CentaurXP全自动化学发光系统检测胰岛素及C肽性能验证

目的对西门子公司生产的ADVIA Centaur XP全自动化学发光分析仪定量检测血清胰岛素(IRI)、C肽(CpS)进行性能验证。方法检测40份体检健康者血液标本,计算IRI、CpS的不精密度及偏倚;验证IRI的线性范围;验证IRI和CpS的参考范围。结果 IRI及CpS批内变异系数(CV)6.25%、批间CV8.33%;检测偏倚均小于12.5%;IRI的线性范围0.50~307.76mIU/L;40份血清检测结果显示IRI全部在厂家提供的参考范围内,CpS有2份不在厂家提供的参考范围内,符合相关要求。结论 ADVIA Centaur XP全自动化学发光系统检测IRI、CpS主要性能指标符合要求,可用于临床检测。     

全自动血液分析仪 Sysmex XT-2000i 与 Mindray BC-5800的比较分析

目的：比较分析 Sysmex XT-2000i 和 Mindray BC-58002类全自动血液分析仪各项检验参数结果的精密度和相关性。方法选取60例 EDTA-K2抗凝静脉全血,对2台仪器各参数进行相关性分析;选取低、中、高值标本分别用2台仪器检测10次,对其进行精密度分析。结果测定 Sysmex XT-2000i 血细胞计数各参数变异系数（CV）为0．02％～5．70％,白细胞分类各参数 CV 为0．06～1．66％,Mindray BC-5800血细胞计数各参数 CV 为0．02％～5．30％,白细胞分类各参数 CV 为0．09％～1．17％。2台仪器间血细胞计数各参数的决定系数（r2）为0．185～0．995。结论2台仪器各参数精密度与设计范围相符合,二者之间的相关性较好。     

副波长对免疫比浊法检测尿微量清蛋白精密度的影响

目的评价添加副波长前后免疫比浊法检测尿微量清蛋白精密度的变化。方法在雅培全自动生化分析仪C16000上检测尿微量清蛋白时,设定主波长为340 nm。在设定副波长(700 nm)前后,每天分别检测10、100、200、400 mg/L 4个浓度的尿微量清蛋白,每个浓度重复检测5次,连续5 d,共检测25次,记录结果,计算批内精密度和总精密度,并与厂商声明的精密度进行比较。结果双波长批内精密度、总精密度均优于单波长。单波长所有标本批内精密度、总精密度,以及双波长10、100 mg/L尿液标本批内精密度及总精密度均未通过厂商声明的允许不精密度5%。而双波长200 mg/L尿液标本总精密度及400 mg/L尿液标本的批内精密度、总精密度符合厂商声明的5%。结论副波长有助于提高免疫比浊法检测尿微量清蛋白检测结果的精密度,并建议应用双波长。     

微板丙酮酸氧化酶动力学法测定ALT活性的应用

目的评价微板丙酮酸氧化酶动力学法测定ALT活性的应用情况。方法应用微板丙酮酸氧化酶动力学法测定血清ALT，对其方法的线性、重复性进行比价，同时与乳酸脱氢酶紫外动力学法进行比较。结果线性试验相关系数r=0．999；批内复性试验低值与高值标本的CV值分别为6．02％、7．55％；批间重复性试验低值与高值标本的CV值分别为8．27％、8．16％；对比试验阴性符合率为100％，阳性符合率为99．19％。结论微板丙酮酸氧化酶动力学法适合血站用于ALT的检测。     

荧光免疫层析法D-二聚体定量检测试剂盒性能评价

目的 评价荧光免疫层析法D--聚体定量检测试剂盒的方法学性能.方法 使用被评价D--聚体试剂盒及配套的KNG-YM-Ⅰ型干式荧光免疫分析仪,对高、中、低各1份标本连续检测20次进行批内精密度测定,对高、低各1份标本分5天每天检测4次进行批间精密度测定,对1份高值标本稀释后进行线性测定,与CA1500凝血分析仪连续5天对8份标本平行检测进行可比性评估,使用TBIL为201.6 μmol/L及TG为32.40 mmol/L的乳糜标本进行系列稀释后加入临床标本中评估抗干扰能力.结果 被评价D-二聚体试剂盒检测高、中、低值血浆样本的批内精密度(CV值)分别为2.5％,3.4％和4.1％,检测高值和低值的批间精密度分别为6.4％和7.3％;对1份D二聚体为12.5 mg/L的全血样品用0.9 g/dl NaCl溶液按100％,80％,60％,40％,20％,10％,5％,2.5％和0％稀释后检测,结果进行直线回归分析,线性实验方程为Y=0.995 9X-0.105 1,相关系数r=0.999 4;对比实验表明与希森美康CA1500凝血分析仪检测结果相关性良好(r=0.977),t=0.97,P＞0.05,差异无统计学意义;黄疸和乳糜干扰物对测试结果的影响度分别为0～-3.8％和o～-1.9％.结论 该试剂盒具有操作简单、报告快捷、重复性好、可比性高、抗干扰能力强等特点,适用于医院门诊、急诊、病房床旁以及社区医疗点.     

Roche Cobas E601电化学发光分析仪检测降钙素原的方法学评价

目的:对Roche Cobas E601电化学发光分析仪检测降钙素原(PCT)进行方法学评价.方法:通过Roche Cobas E601测定PCT的精密度、准确度、分析测量范围和携带污染率来评价其性能.结果:低、高值批内精密度的变异系数(CV)分别为1.16％、0.51％,批间精密度的CV为2.98％、1.96％;测定4份定值校准品的检测结果与靶值的偏倚为-5.26％ ～ 3.16％;线性为0.039 ng/mL ～ 86.325 ng/mL;携带污染率为0.019％.结论:该系统检测性能能够满足PCT的测定要求.     

4种型号便携式血糖仪的性能评价

目的了解四种型号的便携式(POCT)血糖仪的精密度和正确度性能,为选购和使用提供参考。方法 A、B、C、D型共4台POCT血糖仪进行精密度评价;四种型号29台血糖仪与全自动生化分析仪检测结果比对进行正确度评价。结果 A、B、C型血糖仪批内精密度变异系数CV批内=2.65%~3.91%,日间精密度中、高浓度分别为CV日间=2.95%~3.58%和CV日间=3.43%~4.06%;D型血糖仪批内精密度CV批内=5.91%~6.15%;日间精密度CV日间=5.67%~6.33%。A、B、C、D型血糖仪与全自动生化分析仪检测结果的相关系数分别为0.963 7~0.992 4、0.970 6~0.992 2、0.995 3、0.927 6。按相关规范和美国临床和实验室标准协会(CLSI)准则要求,当血糖浓度小于4.2mmol/L时,结果偏差大于0.83mmol无一例;≥4.2mmol/L时,偏倚小于20%的,A型占94.3%、B型占94.7%,D型占40%,均未达到要求,C型占100%。在低浓度医学决定水平的偏倚大于10%的有16台;中、高浓度医学决定水平的偏倚均(1台除外)小于10%。结论不同品牌型号POCT血糖仪检测性能差别悬殊,使用时需谨慎判读结果。     

ISO15189认可关于CYP2C19基因多态性检测性能验证评价

目的评价荧光定量聚合酶链反应(PCR)检测人类CYP2C19基因多态性的分析性能。方法依据ISO15189认可要求对试剂盒的准确度(与金标准比较)、特异度、精密度、检测下限和抗干扰能力进行性能评价。结果 20份临床标本荧光定量PCR与Sanger测序法结果比对,准确度符合率为100%(测序符合率为100%);10份临床标本3个基因型位点荧光定量PCR与Sanger测序法结果均为野生型,特异度符合率为100%;荧光定量PCR对临床标本重复检测15次的结果完全一致,且Ct值CV≤5%;试剂盒最低检出限为0.550ng/μL;血红蛋白、胆红素和三酰甘油3种干扰物质加入已知基因型结果的血液标本后进行检测,与对照结果符合率为100%。结论荧光定量PCR检测人类CYP2C19基因多态性的性能验证满足ISO15189认可要求,适合于临床应用。     

HG-4A型火焰光度计性能评价

目的验正测定HG-4A型火焰光度计测定K^＋、Na^＋的精密度和准确性。方法用3．0mmol／L锂内标准稀释液分别准确配制钾、钠系列标准应用液（1：200）,采用一点定标分别测定K^＋、Na^＋,观察其线性关系。取10份血清标本做回收试验,用定值质控血清测定其精密度和准确性。结果K^＋、Na^＋测定值对浓度都呈现良好线性关系。K^＋回归直线方程Y（测定值）=1．015X-0．087;相关系数r=0．9997;Na^＋回归直线方程Y（N4定值）=0．998X＋0．861,相关系数r=0．9995;精密度：K^＋的批内CV=98．98％,批间CV=98．64％,Na^＋的批内CV=99．58％,批间CV=99．24％。结论该仪器测定K^＋、Na^＋结果随浓度增加或降低,完全成正比例关系。日常测定中只需一点定标即可,给工作带来了方便。该仪器采用Li^＋作为内标准物质,减少了由于雾化速度和火焰温度的波动而引起的误差,提高了测定的精密度和准确性,是一种测定K^＋、Na^＋的好方法。     

Sysmex XE-2100全自动血细胞分析仪对血液病血小板计数的检测价值

目的：探讨SysmexXE-2100全自动血细胞分析仪计数血液病血小板的临床应用价值。方法：选用2份低值血小板标本用仪器第4模式检测10次，观察批内精密度。将115例血液病病人血标本用SysmexXE-2100第3模式电阻法（PLT-I）和第4模式激光法（PLT-O）测定的血小板结果与显微镜计数结果进行相关性分析。结果：2份低值血小板标本用仪器第4模式检测，其批内精密度分别为1．85％和2．03％。Sysmex XE-2100测定115份血液病血小板计数结果与显微镜计数结果相关性良好，激光法相关系数（r）为0．9973，P〈0．01；而电阻抗法r为0．9689，P〈0．01。结论：SysmexXE-2100血细胞分析仪激光法（PLT-O）分析血液病血小板计数的性能良好．具有准确度高、重复性好和简便快捷等优点，是常规实验室测定血液病血小板计数较理想的仪器。     

定量测定HCG的斑点金免疫渗滤试验的临床评价

目的　评价斑点金免疫渗滤试验 (DGIFA)定量测定血清和尿液人绒毛膜促性腺激素 (HCG)的可靠性。方法　分别用化学发光免疫分析法 (CLIA)和DGIFA定量测定HCG试剂盒 (HCG DOT)及DGIFA定量仪测定 4 0份血清样品的HCG含量 ,分别用胶体金免疫层析定性试验 (GICA)和HCG DOT及DGIFA定量仪测定2 70份尿液样品的HCG水平 ;作回收试验和不精密度试验。结果　CLIA和DGIFA定量测定血清样品HCG的相关性好 ;GICA检测阴性的 16 2份尿液样品用HCG DOT测定有 9份为背景红色所致的假阳性 ,1份为血尿导致的假阳性 ,另 2份为阳性 ;GICA检测阳性的 95份和可疑阳性的 13份尿液样品用HCG DOT测定 ,结果均为阳性 ;HCG DOT定量测定高、低浓度HCG血清样品和HCG尿液样品的变异系数 (CV)分别为 5 .38%、4 .13%和 4 .73%、6 .0 1% ;HCG DOT定量测定血清和尿液的HCG回收率分别为 94 .7%和 89.9%。结论　DGIFA定量测定尿液HCG ,对尿液GICA结果可疑者可在妊娠早期作出明确的判断 ;DGIFA定量检测血清和尿液HCG的精密度良好 ,回收率较高 ,适合门急诊应用。     

New rapid kit for determining calcium in serum and urine evaluated

We describe the performance of a colorimetric reagent kit (Diagnostic Systems Laboratories, Inc., Webster, TX 77598) for measuring calcium directly in urine, serum, and ultrafiltered serum, and compare the results with those obtained with atomic absorption spectrophotometry. The CV for within-run precision was 2.8 and 2.1% for urine and whole serum, respectively (n = 10 each). Between-run precision for urine, whole serum, and ultrafiltered serum was 1.9, 1.6, and 2.2%, respectively (n = 8 to 10). Analytical recovery of added calcium from three different urine and serum specimens, to which three different concentrations of calcium had been added, was 101.9 (SD 0.3%) for urine and 100.9 (SD 0.2%) for serum. Assay of 30 urine specimens, 15 ultrafiltered serums, and 20 whole serums by both the kit and atomic absorption spectrophotometry demonstrated correlation coefficients of 0.993, 0.828, and 0.751, respectively. Mg2+, hemolysis, or lipemia does not interfere. Compared with atomic absorption spectrophotometry, the calcium kit procedure is rapid and simple.     

New dip-and-read test for determining leukocytes in urine

A new reagent strip for the determination of leukocytes in urine (LEUKOSTIX; Ames) is described. The test is based on the esterase activity in leukocytes as a marker. Upon contact between the reagent matrix and a urine containing leukocytes, an amino acid ester is hydrolyzed by the esterase to its corresponding alcohol. The free alcohol then couples with a diazonium salt to produce a purple azo dye. The relative concentration of leukocytes in the urine is obtained by visually comparing the strip reaction with a color chart. Performance of the strip was evaluated in a clinical study involving eight different sites and 867 urine specimens. The comparison method was sediment microscopy; specimens containing five cells or more per high-power field were considered to be positive. Sensitivity was 76.3%, specificity 80.8%. Performance was comparable with that of the CHEMSTRIP LN (Boehringer-Mannheim Diagnostics, Inc.) leukocyte test, which we evaluated concurrently.     

苄索氯胺法——一种新的尿蛋白定量检测方法

目的 对苄索氯胺法这种新的尿蛋白检测方法进行评价。方法 收集150例门诊就诊患者尿液,用苄索氯胺法检测其尿蛋白含量,以此评价该方法的线性范围、精确度、灵敏度、回收试验、重复试验。结果该方法线性范围上限达2.014g／L,回收率手工法为86．95％,自动法为106．85％,有良好的精密度（CV分别为4．97％和2．63%）,灵敏度为单一钨酸比浊法的19～34倍,该法与单一钨酸比浊法的相关性良好,相关系数r为0．9846。两法结果进行t检验,t=0．436,P〉0．05,结果 差异无统计学意义。结论 该方法有灵敏度高、重复性好的优点,结果稳定,标本用量少,适用于自动分析,是值得在临床上推广的方法。     

某国产纤维蛋白原试剂在 Sysmex CA1500血凝仪的临床性能验证

目的：某国产纤维蛋白原凝固法-Clauss 法试剂在日本 Sysmex CA1500血凝仪上的临床性能验证。方法国产纤维蛋白原试剂为 A 试剂，德国西门子 Dade Thrombin Reagent 试剂为 D 试剂，均采用 Clauss 法，分别测试两个水平质控品的批内精密度、批间精密度；165例正常临床样本用 A 试剂进行参考值范围验证；用 A 试剂和 D 试剂的200例临床样本纤维蛋白原结果比对，进行显著性检验和等效性检验。结果A 试剂和 D 试剂两个水平质控的批内精密度 CV 分别为4．28％、6．98％和3．45％、5．22％，A 试剂和 D 试剂两个水平质控的批间精密度 CV 分别为6．23％、10．34％和6．20％、9．89％，差异均无统计学意义（P ＞0．05）；A 试剂参考值范围为2．08～3．92 g/L；A 试剂和 D 试剂临床样本的纤维蛋白原结果比对，差异有统计学意义（P ＝0．025）；但是，两组试剂结果均数之差的90％双侧可信区间（90％CI ：-0．09，0．15）位于等效区间（-0．27，0．27）内。结论国产纤维蛋白原凝固法-Clauss 法试剂结果可靠，适用于日本 Sysmex CA1500血凝仪，和德国西门子 Dade 试剂临床应用等效。     

Evaluation of the Bayer microalbumin/creatinine urinalysis dipstick

BACKGROUND: The objective of this study was to evaluate the utility of the Bayer(R) microalbumin/creatinine urine reagent strip compared to established laboratory methods. METHODS: Random urine specimens from low and high risk pregnancy clinics as well as a random cohort from the community were analyzed for microalbumin and creatinine using both the reagent strip and the Roche Integra(R) 700, according to manufacturers' specifications. Sensitivity and specificity were then calculated. RESULTS: For the pregnant cohorts the sensitivities ranged from 19% to 59%, and the range of specificities was 45.4% to 84.2%. Using the microalbumin/creatinine data from the community, the sensitivity and specificity of the strip were 52.4% and 97.6%, respectively. CONCLUSION: The poor sensitivity of the microalbumin/creatinine urine reagent strip to detect significant microalbuminuria will likely limit its usefulness as a screening tool.     

生化分析仪不同标本用量与精密度的关系

目的 评价生化分析仪不同标本用量与精密度的关系.方法 随机收集7份不同乳酸脱氢酶（LDH）浓度新鲜血清标本,用日立7600-020全自动生化分析仪,对标本分别按常规测定参数和相应参数按比例增加后两种方式进行LDH测定,每次每个标本重复测定20次,计算出均值（x）、标准差（S）和变异系数（CV%）.结果 各标本LDH测定均值在参数调整后均比调整前略有升高;CV%值在参数调整后均比调整前减低.结论 适当按比例加大标本和试剂用量,可减低测量不精密度.     

检测粪便隐血的金免疫渗滤法的初步研究

目的建立以人白蛋白为靶抗原的检测人粪便隐血的金免疫渗滤法试剂,并作临床初步应用。方法应用自制的2株抗人白蛋白单克隆抗体,其中1株包被在硝酸纤维素膜上,另1株与胶体金结合,组成金免疫渗滤试剂,并用研制的试剂与商品化便隐血免疫层析法试剂对比检测69例临床粪便标本。结果本研究建立的方法检测范围为10～10 000 mg/L,与免疫层析法试剂条临床比对结果显示,69例标本中除1例本法为（＋）,而免疫层析法为（-）外,其余全部符合。结论本研究研制的金免疫渗滤法粪便隐血试验方法简便、结果可靠,进一步研究后可应用于临床。     

Kinetic fluorometric determination of aluminum in serum

We describe a simple fluorometric method for determining aluminum in serum samples by monitoring the rate of reaction of 2-hydroxy-1-naphthaldehyde-p-methoxybenzoylhydrazone with aluminum ions. The emission of the resulting fluorescent metal-chelate formed is measured at 475 nm. Aluminum was measured in the supernate of serum after proteins were removed by precipitation with concentrated nitric acid, and calculations were based on the technique of standard additions. Within-run precision (CV) was 7.8% and 4.8% at mean aluminum concentrations of 7.7 and 60.7 micrograms/L, respectively (n = 10); between-run precision (CV) was 8.9% and 5.7% at mean aluminum concentrations of 23.3 and 46.8 micrograms/L, respectively (n = 10). The standard curve for the method is linear over the range of 0-250 micrograms of aluminum per liter. Samples from 49 patients were analyzed for aluminum by the proposed method (y) and by electrothermal atomic absorption spectroscopy (x). Linear regression analysis of the results yielded the equation y = 0.98x + 2.3 (r = 0.989, Syx = 6.7). The proposed method is comparable in sensitivity to the well-accepted atomic absorption spectrometric method but is simpler and less expensive.     

Optimized microturbidimetric assay for fibrinogen

In this assay we measure the turbidity produced by precipitation of plasma fibrinogen with a reagent composed of ammonium sulfate, EDTA, and guanidine hydrochloride. The two-step reagent addition, and use of fixed reaction times, eliminates interference from bilirubin, hemoglobin, and chylomicrons. We checked 135 monoclonal proteins for interference, finding the probability of encountering major interference in samples from adults to be very low, P = 0.0002. The method is calibrated with purified fibrinogen and the response is linear over the range 0-10 g/L. Within-run precision (CV) is less than 2% from 1 to 10 g/L. Correlations with the immunoturbidimetric (r = 0.99), chronometric (r = 0.99), and clotting (r = 0.97) methods were extremely high.