Liquid Biopsy from Urine

The nRichDX Revolution Sample Prep System greatly improves the chances of recovering rare mutations from cfDNA, cfRNA, and CTCs from whole urine and cell-free urine samples due to the Revolution System's nRicher Cartridge unequaled sample capacity, which enables analyte extraction from all Colli-Pee device sizes (4 mL - 40 mL) in a single extraction. The patented process captures more actionable cf/ctDNA, cf/ctTNA, and CTC (from whole urine) by combining increased recovery efficiency with the use of a larger sample volume. This combination enables efficient, high-yield analyte capture as compared to other sample preparation methods.

Urine extraction protocols are found within the Instructions for Use (IFU) for the Revolution cfDNA Max 20 and Max 50 kits, cfTNA (Total Nucleic Acid) Max 20 and Max 50 kits, as well as the Revolution CTC Isolation Kit on the Products section on this website.

Why is Revolution Sample Prep superior to other methods?

Other methods aren't as suitable for large volume urine samples, whether column based methods, slurries, or magnetic beads. They use yield-lowering plasticware-to-plasticware sample transfer methods, pooling, concentration steps, and/or have tedious workflows that aren't amenable to automation.

An example is column-based extraction with "tube/column extenders" and a vacuum manifold. Most columns, even with column extenders have a maximum input sample volume per extraction of 5 mL and aren't automated at that input volume.

To maximize yield of liquid biopsy analyte(s) from urine samples and increase assay sensitivity, many would prefer to extract from larger volumes of urine, such as 20 mL or 50 mL; however, columns are not well suited for larger volumes as shown below:

Revolution Sample Prep requires just one high-efficiency extraction and one elution (25µL to 100µL) as compared to columns with tube/column extenders which require 10 separate extractions due to the limited input volume of 5 mL per column, followed by 10 elutions (at a minimal elution volume of 20 µL), which then also requires a pooling step, followed by a concentration step.

Analyte yield is lowered in columns as compared to Revolution Sample Prep due to inherent limitations in the column and protocol. Sample transfers between plasticware within the protocol itself and subsequent pooling and concentration steps all lower yield.

Posters

nRichDX has presented or co-presented several posters at recent key meetings on analyte extraction from urine samples. A complete list of nRichDX posters, presentations, and webinars is available on the nRichDX Reference Materials webpage.

nRichDX Revolution Plus System and the Novosanis Colli-Pee for Urine Collection and Preservation

nRichDX has partnered with OraSure's Novosanis division to ensure compatibility and a comprehensive preanalytical solution for all sizes of the Colli-Pee^® First Void Urine (FVU) Collection Device with the Revolution Sample Prep System. nRichDX and Novosanis combined resources, such as a jointly developed webinar, posters, and an Application Note are available here.