BECKMAN COULTER 4C Plus细胞质控品的稳定性探讨

目的探讨BECKMAN COULTER 4C Plus细胞质控品开盖后的稳定性,以便更经济正确地使用该质控品.方法每月采用BECKMAN COULTER MDⅡ三分群血细胞分析仪对三个不同水平的4C Plus细胞质控品进行测定,每支开盖后测定4周到5周.结果BECKMAN COULTER 4C Plus细胞质控品开盖两周前后各参数的绝大多数结果在统计学上无差异(P＞0.05),尽管个别参数结果于开盖两周前后有差异(P＜0.05),但这些参数95%的结果都在靶值的一个标准差范围内.IQAP回报的结果中只有淋巴细胞百分比略低于组值,其它参数结果均与组值接近且精度良好.结论注意质控品的贮存、预热和混匀,BECKMAN COULTER 4C Plus细胞质控品开盖4周到5周内结果可保持稳定.     

测定全血质控品衡量血细胞分析仪的可靠性

目的 了解血细胞分析仪测定结果的可靠性.方法 分别测试全血质控品的原浓度2、4倍稀释度,每一浓度测试5～7次,计算白细胞、红细胞、血红蛋白、血小板的SD、CV值,并将原浓度测试结果与对应的靶值比较.结果 上述项目的测试结果与靶值比较绝对误差为0.47、0.11、2.57、1.43,各测量值基本上都在允许范围之内,稀释倍率与测定结果之间线性关系良好.各系列SD、CV值均在可接受范围之内,精密度较高.结论 用全血质控品测试血细胞分析仪结果可靠,简便易行.     

网织红细胞质控品研究进展

1概述 网织红细胞freticulocyte．Ret．RET）是幼稚的红细胞．由骨髓中有核红细胞脱去细胞核形成．大约3d后被释放人血液，并进一步通过降解、自噬、胞吐尊复杂机制丢失核糖体、线粒体等细胞器和膜脂、部分血红蛋白、水等成分而获得典型的双凹圆盘状形态．成为成熟红细胞。这一成熟过程不但能在活体血液内完成．在离体抗凝状态下同样可以进行.     

质量控制数据在室内质控品稳定性期间核查中的应用

目的利用前后两组质量控制数据进行统计学分析,对室内质控品进行期间核查,以确保质控品的稳定性,建立一种适合医学实验室室内质控品期间核查的新方法。方法利用乙型肝炎表面抗原,丙型肝炎抗体,梅毒抗体,HIV抗体室内质控品,使用期内前后各2个时间段的质量控制数据,统计分析前后2组数据差异有无统计学意义,判断室内质控品在2组数据之间时间段内的稳定状态。结果统计分析2组数据,丙型肝炎抗体,梅毒抗体,HIV抗体2个时间段的数据差异无统计学意义(P0.05),说明质控品在使用过程中保持了稳定性。乙型肝炎表面抗原的2组数据差异有统计学意义(P0.05),说明质控品在这段时间内没有保持良好的稳定性,应该采取措施。结论利用从室内质控中获得的质量控制数据计算出的均值(x)和标准差(s),进行统计学分析,判断2个时间段的数据差异有无统计学意义,从而达到对室内质控品期间核查的目的。     

网织红细胞质控品研究进展

1概述 网织红细胞(reticulocyte.Ret.RET)是幼稚的红细胞.南骨髓中有核红细胞脱去细胞核形成,大约3d后被释放入血液,并进一步通过降解、自噬、胞吐等复杂机制丢失核糖体、线粒体等细胞器和膜脂、部分血红蛋白、水等成分而获得典型的双凹圆盘状形态,成为成熟红细胞.这一成熟过程不但能在活体血液内完成,在离体抗凝状态下同样可以进行[1～3].     

尿HCG质控品均匀性和稳定性的评价

目的 通过化学发光免疫分析法(CLIA)和胶体金法两种方法对尿人绒毛膜促性腺激素(HCG)质控品的均匀性和稳定性进行评价.方法 采用CLIA和胶体金法检测尿HCG质控品中的HCG.结果 储存4个月内,质控品的均匀性和稳定性均符合要求,两种方法评价的结果一致.质控品储存5个月时,CLIA检测显示:质控品HCG水平不在稳定性范围(92.55～103.89 mIU/mL)内,质控品不稳定;胶体金法检测显示:结果为100％阳性,质控品稳定.结论 用CLIA和胶体金法相结合的评价方式可更准确地评价尿HCG质控品的均匀性和稳定性.     

血细胞分析仪使用的室内质控探讨

我院于2000年2月引进日本产Sysmex的SF-3000全自动五分类血细胞分析仪,极大的提高了工作效率和精密度,但先进的仪器需要全面的质量控制,才能得到合理使用和准确结果。为此,我们采用本省临检中心提供的全血质控物结合Bull浮动均值法原理进行质控。在必要时,再结合手工法显微镜计数分类进行校对。一年来,结果较满意。现将综合全面的质量控制工作方法与同行作一交流探讨。     

血细胞质控品开封后的稳定性研究

目的了解血细胞质控物开封后的稳定性。方法取1瓶全血细胞质控物分装于15支具盖圆底离心管中，贮存于2℃～8℃冰箱。每天取1支分装的质控血按照全血和预稀释两种模式进行测试。测定结果填写到质控图中。质控项目为WBC、RBC、Hb、MCV、HCT、PLT。该批血细胞质控物同时进行不分装连续使用15d的对照，进行稳定性观察。结果分装后第1～15d的各项测定参数之间差异无统计学意义。未分装连续使用的血细胞质控物，其血小板测定结果在第7d即显著性增高（P〈0．05）。预稀释方法测定结果的CV值是全血的1．3～5．5倍。结论1支血细胞质控物开封分装后贮存于2℃～8℃冰箱中至少可使用15d，而开封后不分装只能使用6d。血细胞质控物开封后分装使用稳定性更好。全血模式比预稀释模式具有更好的重复性和准确性。     

补体C3、C4在家犬脑出血模型中的变化

目的:研究家犬脑出血(ICH)模型补体C3、C4与血肿周围脑水肿的关系。方法:30只家犬随机分为正常对照组、影像组和血肿组3组各10只。正常对照组不予任何处理,影像组和血肿组采用立体定向自体血脑内注入法制备ICH模型。正常对照组和影像组分别于术后6 h、24 h、72 h、5 d、7 d检测外周静脉血C3、C4含量,各时间点行头颅CT扫描并计算水肿比值。血肿组分别于术后6 h、24 h、72 h、5 d、7 d检测血肿液C3、C4含量。各时间点采用Purdy PD评分标准评估神经功能缺损。结果:影像组和血肿组外周血、血肿液补体C3、C4含量术后6 h开始升高,72 h达高峰,之后逐渐下降。影像组、血肿组与正常对照组比较,术后6 h外周血C4差异无统计学意义(P>0.05),其余同时间点两两比较差异均有统计学意义(P<0.05)。ICH后Purdy PD评分即有所下降,72 h下降为最低,之后逐渐升高。结论:ICH后补体C3、C4激活可能参与血肿周围脑水肿形成和继发性脑损害的病理过程。     

A case of successful treatment with telaprevir-based triple therapy for hepatitis C infection after treatment failure with vaniprevir-based triple therapy

Recently direct-acting antiviral agents, such as hepatitis C virus (HCV) non-structural 3/4A (NS3/4A) protease inhibitors (PI), have been introduced, and triple therapy regimens that include PI with conventional pegylated interferon α and ribavirin have significantly improved the sustained virological response (SVR) rate, up to 80% for both treatment-naïve and treatment-experienced patients with HCV genotype 1. We here report for the first time a case of the successful treatment of HCV genotype 1 infection with a first generation PI drug (telaprevir) based triple therapy after treatment failure with a second generation PI drug (vaniprevir) based triple therapy. A 67-year-old treatment-naïve Japanese man with HCV genotype 1b infection took part in a phase III clinical trial of vaniprevir-based triple therapy. His serum HCV RNA had become undetectable at week 2 and SVR was highly expected, but HCV RNA reappeared at week 4 after vaniprevir treatment. Polymerase chain reaction direct sequence of the HCV NS3/4A gene at week 8 after vaniprevir treatment showed the emergence of a vaniprevir-resistance mutation (D168V), the probable reason for the treatment failure. Six months later, retreatment with telaprevir-based triple therapy was started. Although the dosages of telaprevir and ribavirin had to be reduced due to severe anemia, the patient achieved an SVR. This case shows the value of repeating PI-based triple therapy with a different drug, a process that would reduce the chance of drug resistant mutation.     

Falsely elevated human epididymis protein 4 results and Risk of Ovarian Malignancy Algorithm in polymorbid women after solid organ transplantation: A pilot and case‐control study

Background

Cancer prevention is essential after transplantation (Tx). The use of HE4 and Risk of Ovarian Malignancy Algorithm (ROMA) is recommended as a tool for selective ovarian cancer screening; however, creatinine is a known confounder. This study assessed the reliability of HE4, CA125, and ROMA after Tx.

Methods

We matched a total of 202 women without gynecological malignancies and 236 men by age and serum creatinine. Each pair consisted of a patient after Tx (kidney, liver, heart, and pancreas) and a diseased but non‐Tx consecutive patient. Serum HE4, CA125 (Roche Cobas 6000), and creatinine (enzymatic, Abbott Architect) were measured in all patients.

Results

Creatinine correlated with HE4 (women: r = .864, P < .0001; men: r = .848, P < .0001). Age correlated slightly with HE4 in women (r = .250, P < .005) and men (r = .240, P < .0005). HE4 in women after Tx (median of 84.8 pmol/L) was significantly higher than non‐Tx women (53.7 pmol/L, P < .0001) in the reference range of serum creatinine. Neither HE4 nor CA125 correlated with tacrolimus concentration, but anemia, hyperparathyroidism, kidney, liver, and lung diseases were possible confounders for HE4 after transplantation (P < .05).

Conclusion

Human epididymis protein 4 (HE4) was significantly increased in women after solid organ transplantation compared to levels without transplants matched by age and serum creatinine. HE4 results may be misleading in these patients.

     

The PRIMAVERA study protocol design: Evaluating the effect of continuous erythropoiesis receptor activator (C.E.R.A.) on renal function in non-anemic patients with chronic kidney disease

Erythropoiesis stimulating agents (ESA) are widely used for hemoglobin correction in patients suffering from renal anemia. However, their beneficial non-hematopoietic effects on renal deterioration have not been adequately assessed. The Primavera study is the first prospective, controlled trial to assess whether ESA treatment could ameliorate progression of chronic kidney disease (CKD) in non-anemic patients. Primavera is a single-blind, 24-month trial in which patients are randomized to placebo or to C.E.R.A., a continuous erythropoietin receptor activator. Patients with type 2 diabetes or who have undergone kidney transplantation are eligible to enter the study if they have CKD stage III (estimated GFR [eGFR] 30–59 mL/min/1.73 m²), urinary albumin to creatinine ratio (UACR) ≥ 50 g/g and ≤ 1500 g/g, or total urine protein ≥ 50 mg/24 h and ≤ 1500 mg/24 h, and hemoglobin 11–14 g/dL. The primary efficacy endpoint is the change in eGFR from baseline to month 24. Secondary efficacy endpoints are the changes in UACR, serum cystatin C and serum creatinine from baseline. Safety endpoints include adverse events and discontinuation due to pre-specified adverse events. An interim analysis will be performed after all patients have completed the first year. The planned sample size is 400 patients (200 type 2 diabetics, 200 transplant recipients) conferring 90% power to detect a prespecified significant difference of 1.5 mL/min/1.73 m² in the annual reduction in eGFR between treatment groups. The results of Primavera are expected in 2013.