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The right reagents boost cost efficiency in molecular Point-of-Care testing

Look beyond price. An optimal cost structure does not compromise performance.

Modern medicine aims to bring timely, life-saving diagnostics and treatment to ever broader populations.  Molecular Point-of-care (PoC) assays are designed precisely for that purpose. Designing assays to feature the functionality, robustness, and speed needed for PoC testing is no small feat.

Molecular assays are also increasingly complex. Newer assays detect multiple targets in biological samples that carry known inhibitors of reactions. 

On top of that, manufacturing and logistics of molecular assays must be cost-efficient. A solution is to use well-designed reagents that save money in the architecture of the assay, the handling of the test, and the logistics of bringing your product to patients.

Smart assay architecture for PoC testing with lyo-ready reagents

How an assay is put together determines the steps to carry out a test. But it also defines how reagents combine in reactions and the efficiency with which reagents are consumed. Roche CustomBiotech lyo-ready reagents are highly concentrated and glycerol-free. As a result, they can be employed in a wide range of assay formats, allowing more flexibility for development. Consequently, the use of low glycerol or glycerol-free reagents during the development phase can reduce costs during commercialization.

Potential cost savings areas for lyo-ready: glycerol-free & high concentration

Glycerol-free formulation = no glycerol removal:

  • can cut reagent loss by up to 20%
  • saves additional processing steps
  • no testing post-glycerol removal necessary

High concentration = lower reagents volumes:

  • saves volume for more sample material
  • boosts sensitivity
  • fewer limitations on development 
Coupling performance and low cost in the manufacture and supply of PoC assays

The need for speed of results and minimal sample preparation has been frequently addressed by overdosing the enzymes used. Since enzymes are the most expensive component of a molecular assay, working with more powerful variants may allow to reduce the need for enzyme overdosing leading to a lower price per reaction.

With that in mind, Roche CustomBiotech offers a suite of high-performing enzymes that can be used in fast-cycling protocols and under minimal sample preparation. For example, PCR with KAPA3G takes 23 minutes; reverse transcription with NxtScript 2G only 5 minutes under some conditions. Both enzymes have also been tested against a broad range of inhibitors. 

Discover fast and inhibitor tolerant enzymes in this video:

Discover lyo-ready reagents for your IVD point-of-care assays
Logistics in a modern world

Simplifying testing protocols at point of use and accelerating test turnaround time to accommodate the variable expertise and fast-paced work of operators could potentially reduce human error and repeat testing.

In a globalized economy, supply chains extend over oceans. Yet, despite variable transportation conditions, manufacturers of PoC assays must maintain product performance. Measures to prevent changes in assay components due to temperature or humidity fluctuations are expensive. With our high-concentration, lyo-ready reagents, assays can be readily dried down, making them less susceptible to environmental variation. Additionally, the smaller size, reduced weight, and extended shelf life of dried-down assays can ease logistics (and the accompanying costs) even further.

Discover how the right reagents reduce costs in mPOC with our infographic

Quality, well-designed reagents translate to cost savings

Using reagents from Roche CustomBiotech specifically made for IVD also saves time and resources. Our IVD reagents are manufactured under ISO13485 to ensure that every lot meets very narrow quality specifications. The resulting lot-to-lot consistency in formulation and performance could alleviate incoming quality control obligations, which can be extensive with more variable raw materials.

 

Building quality into your assay with the right reagents can also build cost efficiency in your operations. Ensuring the performance you need. Looking after the needs of your customers. For more than 30 years.

 

Value lies in design, not price.

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