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

摘要:

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14 d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CMV DNA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3 760元/例。结论(1)CMV-IgM阳性新生儿CMV DNA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。［中国当代儿科杂志，2010，12（10）：796-798］

Abstract:

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 3 760 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.［Chin J Contemp Pediatr, 2010, 12 (10):796-798］