Mh合并感染对多种抗生素表现出耐药性,以美满霉素较为敏感.支原体对中药煎剂较为敏感,但与西药比较无显著性差异.[结论]该市的支原体感染以单纯Uu感染最为普遍,药敏仍以美满霉素、强力霉素为最敏感,支原体感染治疗时应首选美满霉素、强力霉素,也可选用中药煎剂.     

泌尿生殖道支原体检测及其耐药性的实验分析

目的 了解本地区解脲支原体(Uu)和人型支原体(Mh)对泌尿生殖道的感染及耐药状况,为指导临床治疗提供实验依据.方法 采用支原体培养及药敏试剂盒,检测临床泌尿生殖道感染病例548例.分离培养的阳性菌株作Uu、Mh计数及药物敏感试验.结果 548例标本共分离Uu阳性130例,其中67例Uu≥104 ccu/ml;Mh阳性39例,均为＜104 ccu/ml;Uu与Mh混合阳性127例,其中8例Uu、Mh均为≥104 ccu/ml;88例为Uu≥104 ccu/m、Mh＜104 ccu/ml.耐药率较低的3种抗生素是:强力霉素(4.19%)、美满霉素(5.24%)和四环素(11.52%).结论 泌尿生殖道支原体计数及其耐药性监测,对于指导临床治疗、控制耐药性的产生具有重要意义.强力霉素、美满霉素可作为治疗支原体感染的首选药物.     

女性泌尿生殖道支原体检测及耐药性分析

目的为了解泸州地区女性泌尿生殖道支原体感染及耐药情况,以指导临床合理用药。方法采用法国生物梅里埃股份有限公司IST2支原体培养及药敏配套试剂盒,对疑为支原体感染的女性患者泌尿生殖道分泌物进行支原体培养及药敏试验。结果 814例女性泌尿生殖道感染标本中,共检出支原体443例,检出率54.4%(443/814)。在阳性结果中,解脲支原体(Uu)阳性372例,阳性率84.0%(372/443);人型支原体(Mh)阳性42例,阳性率9.5%(42/443);Uu+Mh 29例,阳性率6.5%(29/443)。原始霉素、克拉霉素、强力霉素、交沙霉素、四环素对单纯Uu感染敏感性较好;原始霉素、强力霉素、交沙霉素对单纯(Mh)感染敏感性较好。结论泸州地区女性泌尿生殖道支原体感染以Uu为主,Uu感染率明显高于Mh感染及Uu+Mh混合感染。原始霉素、强力霉素、交沙霉素可作为女性泌尿生殖道支原体感染治疗的首选药物。     

3864份泌尿生殖道标本支原体检测及药敏分析

目的通过对支原体检测及药敏结果分析,指导临床合理用药。方法采用支原体培养、鉴定和药敏试剂盒对某院收集的3 864份泌尿生殖道标本进行培养和体外药敏试验。结果 3 864份患者标本中支原体阳性1 267份(32.8%),其中单纯解脲支原体(Uu)阳性1 040份(82.1%),单纯人型支原体(Mh)阳性17份(1.3%),Uu和Mh均阳性210份(16.6%);药敏结果显示,1 267份Uu对强力霉素、交沙霉素、美满霉素比较敏感,对环丙沙星、螺旋霉素、氧氟沙星比较耐药;17份Mh对强力霉素比较敏感,对左氧氟沙星、氧氟沙星、环丙沙星比较耐药;210份Uu+Mh对强力霉素、交沙霉素、美满霉素比较敏感,对环丙沙星、左氧氟沙星、氧氟沙星比较耐药。结论某院泌尿生殖道标本分离的支原体以Uu为主,且Uu敏感率较高,治疗支原体感染时应首选强力霉素、美满霉素、交沙霉素。     

泌尿生殖道支原体检测及其耐药性的实验分析

目的了解本地区解脲支原体(Uu)和人型支原体(Mh)对泌尿生殖道的感染及耐药状况,为指导临床治疗提供实验依据。方法采用支原体培养及药敏试剂盒,检测临床泌尿生殖道感染病例548例。分离培养的阳性菌株作Uu、Mh计数及药物敏感试验。结果548例标本共分离Uu阳性130例,其中67例Uu≥104ccu/ml;Mh阳性39例,均为<104ccu/ml;Uu与Mh混合阳性127例,其中8例Uu、Mh均为≥104ccu/ml;88例为Uu≥104ccu/m、Mh<104ccu/ml。耐药率较低的3种抗生素是:强力霉素(4.19%)、美满霉素(5.24%)和四环素(11.52%)。结论泌尿生殖道支原体计数及其耐药性监测,对于指导临床治疗、控制耐药性的产生具有重要意义。强力霉素、美满霉素可作为治疗支原体感染的首选药物。     

女性生殖道感染2820例支原体培养及药敏分析

目的对乐清地区女性生殖道感染门诊患者进行解脲支原体（Uu）和人型支原体（Mh）的培养鉴定,了解感染及耐药情况。方法应用珠海迪尔生物工程有限公司的支原体（Uu/Mh）分离培养药敏试剂盒检测。结果 5 755例女性生殖道感染病例,支原体培养阳性2 820例,总感染率49%。其中Uu单独阳性1 897例,Mh单独阳性93例,Uu、Mh混合感染830例。两种支原体对10种抗生素的药敏试验提示对交沙霉素、强力霉素、美满霉素高度敏感,敏感率〉90%。结论女性生殖道支原体感染主要以Uu为主,治疗Uu和Mh感染首选交沙霉素。     

女性泌尿生殖道支原体感染情况及耐药性分析

采用支原体培养及药敏试剂盒,对725例女性泌尿生殖道分泌物进行支原体检测,并对结果进行分析。结果725例患者中462例支原体阳性,阳性率为63.7%;其中Uu阳性327例,Mh阳性19例,Uu和Mh混合阳性116例,阳性率分别为70.8%、4.1%、25.1%;药敏试验结果表明,支原体对常用抗生素的耐药性有不同程度的增加。女性泌尿生殖道支原体感染率较高,以Uu发病率最高,耐药现象严重,临床应根据药敏结果合理科学使用抗生素。     

非淋菌性尿道炎患者支原体培养和药敏试验结果分析

目的了解泌尿生殖道解脲支原体(Uu)和人型支原体(Mh)感染情况及药物情况,以指导临床合理用药。方法采用珠海黑马生物工程公司生产的支原体试剂盒对Uu和Mh进行检测及对12种抗菌药物进行药物敏感试验,并对结果进行统计学分析。结果 957例患者标本检出支原体426例,占总人数的44.5%。Uu阳性360例,占支原体阳性的84.4%;Mh阳性8例,占支原体阳性的2.0%;Uu和Mh混合阳性58例,占支原体阳性的13.6%。Uu对四环素类敏感率均高于80.0%,对喹诺酮类敏感率均低于41.0%,对大环类脂类敏感率高低不一;Uu+Mh混合感染对四环素类敏感率均高于58.0%,对喹诺酮类敏感率均低于23.0%,对大环类脂类敏感率高低不一。结论支原体感染以Uu感染为主,Uu+Mh感染为次,药敏试验结果以四环素类敏感性为最高,以喹诺酮类敏感性为最低。临床医生应加强支原体培养及药敏试验,根据患者临床症状及药敏试验结果合理选用抗菌药物。     

Variation in the sensitivity of HBsAg screening kits

Summary. Fifteen HBsAg kits from 14 manufacturers were assessed. Their sensitivity was evaluated by testing 150 HBsAg-positive sera, sera from four donors who were low-level HBsAg carriers, and sequential specimens from 22 seroconverting individuals together with dilutions of six of these specimens. The British HBsAg Working Standard (0.5IUmL^-1) and the NIBSC/UKBTS HBsAg Monitor Sample (0.125IUmL^-1) were also tested. Five assays failed to detect one of the 150 routine HBsAg-positive sera. Four assays (Auszyme Monoclonal; Monolisa Ag HBs 2nd generation; Murex HBsAg; Ortho HBsAg Test Systems 3) were able to detect HBsAg in all but one of the six sera from low-level carriers, whereas one assay (MicroTrak II HBsAg) detected only one of the six. The most sensitive kit (Monolisa Ag HBs 2nd generation) detected HBsAg in 79 specimens from the seroconversion panels; four other kits detected HBsAg in at least 70 specimens, seven in 60–69, two in 50–59 and the least sensitive in 31. Further analysis of the findings on seroconverters indicated a median reduction in the duration of HBsAg detection of 5 days or more for four assays when compared with the most sensitive assay. One kit (Auszyme Monoclonal) detected HBsAg in 15 of the 18 dilutions prepared from the seroconversion specimens, whereas three kits detected HBsAg in fewer than 10 dilutions. Two kits gave negative reactions with the British HBsAg Working Standard on all of five occasions and six were consistently unreactive with the NIBSC/UKBTS HBsAg Monitor Sample; only three kits (Bioelisa, Enzygnost, Murex) were always reactive. There is therefore substantial variation in sensitivity among the HBsAg kits currently available.     

Ten commercial kits compared for assay of thyrotropin in the normal and thyrotoxic range

I developed a standard procedure for assessing sensitivity, intra-assay precision, parallelism of sample dilutions, and assay drift, using a single trial assay kit. I used this to compare the performance of 10 commercial kits with an in-house radioimmunoassay for human thyrotropin. No one kit stood out as clearly superior overall. Differences in calibration between kits were evident in a comparison of thyrotropin concentrations measured in clinical samples, and by direct comparison of standards from different kits in a single assay. However, all kits gave clinically consistent results with respect to their published normal reference interval. Moreover, the performance of human thyrotropin assay kits has improved during the 14 months of this study.     

Trustline结核分枝杆菌IgG/IgM抗体检测试剂盒(胶体金法)的临床应用评价

目的 评价Trustline结核抗体IgG/IgM检测试剂盒临床应用效果。 方法 选用3家医院的1009份血清标本,其中628份为结核病患者血清(308例菌阳病例,320例菌阴病例);对照组381份非结核病血清。采用Trustline试剂盒及一种已上市的试剂盒(对照试剂盒)分别检测1009份血清,计算多项检测指标,从而评价试剂盒的检测效果。 结果 通过检测1009份临床血清标本, Trustline试剂盒检测血清抗体(IgG+IgM)的灵敏度、特异度、阳性预测值、阴性预测值、 Youden 指数分别为61.3%、79.8%、 83.3%、 55.6% 和0.411,对照试剂盒检测血清抗体(IgG) 的结果分别为53.7%、89.0%、88.9%、 53.8%和0.426。经统计分析表明Trustline试剂盒的灵敏度显著优于对照试剂盒(P0.01),特异度低于对照试剂盒(P0.01),但阳性诊断效率和阴性诊断效率方面差异无统计学意义,Youden指数相接近。 进一步分析显示Trustline试剂盒对菌阳样本及菌阴样本的检出率分别77.6%和44.7%,对照试剂盒则为67.9%和40.0%,对菌阳样本检出率的差异有统计学意义。检测1009份标本,Trustline试剂盒共得IgM阳性35例,其中结核组阳性30例(4.8%),非结核组阳性5例(1.3%)。 结论 Trustline试剂盒检测结核抗体的灵敏度显著优于对照结核抗体试剂盒,并可同时用于检测IgG/IgM抗体,可以应用于结核病的快速诊断。     

四种酶联免疫吸附试验试剂检测梅毒抗体的比较

目的评价国内常用的4种梅毒酶联免疫吸附试验（ELISA）试剂的有效性,为临床选择梅毒诊断试剂提供依据。方法对180例临床血清分别进行快速血浆反应素环状卡片试验（RPR）、梅毒螺旋体颗粒凝集试验（TPPA）和4种试剂的ELISA（试剂分别为A、B、C、D）。以TPPA结果为参考对照,分别统计各ELISA试剂的敏感性、特异性、阳性预测值和阴性预测值。结果 180例血清标本中,RPR阳性58例,TPPA阳性84例,两者均阴性95例。TPPA检测阳性率为46.67%（84/180）,A试剂为44.44%（80/180）,B试剂为45.00%（81/180）,C试剂为45.00%（81/180）,D试剂为28.33%（51/180）。D试剂与TPPA及其他3种试剂的检测阳性率差异有统计学意义（P均〈0.01）。D试剂的敏感性最差（57.14%）,而其他几种ELISA试剂的敏感性较好（94.05%~95.24%）。4种ELISA试剂的特异性均较理想（96.88%~100.00%）。结论个别国产ELISA试剂的敏感性差,提示在选择这类试剂时,应以质控血清进行预试验,使用符合要求的试剂。     

两种试剂检测抗心磷脂抗体的比较

目的 对两种商品化的抗心磷脂抗体(Anti-cardiolipin,ACA)试剂的检测结果进行比较。方法 采用欧蒙公司ACA-IgA/G/M(总ACA)检测试剂和亚辉龙公司ACA-IgG,IgM和抗β2糖蛋白I(β2GPI)抗体IgG(ACA 3项)测定试剂盒,同时检测66例血清样本,比较两者结果的差异,并分析两者之间的关系。结果 欧蒙总ACA试剂的检出阳性率为37.88%(25/66); 亚辉龙ACA 3项试剂的检出阳性率为31.82%(21/66,ACA-IgG,IgM和抗β2GPI IgG三者任一阳性),两种试剂检测结果不具有统计学差异; 两者的检测符合率为87.88%(58/66)。欧蒙试剂ACA-IgA/G/M的检测结果与亚辉龙试剂ACA-IgG,IgM和抗β2GPI IgG 3个检测值的总和具有良好的相关性(r²=0.892,P<0.01)。结论 两种试剂检测结果符合性较高,具有良好的相关性,能满足临床应用的需要; 两种试剂各具特色,可以根据需要选择合适的试剂单独或联合进行检测。     

两种RT-PCR 检测SARS-CoV-2 核酸试剂盒实验室应用评价

目的　应用两个厂家生产的试剂盒平行检测新型冠状病毒（SARS-CoV-2）感染的肺炎（COVID-19）患者样本, 对其检测效果进行实验室应用评价。方法　A,B 两试剂盒共同靶基因为ORF1ab 和N,B 试剂盒增加靶基因E;两试 剂盒同为磁珠核酸提取,RT-PCR 扩增法。结果　298 份痰液、咽拭子、肛拭子和尿液标本中,两种试剂盒共同确认阳 性结果120 份,阴性结果178 份。其检测分别表达为:A 试剂盒ORF1ab 阳性120 份,N 阳性120 份,阴性178 份,内 标（IC）297 份,质控合格全覆盖;B 试剂盒ORF1ab 阳性120 份,N 阳性118 份,E 阳性120 份,阴性178 份,内标（IC） 298 份,质控合格全覆盖;阳性结果的Ct 值有限配对的t 检验,均P ＞ 0.05（ORF1ab:n=120,t=1.839,P=0.069;N:n=118, t=1.881,P=0.063）, 差异无统计学意义。结论　两种试剂盒表达的Ct 值趋同性较理想,标本的阳性表达上符合指南规定, 结果一致。A 试剂盒有内标（IC）1 份未能表达,不可忽视;B 试剂盒N 基因有2 份缺项需找原因克服,而具备的E 基 因提高了SARS-CoV-2 核酸检测的可控性。     

两种HBV DNA检测试剂的比较

目的 分析两种试剂在HBV DNA定量检测中的相关性,评价其在不同病毒载量时的检测性能.方法 用人AB型血清将WHO第2代HBV DNA国际标准品(编号:97/750)配制成不同浓度的10份样本,10份样本的浓度分别为1×106、5×106、1×105、5×104、1×104、5×103、1×103、5×102、1×102、1×101 kIU/L.采用深圳匹基生物工程股份有限公司生产的HBV DNA荧光定量PCR检测试剂(PG试剂)和美国罗氏公司生产的定量PCR试剂(罗氏试剂)检测78份HBV感染者血清、30份健康献血者血清和10份不同浓度范围的WHO标准品中HBV DNA含量.对两种试剂检测HBV DNA结果相关性进行分析;对试剂在不同病毒载量时的检测性能进行评价;并对漏检情况进行分析.两种试剂每批检测均设有阴性质控、弱阳性质控和强阳性质控.结果 两种试剂对WHO HBV DNA标准物质稀释血清均能正确检出,罗氏试剂能检出最高稀释度样本浓度为2.00(kIU/L,lg),PG试剂能检出最高稀释度样本浓度为3.00(kIU/L,lg);两种试剂检测结果存在线性相关(R2=0.938 7,P<0.01),罗氏试剂检测上限与理论值相符,大于检测上限的标本经稀释重复测定,罗氏试剂检测结果[(8.35±0.20)kIU/L,lg]高于PG试剂检测结果[(7.73±0.42)klU/L,lg],差异有统计学意义(t=3.776,P<0.05).两种试剂检测108份血清标本中HBV DNA含量,罗氏试剂检测值[(5.88±1.64)kIU/L,lg]高于PG试剂检测值[(5.25±1.55)kIU/L,lg],差异有统计学意义(t=12.297,P<0.01);检测高HBV病毒载量[(>5.00～≤7.00)kIU/L,lg和(>7.00～≤9.00)kIU/L,lg]组,两种试剂的相关性较高(R2分别为0.779 7、0.603 7,P均<0.01);对低HBV病毒载量(>3.00～≤5.00 kIU/L,lg)组,两种试剂的相关性较低(R2=0.417 3,P<0.01);病毒载量为>3.00～≤4.00 kIU/L,lg组,PG试剂的漏检率为33.3%(5/15);病毒载量为>1.08～≤3.00 kIU/L,lg组,PG试剂未检出.结论 PG试剂与岁氏试剂检测结果虽存在一定差距,但相关性较好.两种试剂低病毒载量标本的相关性要低于高病毒载量标本,PG试剂检测HBV DNA的线性范围较窄.

Abstract：

Objective To evaluate clinical significance of two real-time fluorescence quantitative PCR kits for quantitative detection of HBV DNA and detection performance at different viral load levels.Methods A series of calibrators with different concentrations(1×106,5×105,1×105,5×104,1×104,5×103,1×103,5×102,1×102,1×101 kIU/L) were prepared with AB-type sera using the second generation WHO international standard (NIBSC code:97/750). HBV viral load in the sera of 78 patients,30 healthy blood donors and 10 calibrators were detected by real-time fluorescence quantitative PCR HBV DNA test kit from PIJI Bio-Technical Development Company Ltd (PG kit) and Cobas AmpliPrep/Cobas TaqMan HBV test kit. The correlation of the two methods was evaluated, and the performance of the two kits different viral load levels was evaluated. The false negative rate was analyzed. Negative control, low positive control and high positive control were included in every batch. Results Both two kits showed the correct results for the 10 specimens from the WHO international standards. The lowest detection limit of HBV DNA for Roche Cobas AmpliPrep/Cobas TaqMan HBV test and PG kit were 2.00 (kIU/L, lg) and 3.00 (kIU/L,lg) ,respectively. There was linear correlation between the results from Roche Cobas AmpliPrep/Cobas TaqMan HBV test and PG kit ( R2=0.938 7, P < 0.01 ), the upper limit of Roche kit had coincided with theoretical value. The samples with HBV DNA level above the upper limit of detection were diluted and retested to obtain the precise result. The result form Roche Cobas AmpliPrep/Cabas TaqMan HBV test [(8.35±0.20) kIU/L, lg] was higher than that from PG kit [(7.73±0.42 ) kIU/L, lg] (t=3. 776, P <0.05) . The detection of 108 serum samples showed that the level of HBV DNA detected by Roche Cobas AmpliPrep/Cobas TaqMan HBV test [(5.88±1.64) kIU/L, lg] was higher than that by PG kit [(5.25±1.55 kIU/L,lg] (t=12. 297 ,P <0.01 ). The correlation coefficients were high in samples with high HBV viral load[HBV DNA(>5.00 and≤7.00) kIU/L,Ig,R2=0. 779 7, P <0.01 ;HBV DNA( >7.00 ands≤9.00) kIU/L,lg,R2=0.603 7, P <0.01]. The correlation coefficient was low in samples with low HBV viral load[HBV DNA ( > 3.00 and≤5.00) kIU/L, lg, R2=0. 417 3, P <0.01 )]. When HBV DNA ( >3.00 and≤4.00) kIU/L,lg,the false negative rate was 33.3% (5/15). When HBV DNA ( > 1.08and≤3.00) kIU/L,lg,none of positive samples was detected with PG kit. Conclusions PG kit is not as good as Cobas AmpliPrep/Cobas TaqMan HBV test . The linear correlation between the results from the two kits is good. The correlation between the results detected with PG kit and Cobas AmpliPrep/Cobas TaqMan HBV test is higher in the high viral load groups than in the low viral load group. It is suggested that PG kit had a narrower linear range.     

Development of an economic and efficient strategy to detect HBsAg: application of "gray-zones" in ELISA and combined use of several detection assays

BackgroundELISA and CMIA are commonly used for detection of HBsAg. However, few investigations have been performed to evaluate their value in clinical practice, especially when jointly used. A reasonable and economic HBsAg testing algorithm is in great need.MethodsA total of 161,426 specimens in China were tested for 5 serum HBV markers with commonly used ELISA kits. 498 of these specimens were further tested for HBsAg by another ELISA kit, a CMIA kit and an HBsAg confirmatory assay.ResultsThe sensitivities of the 2 ELISA kits were 76.21% and 88.42%, respectively. However, when using “gray-zones”, the sensitivities were significantly improved to 97.43% and 96.43%. Furthermore, the combined use of the 2 ELISA kits and their “gray-zones” improved the sensitivity to 99.04%. Nevertheless, 2.91% of the samples with S/CO values below the lower “gray-zone” limits were reactive by the CMIA kit and then confirmed as HBsAg positive. However, 71.43% of the samples with HBsAg values within 0.05 and 0.10 IU/ml detected by the CMIA kit could not be confirmed.ConclusionsAs a rational and economic strategy, combined use of “gray-zones” in ELISA and several different detection assays can significantly increase the efficiency of HBsAg detection.     

Kits for the diagnosis of infectious mononucleosis compared with the Paul-Bunnell test

We compared the results obtained with six different test kits for infectious mononucleosis with those obtained with the Paul-Bunnell test. The investigation was carried out in one laboratory using 149 selected pools of patient sera. Each pool was tested three times with the Paul-Bunnell test and once with each kit. The results obtained with the kits were grouped according to the titre found with the Paul-Bunnell test. The percentage of positive results within each group was calculated for each kit. The Paul-Bunnell titre, which would have classified 50% of the specimens as positive, was estimated for each kit and this was designated the 50% cut off value. In general, there was good agreement. However, false positive test results were found rather frequently with one kit (19%) and the 50% cut off values differed. One kit showed a 50% cut off value at about 8, another at about 16, and the rest at between 16 and 32. We suggest the introduction of improved internal quality control combined with external quality assessment.     

Improvement in the performance of HIV screening kits

summary .  The aim of this study was to assess the performance of HIV screening kits introduced over a 12-year period. HIV kits used by the National Blood Service (NBS) were assessed in the context of other HIV kits employed by diagnostic and reference laboratories. Thirty-three HIV screening kits were assessed and 13 had the potential to be used by the NBS. Specimens applied to NBS evaluations included 2000 HIV-negative specimens collected from blood donors, 200 HIV-positive specimens and 21 seroconversion panels, with larger numbers applied to the latter two categories prior to implementation of Communauté Européennes (CE) marking. The 33 HIV kits gave repeat reactive rates, based on HIV-negative specimens, of between 0% and 0·8% (and between 0% and 0·2% for kits relevant to the NBS). When examined for diagnostic sensitivity, the 33 kits gave sensitivities between 99·78% and 100%. Kits relevant to NBS gave sensitivities of 100% except one kit, which failed to detect one anti-HIV-2-positive specimen. Twenty-six kits were compared for detection of primary HIV infection. Of these, the 10 combined HIV antigen/antibody kits examined were more sensitive than other formats and have been exclusively adopted by NBS where operational considerations allow. Their added seroconversion sensitivity makes them the screening method of choice for populations at increased risk, e.g. in sexually transmitted infection (STI) clinics. The regular review of evaluation results has demonstrated a continuing improvement over time in the performance of HIV screening kits and contributed to advances in blood safety.