Dried Blood Spot Real-time Polymerase Chain Reaction Assays to Screen Newborns for Congenital Cytomegalovirus Infection

被引:253
作者
Boppana, Suresh B. [1 ,3 ]
Ross, Shannon A. [1 ]
Novak, Zdenek [1 ]
Shimamura, Masako [1 ]
Tolan, Robert W., Jr. [5 ]
Palmer, April L. [6 ]
Ahmed, Amina [7 ]
Michaels, Marian G. [8 ,9 ]
Sanchez, Pablo J. [10 ]
Bernstein, David I. [11 ,12 ]
Britt, William J. [1 ,3 ,4 ]
Fowler, Karen B. [1 ,2 ]
机构
[1] UAB, Dept Pediat, Birmingham, AL 35233 USA
[2] UAB, Dept Epidemiol, Birmingham, AL 35233 USA
[3] UAB, Dept Microbiol, Birmingham, AL 35233 USA
[4] UAB, Dept Neurobiol, Birmingham, AL 35233 USA
[5] St Peters Univ Hosp, Dept Pediat, New Brunswick, NJ USA
[6] Univ Mississippi, Med Ctr, Dept Pediat, Jackson, MS USA
[7] Carolinas Med Ctr, Dept Pediat, Charlotte, NC 28203 USA
[8] Univ Pittsburgh, Dept Pediat, Pittsburgh, PA 15260 USA
[9] Childrens Hosp Pittsburgh, Pittsburgh, PA 15213 USA
[10] Univ Texas SW Med Ctr Dallas, Dept Pediat, Dallas, TX 75390 USA
[11] Cincinnati Childrens Hosp, Med Ctr, Cincinnati, OH USA
[12] Univ Cincinnati, Cincinnati, OH USA
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2010年 / 303卷 / 14期
关键词
SENSORINEURAL HEARING-LOSS; CMV INFECTION; DNA DETECTION; FILTER-PAPER; RAPID DETECTION; VIRAL-LOAD; CHILDREN; DISEASE; VIRUS; PREVALENCE;
D O I
10.1001/jama.2010.423
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Context Reliable methods to screen newborns for congenital cytomegalovirus (CMV) infection are needed for identification of infants at increased risk of hearing loss. Since dried blood spots (DBS) are routinely collected for metabolic screening from all newborns in the United States, there has been interest in using DBS polymerase chain reaction (PCR)-based methods for newborn CMV screening. Objective To determine the diagnostic accuracy of DBS real-time PCR assays for newborn CMV screening. Design, Setting, and Participants Between March 2007 and May 2008, infants born at 7 US medical centers had saliva specimens tested by rapid culture for early antigen fluorescent foci. Results of saliva rapid culture were compared with a single-primer (March 2007-December 2007) and a 2-primer DBS real-time PCR (January 2008-May 2008). Infants whose specimens screened positive on rapid culture or PCR had congenital infection confirmed by the reference standard method with rapid culture testing on saliva or urine. Main Outcome Measures Sensitivity, specificity, and positive and negative likelihood ratios (LRs) of single-primer and 2-primer DBS real-time PCR assays for identifying infants with confirmed congenital CMV infection. Results Congenital CMV infection was confirmed in 92 of 20 448 (0.45%; 95% confidence interval [CI], 0.36%-0.55%) infants. Ninety-one of 92 infants had positive results on saliva rapid culture. Of the 11 422 infants screened using the single-primer DBS PCR, 17 of 60 (28%) infants had positive results with this assay, whereas, among the 9026 infants screened using the 2-primer DBS PCR, 11 of 32 (34%) screened positive. The single-primer DBS PCR identified congenital CMV infection with a sensitivity of 28.3% (95% CI, 17.4%-41.4%), specificity of 99.9% (95% CI, 99.9%-100%), positive LR of 803.7 (95% CI, 278.7-2317.9), and negative LR of 0.7 (95% CI, 0.60.8). The positive and negative predictive values of the single-primer DBS PCR were 80.9% (95% CI, 58.1%-94.5%) and 99.6% (95% CI, 99.5%-99.7%), respectively. The 2-primer DBS PCR assay identified infants with congenital CMV infection with a sensitivity of 34.4% (95% CI, 18.6%-53.2%), specificity of 99.9% (95% CI, 99.9%100.0%), positive LR of 3088.9 (95% CI, 410.8-23 226.7), and negative LR of 0.7 (95% CI, 0.5-0.8). The positive and negative predictive values of the 2-primer DBS PCR were 91.7% (95% CI, 61.5%-99.8%) and 99.8% (95% CI, 99.6%-99.9%), respectively. Conclusion Among newborns, CMV testing with DBS real-time PCR compared with saliva rapid culture had low sensitivity, limiting its value as a screening test. JAMA. 2010; 303(14): 1375-1382
引用
收藏
页码:1375 / 1382
页数:8
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