FQ-PCR检测法诊断先天性巨细胞病毒感染的卫生经济学评价

Economic evaluation on diagnosis of congenital cytomegalovirus infection by fluorescent quantitative polymerase chain reaction in neonates

目的探讨采用荧光定量聚合酶链式反应(FQ-PCR)检测法诊断新生儿先天性巨细胞病毒(CMV)感染的经济学成本。方法对610例日龄在14d以内的新生儿采用酶联免疫吸附法检测血清CMV抗体,对于CMV-IgM或IgG阳性新生儿采用FQ-PCR检测其尿液CMV含量,并分析确诊1例CMV感染病例的平均费用。结果 CMV-IgM阳性新生儿的FQ-PCR阳性率为42.9%(15/35);单纯IgG阳性者为2.9%(16/547)。CMV-IgM阳性组CMVDNA对数值的均值为5.79±1.24,明显高于单纯CMV-IgG阳性组(4.11±0.87)(P<0.01)。CMV-IgM阳性病例确诊先天性CMV感染的平均费用为256元/例,单纯IgG阳性者为3760元/例。结论 (1)CMV-IgM阳性新生儿CMVDNA含量高于单纯CMV-IgG阳性者;(2)FQ-PCR确诊CMV-IgG阳性的新生儿为先天性CMV感染的成本-效益比远高于CMV-IgM阳性的患儿,对于CMV-IgG阳性新生儿,该法不适合于大规模流行病学诊断性研究。

Objective To explore the cost-effectiveness of the diagnosis of congenital cytomegalovirus （ CMV） infection by fluorescent quantitative polymerase chain reaction （ FQ-PCR ） in neonates. Methods Serum CMV immunoglobulin M （ CMV-IgM） and CMV-IgG were detected using ELISA in 610 neonates aged less than 14 days. CMV DNA content was detected by FQ-PCR. The cost-effectiveness analysis was then performed. Results The positive rate of FQ-PCR in neonates with positive CMV-IgM was 42. 9% （ 15 /35） ,while,2. 9% （ 16 /547） in neonates with positive CMV-IgG. The mean logarithm values of CMV DNA in neonates with positive CMV-IgM were higher than those in neonates with positive CMV-IgG （ 5. 79 ± 1. 24 vs 4. 11 ± 0. 87; P 0. 01） . The costs of the diagnosis of CMV infection by FQ-PCR were 256 RMB /case in neonates with positive CMV-IgM,and 3760 RMB /case in neonates with positive CMV-IgG. Conclusions The CMV DNA content in neonates with positive CMV-IgM is higher than that in neonates with positive CMV-IgG. Diagnosis of congenital CMV infection by FQ-PCR in neonates with positive CMV-IgG is not suitable for large scale epidemiological survey because of high cost-effectiveness ratio.