Regional Public Health Laboratory Kennemerland, Boerhaavelaan 26, 2035 RC, Haarlem, The Netherlands.
J Med Microbiol. 2018 Dec;67(12):1743-1746. doi: 10.1099/jmm.0.000877. Epub 2018 Nov 7.
In this study, we evaluated the Sofia Streptococcus pneumoniae FIA test (Quidel Corporation, San Diego, CA, USA), a new immunofluorescence-based lateral flow test for the qualitative detection of S. pneumoniae antigen in urine or cerebrospinal fluid specimens. The analyses of 100 non-concentrated urine samples (including 50 samples from S. pneumoniae cases) showed a sensitivity and specificity (95 % CI) of, respectively, 66.0 % (52.2-77.6) and 100.0 % (92.9-100.0) for the Sofia test, and 62.0 % (48.2-74.1) and 98.0 % (89.5-99.7) for the BinaxNOW SPN Antigen Card. There were no significant differences in sensitivity and specificity between the tests (McNemar's tests, P=0.625 and P=1.000). In conclusion, this study indicates that the Streptococcus pneumoniae FIA test shows similar sensitivity and specificity rates compared to the BinaxNOW SPN Antigen Card.
在这项研究中，我们评估了 Sofia 肺炎链球菌 FIA 检测（Quidel 公司，圣地亚哥，加利福尼亚州，美国），这是一种新的免疫荧光基于侧向流动测试，用于定性检测尿液或脑脊液标本中的肺炎链球菌抗原。对 100 份未浓缩的尿液样本（包括 50 份肺炎链球菌病例样本）的分析表明，Sofia 检测的灵敏度和特异性（95%置信区间）分别为 66.0%（52.2-77.6）和 100.0%（92.9-100.0），BinaxNOW SPN 抗原卡的灵敏度和特异性分别为 62.0%（48.2-74.1）和 98.0%（89.5-99.7）。两种检测方法的灵敏度和特异性均无显著差异（McNemar 检验，P=0.625 和 P=1.000）。总之，这项研究表明，肺炎链球菌 FIA 检测与 BinaxNOW SPN 抗原卡相比具有相似的灵敏度和特异性。
