Technology Assessment Unit of the McGill University Health Centre, Montréal, Quebec, Canada.
J Clin Microbiol. 2013 Jul;51(7):2303-10. doi: 10.1128/JCM.00137-13. Epub 2013 May 15.
Standard culture methods for diagnosis of Streptococcus pneumoniae pneumonia take at least 24 h. The BinaxNOW urine-based test for S. pneumoniae (BinaxNOW-SP) takes only 15 min to conduct, potentially enabling earlier diagnosis and targeted treatment. This study was conducted to assess whether the use of BinaxNOW-SP at the time of hospital admission would provide adequate sensitivity and specificity for diagnosis of community-acquired pneumonia (CAP) in adult patients. We searched PubMed, EMBASE/OVID, Cochrane Collaboration, Centre for Reviews and Dissemination, INAHTA, and CADTH for diagnostic or etiologic studies of hospitalized predominately adult patients with clinically defined CAP that reported the diagnostic performance of BinaxNOW-SP versus cultures. Two authors independently extracted study details and diagnostic two-by-two tables. We found that 27 studies met our inclusion criteria, and three different reference standards were used between them. A bivariate meta-analysis of 12 studies using a composite of culture tests as the reference standard estimated the sensitivity of BinaxNOW-SP as 68.5% (95% credibility interval [CrI], 62.6% to 74.2%) and specificity as 84.2% (95% CrI, 77.5% to 89.3%). A meta-analysis of all 27 studies, adjusting for the imperfect and variable nature of the reference standard, gave a higher sensitivity of 74.0% (CrI, 66.6% to 82·3%) and specificity of 97.2% (CrI, 92.7% to 99.8%). The analysis showed substantial heterogeneity across studies, which did not decrease with adjustment for covariates. We concluded that the higher pooled sensitivity (compared to culture) and high specificity of BinaxNOW-SP suggest it would be a useful addition to the diagnostic workup for community-acquired pneumonia. More research is needed regarding the impact of BinaxNOW-SP on clinical practice.
标准的肺炎链球菌性肺炎诊断培养方法需要至少 24 小时。BinaxNOW 尿液检测法(BinaxNOW-SP)仅需 15 分钟,可实现更早的诊断和靶向治疗。本研究旨在评估入院时使用 BinaxNOW-SP 是否能为成人社区获得性肺炎(CAP)提供足够的敏感性和特异性。我们在 PubMed、EMBASE/OVID、Cochrane 协作组织、中心评估与传播数据库、INAHTA 和 CADTH 中检索了以临床诊断的 CAP 为主的住院成年患者的诊断或病因学研究,这些研究报告了 BinaxNOW-SP 与培养物的诊断表现。两位作者独立提取研究细节和诊断 2×2 表。我们发现,27 项研究符合纳入标准,其中三项研究使用了不同的参考标准。对使用混合培养物作为参考标准的 12 项研究进行的双变量 Meta 分析,估计 BinaxNOW-SP 的敏感性为 68.5%(95%可信区间[CrI],62.6%至 74.2%),特异性为 84.2%(95% CrI,77.5%至 89.3%)。对所有 27 项研究进行的 Meta 分析,在调整参考标准不完善和多变的性质后,敏感性更高,为 74.0%(CrI,66.6%至 82·3%),特异性为 97.2%(CrI,92.7%至 99.8%)。分析表明,研究之间存在很大的异质性,调整协变量后并没有减少。我们的结论是,BinaxNOW-SP 较高的合并敏感性(与培养物相比)和高特异性表明,它将是社区获得性肺炎诊断的有用补充。需要进一步研究 BinaxNOW-SP 对临床实践的影响。