Table I.
Terminology of Analyte Forms in Biological Fluids and Assay Types
Term | Definition |
---|---|
Free drug, mAbfree (interchangeable with “active mAb”) | The sum of bivalent and monovalent unbound forms of mAb |
Partially free mAb | mAb with one site (monovalent) bound to L and the other site unbound |
Active mAb (interchangeable with “free mAb”) | The sum of both unbound forms of mAb (bivalent and monovalent) that are able to bind to L to interfere biological actions of L |
Bound mAb, mAbbound | mAb with both sites bound to L |
Total mAb, mAbtotal | Sum of bound and free mAb (mAbbound + mAbfree) |
Free target ligand, Lfree | Unbound L |
Bound target ligand, Lbound | L bound to mAb |
Total target ligand, Ltotal | Sum of bound and free (unbound) L (Lbound + Lfree) |
Specific assay | Measures a known form(s) of the analyte. Example: the combination of the capture and the detection reagents is directed towards a unique epitope of L or mAb. |
Generic assay | Measures a class of analytes with shared epitope recognized by the reagents; the exact measurements may include more than one analyte. |
Non-inhibitory assay | The capture and/or the detection reagents are directed toward an epitope that is non-competitive to L (or mAb) of interest, thus no or minimal inhibition is observed from L (or mAb). |
Inhibitory assay | The capture and/or the detection reagents are directed toward a competitive epitope of L (or mAb), which will inhibit the assay at an appropriate molar ratio. |
“mAb” is defined as a monoclonal antibody therapeutic in the paper, “L” refers to the target ligand in circulation. For simplicity, L is treated as monovalent