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 assayEstimates as units of U.S. references under sample code:Estimates for B and C as equivalent ml of A and DEstimates for B and C in terms of AbProposed 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 ELISA340 (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 assay307 (140-677) [3]d96 (49-185) [3]e0.31 (0.08-1.25) [3]NAcNA
IgG anti-FHA ELISA131 (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 ELISA65 (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
  • a 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.

  • b Using proposed IU for sample A.

  • c NA, not applicable.

  • d Overall GM for samples A and D.

  • e Overall GM for samples B and C.