RAPID BIOTIN ASSAY
Research Use Only
Binds to streptavidin with high affinity.
Useful for immunoassays.
Less paperwork. More productivity.
Reports of biotin interference with laboratory tests are alarming. Biotin binds to streptavidin with high affinity, making the biotin-streptavidin system useful for immunoassays; however, elevated concentrations of biotin can interfere. In competitive assays, useful for small molecules such as thyroxine (T4) and hormones, there is an inverse association between analyte concentration and assay signal; biotin interference causes a low signal and a falsely high result. In sandwich assays, like thyroid stimulating hormone (TSH), the assay signal is proportional to analyte concentration, and biotin interference causes a low signal and a falsely low result. In response, the FDA released a safety communication in November 2017 and a draft guidance document for manufacturers in June 2019.
In response, Sun Diagnostics has developed a rapid microtiter plate assay to measure potentially interfering concentrations in patient samples.
The Sun Diagnostics Biotin Assay is available as a research-use only kit and takes only about 75 minutes. The assay has a limit of blank (LoB) of 13 ng/mL, a limit of detection (LoD) of 32 ng/mL and is linear up to 200 ng/mL. Total imprecision ranged from 4.2% at 35 ng/mL to 13.2% at 175 ng/mL.
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