TABLE 1.

Sample informationa

Study codeSample/references ampoule codeDescription
A06/140Freeze-dried preparation of “high” anti-PT IgG content human serum
B06/142Freeze-dried preparation of “low” anti-PT IgG content human serum
C06/144Freeze-dried preparation of “low” anti-PT IgG content human serum
D06/146Freeze-dried preparation of “high” anti-PT IgG content human serum
EPM-06-047Baseline control serum; freeze-dried preparation of human serum with “undetectable” IgG anti-PT content
U.S. lot 3U.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 4U.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 5U.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)
  • a For use in assays, all preparations were reconstituted with 1.0 ml of sterile water.