Evaluation of three automated Treponema pallidum antibody assays for syphilis screening

The accuracy of the test is critical for the syphilis serology diagnosis. This study aims to evaluate the values of the Elecsys syphilis assay, the Architect syphilis assay, and the Mindray syphilis assay, as syphilis screening tests for pregnant women and patients with syphilis or other diseases. A reverse algorithm was used for the syphilis serology diagnosis. Serum samples (n = 584) were tested with three automated screening assays. All reactive sera by one, two, or three screening assays were further analyzed with the tolulized red unheated serum test (TRUST). Inconsistent results were confirmed by the Treponema pallidum particle agglutination assay (TPPA). The final patient diagnosis was made according to the results of syphilis serology, clinical evidence, and past medical history. The sensitivity, specificity, accuracy, and kappa value of each assay were as follows: for the Elecsys syphilis assay, 100.0%, 98.5%, 98.6%, and 0.927, respectively; for the Architect syphilis assay: 100.0%, 94.5%, 95.0%, and 0.770; and for the Mindray syphilis assay: 100.0%, 97.0%, 97.3%, and 0.862. The McNemar test showed that there were significant differences in the performance between the Elecsys syphilis assay and the Architect syphilis assay (P < 0.001), and between the Mindray syphilis assay and the Architect syphilis assay (P = 0.001). Our study demonstrated that three automated Treponema pallidum antibody assays generally showed high sensitivities and specificities, and so, they are suitable for use in screening for syphilis. The performances of the Elecsys syphilis assay and the Mindray syphilis assay are superior to Architect syphilis assay.     

CMIA、FPIA及MS在全血环孢霉素A浓度监测中的对比分析

目的通过荧光偏振免疫法(FPIA)、化学发光微粒子法(CMIA)和质谱法(MS)对全血环孢霉素A(CsA)谷浓度测定结果的比较,了解3种方法检测结果的差异,以便更加合理地选择CsA浓度监测方式。方法采集分离100例肾移植术后患者稳态浓度的血浆样品,以CMIA、FPIA以及MS法测定CsA浓度,并对3种方法测定结果进行统计分析。结果 FPIA的线性范围在0～800ng/ml,最低检测浓度为43.0ng/ml,而CMIA法测定的线性范围在0～1500ng/ml,最低检测浓度为24.1ng/ml;3种方法中,FPIA法和CMIA法的检测结果与和MS的相关系数r分别为0.96和0.97;FPIA和CMIA法的检测结果均高于MS(P<0.01),但相比FPIA法,CMIA的测定值明显更低,两组数据差异具有统计学意义(P<0.01);Bland-Alman一致性分析显示,CMIA法的测定结果较FPIA法普遍偏低,平均偏差为-76.5ng/ml。结论 CMIA相比FPIA法,灵敏度和特异度更高,是更为客观和理想的CsA血药浓度的检测方法,建议可推广入临床常规监测。     

化学发光法检测梅毒抗体在血清学中的临床应用

目的探讨化学发光法（CMIA）在梅毒感染血清检测中的应用。方法用梅毒螺旋体明胶凝集试验（TPPA）和甲苯胺红不加热血清试验（TRUST）对CMIA初筛阳性标本进行进一步检测,并以TPPA为金标准对CMIA进行确认。结果 16 548例血清标本经CMIA初筛阳性的274例,274例阳性标本经TPPA复检阳性193例,阳性检出率为70.4%;而TRUST检测75例,阳性检出率27.4%。以TPPA为金标准,用CMIA对TPPA初筛阳性及阴性标本各60例进行复检,CMIA敏感性为100%（60/60）,特异性为96.7%（58/60）。结论 CMIA敏感性及优于TPPA和TRUST,重复性好,操作简便,可用于梅毒的临床初筛。     

CMIA法在出入境人员乙肝两对半定量检测中的探讨

本文通过对出入境人员250例标本分别采用CMIA、ELISA方法进行乙肝两对半测定和临床观察,发现由于受检抗原抗体定性结果不是阳性就是阴性,无法动态观察病情和疗效的变化,尤其是出入境人员所能提供的信息有限,定量检测可与血清HBV-DNAPCR测定相互补充,综合评价患者病情与药物疗效。     

比较HPLC和化学发光微粒子免疫法测定癫痫患儿血浆中丙戊酸的浓度

摘 要 目的： 用HPLC法测定癫痫患者血浆中丙戊酸的浓度,与化学发光微粒子免疫法（CMIA）比较,评价两种测定方法的一致性。方法: 分别用 HPLC法和CMIA 法测定230例癫痫患者血浆中丙戊酸的浓度,测定值用Passing Bablok回归法和Bland Altman法分析,考察2种方法的相关性及差异。结果: HPLC法（Y）和CMIA（X）法的回归方程为Y=1.069 7X+2.338 2(R2=0.969,n=230),显示两种方法相关性良好;Bland Altman法分析表明两种测定方法的一致性欠佳,HPLC法测定值偏高。结论:HPLC法和CMIA法测定癫痫患者血浆中丙戊酸的浓度具有较好的相关性,但一致性欠佳,且存在系统误差,在临床治疗中,两种方法不可以互换,应注意调整和选择。     

The prevalence of hepatitis B core antibody in vaccinated Chinese children: A hospital-based study

Background & aims

After nearly 30?years of immunization, there is little known about the prevalence of hepatitis B core antibody (anti-HBc) in Chinese children. The clinical significance of anti-HBc would be more and more important. In this study, we had tried to analyse the prevalence of anti-HBc in vaccinated Chinese children, exploring the post-immunization status based on a large sample sized investigation.

Evaluation of the Architect tacrolimus assay in kidney,liver, and heart transplant recipients

The narrow therapeutic range of tacrolimus requires therapeutic drug monitoring to prevent transplant rejection and to minimize nephrotoxicity. The aim of this study was to evaluate the analytical performance of the tacrolimus chemiluminescent microparticle immunoassay (CMIA) in everyday practice comparatively with other methods. CMIA imprecision and accuracy were tested using low, medium, and high concentrations in control samples. The limits of quantification (LOQ) of CMIA and antibody-conjugated magnetic immunoassay (ACMIA) were evaluated using negative whole-blood samples containing 0.4–5.7 ng/ml of tacrolimus from a stock solution. CMIA was compared with ACMIA, enzyme multiplied immunoassay (EMIT), and liquid chromatography–tandem mass spectrometry (LC–MS/MS), using 176 samples from recipients (135 men and 41 women) of heart (n = 19), kidney (n = 107), or liver (n = 50) transplants. CMIA total precision was 5.7%, 3.7% and 3.6% with the low-, medium-, and high-concentration controls, respectively; corresponding values for accuracy were 98%, 104%, and 104%. LOQ was 0.5 (95%CI, 0.22–1.38) with CMIA and 2.5 ng/ml with ACMIA. Linear regression results were as follows: CMIA = 1.2LC–MS/MS + 0.14 (r = 0.98); CMIA = 0.93EMIT + 0.36 (r = 0.975); CMIA = 1.15ACMIA − 0.25 (r = 0.988); and, for tacrolimus concentrations in the 1–15 ng/ml range, of special interest as many transplant recipients are given low-dose tacrolimus, CMIA = 1.05LC–MS/MS + 0.38 (r = 0.94). Two patients had falsely elevated tacrolimus concentrations due to interference in the ACMIA assay; one was a renal transplant recipient who stopped her treatment and had tacrolimus concentrations of 12.5 ng/ml by ACMIA and <0.5 ng/ml by CMIA; the other was an HIV-positive renal transplant recipient whose tacrolimus concentrations by ACMIA were 1.8–43.7-fold those by CMIA. Such interferences with ACMIA, which may be related to endogenous antibodies in the plasma, are likely to negatively impact patient care. In conclusion, the tacrolimus CMIA assay is suitable for routine laboratory use and does not suffer from the interferences seen with ACMIA in some patients.     

广州市学龄前儿童乙肝疫苗免疫效果的定量分析

目的:了解广州市学龄前儿童乙肝疫苗的免疫效果,为乙肝疫苗加强免疫提供科学依据。方法:采用化学发光微粒子免疫分析法(CMIA)定量检测2 542名广州市0～6岁HBsAg阴性儿童血清抗-HBs浓度。结果:CMIA检测广州市0～6岁儿童血清抗-HBs总体阳性率为94.34%,随着年龄增长,血清抗-HBs阳性率逐渐降低,组间差异存在统计学意义(P<0.01);血清抗-HBs浓度亦逐渐下降,组间差异有统计学意义(P<0.01)。结论:广州市学龄前儿童乙肝免疫整体处于较高水平,但由于抗体的时效性,应定期检测血清抗-HBs浓度,及时复种加强免疫。     

免疫层析技术和化学发光法免疫分析法在梅毒检测中的效果比较

目的:考察全自动微粒子化学发光免疫实验(CMIA)与免疫层析技术(GICA)在梅毒检测中的应用效果差异。方法:采用TPPA法作为金标准检测1500例住院患者血清标准,评价CMIA与GICA在梅毒检测中敏感性和特异性。结果:金标准中1500例血清标本梅毒检出率为12.1%,CMIA阳性检出率为12.5%,GICA为12.7%。CMIA法灵敏度为92.86%,特异性为98.,6%,阳性预测值为89.89%,阴性预测值为99.01%。GICA法灵敏度为98.35%,特异性为99.77%,阳性预测值为98.35%,阴性预测值为99.77%。两组间灵敏度和阴性预测值存在显著差异(P0.05)。结论:GICA的灵敏性和阴性预测值优于GICA法,可以提到TPPA成为梅毒检测的血清学检测首选方法。     

化学发光微粒子免疫法和酶放大免疫法检测环孢素A全血浓度的相关性分析

目的 通过化学发光微粒子免疫法（CMIA）和酶放大免疫法（EMIT）检测环孢素A全血浓度,评价2种方法检测结果的准确性和相关性。方法 CMIA和EMIT检测低、中、高3个全血免疫抑制剂质控物,进行准确度和批内、批间精密度分析;已知浓度的环孢素A（49.5,155.2,395.8,500.0,995.0,1 390.1 ng·mL^-1）加入到不含环孢素A全血样本中,检测后计算结果回收率;测定100份环孢素A患者全血样本,测定值用Deming法进行线性回归分析和Bland-Altman法计算偏倚。结果 CMIA低、中、高3个全血免疫抑制剂质控物准确度相对误差分别为5.8%,5.2%,9.1%,其批内和批间的变异系数分别为7.4%,6.9%,8.6%和10.1%,11.3%,8.7%,CMIA回收率分别为91%,95%,103%,102%,102%,104%;EMIT低、中、高3个全血免疫抑制剂质控物的相对误差分别为2.8%,2.3%,4.3%,其批内和批间的变异系数分别11.2%,5.9%,5.7%和11.3%,9.2%,8.3%,EMIT回收率分别为90%,92%,97%,98%,99%,102%;CMIA和EMIT平均差异偏倚21.7 ng·mL^-1（95% CI：-125.1~168.4 ng·mL^-1）,EMIT测定值/CMIA测定值平均为0.951（95% CI：0.56~1.34）,EMIT测定结果平均低于CMIA 5%左右。结论 CMIA和EMIT检测环孢素A全血浓度符合免疫分析精密度的要求,2种方法的检测结果相关性好,临床合理调整用药剂量时应考虑检测方法类型不同造成的影响。