PHASE III | Rural clinic Pima™ (3 sites) versus Predicate (Phase IIIA) | Inner-city clinic Pima™ (1 site) versus Predicate (Phase IIIB) | ||||
---|---|---|---|---|---|---|
PREDICATE | Pima™ | PREDICATE | Pima™ Lancet 1 (Sarsedt) | PREDICATE | Pima™ Lancet 2 (Caralet Blue) | |
N | 96 | 96 | 87 | 87 | 52 | 52 |
Range of CD4 counts* | 2 - 1871 | 31 - 2747 | 2 - 1604 | 1 - 1358 | 3 - 966 | 2 - 968 |
Mean CD4 count*(median) | 617.5 (492.0) | 719.4 (677.5) | 350 (302.0) | 359.0 (305.0) | 268.4 (255.5) | 257.2 (238.0) |
% Similarity to Predicate ( %SIM Mean ± SD) | 114.8% ± 32.6 | 101.4% ± 10.1 | 98.6% ± 11.2 | |||
%SIM CV # | 28.4%CV | 10.0% | 11.3% | |||
BA bias* ± 1 STDev (PIMA - PLG) (95% CI of bias mean) | +105.7 ± 225.4 (60.1 to 151.4) | +8.9 ± 112.3 (-14.9 to 32.8) | -11.2 ± 69.3 (-30.5 to 8.1) | |||
BA 95% LOA* | -336.0 to 547.0 | -211.1 to 229.0 | -147.0 to 124.6 |