TABLE 1.
Study code | Sample/references ampoule code | Description |
---|---|---|
A | 06/140 | Freeze-dried preparation of “high” anti-PT IgG content human serum |
B | 06/142 | Freeze-dried preparation of “low” anti-PT IgG content human serum |
C | 06/144 | Freeze-dried preparation of “low” anti-PT IgG content human serum |
D | 06/146 | Freeze-dried preparation of “high” anti-PT IgG content human serum |
E | PM-06-047 | Baseline control serum; freeze-dried preparation of human serum with “undetectable” IgG anti-PT content |
U.S. lot 3 | U.S. reference pertussis antiserum (human) lot 3; freeze-dried reference preparation of serum with the following units: IgG anti-PT (200 EU/ml); IgA anti-PT (15 EU/ml); IgG FHA (200 EU/ml); and IgA FHA (100 EU/ml) | |
U.S. lot 4 | U.S. reference pertussis antiserum (human) lot 4; freeze-dried reference preparation of serum with the following units: IgG anti-PRN (90 EU/ml) and IgA anti-PRN (25 EU/ml) | |
U.S. lot 5 | U.S. reference pertussis antiserum (human) lot 5; a secondary reference with units assigned based on U.S. lots 3 and 4: IgA anti-PT (140 EU/ml); IgA anti-FHA (280 EU/ml); and IgA anti-PRN (90 EU/ml) |
For use in assays, all preparations were reconstituted with 1.0 ml of sterile water.