不同厂家的镁离子稳定性研究

目的 探讨镁二甲苯胺蓝比色法测定试剂校准周期与稳定性的验证方法,以保证临床检验结果 的准确性.方法 连续测定稳定质控品,观察其变化情况,以确定开瓶稳定时间.结果 pH在10.5~11.0的镁单试剂校准周期与开瓶稳定性均可达30 d.结论 临床实验室应该对校准周期与开瓶稳定性进行验证,目前本科室使用的新成生物的镁二甲苯胺蓝比色法测定试剂完全能够满足临床应用要求.     

长效生化试剂瓶提高钠离子酶比色法试剂开瓶稳定性的性能评价

酶比色法测定钠离子（Na＋）检测速度快、操作简便、无需增加电极模块，是近年来临床实验室逐渐广泛应用的自动化检测方法之一。但目前市售的Na＋酶法试剂开瓶稳定性普遍较差，其中稳定性较好的Randox公司钠离子检测试剂，其校准周期通常只有3～5d。     

总二氧化碳干粉试剂稳定性的探讨

随着全自动生化分析仪的普及,血清总二氧化碳测定中酶法因准确性,方便性和经济实用性而得到广泛的应用,但是,在临床检验中,血清总二氧化碳测定结果会产生偏差,特别是干粉试剂的使用不当对测定结果影响很大,本文就总二氧化碳干粉试剂的使用情况进行分析,找出干粉试剂不稳定的原因及解决问题的方法,以保证检测结果的质量。     

总二氧化碳干粉试剂稳定性的探讨

随着全自动生化分析仪的普及,血清总二氧化碳测定中酶法因准确性,方便性和经济实用性而得到广泛的应用,但是,在临床检验中,血清总二氧化碳测定结果会产生偏差,特别是干粉试剂的使用不当对测定结果影响很大,本文就总二氧化碳干粉试剂的使用情况进行分析,找出干粉试剂不稳定的原因及解决问题的方法,以保证检测结果的质量。     

镁试剂的校准轨迹与质量控制

目的 通过对镁试剂的校准轨迹全程进行探讨,决定其校准周期及频率,为做好室内质控打下基础.方法 在一个分析检测系统相同的条件下,使用相同批号试剂与校准品,分新开封试剂、试剂开封后连续使用、已用剩余试剂混合后再次使用试剂校准后不同K值而形成不同的校准轨迹图形,决定校准周期及频率.结果 镁试剂在新开封时、试剂开封后连续使用时、已用剩余试剂混合后再次使用时,其校准K值有校大的波动.结论 镁碱性试剂新旧试剂相差较大,严禁新旧试剂混合使用.其在新开封时、试剂开封后连续使用时、已用剩余试剂混合后再次使用时一定要先进行校准,校准合格后再作质控和患者样本检测.     

不同校准品对血清葡萄糖测定的影响

在临床化学分析中 ,试剂、校准品的使用比较混乱 ,忽略了基体效应对检验结果的影响。我们观察了不同的校准品对血清葡萄糖测定的影响。1　材料和方法1.1　仪器　东芝ＴＢＡ 30。1.2　试剂　中生葡萄糖试剂ＧＯＤ法及单一校准品 ,Ｒｏｃｈｅ血清葡萄糖试剂 (ＧＯＤ法和ＨＫ法 )及ｃｆａｓ校准品。2　实验与结果分别使用不同试剂和校准品进行血清葡萄糖测定 ,分别同时测定 2 0个新鲜病人标本和两种浓度罗氏质控血清 ,每个方法做 3次 ,结果取均值。各组结果作配对ｔ检验 ,经统计学处理后表明 :中生试剂单一校准品结果偏低 ,而使用中生试剂ｃｆ…     

稳定型总蛋白(TP)试剂的研制

目的改良测定总蛋白(TP)的双缩脲试剂,提高试剂开瓶放置的稳定性和检测结果的准确性.方法在双缩脲基础试剂(由氢氧化钠、酒石酸钾钠、碘化钾和硫酸铜组成)中分别加入EDTA-Na2、非离子表面活性剂Triton X-100、碳酸钠等成份,通过测定50份无黄疸、甘油三酯(TG)＜2.5mmol/L血清标本和27份单纯TG＞3.0mmol/L血清标本32份总胆红素浓度在37.4～649.3μmol/L范围内的血清标本的TP值,以观察这些成份对总蛋白测定的影响;同时对自配稳定型双缩脲试剂的性能指标如线性范围、回收试验、不精密度、方法对比实验、干扰试验、试剂开瓶稳定性、试剂盒有效期进行了监测和评估.结果基础试剂在分别加入EDTA-Na2和Triton X-100后,测得血清TP值均较加入前明显下降(P＜0.05或P＜0.01),而临床对比检测试验则显示在日立7600生化仪上自配试剂与参照试剂的检测结果非常一致,且与杜邦RXL生化仪及配套进口试剂的检测结果也非常一致,均无显著差异(P＞0.05).自配试剂的线性范围、回收试验,不精密度,抗干扰能力,试剂开瓶放置的稳定性等性能指标均符合实验要求.结论自配稳定型试剂重复性好,性能稳定,抗干扰能力强,开瓶放置时质量稳定,线性范围宽,检测结果准确,完全可以应用于临床生化检验.     

酶法测定血清TCO_2值偏低原因分析

工作中我们发现酶法测定血清总二氧化碳（ＴＣＯ２）所得测定值往往偏低。为此，我们比较了定值质控血清和正常人血清标本，用不同时间不同ｐＨ蒸馏水复溶酶法干粉试剂后平衡，进行检测，结果报告如下。１材料１．ｌ仪器康艺ＫＯＮＥＰｒｏ全自动生化分析仪。每天测定前均按要求对仪器例行保养及校正。１．２试剂中外合资上海长征康仁医学科学有限公司生产的ＴＣＯ２酶法测定干粉试剂。１．３质控血清Ｒａｎｄｏｘ多参数定值质控血清，批号为１９７ＵＮ，使用前按标签所示加入５ｍｌ重蒸馏水溶解。１．４正常人血清收集当天门诊工作中的无黄…     

XE-2100全自动血细胞分析仪质控物的性能验证

目的对Sysmex公司生产的血液质控物e-CHECK的性能进行验证。方法依据《中华人民共和国医药行业标准YY/T0702-2008》对血细胞分析仪用质控物(品)的要求,使用XE-2100全自动血液分析仪、电化学发光分析仪等对质控物eCHECK(包括水平1,水平2,水平3)的外观、瓶内均匀性、瓶间均匀性、定值、长期稳定性、开瓶有效期稳定性(短期稳定性)、生物安全性等性能进行验证。结果瓶内均匀性性能验证试验显示:低水平质控物PLT和PCT参数的变异系数分别为4.42%、8.93%,略微高于XE-2100分析仪的重复性要求(CVplt≤4.0%,CVpct≤5.0%),其他各项性能指标包括外观与装量、瓶间均匀性、质控物定值、生物安全性、长期稳定性及开瓶有效期稳定性(短期稳定性)等均符合中华人民共和国医药行业标准对全血质控物的要求。结论 Sysmex公司生产的血液质控物e-CHECK均匀稳定、可靠,有条件的实验室应使用配套的血液质控物对血液分析仪进行质量控制。     

冷藏ACD-EDTA抗凝血和全血细胞计数稳定性观察

目的观察ACD-EDTA抗凝血作为血细胞计数质控物或校准物的稳定性.方法在ACD抗凝血中加入适量EDTA抗凝剂,冷藏保存,在Beckman-Coulter ACTdiff Ⅱ、Sysmex K-4500、Abbott Cell-Dyn 1200和ABX Micros 60共4台仪器上连续测定10 d,观察白细胞(WBC)、红细胞(RBC)、血红蛋白(HGB)、血细胞比容(HCT)和血小板(PLT)共5项参数的变化.结果每天新开瓶的ACD-EDTA抗凝全血在10 d内,各仪器测定结果的偏倚值差异无显著性(P>0.05).每天新开瓶的ACD-EDTA抗凝红细胞悬液在10 d内,各仪器测定WBC和PLT结果的偏倚值差异有显著性(P<0.01).ACD-EDTA抗凝全血一次性开瓶后,连续测定10 d,则各仪器测定WBC和PLT结果的偏倚值差异有显著性(P<0.01).结论 ACD-EDTA抗凝血在冷藏条件下能稳定10 d左右,但在不同仪器有不同的测定值.总之,ACD-EDTA抗凝血因其制备方便,相对稳定,可作为短期质控物或校准物使用.     

Multiple calibrator measurements improve accuracy and stability estimates of automated assays

Objectives The effects of combining multiple calibrations on assay accuracy (bias) and measurement of calibration stability were investigated for total triiodothyronine (TT3), vitamin B12 and luteinizing hormone (LH) using Beckman Coulter’s Access 2 analyzer. Methods Three calibration procedures (CC1, CC2 and CC3) combined 12, 34 and 56 calibrator measurements over 1, 2, and 3 days. Bias was calculated between target values and average measured value over 3 consecutive days after calibration. Using regression analysis of calibrator measurements versus measurement date, calibration stability was determined as the maximum number of days before a calibrator measurement exceeded 5% tolerance limits. Results Competitive assays (TT3, vitamin B12) had positive time regression slopes, while sandwich assay (LH) had a negative slope. Bias values for TT3 were??2.49%, 1.49%, and??0.50% using CC1, CC2 and CC3 respectively, with calibrator stability of 32, 20, and 30 days. Bias values for vitamin B12 were 2.44%, 0.91%, and??0.50%, with calibrator stability of 4, 9, and 12 days. Bias values for LH were 2.26%, 1.44% and??0.29% with calibrator stability of >43, 39 and 36 days. Measured stability was more consistent across calibration procedures using percent change rather than difference from target: 26 days for TT3, 12 days for B12 and 31 days for LH. Conclusions Averaging over multiple calibrations produced smaller bias, consistent with improved accuracy. Time regression slopes in percent change were unaffected by number of calibration measurements but calibrator stability measured from the target value was highly affected by the calibrator value at time zero.     

An evaluation of six solid-phase thyrotropin (TSH) kits

This article describes an objective evaluation of six thyrotropin (TSH) kits. One was a radioimmunoassay kit taken for comparison, three were immunoradiometric assays and one was an immunoenzymometric assay. The laboratory internal immunoluminometric assay for thyrotropin was used to measure the concentrations of thyrotropin in the kit standards using a standard curve of WHO 68/38 international reference preparation in serum from a thyrotoxic patient as matrix. The in-house assay was used to demonstrate the "sensitivity" to citrated plasma and the fact that kit standards could only measure "correctly" when used in its own kit. The study was carried out in a "blind" way, the assayist and organiser not knowing from which of the four groups under test (blood donors - serum and citrated plasma, thyroliberin-test and thyroid outpatient clinic patients) the samples came until the study had been completed. The immunometric assay kits were able to differentiate statistically between euthyroid and untreated hyperthyroid patients, although one IRMA kit (Kit F) had a large "grey zone" where both euthyroid and hyperthyroid patients overlapped. Compound precision profiles covering the range 0-5 mU/l thyrotropin were good, a mean coefficient of variation under 5% within the range 0.5-5 mU/l being demonstrated by 3 immunometric assays. The immunometric assay kit with the most cumbersome methodology showed, as was to be expected, the worst precision. The euthyroid ranges for thyrotropin were similar in 3 immunometric assay kits using the WHO 68/38 reference material as calibrator (Kits C and E, 0.25-3 mU/l) and correlated well with one kit using the 2nd IRP (NIBSC 80/558) as calibration material (Kit D 0.33-4 mU/l), although the results were around 30% higher in Kit D. The second kit (Kit A) using the 2nd IRP material as calibrator gave identical values with the kits using the WHO 68/38 reference thyrotropin-preparation for calibration purposes. In a further kit (Kit F) it was stated that both thyrotropin international reference preparations gave rise to identical serum values when used as calibrators. The thyroliberin-test may have an additional role to play in monitoring returning pituitary function in thyrotoxic patients under treatment as the immunometric assay kits were easily able to measure a thyrotropin difference of 0.5 mU/l in the range 0-1 mU/l. The conventional radioimmunoassay (Kit B) was unable to match the precision and sensitivity of the better immunometric assay kits in the range under 1 mU/1.(ABSTRACT TRUNCATED AT 400 WORDS)     

基于CLSI-M43国际标准改良的Mycoview-AST试剂盒检测性能评估

目的 基于美国临床标准化协会(clinical and laboratory standards institute,CLSI)M43国际标准改进的泌尿生殖道支原体Mycoview-AST试剂盒检测性能评估。方法 以法国MYCOFAST^○Rrevolution支原体试剂盒为比对标准,用CLSI-M43规定的质控株和有关指标及60例临床标本对新改进的试剂盒性能进行评估。结果 Mycoview-AST试剂盒以质控菌株检测的药敏结果与MYCOFAST11^○Rrevolution试剂盒一致。60例临床标本,阴性标本37例,解脲支原体(Uu)阳性16例,人型支原体(Mh)阳性5例,Uu与Mh均阳性的标本2例。两种试剂盒Uu和Mh的鉴定结果一致。23例阳性标本的药敏结果共161个,与进口比对试剂MYCOFAST^○R比对,154个结果符合,药敏结果符合率为95.6%(154/161)。结论 基于CLSI-M43国际标准改进后的Mycoview-AST试剂盒检测性能与国际知名品牌MYCOFAST^○Rrevolution试剂盒相当。     

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.     

人巨细胞病毒IgG抗体质控盘的建立

目的建立人巨细胞病毒IgG抗体质控盘,为以酶联免疫法和化学发光法为原理的人巨细胞病毒IgG抗体诊断试剂盒的性能评价提供可靠的质控物质。方法通过试剂盒筛选出人巨细胞病毒IgG抗体的阳性和阴性血清,将10份不同来源的阳性血清作为质控盘的P1~P10,5份不同来源的阴性血清作为质控盘的N1~N5,5份阳性血清混合制成质控盘的L1~L3。之后,用不同的试剂盒验证建立的质控盘。结果六家公司的试剂盒对本质控盘进行的准确性、特异性和检测限的验证结果均符合要求。对本质控盘的稳定性研究结果表明,质控盘的稳定性良好。成功建立了人巨细胞病毒IgG抗体质控盘。结论本研究建立的质控盘可用于以酶联免疫法和化学发光法等原理的人巨细胞病毒IgG抗体诊断试剂盒的性能评价。     

Comparison of five commercial DNA extraction kits for the recovery of Francisella tularensis DNA from spiked soil samples

Francisella tularensis is the etiologic agent of the zoonotic disease tularemia and is thought to be maintained in the environment principally by various terrestrial and aquatic vertebrate animals. The organism is known to persist in water or mud for long periods of time and Francisella-specific DNA has been identified from water and soil. To gain a better understanding of the ecology and epidemiology of F. tularensis, it will be important to further explore its distribution in the environment. Therefore, methods must be established to efficiently extract Francisella-specific DNA from the soil and be able to eliminate potential PCR inhibitors. Thus, we evaluated five commercial DNA extraction kits for their ability to recover F. tularensis-specific DNA from soil samples and eliminate potential PCR inhibitors. The kits evaluated included the Puregene DNA purification kit, QIAamp Stool Mini kit, Epicentre Biotech SoilMaster DNA extraction kit, and the UltraClean and PowerMax soil DNA isolation kits from MoBio. Soil samples were spiked with gamma-irradiated F. tularensis SHU-4 strain (corresponding to a range from 10 to 10(5)CFU). Spiked samples were extracted with each kit and evaluated using a F. tularensis-specific real-time PCR assay and an internal positive control assay that measures the presence of potential PCR inhibitors. DNA extraction using the UltraClean and PowerMax kits resulted in the most consistently positive results at the lowest limit of detection (20 and 100CFU/g soil, respectively) for all soil types tested, suggesting that these kits can provide the most sensitive methods for extracting F. tularensis from environmental soil samples. Processing time and cost were also evaluated.     

克劳斯法测定纤维蛋白原及其影响因素

目的 探讨克劳斯法的影响因素,以推荐在我国临床实验室应用克劳斯法测定纤维蛋白原。方法 分别采用进口试剂盒和国产试剂,建立各自的纤维蛋白原标准曲线,并通过对标准品的测定进行比较,探讨缓冲液ｐＨ、凝血酶浓度和测定温度对测定结果的影响。结果 应用国产试剂,建立的克劳斯法,重复性良好,日内ＣＶ＝０．０３９１,日间ＣＶ＝０．０４９７。对标准品分别用进口试剂盒和国产试剂进行测定,相对误差分别为＋３．１７％、＋４．７６％和－６．０３％。对１份冻干血浆测定,两者结果相近。结论 完全要用国产试剂代替价格昂贵的进口试剂盒,有利于克功斯法在国内的推广应用。     

Results with commercial radioassay kits compared with microbiological assay of folate in serum and whole-blood.

We compared results with three commercial folate radioassay kits [Bio-Rad, New England Nuclear (NEN), and RIA Products] with those by microbiological assay for more than 200 samples of human serum and whole blood. All but one kit (NEN) compared favorably with the microbiological assay for serum samples, although there were notable diagnostic discrepancies. Two kits (NEN and Bio-Rad) were tested on whole-blood samples; both yielded values significantly higher than those by microbiological assay. The frequency distributions of erythrocyte folate data differed strikingly between the two kits; the NEN method yielded a much narrower range of normal values than did either the Bio-Rad or the microbiological assay. Radioassay kits appear to be suitable diagnostic agents for serum folate, if the behavior of a particular kit is investigated thoroughly before its routine use. However, the diagnostic value of radioassays of erythrocyte folate needs to be validated.     

利用校准周期图建立日立7600生化仪检测系统校准周期

目的利用校准周期图建立日立7600生化仪检测系统校准周期。方法利用校准周期图,更换试剂后对日立7600生化仪检测系统进行校准,每2 h检测一批质控血清,每批3种水平,每个水平做4次重复检测,以累积CV小于CLIA′88允许误差的1/6作为评价标准。结果肌酐从校准后8 h即有低水平的质控血清累积CV>2.59,其校准周期最短,ISE离子类校准周期每12 h需要校准一次,酶类校准周期可达30 d以上。结论在确立检测系统的校准周期时,一定要选用接近于检测下限的质控血清,选用高浓度的质控血清可能会造成确立的校准周期过长。