Product Manual

Nasal Swab Samples
REFERENCE (VIRUS CULTURE) RESULTS
OSOM
Ultra Flu A & B
Flu A
Positive
Flu A
Negative
Total Performance
Flu A
Positive
33 80* 113
Sensitivity
91.7%
95% CI: 78.2-
97.1%
Flu A
Negative
3** 242 245
Specificity
75.2%
95% CI: 70.2-
79.6%
Total 36 322 358
*Of 80 discrepant results, 65 were positive by both OSOM Ultra Flu A&B and PCR
**Of 3 discrepant results, all 3 were positive by PCR
REFERENCE (VIRUS CULTURE) RESULTS
OSOM
Ultra Flu A & B
Flu B
Positive
Flu B
Negative
Total Performance
Flu B
Positive
14 40* 54
Sensitivity
82.4%
95% CI: 59.0-
93.8%
Flu B
Negative
3** 301 304
Specificity
88.3%
95% CI: 84.4-
91.3%
Total 17 341 358
*Of 40 discrepant results, 19 were positive by both OSOM Ultra Flu A&B and PCR
**Of 3 discrepant results, 1 was negative by both OSOM Ultra Flu A&B and PCR
REFERENCE (VIRUS CULTURE) RESULTS
OSOM
Ultra Flu A & B
Flu A
Positive
Flu A
Negative
Total Performance
Flu A
Positive
26 51* 77
Sensitivity
89.6%
95% CI: 84.0-
95.2%
Flu A
Negative
3** 171 174
Specificity
77. 0 %
95% CI: 74.2-
79.8%
Total 29 222 251
*Of 51 discrepant results, 42 were positive by both OSOM Ultra Flu A&B and PCR
**Of 3 discrepant results, 1 was negative by both OSOM Ultra Flu A&B and PCR
REFERENCE (VIRUS CULTURE) RESULTS
OSOM
Ultra Flu A & B
Flu B
Positive
Flu B
Negative
Total Performance
Flu B
Positive
33 15* 48
Sensitivity
86.8%
95% CI: 81.4-
92.2%
Flu B
Negative
5** 198 203
Specificity
92.9%
95% CI: 91.2-
94.6%
Total 38 213 251
*Of the 15 discrepant results, 8 were positive by both OSOM Ultra Flu A&B and PCR
**Of the 5 discrepant results, 2 were negative by both OSOM Ultra Flu A&B and PCR
Nasopharyngeal Swab Sample