Table 1A.
Performance characteristics of the VISITECT® CD4 Test.
| Flow cytometry |
VISITECT®CD4 test (visual reading) |
|||
|---|---|---|---|---|
|
Venous blood |
Finger-prick blood |
|||
| ≤350 cells/µL | >350 cells/µL | ≤350 cells/µL | >350 cells/µL | |
| ≤350 cells/µL (145) | 140 | 5 | 123 | 22 |
| >350 cells/µL (55) | 16* | 39* | 15 | 40 |
| Sensitivity, % (95%CI) | 96.6% (92.1% to 98.9%) | 84.8% (77.9% to 90.2%) | ||
| Specificity, % (95%CI) | 70.9% (57.1% to 82.4%) | 72.7% (59.0% to 83.9%) | ||
| PPV, % (95%CI) | 89.7% (83.9% to 94.0%) | 89.1% (82.7% to 93.8%) | ||
| NPV, % (95%CI) | 88.6% (75.4% to 96.2%) | 64.5% (51.3% to 76.3%) | ||
*The results of the second (duplicate) VISITECT®CD4 test using venous blood were 17 and 38 participants with ≤350 and >350 cells/μL, respectively, giving a sensitivity of 96.6% (92.1% to 98.9%), a specificity of 69.1% (55.2% to 80.9%), a PPV of 89.2% (83.2% to 93.6%) and a NPV of 88.4% (74.9% to 96.1%).