Table 2 Hospital antenatal Pima™ field testing using capillary blood
Phase II | Laboratory Pima™ vs. Predicate | Clinic Pima™ vs. Predicate | ||||
|---|---|---|---|---|---|---|
Venous EDTA blood | Capillary blood | |||||
*Pima #1 | *Pima #4 | *Mean Pima #1 and #4 | Pima #3 | Pima #2 | All values | |
N | 91 | 91 | 91 | 43 | 34 | 77 |
Range of CD4 counts* | 32 - 1186 | 23 - 1299 | 28 - 1243 | 28 - 1092 | 50 - 1056 | 28 - 1092 |
Mean CD4 count*(median) | 385.6 (341.0) | 399.8 (357.0) | 392.7 (347.0) | 335.0 (405.0) | 350.2 (290.0) | 380.8 (329.0) |
%Similarity to Predicate ( %SIM Mean ± SD) | 96.9% ± 7.89 | 98.3% ± 7.05 | 97.6% ± 6.5 | 98.6% ± 28.45 | 96.1% ± 16.8 | 98.7 ± 23.02 |
%SIM CV # | 8.1% | 7.2% | 6.7% | 28.8% | 17.6% | 23.3 |
BA bias* ± 1 STDev (PIMA - PLG) (95% CI of bias mean) | -26.6 ± 73.3 (-41.9 to -11.4) | -12.4 ± 68.1 (-26.6 to 1.8) | -19.6 ± 66.1 (-33.3 to -5.8) | -31.79 ± 213.1 (-97.4 to 33.8) | -45.5 ± 127.7 (-90.1 to -1.0) | -37.9 ± 179.5 (-78.3 to 2.87) |
BA 95% LOA* | -170.4 to 117.1 | -145.8 to 121.0 | -149.1 to 110.0 | -147.4 to 385.9 | -295.8 to 204.6 | -389.1 to 309.8 |