XF (Xtraction Free) Reagent System

Field-Deployable Real-Time PCR Diagnostic Assays with Lab-Grade Performance

CENOS™ assays are developed using an advanced in silico pipeline that models primer/probe binding using a multi-state hybridisation model. This allows targeting of genetically diverse pathogens, including highly heterogeneous viruses, and supports multiplex diagnostics across genotypes.

  • Sensitivity: Validated to detect ≤5 copies/reaction
  • From crude samples: No concentration or extraction required
  • Performance: Detects <1,000 genomes/swab or ml of blood
  • Specificity: Routinely tested against unrelated high-titre pathogens
  • Design adaptability: Compatible with rapid custom assay design
  • Multiplex Detection: Supports differential diagnostics for blood borne and respiratory panels 

New assays can be designed, validated, and deployed in under 8 weeks from sequence availability. Existing assay designs can also be ported over and optimised as part of the proprietary CENOS™ platform. 

Delivering Lab-Quality Diagnostics Anywhere…..Without a Lab

The XF Reagent System detects pathogen genomes directly from crude unprocessed biological samples including blood, saliva and swabs. This removes the requirement for sample transportation and upstream purification. No spin columns, no centrifuges, no kits or other specialist equipment. Just sample in and result out, all in under 30 minutes.

A proprietary mix of heat, solvents, and detergents lyses the sample and stabilises nucleic acids in a single step process. This enables direct amplification by real-time PCR delivering rapid, accurate and gold-standard results.

Using a patented multi-cycle high-temperature reverse transcription methodology, the XF Reagent System matches the diagnostic sensitivity of traditional gold-standard reference lab tests - without any extraction or processing steps. This enables the early detection (low viral load) of subclinical, asymptomatic and non-symptomatic cases - providing actionable results and data (without the need to verify with lab based testing) to support informed decision making relating to triaging, containment, treatment and surveillance activities.

Lyophilised, cold-chain free and shelf-stable, XF Reagents are designed for deployment in the field on the frontline. Users simply rehydrate the reagent using the provided reconstitution buffer, add the sample, and run the test. No cold chain. No laboratory trained staff required… a simple workflow process.

The XF Reagent System is optimised for outbreak response and scalable deployment:

  • Rapid development of new assays in response to emerging diseases
  • Field-ready lyophilised cold-chain free format
  • Minimal setup and no specialist labour requirements
  • Built for remote decentralised settings including clinics, mobile labs, farms, ports, operating bases, or border control points

Diagnostics at the Point-of-Decision demands speed, simplicity, performance and scale. The XF Reagent System does it all.

CENOS uses a novel and propriety Xtraction Free (XF) Reagent System to perform RT-qPCR detection direct from crude samples. There is no time consuming nucleic extraction or purification processes. Users simply add the unprocessed biological sample directly into the biosecure reaction vessel to perform the closed tube reaction. Biological sample input types include whole blood, serum, plasma, saliva, cerebrospinal fluid, cloacal and nasopharyngeal swabs. Internal positive controls based on Armoured RNA provide complete confidence in results.

CENOS is capable of performing multiplex RT-qPCR which includes integrated internal controls for validation of results. The platform uses a sensitive bicolour optical detection system to simultaneously detect and differentiate between multiple target pathogens in a single test. Multiplex detection is used to support differential diagnostics distinguishing a particular disease from others that present similar clinical symptoms. Multiplex panels can be configured in accordance with defined user requirements (e.g. respiratory, blood borne and Viral Haemorrhagic Fevers) complete with internal controls.

CENOS delivers sensitive “gold standard” RT-qPCR that meets LLOD laboratory reference tests enabling the early detection (low viral load) of subclinical, asymptomatic and non-symptomatic cases. This provides actionable results and data to support informed clinical decision making relating to triaging, containment, treatment, surveillance activities and pandemic preparedness. Patients can be isolated and treated prior to becoming infectious; this in turn will help prevent the spread and detrimental effects of High Consequence Infectious Diseases (HCIDs).

Our proprietary reagents are supplied lyophilised ready to use in our dedicated consumable. They are cold-chain free and stable at ambient temperatures eliminating the need for cold storage facilities and simplifying logistics in remote regions. Aptamer-controlled hot-start functionality ensures reactions can be set-up at up to 35°C with no adverse effect on performance or sensitivity. This means testing efforts can be carried out in-field in almost any geographical location from Europe to warmer climates such as Africa, South America and Southern Asia.

CENOS is an open platform that allows for rapid assay design, validation and delivery at scale. Our robust bioinformatics pipeline streamlines the creation of new diagnostic assays and modification of existing ones for use with the CENOS platform. Development to validation in accordance with ISO 13485 standards is 6-8 weeks. This allows high sensitivity diagnostic assays to be rapidly configured, optimised and deployed in response to new or emerging pathogens or variants including Virus X. The CENOS platform offers a complete plug-and-play solution for outbreak response and pandemic preparedness.