Analytical validation of a novel bioassay for thyroid-stimulating immunoglobulin.

ABSTRACT:

Background

A novel and rapid cell-based bioassay, Turbo TSI, for measurement of thyroid-stimulating immunoglobulins (TSI) was recently reported. An assessment of the analytical performance of this TSI bioassay is described herein.

Methods

Thawed cells from Turbo TSI kits were treated with different concentrations of a World Health Organization (WHO) international standard (IS) TSI-positive serum. TSI was measured as a function of luciferase activity measured as relative light units (RLU) and converted into international units per liter (IU/L). Analytical performance studies were performed on numerous samples, over multiple days, by two users at two sites.

Results

The limit of blank, limit of detection and limit of quantitation were determined to be 0.007 IU/L, 0.014 I

SUBMITTER: Olivo PD 

PROVIDER: S-EPMC11746106 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature