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. 2025 May 1;45:e00472. doi: 10.1016/j.plabm.2025.e00472

Table 6.

The table lists the biotin tolerance levels of onboard reagents compared with the specifications in the package inserts. The biotin tolerance levels were determined as the final biotin levels that fell within a ±10 % change. For the reagents CEA, CA125, CA153, CA199, and HBeAg, no final data point fell within the ±10 % change threshold, and thus they are classified as "Indeterminate."

Biotin tolerance of onboard reagents
Reagents Determined by our laboratory (ng/mL) Package inserts (ng/mL)
TSH (newer) <1500 ≤1200
CEA (older) Indeterminate <120
CA125 (older) Indeterminate <70
CA153 (older) Indeterminate <100
CA199 (older) Indeterminate <100
FPSA (newer) <1500 <1200
TPSA (newer) <2500 <1200
HBeAg (older) Indeterminate <40
HBsAg (newer) <500 ≤1200