What Are Diagnostic Reagents?

Diagnostic reagents are used to diagnose a range of health issues by screening for pathogens, antigens, co-infections, genetic diseases, and a host of other physical diseases. They can be used either in vivo or in vitro, and are most commonly known today as the key player in rapid diagnostic tests (RDT) for COVID-19.

What Are IVD Reagents?

Good healthcare depends on the biological and clinical analysis of samples that provide consistently accurate diagnoses. Most of the medical devices that perform these analyses require in vitro diagnostic (IVD) reagents to deliver accurate results, enabling healthcare providers to dispense targeted treatment plans.

With accreditation to the ISO 13485 Standard, we’re able to manufacture IVD reagents to customers’ exact formulation for use with medical devices. The products we supply, primarily to the life sciences and molecular diagnostics industries, provide consistent, reliable results and meet stringent IVD requirements.

All the IVD reagents we manufacture use chemicals approved for their intended use, are subject to extensive quality checks, and we have full change control and notification processes in place. 

We can also pack IVD reagents in sterile, DNAse and RNAse-free packaging, and manufacture them in ISO Class 7 cleanroom conditions. Products are routinely filtered to 0.2µ during the packing process. We are also able to produce and pack reagents that have a short shelf-life, as we have both cold and frozen storage available. That means we can store and transport products at the optimum temperature to prevent degradation of the product.

Medic Diagnostic Reagents

Medic diagnostic reagents are a vital part of medicine. The analysis of saliva, blood, tissue, and other bodily fluids provides doctors with the critical information they need to give a medical diagnosis. It’s often the case that the medical devices producing the results run continuously to meet service demand, so consistent reliability and accuracy of analysis is crucially important.

The efficient, high-quality manufacture, handling, and delivery of IVD reagents can therefore assist in reducing costs incurred through equipment downtime, while improving service demand.

At ReAgent, we have in-depth experience in manufacturing a range of high-quality reagents, including:

Ancillary Reagents

These are used in the manufacture of cell therapy products. The ancillary reagents we produce include instrument consumables for immunohistochemistry (IHC) and in situ hybridization (ISH). We manufacture epitope retrieval solutions, pre-treatments, detection components, and wash buffers for either manual and automated use

COVID-19 Testing Reagents

We can manufacture and supply buffers and reagents for use in different types of coronavirus test kits, including lateral flow test kits and LAMP tests. We have the capacity, expertise, and flexibility to manufacture enough solutions for tens of millions of tests per week, supplied in drums or IBCs. To talk to a specialist in buffers for COVID-19 test kits, please call us on +44 1928 716 903

Peace of Mind with ISO 13485 Accreditation

ReAgent is accredited to ISO 13485, and you can rest assured that all our clinical diagnostic reagents adhere to the strict requirements of a quality management system specific to the medical devices industry. We meet the current Medical Device Directives, regulations, and responsibilities, and are committed to the safety and quality of the medic diagnostic reagents we supply.

You can benefit from this accreditation with:

• Peace of mind that we have manufacturing processes and controls suitable for diagnostic reagents used in medical devices
• More time to focus on the bespoke diagnostic reagent you need, rather than on systems and processes
• The ability to provide confidence and quality assurance to your end user
• The knowledge that ReAgent is a credible, trustworthy manufacturer of bespoke diagnostic reagents

Our High Quality Standards

Additionally, while all our raw materials are usually sourced from around the world, we manufacture our clinical diagnostic reagents and biological buffers in our state-of-the-art facility in Cheshire, UK. This is so we can ensure our products meet the stringent ISO 9001:2015 Quality Standard and our ISO 14001:2015 Environmental Standard, as well as ISO 13485 – we also hold the ISO 45001:2018 Occupational Health & Safety Standard. This means we’re able to manufacture your products as quickly as possible, and provide better value for money.

We also employ LEAN manufacturing principles and continually look to improve. We use the most efficient techniques available, can expand our services to meet your requirements, and ensure on-time delivery, as well as end-to-end support, from pre-sales technical advice to managing inventory and the supply chain.

Working Together

As a customer-led business, we can be flexible and adapt to meet your requirements for reagents, no matter the type. This could mean we develop new manufacturing techniques, invest in new equipment, or undertake training. Even if you need us to adopt industry-specific systems to meet the necessary standards, we are happy to do so.

Whatever your requirements, we’ll work closely with you to supply the diagnostic reagent you need, in the quantity you need, when you need it. Our expert technical team will also provide their advice and expertise every step of the way. This team approach and our ability to adapt are just a couple of reasons why we have an outstanding reputation as a high-quality chemical and contract manufacturer.