Table 1.

Performance characteristics of enzymatically calibrated PAM-AMA Assay.

Analytical performance characteristics of the AMA assay
Calibrator range	0.712–121.865 AMA units (0–4000 ng/mL)
Intra-assay CV	3–6%
Limit of detection	1.94 AMA units (42.4 ng/mL)
Limit of quantification	2.44 AMA units (60.4 ng/mL)
Accuracy (recovery of added PAM to serum)	Average (range) % recovery from expected = 108% (103–116%)
Linearity (mixing studies) 12 ×	Range: 3.2–16.5 AMA units Average (range) % recovery from expected = 91% (82–101.6%)
Dilution linearity (10–100 × in assay)	Range: 0–16.5 AMA units Average (range) % recovery from expected = 98% (91–103%)
Variation of substrate concentration CV	Range: 10–40 ng/mL; CV: 1.2–2.4%