Clinique Sainte-Elisabeth, rue de Naimeux 17, 4802 Heusy, Belgium.
J Clin Virol. 2010 Nov;49(3):192-7. doi: 10.1016/j.jcv.2010.07.024. Epub 2010 Aug 30.
Reliable laboratory methods for detecting congenital CMV infection are valuable since CMV infections are asymptomatic and because early detection is important for correct management and counseling of expectant mothers.
Compare the Beckman Coulter Access(®) method for the Unicel(®) DxI 800 analyzer with the bioMérieux VIDAS(®) method for two serological markers: CMV IgG and CMV IgM.
Precision was determined with CLSI EP5-A2 protocol. Linearity of the Access CMV IgG was evaluated using selected high positive samples. Performance was assessed by testing non-selected pregnant women, frozen negative and positive samples with recent and old infections. Kinetics of the anti-CMV antibodies response was studied using samples from pregnant women with a recent infection. In a prospective study, 3992 pregnant women were screened for determining prevalence of a primo-infection and CMV IgM non-specific rate.
Total CV is lower than 10% and 12% for Access CMV IgG and CMV IgM. The IgG method is linear (R(2)=0.999) with recoveries between 85% and 108%. Correlation between Access and VIDAS CMV IgG is highly significant (P<0.001). Observed agreement was 97.4% for CMV IgG and 93.7% for CMV IgM. Relative sensitivity and specificity was 97.2% and 100% for IgG and 100% and 97.4% for IgM. Kinetics of the antibody response measured with Access methods is significantly higher (P<0.02) when compared with VIDAS and probably easier to interpret. Prevalence of a recent infection was 0.85% and CMV IgM non-specific rate was 2.9%.
Good sensitivity and specificity and pronounced anti-CMV antibody response make the Access CMV IgG and IgM tests suitable for screening prenatal CMV infections.
可靠的实验室方法检测先天性 CMV 感染具有重要价值，因为 CMV 感染无症状，且早期检测对正确管理和咨询孕妇至关重要。
比较贝克曼库尔特 Access（®）法和生物梅里埃 VIDAS（®）法在两种血清学标志物：CMV IgG 和 CMV IgM 上的检测结果。
根据 CLSI EP5-A2 方案确定精密度。采用选定的高阳性样本评估 Access CMV IgG 的线性。通过检测非选择的孕妇、近期和陈旧感染的冷冻阴性和阳性样本评估性能。采用近期感染孕妇的样本研究抗 CMV 抗体反应的动力学。前瞻性研究中，对 3992 名孕妇进行筛查，以确定初次感染的流行率和 CMV IgM 非特异性率。
Access CMV IgG 和 CMV IgM 的总 CV 低于 10%和 12%。该 IgG 方法具有线性（R²=0.999），回收率在 85%至 108%之间。Access 和 VIDAS CMV IgG 之间的相关性高度显著（P<0.001）。对于 CMV IgG，观察一致性为 97.4%，对于 CMV IgM，观察一致性为 93.7%。对于 IgG 和 IgM，相对灵敏度和特异性分别为 97.2%和 100%、100%和 97.4%。用 Access 方法测量的抗体反应动力学明显更高（P<0.02），且可能更容易解释。近期感染的流行率为 0.85%，CMV IgM 非特异性率为 2.9%。
良好的灵敏度和特异性以及明显的抗 CMV 抗体反应使 Access CMV IgG 和 IgM 检测适用于筛查产前 CMV 感染。
