Neutralization of biotin interference: preliminary evaluation of the VeraTest Biotin™, VeraPrep Biotin™ and BioT-Filter^®

Results of the first pilot external quality assessment (EQA) scheme for anti-SARS-CoV2-antibody testing

“…The analytical variability of anti-SARS-CoV-2 IgG testing between different methods did not differ substantially. This indicates that harmonization of test results from different providers could be achieved by optimizing cutoffs, as recently supposed by Plebani et al and others [14,[28][29][30]. Interestingly, some results reported by laboratories using the same commercial test system differed substantially.…”

“…Including the remaining data for the antibody classes IgA and IgM, there is a significant decrease in overall [31,32], the immune response against SARS-CoV-2 does not seem to follow the general rule that IgM antibodies usually occur before IgG [2,27,33,34]. Several studies have investigated the detection and time-dependent course of IgA, IgM, and IgG antibodies in SARS-CoV-2 infections [9,29,[35][36][37]. Their results indicate that certain methodological peculiarities must be considered for IgM detection, which may also explain the comparatively low concordance rate in our EQA scheme.…”

Development and Evaluation of an Anti-Biotin Interference Method in Biotin-Streptavidin Immunoassays

“…There have been several studies that sought to detect and counter biotin interference using different approaches, such as the detection of biotin concentrations in serum samples [ 2 ]; inquisition of patients regarding consumption of biotin supplements [ 10 ]; manual incubation of the serum sample with streptomycin-coated magnetic particles outside the instrument, following which the incubated supernatant is separated and used as a sample for detection [ 11 , 12 ]; sample dilution [ 13 ]; and reagent improvement by adding biotin antibody to reagent [ 14 , 15 ]. Biotin concentration detection using these methods is limited because techniques such as enzyme-linked immunosorbent assays (ELISA) and high-performance liquid chromatography (HPLC), which require additional reagents or equipment, are not widely available; investigating patients’ biotin supplementation history is time-consuming and laborious, and the reliability is poor; and it takes a long time to adsorb and neutralize biotin through streptavidin magnetic particles outside the instrument before detection, and this process is complicated and liable to large human error.…”

“…Thus, the ideal anti-biotin interference method is one that has a fully automatic operation, wherein the analyte of serum sample can be directly put into the instrument for detection without any pre-treatment. In 2019, Roche [ 14 ] and Siemens [ 15 ] invented a fully automated method of anti-biotin interference through reagent improvement on the existing detection platform. However, many other detection platforms have no corresponding anti-biotin interference measures.…”