TABLE 2.
Sensitivity and specificity of the reporter enzyme fluorescence diagnostic assay
| Group (no. of samples)a | % Female (no.)b | S+, C+ (no.)c | S−, C+ (no.)d | Specificity (no.)e |
|---|---|---|---|---|
| Age range | ||||
| 15–25 (11) | 18.1 (2) | 0 (1) | 0 (0) | 100 (10) |
| 26–35 (33) | 51.5 (17) | 57.1 (7) | 87.5 (8) | 89 (18) |
| 36–45 (38) | 31.6 (12) | 100 (11) | 80 (5) | 68 (22)f |
| 46–55 (26) | 19.2 (5) | 100 (6) | 66.6 (3) | 76 (17)g |
| 56–65 (37) | 40.5 (15) | 100 (7) | 100 (6) | 75 (24)h |
| >65 (15) | 60.0 (9) | 100 (3) | 100 (2) | 100 (10) |
| Sex | ||||
| Male (100) | 0.0 (100) | 92 (25) | 93.3 (15) | 82 (60) |
| Female (60) | 100 (60) | 80 (10) | 77.7 (9) | 81 (41) |
| Total no. (160) | 37.5 (60) | 89 (35) | 87.5 (24) | 82 (101) |
Clinical samples were divided into groups by age and sex to evaluate whether any of these differences impact the performance of the tuberculosis reporter enzyme fluorescent (REFtb) diagnostic assay. The total number of samples (n) in each group is shown in parentheses.
The percentage of female patients within the group. The number of samples in this group that were from female patients is shown in parentheses.
Sensitivity of the REFtb assay versus smear-positive (S+) and culture-positive (C+) samples calculated as the number of positives by REFtb divided by the number of positives by both smear and culture times 100 to make a percentage. The number (no.) of samples in this group that were smear positive and culture positive is shown in parentheses.
Sensitivity of the REFtb assay versus smear-negative (S−) and culture-positive samples calculated as the number of positives by REFtb divided by the number of positives by culture only times 100 to make a percentage. The number of samples in this group that were smear negative and culture positive is shown in parentheses.
Specificity of the REFtb assay-negative samples versus samples negative by both smear and culture calculated as the number of negatives by REFtb divided by the number of negatives by both smear and culture times 100 to make a percentage. The number of samples in this group that were both smear and culture negative is shown in parentheses. P values calculated using Boschloo’s exact test compared to the specificity of the >65 age group.
P = 0.02.
P = 0.06.
P = 0.05.