Analytical validation of ONCURIA™ a multiplex bead-based immunoassay for the non-invasive bladder cancer detection

ONCURIA™ 的分析验证,这是一种用于非侵入性膀胱癌检测的多重珠状免疫测定法

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作者:Hideki Furuya, Lindlelyn Tabula, Riko Lee, Paul Kralovec, Martin Ramsden, Regan Wong, Charles J Rosser

Background

The

Conclusion

To our knowledge, this is the first multiplex bead-based immunoassay for the non-invasive detection of bladder cancer that has been analytically validated as a tool with the potential to help clinicians manage patients at risk of harboring bladder cancer.

Results

Analytical evaluation demonstrated a) all antigen cross-reactivity was noted to be <1% of the tested concentration, b) minimal detected dose ranged from 0.295 ​pg/mL in IL8 to 31.1 ​pg/mL in APOE, c) highly reproducible and accurate noting coefficient of variation (CV) and relative error (RE) values below 15% for all analytes and d) minimal interference. The assay can be completed in <5 ​h using as little as 150 ​μL of voided urine.

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