Table 1. Accuracy of the BD Directigen Flu A+B test and the BD Directigen EZ Flu A+B test during different influenza seasons calculated using the RT-PCR (A+B) assay as a gold standard.
PCR negative | PCR positive | Sensitivity % (95%CI) | Specificity % (95% CI) | PPV % (95% CI) | NPV % (95% CI) | |
---|---|---|---|---|---|---|
BD Directigen Flu A+B (RT) | ||||||
2003–2004 | ||||||
negative | 172 | 23 | 49 (34–64) | 100 (97–100) | 100 (81–100) | 88 (82–92) |
positive | 0 | 22 | ||||
n = 217 | 172 | 45 | ||||
2006–2007 | ||||||
negative | 212 | 155 | 40 (34–46) | 99 (97–99) | 99 (94–99) | 57 (52–62) |
positive | 1 | 105 | ||||
n = 473 | 213 | 260 | ||||
2007–2008 | ||||||
negative | 126 | 222 | 38 (33–43) | 97 (92–99) | 97 (92–99) | 36 (31–41) |
positive | 4 | 136 | ||||
n = 488 | 130 | 358 | ||||
2008–2009 | ||||||
negative | 231 | 166 | 36 (30–42) | 99 (96–99) | 97 (91–99) | 58 (53–63) |
positive | 2 | 94 | ||||
n = 493 | 233 | 260 | ||||
Total | ||||||
negative | 741 | 566 | 39 (35–42) | 99 (97–99) | 98 (95–99) | 56 (53–59) |
positive | 7 | 357 | ||||
n = 1671 | 748 | 923 | ||||
BD Directigen EZ Flu A+B (RT) | ||||||
2010–2011 | ||||||
negative | 56 | 42 | 51 (40–62) | 100 (92–100) | 100 (90–100) | 57 (47–67) |
positive | 0 | 45 | ||||
n = 143 | 56 | 87 | ||||
2011–2012 | ||||||
negative | 57 | 37 | 41 (29–54) | 100 (92–100) | 100 (83–100) | 60 (49–70) |
positive | 0 | 26 | ||||
n = 120 | 57 | 63 | ||||
2012–2013 | ||||||
negative | 87 | 83 | 47 (39–55) | 98 (91–99) | 98 (91–99) | 51 (43–58) |
n positive | 1 | 74 | ||||
n = 245 | 88 | 157 | ||||
Total | ||||||
negative | 200 | 162 | 47 (41–53) | 100 (97–100) | 99 (95–99) | 55 (50–60) |
positive | 1 | 145 | ||||
n = 508 | 201 | 307 |
Key: CI—confidence interval
PPV—positive predictive value
NPV—negative predictive value