评价中国北京市加速消除麻疹时代麻疹实验室诊断检测的充足性。

Evaluation of the adequacy of measles laboratory diagnostic tests in the era of accelerating measles elimination in Beijing, China.

机构信息

EPI Department, Beijing Center for Disease Control and Prevention, Beijing 100013, PR China.

出版信息

Vaccine. 2019 Jun 27;37(29):3804-3809. doi: 10.1016/j.vaccine.2019.05.058. Epub 2019 May 29.

DOI:10.1016/j.vaccine.2019.05.058

PMID:31153690

Abstract

BACKGROUND

Measles-containing vaccine (MCV) was introduced in 1965 in Beijing and given to the children aged 8m-14y. In population-based surveillance system, real-time polymerase chain reaction (RT-PCR) and immunoglobulin M(IgM) serology tests have been conducted for each suspected case since 2013. We used the surveillance data to evaluate the adequacy of the tests for laboratory confirmation during 2014-2016.

METHODS

Informations on IgM tests, RT-PCR, age, vaccination history for confirmed cases were from the surveillance system. Laboratory confirmed cases were defined as cases with positive IgM serology and/or positive RT-PCR. All tests were conducted in the laboratories accredited by Beijing CDC or Beijing CDC laboratory.

RESULTS

Totally 4600 cases were confirmed. Sensitivities of IgM tests within 0-3 days post rash, IgM tests within 4-28 days post rash and RT-PCR within 0-3 days post rash were 56.53%, 82.06% and 94.39%, respectively. The combined sensitivity of IgM tests and RT-PCR decreased by the interval between rash onset and collection of virologic specimen. MCV immunization history lowered sensitivity of IgM tests and RT-PCR. Among the cases aged ≥ 15 years, around 95% had no written immunization records. The sensitivity of IgM tests within 0-3 days post rash was less than 60%. Around 60% had unknown immunization histories. Compared with unvaccinated cases based on written records, unvaccinated cases based on recollection had no significantly different sensitivity of laboratory tests. But unknown immunization history significantly lowered sensitivity of RT-PCR within 0-3 days post rash.

CONCLUSIONS

Neither IgM tests nor RT-PCR reached 100% sensitive for confirmed cases. Virologic specimen should be collected as early as possible to achieve maxim sensitivity. Cases with unknown immunization history could not be treated as unvaccinated. Combination of the two tests and further laboratory assays were needed especially for vaccinated cases or cases aged ≥15 years.

摘要

背景

麻疹疫苗（MCV）于 1965 年在北京引入，适用于 8 个月至 14 岁的儿童。自 2013 年以来，基于人群的监测系统对每个疑似病例均进行实时聚合酶链反应（RT-PCR）和免疫球蛋白 M（IgM）血清学检测。我们使用监测数据评估了 2014-2016 年期间实验室确诊病例的检测方法是否充分。

方法

确诊病例的 IgM 检测、RT-PCR、年龄和疫苗接种史等信息均来自监测系统。实验室确诊病例定义为 IgM 血清学检测和/或 RT-PCR 检测阳性的病例。所有检测均在北京 CDC 或北京 CDC 实验室认可的实验室中进行。

结果

共确诊 4600 例病例。出疹后 0-3 天内 IgM 检测、出疹后 4-28 天内 IgM 检测和出疹后 0-3 天内 RT-PCR 的敏感性分别为 56.53%、82.06%和 94.39%。IgM 检测和 RT-PCR 的联合敏感性随着出疹与采集病毒学标本之间的时间间隔而降低。MCV 免疫接种史降低了 IgM 检测和 RT-PCR 的敏感性。在年龄≥15 岁的病例中，约 95%无书面免疫接种记录。出疹后 0-3 天内 IgM 检测的敏感性低于 60%。约 60%的病例免疫史不详。与根据书面记录确定的未接种疫苗病例相比，根据回忆确定的未接种疫苗病例的实验室检测敏感性无显著差异。但免疫史不详显著降低了出疹后 0-3 天内 RT-PCR 的敏感性。