TABLE I

Dilutions Used for Each Product in the Limulus Amoebocyte Lysate- and Recombinant Factor C-Based Assays and Their Sensitivities

ProductMVDaKQCLbENDOSAFE-MCSENDOZYME IIENDOLISA
Assay sensitivity: 0.005 EU/mLAssay sensitivity: 0.05 EU/mL
Product A200,00020,000dilution: 1/100, assay sensitivity: 0.005 EU/mLdilution: 1/100, assay sensitivity: 0.05 EU/mLdilution: 1/100, assay sensitivity: 0.005 EU/mLdilution: 1/10, assay sensitivity: 0.05 EU/mL
Product A pretreatedcdilution: 1/10 heat-treated, further dilution: 1/10 (total 1/100), assay sensitivity: 0.005 EU/mLdilution: 1/10 heat-treated, further dilution: 1/10 (total 1/100), assay sensitivity: 0.05 EU/mLdilution: 1/10 heat-treated, further dilution: 1/10 (in total 1/100), range assay sensitivity: 0.005 EU/mLdilution: 1/10 heat-treated, assay sensitivity: 0.05 EU/mL
Product B10,0001000dilution: 1/100, assay sensitivity: 0.005 EU/mLdilution: 1/100, assay sensitivity: 0.05 EU/mLdilution: 1/100, assay sensitivity: 0.005 EU/mLdilution: 1/10, assay sensitivity: 0.05 EU/mL
Product C96,0009600dilution: 1/1000, assay sensitivity: 0.005 EU/mLdilution: 1/100, assay sensitivity: 0.05 EU/mLdilution: 1/10,000, assay sensitivity: 0.005 EU/mLdilution: 1/100, assay sensitivity: 0.05 EU/mL
Product D5000500dilution: 1/100, assay sensitivity: 0.005 EU/mLdilution: 1/100, assay sensitivity: 0.05 EU/mLdilution: 1/2500, assay sensitivity: 0.005 EU/mLdilution: 1/100, assay sensitivity: 0.05 EU/mL

  • ↵a MVD is maximum valid dilution.

  • ↵b Dilutions defined and used in routine testing.

  • ↵c Tested in one run.