Table 2.
Definitions used to determine QFT conversion at visit 2 and visit 3
| Conversion definition 1a (< 0.35, ≥0.35) |
Conversion definition 2 (< 0.2, ≥0.7) |
Conversion definition 3 (< 0.2, ≥1.05) |
Conversion definition 4 (< 0.2, ≥1.4) |
|
|---|---|---|---|---|
| Eligible for analysis if negative at visit 1 | ||||
| Nil | ≤8.0 | ≤8.0 | ≤8.0 | ≤8.0 |
| TBAgNil | < 0.35 or < 25% Nil | < 0.2 or < 25% Nil | < 0.2 or < 25% Nil | < 0.2 or < 25% Nil |
| MitogenNil | ≥0.5 | ≥0.5 | ≥0.5 | ≥0.5 |
| Positive at visit 2 and/or visit 3 | ||||
| Nil | ≤8.0 | ≤8.0 | ≤8.0 | ≤8.0 |
| TBAgNil |
≥0.35 & ≥ 25% of Nil & absolute increase of ≥0.35 IU/mlover baseline value |
≥0.7 & ≥ 25% of Nil | ≥1.05 & ≥ 25% of Nil | ≥1.4 & ≥ 25% of Nil |
| Negative at visit 2 and/or visit 3 | ||||
| Nil | ≤8.0 | ≤8.0 | ≤8.0 | ≤8.0 |
| TBAgNil | < 0.35 or < 25% Nil | < 0.7 or < 25% Nil | < 1.05 or < 25% Nil | < 1.4 or < 25% Nil |
| MitogenNil | ≥0.5 | ≥0.5 | ≥0.5 | ≥0.5 |
| or | ||||
| Nil | ≤8.0 | |||
| TBAgNil |
≥0.35 & ≥ 25% of Nil & absolute increase of < 0.35 IU/ml over baseline value |
|||
| MitogenNil | ≥0.5 | |||
| Indeterminate | all other values | all other values | all other values | all other values |
aManufacturer’s recommended assay cut-off
Footnote: Nil negative control response, TBAgNil antigen response minus negative control response, MitogenNil positive control response minus negative control response