ADVIA2120血液分析仪常用实验动物血液白细胞分类性能评价

目的对ADVIA2120血液分析仪实验动物白细胞分类性能进行评价。方法将ADVIA2120血液分析仪常用实验动物白细胞五项分类结果与手工镜检分类结果进行对比,运用SPSS17.0软件对分类结果进行统计分析。结果除比格犬、Wistar大鼠、食蟹猴嗜碱粒细胞外,其余各项白细胞分类结果仪器分类和手工镜检相比无显著差异(P>0.05),且相关性较好(r>0.9)。结论在仪器有白细胞相关提示警告时,无论各项分类指标是否在正常范围,应镜检为宜。     

ADVIA 2120血液分析仪常用实验动物血液白细胞分类性能评价

目的 对ADVIA 2120血液分析仪实验动物白细胞分类性能进行评价。方法 将ADVIA 2120血液分析仪常用实验动物白细胞五项分类结果与手工镜检分类结果进行对比,运用SPSS 17.0软件对分类结果进行统计分析。结果 除比格犬、Wistar大鼠、食蟹猴嗜碱粒细胞外,其余各项白细胞分类结果仪器分类和手工镜检相比无显著差异（P＞0.05）,且相关性较好（r＞0.9）。结论 在仪器有白细胞相关提示警告时,无论各项分类指标是否在正常范围,应镜检为宜。     

日本光电MEK-7222K全血细胞分析仪性能评价

目的:对日本光电MEK-7222K全血细胞分析仪的主要性能作初步评价。方法:按照国际血液学标准化委员会(ICSH)的有关规定对全血细胞指标进行测试。从精密度、总重复性、携带污染率、线性、白细胞分类结果与手工镜检的相关性、与SysmexXE-2100相关性以及仪器全血和预稀释两种计数模式之间的相关性等方面评价MEK-7222K全血细胞分析仪。结果:日本光电MEK-7222K全血细胞分析仪的批内、批间精密度CV值及总重复性CV值均在可接受范围内;各分析参数的携带污染率均<1%;线性良好;与SysmexXE-2100对比分析,所对比参数相关性良好;白细胞分类结果与手工镜检的相关性良好;全血和预稀释两种计数模式的相关性良好。结论:日本光电MEK-7222K全血细胞分析仪分析结果准确、可靠,仪器的各项主要性能都能满足临床的需要,可供国内大中小医院选用。     

五分类血细胞分析仪在临床血液学检验质量方面的应用分析

目的对五分类血细胞分析仪在临床血液学检验质量方面应用进行分析。方法用正常人抗凝血样本对我院全自动血细胞分析仪进行准确度、精密度、线性进行分析,并对不同疾病患者的抗凝血样本进行自动分类和手工分类(显微镜下计数)相比较研究。取3份标本,连续测定10次,观察其批内精密度;用质控物,连续测定20天,观察其批间精密度;将116份临床血液样本的全自动五分类血细胞分析仪检测结果与显微镜目测法得到的结果进行相关性回归分析。结果血细胞分析仪白细胞分类的批内精密度和批间精密度均在允许范围内,仪器法白细胞分类结果与显微镜目测法结果之间亦具有良好的相关性。结论全自动五分类血细胞分析仪是一种较为理想的血细胞分析仪,分析速度快,准确度高,提高了临床检验效率。     

BECKMAN COULTER HMX全自动五分类血细胞分析仪的临床应用

目的对BECKMAN COULTER HMX全自动血细胞分析仪的主要性能进行评价。方法我们安昭《全国临床检验操作规程》及贝克曼公司提供的方法,对ECKMAN COULTER HMX全自动五分类血细胞分析仪的精密度、准确度,线性范围和交叉污染率进行测定并和SYSMEX KX-21进行比较。结果 BECKMAN COULTER HMX全自动五分类血细胞分析仪精密度、准确度高,稳定性好,线性范围宽,交叉污染率低。结论 BECKMAN COULTER HMX全自动五分类血细胞分析仪是一台较理想的血细胞分析仪,适合在检验科中使用。     

Sysmex xs-1000i血细胞分析仪的应用评价

目的 评价Sysmex xs-1000i血细胞分析仪的性能.方法 用Sysmex xs-1000i血细胞分析仪和贝克曼库尔特LH750全自动血细胞分析仪检测临床血液标本,同时手工血细胞涂片法分类对照.结果 批内、批间精密度和总重复性CV值均小于5.0%;携带互染率小于1.0%;对白细胞、红细胞、血红蛋白、血小板测定结果,与LH750全自动血细胞分析仪密切相关,r均＞0.99;与人工白细胞分类比较具有相关性,r值在0.6187～0.9551之间;对异常形态细胞的筛查,特异性为91.2%.结论 Sysmex xs-1000i血细胞分析仪性能良好,是一种快速、有效筛检标本的血细胞分析仪.     

Cell-Dyn1800血液细胞分析仪临床应用评价

目的对雅培Abbottcell-Dyn1800（CD1800）血细胞分析仪进行应用评价。方法参照国际血液学标准化委员会（ICSH）颁布的文献方法对CD1800的主要性能进行检测。结果CD1800血液分析仪精密度、携带污染率、线性等均符合要求,与CoulterACTdiff2比较相关性良好。白细胞分类计数与人工法具有较好的一致性。结论CD1800血液分析仪性能良好能满足血液分析的一般要求。     

Sysmex-XN1000全自动血细胞分析仪的性能分析

目的分析Sysmex-XN1000全自动血细胞分析仪的性能。方法分析Sysmex-XN1000全自动血细胞分析仪携带污染率、精密度和空白计数。结果红细胞计数、白细胞计数、血红蛋白和血小板计数携带污染率均显著可允许范围;除批间精密度中低值血小板计数和变异系数高于标准外,其他均在标准中;通过空白计数试验白细胞计数、红细胞计数、血小板计数和血红蛋白最大值均低于允许范围。结论 SysmexXN1000全自动血细胞分析仪性能良好,满足临床工作需求。     

迈瑞BC-5500全自动血细胞分析仪应用评价

目的:初步评价迈瑞BC-5500全自动血细胞分析仪主要性能的可靠性.方法:按照国际血液学标准化委员会的有关规定对迈瑞BC-5500全自动血细胞分析仪进行测试,从精密度、携带污染率、线性及与SYSMEX XE-2100全自动血细胞分析仪相关性等进行评价.结果:迈瑞BC-5500全自动血细胞分析仪的批内、批间精密度及总精密度变异系数(CV)值均在可接受范围内;各分析参数的携带污染率均小于0.5%.线性良好;与SYSMEX XE-2100全自动血细胞分析仪对比分析,各研究参数相关性良好.结论:迈瑞BC-5500全自动血细胞分析性能优良,检测结果准确、可靠.     

迈瑞BC-5500全自动血细胞分析仪应用评价

目的:初步评价迈瑞BC-5500全自动血细胞分析仪主要性能的可靠性.方法:按照国际血液学标准化委员会的有关规定对迈瑞BC-5500全自动血细胞分析仪进行测试,从精密度、携带污染率、线性及与SYSMEX XE-2100全自动血细胞分析仪相关性等进行评价.结果:迈瑞BC-5500全自动血细胞分析仪的批内、批间精密度及总精密度变异系数(CV)值均在可接受范围内;各分析参数的携带污染率均小于0.5%.线性良好;与SYSMEX XE-2100全自动血细胞分析仪对比分析,各研究参数相关性良好.结论:迈瑞BC-5500全自动血细胞分析性能优良,检测结果准确、可靠.     

WS/T406-2012标准在Sysmex CS-2000i血凝仪分析性能验证中的应用

目的 评价Sysmex CS-2000i全自动血凝仪的分析性能.方法 根据中华人民共和国卫生行业标准WS/T406-2012文件及相关文献,对Sysmex CS-2000i全自动血凝仪检测PT、APTT和Fib的批内精密度、日间精密度、线性、正确度和准确度进行验证,确保分析性能满足临床需要.结果 PT、APTT、Fib的批内精密度1.44％～3.58％,日间精密度2.28％～4.88％;Fib的标本浓度在0.39～7.79 g/L范围内呈一次线性;正确度和准确度均符合WS/T406-2012标准要求.结论 Sysmex CS-2000i全自动血凝仪分析性能满足临床需要,WS/T406-2012行业标准具有较好的操作性和实用性,易于常规实验室使用和推广.     

ADVIA2120型血液分析仪异常报警参数及其可靠性分析

目的 了解ADVIA2120型全自动血液分析仪对细胞形态异常提示功能的可靠性.方法 将395例仪器提示异常参数的标本和268例无异常提示的标本作血涂片,经瑞特-姬姆萨染色镜检后比较结果.结果 真阳性率,未成熟粒细胞(IG)、血红蛋白浓度不等(HC-VAR)、小红细胞(MICRO)、核左移(LS)、大红细胞(MACRO)...     

两种分析仪C反应蛋白检测结果的比对

目的评价QuikRead101CRP分析仪的性能。方法以ARRAY360特定蛋白分析仪为比较方法,评估QuikRead101分析仪测定CRP的准确性、精密度、线性范围及两者的可比性。结果 QuikRead101CRP分析仪精密度良好,线性范围较宽,两检测系统间相关性较好。结论 CRP QuikRead101CRP分析仪操作简便、用血量少、检测速度快、精密度高、可比性好,特别适用于急诊需求。     

尿沉渣分析仪检测白细胞和细菌对尿路感染的筛查价值

目的 评估Uf-1000i尿沉渣分析仪检测白细胞和细菌的基本性能及对尿路感染的筛查价值. 方法 收集304例疑是尿路感染做尿培养的患者的中段尿,用尿沉渣分析仪Uf-1000i检测尿白细胞(WBC)和细菌(BACT).分析两项参数的精密度、线性和携带污染率.以尿细菌培养阳性为金标准,绘制尿白细胞和细菌计数的ROC曲线,并评价其诊断尿路感染的敏感度、特异度、假阳性率、假阴性率、阳性预期值、阴性预期值. 结果 Uf-1000i检测白细胞和细菌的批内精密度、日间精密度、携带污染率和线性范围均符合厂家标准;Uf-1000i尿沉渣分析仪用于诊断尿路感染的阈值,为白细胞计数173.5个/μL和细菌计数513.5个/μL.若以白细胞或细菌任意一项阳性来判断尿路感染,敏感度、特异度、假阳性率、假阴性率、阳性预期值、阴性预期值分别为83.3%、73.0%、27.0%、16.7%、62.9%、88.8%.以白细胞和细菌双阳性来判断尿路感染,敏感度、特异度、假阳性率、假阴性率、阳性预期值、阴性预期值分别为54.6%、93.9%、6.1%、45.4%、83.1%、79.0%.结论 Uf-1000i尿沉渣分析仪检测白细胞和细菌的性能符合厂家标准,对尿路感染能早期筛查,便于临床医师决定是否需要培养及选择早期用药.     

Simultaneous determination of multiple drugs of abuse and relevant metabolites in urine by LC-MS-MS

A method was developed for the quantitative analysis of 30 drugs of abuse and their metabolites in urine, including opiates, barbiturates, amphetamines, cocaine, cannabinoids, phencyclidine, methadone, and benzodiazepines. This method uses solid-phase extraction (SPE) on an Oasis HLB column followed by liquid chromatography-tandem mass spectrometry. Analytes were quantified by multiple reaction monitoring with the deuterated analogues as internal standards, using an atmospheric pressure ionization-electrospray interface. The method was validated by examining specificity, precision, accuracy, linearity, recovery, reproducibility, and detection limits. The limits of detection ranged from 9 pg/mL to 2.29 ng/mL in urine depending on the analyte. The SPE procedure was automated on a RapidTrace workstation to increase analytical throughput, and the results obtained via automated SPE were compared to those obtained by manual SPE to examine carryover effect, precision, accuracy, recovery, and reproducibility. To evaluate method performance, 108 urine samples were collected anonymously and tested for the presence of these drugs.     

尼麦角林残留量检验方法研究

目的通过对尼麦角林残留量高效液相色谱检验方法的验证,确定尼麦角林残留量用该检验方法检测的线性、灵敏度和回收率(准确度)。确保该方法对尼麦角林残留量浓度检测结果的准确性。方法高效液相色谱法。结果该检测方法的线性范围为1.0～15.0μg.mL-1;检测方法的回收率为99.4%,精密度与重复性良好;检测限为:0.001μg.mL-1;定量限为:0.009μg.mL-1。确定了凡残留量1.0～15.0μg.mL-1范围内,均可采用此方法检测。结论此方法操作简单,精密度、准确度、重复性较好。     

NM-BAPTA法钙检测试剂盒的性能评价

目的 对NM-BAPTA法钙检测试剂盒进行性能评价.方法 根据美国临床与实验室协会(CLSI)指南文件EP15-A2、EP9-A2、EP6-A、C28-A2,验证日立7180生化分析仪上NM-BAPTA法钙检测试剂盒的精密度、准确度、线性范围、生物参考区间.结果 高低2个浓度的血钙质控品批内精密度标准差(SD)分别为0.03 mmol/L、0.02 mmol/L,批间精密度标准差分别为0.08 mmol/L、0.06 mmol/L;准确度验证其血钙结果与参比系统cobas 8000血钙结果呈良好的相关性,r2=0.954 8,相对偏差＜12.5％;线性范围验证斜率为0.971,r2=0.999,线性范围为1.00～4.70 mmol/L,线性理想;参考区间验证符合率100％.结论 NM-BAPTA法钙检测试剂盒在日立7180生化分析仪上的分析性能符合质量目标要求,可应用于临床检测.     

Rapid, simultaneous determination of headspace oxygen and moisture in pharmaceutical packages using muGC

The rapid, accurate determination of headspace oxygen and moisture in various pharmaceutical packages is important for both product packaging development and the implementation of new packaging technologies. Current headspace oxygen measurement techniques suffer from serious drawbacks in terms of potential sampling contamination, lengthy analysis times, and large required analysis volumes. In addition, relatively few techniques currently exist for the convenient determination of headspace moisture in packaging systems. Efforts herein focused on the development and application of a new method for the rapid and simultaneous determination of headspace oxygen and moisture in pharmaceutical packages using micro-gas chromatography (muGC). Studies showed that both headspace oxygen and moisture could be simultaneously quantified in <90 s on sample volumes of 50-100 microL by employing muGC with dual chromatographic analysis modules. Sampling issues common to manual syringe-based injections were also alleviated in the current studies by use of the built-in diaphragm pump sampling interface of the portable muGC system. The performance of the analytical approach was evaluated and shown to exhibit excellent linearity, accuracy, and precision for both analytes. High sensitivity for headspace oxygen was demonstrated, allowing for levels of oxygen as low as 0.03% to be accurately quantified. The subject method was applied to measure the headspace oxygen and moisture in pharmaceutical blister packaging and glass vials.     

Determination of remifentanil, an ultra-short-acting opioid anesthetic, in rat blood by high performance liquid chromatography with ultraviolet detection

Remifentanil is an ultra-short-acting opioid under evaluation for use during surgical procedures which require opioid analgesia or anesthesia. It has an N-substituted methyl propanoate ester group which is highly susceptible to cleavage by blood and tissue esterases as well as to chemical hydrolysis. A selective and specific high performance liquid chromatography method was developed to quantitate remifentanil in rat blood. A liquid-liquid extraction method using n-butyl chloride was used to separate interfering endogenous products from the compound of interest. Reverse phase chromatography with ultraviolet (λ 210 nm) detection was used to quantitate the eluate. The calibration curves were found to be linear in the range 2.5–250 ng ml⁻¹. Intra-day assay variability was 15% or less for all standards evaluated. The method was applied to blood samples collected from a short-term infusion study in rats. Good recovery, linearity, accuracy and precision were achieved with the assay.     

Challenges of developing a bioanalytical method for a macrolide immunosuppressant compound by LC-MS/MS

The quantification of tacrolimus in human whole blood was developed by LC-MS/MS for a range of 50.0 to 50,000.0 pg/ml. Different challenges were faced during method development due to ion-suppression, lack of sensitivity and low recovery. The optimization of the extraction procedure played a crucial role as tacrolimus had to be isolated from red blood cells, to which it is strongly bound. Another particular challenge arose from the freeze-thaw stability where the extracted samples from fresh blood always showed a lower recovery. Finally, matrix effect was observed in some matrices over time, which resulted in a failed long-term stability in whole blood. In order to resolve the matrix effect issue, the sample procedure had to be improved. The final assay showed good recovery, low matrix effect, linearity, blood stability and good precision and accuracy.