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.
【저자키워드】 diagnostics, antigen test, Evaluation, Streptococcus pneumoniae,