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.

Types of Diagnostic Reagents:

1. 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.
2. 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.
3. Ancillary reagents
   Ancillary materials (AMs) are reagents used in the manufacture of cell therapy products. Even though they are not intended to be present in the final product formulation, they are still crucial to ensuring the critical quality attributes of the final product.

Our Diagnostic Reagent Services

As a leading diagnostic reagents supplier, we have in-depth experience in manufacturing a range of high-quality reagents, including:

Medic Diagnostic Reagents

With accreditation to the ISO 13485 standard, we’re able to manufacture medical reagents to customers’ exact formulation for use with medical devices. Medic diagnostic reagents we manufacture include IVD, ancillary, and COVID-19 testing reagents.

The products we supply, primarily to the life sciences and molecular diagnostics industries, provide consistent, reliable results and meet stringent IVD requirements.

IVD Reagents

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.

Ancillary Reagents

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.

To ensure our ancillary reagents meet the stringent quality standards, we conduct rigorous analysis and pass them through a 0.2 micron filter so that any particulate contamination is eliminated.

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 0800 9555 798

Peace of Mind with ISO 13485 Accreditation

ReAgent is accredited to ISO 13485, so you can rest assured that all our medical reagents adhere to the strict requirements of a QMS specific to the medical devices industry.

You can benefit from this accreditation with:

• Peace of mind that we have manufacturing processes and controls suitable for clinical 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

ReAgent’s High Quality Standards

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 that we can ensure our products meet the stringent requirements of all out ISO accreditations, including:

ISO 13485:2016

We adhere to the quality management system specific to the medical devices industry. This ensures we meet the current Medical Device Directives, regulations, and responsibilities.

ISO 9001:2015

Our accreditation to this quality standard ensures our products are always manufactured to the highest quality and we’re always embracing new ways to improve our processes.

ISO 14001:2015

We achieved accreditation to ISO’s environmental standard as part of our ongoing commitment to sustainability and minimising our impact on the environment.

ISO 45001:2018

We’re also accredited to the occupational health & safety standard, meaning 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.

In addition to our ISO standards, we employ LEAN manufacturing principles and continually look to improve our processes. 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 With Our Expert Team

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.

Why Choose ReAgent For Diagnostic Reagent Services?

• Face to face contact and support

If you have a technical question, want to talk through ideas face to face or even perform an audit on us our door is always open, just get in touch!

• Fully traceability on all batches

All consignments are fully traceable and our bespoke in-house system means we have full traceability on all stock and each batch in our facility.

• Place your order, sit back and we take care of the rest

Our service doesn’t stop when we’ve finished manufacturing your product, we can also deliver and label your products with your own labels and company branded documents direct to either you or your customers.