Solutions for COVID-19 Detection and Monitoring

Fully Automated COVID-19 Testing – The Randox Discovery

• The Discovery is an exciting and disruptive analyser capable of molecular & immunoassay testing
• Detection of up to 10 viral targets, including SARS-CoV-2 from a single patient sample via patented biochip
  technology via patented biochip technology
• Rapid turnaround of 3 hours for the first batch of results, with subsequent results available every hour
• Fully automated platform increasing operator walkaway time
• Simple and easy to use due to the intuitive user interface, guiding the operator through the entire testing process
• Consolidates the workflow of multiple laboratories, performing extraction, PCR & detection on one benchtop platform

Fully Automated POC COVID-19 Testing – The Vivalytic

• Fully automated, sample to answer point of care diagnostics
• Gold standard PCR testing for infectious disease with test results in as little as 40 minutes
• Unique test menu covering a diverse range of respiratory, genitourinary and hospital acquired infections
• Easy 4 step process from sample entry to results. No laboratory training required
• Wireless connectivity, no peripherals required making Vivalytic a unique space saving & hygienic solution
• Hi-Plex & Lo-Plex Capabilities. Powered by Randox Biochip Technology enabling multiple results from one patient sample
• Full molecular workflow consolidated into one small benchtop platform

Semi-Automated COVID-19 Testing – The Evidence Investigator

• Detection of up to 10 viral targets from 54 patient samples simultaneously
• Comprises Sarbecovirus as a confirmatory target ensuring accurate diagnosis
• Availability of Hi-Plex and Lo-Plex testing options for SARS-CoV-2
• Target genes in line with WHO and CDC recommendations
• Medium to high throughput analyser capable of processing up to 540 results in <5 hours
• Evidence Investigator is suitable for use within a laboratory setting

Viral RNA Extraction Kits

• Efficient and automated purification of nucleic acid material
• Extraction from nasal-throat swabs following brief lysis steps
• Convenient room temperature storage
• Yields highly concentrated nucleic acids that are ready to use in downstream applications such as
  qualitative or quantitative PCR
• Available for use on any automated extraction platform
• Quick assay protocol

COVID-19 qPCR Assay

• Multiplex PCR assay accurately detecting both SARS-CoV-2 (ORF1ab) and Sarbecovirus (E-gene)
• Highly sensitive assay, LOD 750 copies / ml ensuring accurate & reliable results
• Rapid turnaround time & PCR run time of 75 minutes
• High throughput: 96 sample in 2.5 hours from extraction to analysis from automated nucleic acid isolation

SARS-CoV-2 Antibody Testing

SARS-CoV-2 IgG (RBD & NP) Array

• Uniquely measuring antibodies reactive to both RBD and NP
• Simultaneous detection of IgG antibodies to RBD & NP maximises assay sensitivity reducing false negatives
• Distinguish vaccinated from naturally infected individuals
• Identify incidence of SARS-CoV-2 infection in vaccinated individuals
• Confirmation of an adaptative immune response to SARS-CoV-2
• Specificity of 99.5% and sensitivity of 100% ≥ 14 days post SARS-CoV-2 PCR confirmation
• Qualitative and semi-quantitative results provided
• Available on the Evidence Investigator & Evidence+

SARS-CoV-2 Surrogate Virus Neutralsation Assay

• Qualitative detection of SARS-CoV-2 virus neutralising antibodies (VNabs)
• Enables identification of a protective immune response to SARS-CoV-2
• Aids in the stratification of at risk groups where additional booster vaccinations may be required
• Accurate assessment of herd immunity and measurement of vaccine efficacy
• Capable of detecting VNabs in an isotype and species independent manner
• Rapid results (1.5 hours) without the need for Biosafety level 3 requirements
• Specificity of 100% and sensitivity of 98% compared to conventional virus neutralisation test
• Direct sample addition to Biochip well. No off-board sample incubation required
• Available on the Evidence Investigator

Quality Control & EQA

Acusera SARS-CoV-2 Antibody Control

• Liquid ready-to-use format for convenience and ease-of-use
• 100% human plasma
• True third party control ensuring unbiased performance assessment
• Open vial stability of 30 days at +2ºC to +8ºC
• Suitable for use with Anti SARS-CoV-2 assays
• Control is CE marked

Qnostics

Qnostics, a world leading manufacturer of QC solutions for molecular infectious disease testing has developed a range of products designed to support the validation, verification and performance monitoring of molecular assays used in the testing of SARS-CoV-2. Whole pathogen controls designed to monitor assay performance on a run to run basis. As true third party controls, assay drift is detected, monitored and managed helping to ensure accurate and reliable results.

QCMD

QCMD provide two EQA programmes for SARS-CoV-2. Each programme is designed to evaluate a laboratory’s ability to detect SARS-CoV-2 using routine molecular methods and will provide an opportunity to assess performance against an international peer group.