Industry Workshop: Presented by DCN and ESE: Application of Fluorescence in Next Generation Lateral Flow Assays

Abstract: In this workshop, attendees were introduced to a variety of portable handheld and benchtop fluorescent and visual lateral flow assay readers, and to a variety of custom labels designed specifically for use in high sensitivity lateral flow applications. A variety of clinically relevant assay systems were presented that demonstrate the increase in sensitivity that can be achieved with these custom fluorescent labels, compared to standard visual labels such as colloidal gold.

Whatman / GE Healthcare Workshop and Reception: The New Frontier for Lateral Flow Assays

Abstract: Dr Brendan O’Farrell presented on “Evolution in Rapid Assays” at this special event and reception sponsored by Whatman /GE Healthcare.

OEM Lecture: Development of a novel lateral-flow assay for Bacillus anthracis protective antigen

Abstract: DCN’s Vice President of R&D, Dr Roy Chung, presented data from a highly sensitive assay for Bacillus anthracis that combines novel fluorescent labels with a low cost, field use reader.

DCN’s unique formula and highly controlled manufacturing process for Colloidal Gold allows us to create gold colloids of the highest quality, designed specifically for use in lateral flow, flow through and microfluidic applications. Our gold undergoes strict quality control to ensure monodispersity, uniformity and stability.

The use of the highest quality gold colloids is essential to the quality of your assay. Colloids should be uniform in size and shape and be monodisperse in nature. We manufacture our colloids using the highest quality water and gold chloride, under highly controlled conditions to ensure these characteristics.

Our standard colloids are 20nm and 40nm in diameter, and are manufactured at OD 1.0, but other concentrations can be produced on request.

DCN’s colloids are stable in excess of 12 months when stored unopened at 4-25°C.
For standard pricing information, see our catalog. For bulk pricing, please contact us.

Gold Conjugates

DCN provides a range of off-the-shelf gold conjugates for a range of assays and uses, including

• Protein A gold
• Protein G gold
• Streptavidin gold
• Anti – hCG gold
• Small molecule conjugates are also available, including for MDMA, methamphetamine, amphetamine cocaine

See our catalog for details.

Custom Conjugation

DCN provides custom conjugation services for Colloidal Gold, colored, visual, fluorescent and paramagnetic particles. For details, see our Custom Conjugation page.

DCN can assist you in securing a license to this patented technology and develop assays on the system for you

Lateral Flow Immunoassay (LFIA) is not the only potential format for point of need membrane based diagnostics. Other formats, such as flow through assays may have advantages, particularly in assays that demand difficult sample processing, high sensitivity and quantification.

Flow Through Assays

In flow through systems, a membrane is still used as a reaction matrix, onto which capture and control lines of proteins or oligonucleotides are striped. In the flow through system, however, the remaining reagents – sample, wash buffers and conjugates – pass vertically through the membrane and are captured in an absorbent wick beneath the membrane.

Advantages and Disadvantages of Flow Through systems

Flow through assays can be more sensitive and less variable than LFIA’s, while utilizing the same labeling and reading technologies. This format also has a significantly cleaner patent environment, allowing for an easier path to market. The drawback has been that traditionally, the user had to perform multiple steps to run the assay, rather than a single addition, as in a typical LFIA. This issue can, however, be overcome using the DiagnostIQ™ platform.

The DiagnostIQ™ is a vertical flow assay system that possesses several novel elements, including a proprietary pre-incubation chamber and filtration area, where the conjugate can be pre-mixed with the sample and thereafter filtered onto the membrane. There the reactants are captured by pre-striped capture and control lines. DCN offers assay development services and can arrange development licenses for third parties wishing to develop assays on this device.

Operation of The DiagnostIQ™

Result Interpretation and Application

The DiagnostIQ can be interpreted by eye or using a proprietary integrated reader system. DCN can integrate this reader to your assay to generate highly quantitative assays with frequently better reproducibility that lateral flow.

For more information click on the link below:
DiagnostIQ Application Sheet

The DiagnostIQ™ Platform

The DiagnostIQ™ is an example of a unique, very applicable technology that DCN offers to clients for integration into their applications. For details of the DiagnostIQ™ Platform, please click here.

The Development Process

On commencement of a project, a development team will be appointed to work closely with you through the product feasibility and development process. We are extremely collaborative, and welcome as much or as little customer input as you wish. We provide regular reports during the process, and welcome customer audits.

DCN’s project design strategy is compatible with US and international regulation in numerous industry segments. The outline is shown below. A detailed planning outline of inputs and outputs for each phase can be supplied on request.

Summary

Design Input Phase

The first step in the process is the definition of project objectives. We work with you to generate the assay specifications and determine your exact needs from the process. A design input document is created, and a workplan and proposal are created for the first phase, Feasibility and Prototyping. This proposal will include a resource evaluation for the project, the proposed workplan, timeline and cost.

Feasibility and Prototyping

This phase involves the development of working prototypes.and the determination of the functional characteristics of the assay relative to the design inputs created in the Design Input Phase. The assay will be optimized and the performance of the reagents assessed in terms of analytical sensitivity, specificity, cross reactivity, and stability (accelerated). Limited clinical studies will be performed. At the end of this Phase, a set of prototypes will be generated and given to the client for assessment, along with a full report and a set of SOPs used for production of the prototypes. At the end of this phase, the client can choose to complete development themselves, or move into the Development Phase with DCN. If the client wishes to move forward, DCN will produce a Risk Analysis document for the product development phase, and generate a full proposal for complete product development to commercialization.

Development Phase

In this phase, the prototype product developed to date will be optimized in the best industrial conditions, taking cost and manufacturability into consideration. The assay performance will be validated, and the manufacturing process will be defined, validated and scaled up. Integration of other assay components will occur during this phase, including cassettes (novel or off the shelf), sample handling and delivery elements, and reader systems. We will work with our partner companies to provide any required assay system components, and manage those aspects of the project, so that our clients need only deal with a single source supplier for all elements – DCN. At the end of this phase, a complete Device History File will be delivered, along with a full set of validated manufacturing SOPs. Entry into the manufacturing transfer phase is the next step.

Overview

Production

LATERAL FLOW TEST COMPONENTS

CUSTOM PARTICLE AND SMALL MOLECULE CONJUGATIONS

ANTIBODIES

ANTIGENS

PARTICLE CONJUGATES

GENERAL REAGENTS

ASSAY STANDARDS/HUMIDITY CONTROL PRODUCTS

ORDERING INFORMATION

• Regulatory affairs
• Quality system design
• Market evaluation
• Product troubleshooting
• Manufacturing process scale up
• Equipment selection and facility design
• Device design
• Technology evaluation

Inquire for details on any of these services.

Manufacturing Transfer and Industrial Validation

This phase involves installation of the product at the manufacturing site, training of manufacturing personnel, validation of processes and product, and verification of the ability to reproduce performance lot by lot and run by run. This process is greatly simplified if manufacturing is to be performed by DCN, however, should the client choose to transfer manufacturing to another site, DCN will develop a plan with the customer and perform the transfer at the site of their choosing.

Manufacturing Services

DCN can transfer your assay internally to our manufacturing facility, where we will provide high quality ongoing manufacturing of the product at any volume level.

Troubleshooting and Follow up

DCN will continue to work with the client and their manufacturing group until the product is completely stabilized and in production. We are your partner in getting your product to market and will stay with you all the way. If we are your chosen manufacturing partner, we will work diligently to ensure the highest product quality, on time, every time.

Overview

Process