TABLE 5.
Validation of sensitivity and specificity of TB Screen Test by studies by external agencies
| Study and group | No. of samples tested | Clinical history | No. of samples with the following TB Screen Test result:
|
Sensitivity (%) | Specificity (%) | ||
|---|---|---|---|---|---|---|---|
| Positive | Negative | Indeterminate | |||||
| Sensitivity study | |||||||
| Pulmonary TB tuberculosis | 204 | Clinically confirmed | 198 | 4 | 2 | 97.1 | |
| Extra-pulmonary TB | 28 | Clinically confirmed | 24 | 4 | 87.5 | ||
| TB-HIV coinfected | 8 | HIV positive and M. tuberculosis positive by smear and culture | 7 | 1 | 88.8 | ||
| Subtotal | 240 | 229 | 8 | 3 | 95.41 | ||
| Specificity study | |||||||
| Leprosy | 28 | Clinically confirmed | 2 | 25 | 1 | 93.3 | |
| HIV and M. tuberculosis positive | 10 | Clinically confirmed | 10 | 100 | |||
| Other common infections | 63 | Clinically confirmed | 62 | 1 | 100 | ||
| Pneumonia | 15 | Clinically confirmed | 15 | 100 | |||
| Bronchitis | 10 | Clinically confirmed | 09 | 1 | 100 | ||
| Malaria | 18 | Clinically confirmed | 18 | 100 | |||
| Typhoid | 12 | Clinically confirmed | 12 | 100 | |||
| Hepatitis | 8 | Clinically confirmed | 8 | 100 | |||
| Rheumatoid arthritis | 6 | Clinically confirmed | 1 | 5 | 85.7 | ||
| BCG vaccinated | 435 | Histopathologically and physiologically confirmed | 8 | 419 | 8 | 94.5 | |
| Subtotal | 605 | 11 | 583 | 11 | 96.36 | ||