TABLE 2.
Overall summary results of estimates, with 95% confidence limits, for samples A to D (IgG) in terms of U.S. lot 3 (for anti-PT and anti-FHA) and U.S. lot 4 (for anti-PRN)a
| Antibody and assay | Estimates as units of U.S. references under sample code:
|
Estimates for B and C as equivalent ml of A and D | Estimates for B and C in terms of Ab | Proposed IU for A and D (06/140 and 06/146) | |||
|---|---|---|---|---|---|---|---|
| A (06/140) | D (06/146) | B (06/142) | C (06/144) | ||||
| IgG anti-PT ELISA | 340 (315-368) [22] | 331 (320-363) [22] | 108 (100-117) [22] | 105 (94-118) [22] | 0.32 (0.30-0.34) [22] | 106 (100-113) [22] | 335 |
| IgG anti-PT CHO cell assay | 307 (140-677) [3]d | 96 (49-185) [3]e | 0.31 (0.08-1.25) [3] | NAc | NA | ||
| IgG anti-FHA ELISA | 131 (120-142) [18] | 129 (121-137) [18] | 123 (116-131) [18] | 120 (111-130) [18] | 0.94 (0.89-0.99) [18] | 122 (116-128) [18] | 130 |
| IgG anti-PRN ELISA | 65 (58-72) [16] | 64 (59-70) [16] | 39 (35-44) [16] | 38 (34-43) [16] | 0.60 (0.57-0.63) [16] | 39 (37-41) [16] | 65 |
Values are overall GM estimates of the laboratory GMs. The 95% confidence limits are given in parentheses. The numbers of estimates (one estimate per laboratory) combined are indicated in brackets.
Using proposed IU for sample A.
NA, not applicable.
Overall GM for samples A and D.
Overall GM for samples B and C.