肌酐自建检测系统准确度性能评价

 检验结果的准确度是医学检验质量管理中的核心内容，怎样评价检测项目的准确度以及如何实现检测结果的准确性，是检验人员非常关心的问题。检测系统是指完成一个项目检测所涉及的仪器、试剂、校准品、操作程序、质量控制、保养计划等的组合。经有关权威部门批准认可的完整检测系统的准确度性能是可以信赖的，但在现实中大部分实验室使用的是拼凑的自建检测系统，即使用的仪器、试剂、校准品不配套，这样的检测系统检测结果的准确度是未知的，需要采用某些方法以提供检测结果的可信度，ISO/15189《医学实验室-质量和能力的专用要求》[1]强调可以采用比对试验、使用相应的参考物质、参加适当的室间比对计划等方法来验证准确度。为了纠正自建检测系统的系统误差，使其与完整检测系统的检测结果具有可比性，我们采用方法学比对试验，对肌酐自建检测系统的准确度性能进行了评价，现报告如下。     

四种乙肝病毒表面抗原ELISA诊断试剂的评价

目的 对四种国内乙肝病毒表面抗原诊断试剂进行评价。方法 用四种试剂分别对标准品和未知血清进行检测，用几种常用诊断试验评价方法对检测结果进行分析和比较。结果 四种试剂对标准血清的检测结果较好，A、B两种试剂的总符合率为100％，另两种的总符合率也在90％以上，其中B试剂有较好的精密性。δ值比较显示A和B两种试剂有较好的诊断特性。四种试剂在一定的抗原浓度范围内都有良好的线性关系。针对于未知样本的检测中，四种试剂与采用电发光法的罗氏诊断试剂有较好的一致性。结论 国内主要厂家的HBsAg ELISA诊断试剂具有较高的检测效能。在实际工作中，可以通过常用的诊断试剂筛选实验，经统计分析后筛选出较高效能诊断试剂用于检测。     

HIV-1/2抗体和P24抗原联合检测试剂盒的研制与评价

目的研制HIV-1／2抗体和P24抗原联合检测酶免疫试剂盒并评价其实用性。方法联合使用基因工程HIVI／2型抗原和抗HIVP24单克隆抗体包被酶联反应板，以辣根过氧化物酶标记的HIVI／2型抗原和生物素化的兔抗HIVP24抗体作为标记物，研制了联合检测HIVI／2抗体和P24抗原的ELISA诊断试剂，并对其特异性、敏感性、稳定性等进行评价和临床考评。结果检测P24抗原质控品的灵敏度可达0．2ng／ml；与雅培公司试剂比较检测78份AIDS患者血清和85份正常人血清、对照检测中国药品生物制品检定所研制的HIV参比血清，特异度和灵敏度均为100％。临床考核检测12051份各种血清，灵敏度为100％（543／543），特异度为99．48％（11448／11508）。试剂在37℃放置6d后，试验结果无明显差异。结论本试剂盒具备特异度强、敏感度高、稳定性好、操作简便等优点，可以一步检出HIV特异性抗体和HIVP24抗原，缩短了HIV感染的检测窗口期，适用于HIV感染的实验室诊断和流行病学调查。     

Performance of two commercially available sequence-based HIV-1 genotyping systems for the detection of drug resistance against HIV type 1 group M subtypes

The use of genotyping assays for the detection and evaluation of drug resistance mutations within the polymerase gene of human immunodeficiency virus type 1 (HIV-1) is becoming increasingly relevant in the clinical management of HIV-1 infection. However, genotypic resistance assays available currently have been optimised for genetic subtype B strains of the virus and many clinical centres are presented with strains from subtypes A, C, and D. In the present report, we compare the performance of two sequence-based commercially available kits, the ViroSeq Genotyping System (Applied Biosystems, Foster City, CA) and the TruGene HIV-1 Genotyping Kit (Visible Genetics, Toronto, Ontario) against a panel of 35 virus isolates from HIV-1 Group M (subtypes A-J). Full-length consensus sequences were generated by the ViroSeq genotyping system for 26 of 31 (83.8%) of the isolates tested, in contrast to the TruGene genotyping system, which generated 16 of 30 (53%) usable sequences overall. Overall, subtype B isolates were sequenced with a greater degree of success than non-subtype B isolates. Discrepancies were found between the consensus sequences reported by each system for each sample (mean difference 1.0%; range 0.0-3.2%), but these appeared to be random and did not affect interpretation of the major resistance codons. In addition, both systems were able to amplify template RNA from low copy viral load plasma samples (10(2)-10(3) RNA copies/ml) taken from a random selection of patient samples encompassing subtypes A-C. While the availability of these genotyping systems should facilitate studies of HIV-1 drug resistance in countries in which these subtypes are prevalent, the performance against subtypes other than B needs to be improved.     

Lyme borreliosis in Sweden--diagnostic performance of five commercial Borrelia serology kits using sera from well-defined patient groups

Five commercial Borrelia serology kits available in Sweden were evaluated and compared for their diagnostic performance in sera from clinically well-characterized patient groups. With the clinically defined groups as the gold standard, i.e. without knowledge of antibody status in serum and cerebrospinal fluid, the diagnostic performance of the kits was compared and important differences in diagnostic usefulness were found. The kits from Abbot and DAKO, that often predict clinically relevant Borrelia infection and do not detect antibodies in sera from patients without strong suspicion of Borrelia infection, were considered the most useful in the population studied. This kind of validation study is an important part of good laboratory practice and should be performed by laboratories serving patient populations with varying endemicity of Borrelia.     

一种国产HBsAg确认试剂的临床应用评价

Objective To carry out the clinical validation of a domestic HBsAg kit to evaluate its application value. Methods 543 serum samples with HBsAg ELISA values of S/CO ≥ 0. 7 were tested by HBsAg confirmatory test. Specific anti-HBs reagent and control reagent were added separately into duplicate wells of HBsAg ELISA plate, in which test sample was also added. After incubation at 37℃, HBsAg was detected by routine ELISA, and the inhibition rate was calculated using absorbanee (A) result of anti-HBs reagent well and control reagent well according to the provided formula. The sample was confirmed as HBsAg positive when the inhibition rate was≥50%. For HBsAg weakly positive samples, "prolonged confirmatory test" (conjugate reaction time was prolonged to 120 rain) was applied to increase the sensitivity. 39 samples were randomized selected for testing and comparison with Abbott Murex confirmatory test. Results 543 serum samples in total were tested by the confirmatory test. Among the 504 cases which showed positive reaction in screening HBsAg ELISA, 89 ( 17. 7% ) were confirmed as negative. According to their S/CO value of the screening HBsAg test, the ratio of negative cases / tested eases in the group were:S/CO≤<5.0, 87/143 (60. 8% ) ;5.0 < S/CO ≤ 10. 0,0/25 (0) ;10. 0 < S/CO ≤ 15.0, 1/21 (4. 8% ) ;15.0 < S/CO ≤ 20. 0, 1/23 (4. 4% ) ;S/CO 20. 0, 0/292(0). Among 39 cases with negative HBsAg (0. ≤kits. Weakly positive (S/CO≤5.0) serum samples detected by primary HBsAg ELISA should be tested with confirmatory test, which is not necessary for strongly positive (S/CO 20. 0) samples. More clinical studies should be performed to establish a proper cut-off for the S/CO value of weakly positive samples.     

Abstract Digest

Abstract

A commercially available diluting buffer (ADB) was used to customize prediluted immunohistochemical kits from the less expensive concentrated form. These kits were used for a broad spectrum of antibodies in our neuropathology laboratory. The ADB allows the conversion of existing immunohistochemical (IHC) stains that employ concentrated regents into a complete prediluted system, without the necessity for changing existing dilutions and incubation times. This commercial buffer enables the user to predilute and store in bulk not only primary antibodies (up to 1 yr at 4°C) but blocking serum, biotinylated antiserum, and enzyme conjugated antiserum (up to 2 mo at 4°C). Furthermore, a color coding kit for visual identification of the various reagents is available to complement this system. An in-house prediluted system enables the technologist to reduce the initial preparation time, and is far more cost effective than prediluted kits and primary antibodies. (The J Histotechnol 18:41, 1995)     

Efficacy of a lead based paint XRF analyzer and a commercially available colorimetric lead test kit as qualitative field tools for determining presence of lead in religious powders

The performances of a portable X-Ray Fluorescence (XRF) lead paint analyzer (RMD LPA-1, Protec Instrument Corp., Waltham, MA) and a commercially available colorimetric lead test kit (First Alert Lead Test Kit, eAccess Solutions, Inc., Palatine, IL) were evaluated for use by local or state health departments as potential cost-effective rapid analysis or “spot test” field techniques for tentative identification of lead content in sindoor powders. For both field-sampling methods, sensitivity, specificity and predictive values varied widely for samples containing <300,000 µg/g lead. For samples containing ≥300,000 µg/g lead, the aforementioned metrics were 100% (however, the CIs had a wide range). In addition, both field sampling methods showed clear, consistent positive readings only for samples containing ≥300,000 µg/g lead. Even samples with lead content as high as 5,110 µg/g were not positively identified by either field analysis technique. The results of this study suggest the XRF analyzer and colorimetric lead test kit cannot be used as a rapid field test for sindoor by health department inspectors.     

人乳头瘤病毒多型别感染与子宫颈病变的关系的研究进展

由于检测技术的进步,近几年来的研究显示,子宫颈上皮内人乳头瘤病毒(human papillomavirus,HPV)的多型别感染(infection with multiple types)呈现明显增高的检出态势。宫颈组织HPV多型别感染的情况已受到越来越多关注。本文作者就几种不同标本类型——宫颈脱落细胞,宫颈活检组织和宫颈肿瘤,根据研究者采用的不同检测方法——商用检测试剂盒及实验室研究性检测,对不同宫颈病变HPV多型别检出的研究情况进行了综述。