Novacyt UK Holdings Ltd

VersaLabTM Portable is the latest addition to the versatile VersaLabTM product range – enhancing our abilities to support private sector testing of infectious diseases.

It’s a rapid, lightweight COVID-19 test on the go – providing rapid turnaround polymerase chain reaction (PCR) testing on-site.

VersaLabTM Portable, initially focused on COVID-19, aims to broaden access to affordable testing in areas that lack the infrastructure for laboratory-based testing with gold standard PCR results from optimised reagents.

The product is a “PCR Lab-in-a-box” and as such comes with all the equipment required to provide near-patient PCR testing using Novacyt’s PROmate® workflow in non-clinical settings, such as offices and workplaces.

The 8-piece standard equipment for the PROmate® and genesig® q16 instrument workflow is packed neatly in a lightweight carry case. It means that testing can be carried out closer to patients – anywhere at any time. There’s just one pipetting step, for optimum efficiency – saving time and money.

PROmate® is the only rapid direct-to-PCR COVID-19 assay approved by the Department of Health and Social Care’s Technology Validation Group. PROmate®’s unique workflow allows Novacyt to provide rapid results to patients in under 80 minutes, saving time and minimising the risk of infection spreading.

VersaLabTM Portable represents an exciting evolution of the VersaLabTM product portfolio, designed to bring PCR technology outside of the central laboratory and closer to patients. We aim to provide companies and communities with reliable and fast turnaround results to deal with localised surge infections or for routine localised mass testing. VersaLabTM is an asset in any country’s toolkit for localised community testing and monitoring of COVID-19 infections, providing an additional level of support in near-patient testing environments.

For further information, please visit www.novacyt.com or email a question to enquiries@primerdesign.co.uk. 

Total workflow solution to detect SARS-CoV-2 viral RNA

 

PROmate® COVID-19 is a total workflow solution for the qualitative detection of SARS-CoV-2 viral RNA – enabling easy, time-efficient testing without the need for a biosafety cabinet.

 It includes sample preparation, qPCR amplification and analysis on our genesig® q16 and q32 instruments, specifically for the detection of SARS-CoV-2.

With only one pipetting step, the assays provide rapid screening of people for SARS-CoV-2 infection and aid the diagnosis of suspected COVID-19 in patients.

PROmate® remains the only direct-to-PCR (polymerase chain reaction) assay approved by the UK’s Technology Validation Group and enables near-to-patient testing with results within 80 minutes – including swab sample processing, PCR set-up and PCR run time. Its innovative 1G test – CE-IVD PROmate® COVID-19 - identifies the SARS-CoV-2 ORF1ab target. Building on its success, we developed a two gene test – CE-IVD COVID-19 2G – which adds NSP16 gene identification, meeting emerging need for identifying both genes at the same time.

Launch of a two gene testing solution to add to the existing one gene test expanded the scope of the PROmate® option, with one of the highest sensitivities in near-patient settings. With no need for highly trained personnel to administer the tests, it is ideal for seamless testing at sporting or entertainment events, in airports, on cruise ships and in business or academic settings.

Both tests detect nucleic acid from SARS-Cov-2 from anterior nasal and throat* specimens prepared on dry swabs. With just one pipetting step, it makes testing effortless, enabling time-efficient rapid screening which aids the diagnosis of suspected COVID-19 patients.

PROmate®COVID-19 provides total viral inactivation, with a ready-prepared Master Mix containing internal control for run validity. This means there is no need for a category 2 laboratory to handle the live virus, so risk in handling is nullified. Two discrete protocols are provided for users with or without a Class II Biosafety Cabinet, allowing total flexibility with use of the product, depending on workflow set-up.

Both PROmate® workflow solutions are also available in our VersaLabTM mobile processing laboratories, which provide rapid turnaround PCR testing on-site, using the gold standard sensitivity and specificity of PCR technology.

These versatile mobile labs support easy and accessible private sector testing, when and where it is needed – helping to fast-track SARS-CoV-2 detection and monitoring, plus enabling early identification of outbreaks or hotspots.

Our PROmate® workflow solution is also being explored with other pathogens, such as SARS-CoV-3 and respiratory syncytial virus (RSV) – to continue applying our innovation and expertise to support countries maintaining their economies and population health during virus threats.

*Throat specimens sample for PROmate® COVID-19 (1 gene) only.

For further information, please visit www.novacyt.com or email a question to enquiries@primerdesign.co.uk. 

genesig® is Novacyt’s well-established range of qPCR kits for pathogen detection, food and water testing, veterinary and agricultural testing.

As a pioneer in clinical diagnostics, we have a proven history of responding quickly to changing global health needs, including providing testing solutions for Zika, swine flu and Ebola viruses. Solidifying this position, we were among the first to respond to the COVID-19 pandemic in 2020, providing a rapid and reliable CE-IVD marked SARS-CoV-2 test kit. genesig® real-time PCR COVID-19 (CE) was the first CE-mark approved test form clinical diagnosis of the original 2019 strain of the novel coronavirus.

From this first breakthrough, we have responded quickly to the evolving testing needs of the virus, and since developed a suite of solutions for COVID-19 top better manage the pandemic.

The genesig® COVID-19 Real-Time PCR range is a gold standard portfolio of CE marked, in vitro diagnostic, real-time, reverse transcriptase PCR (RT-PCR) assays intended for the qualitative taction of nucleic acid from SARS-CoV-2.

Backed by our world-class surveillance programme of comprehensive virus monitoring, this range continues to evolve, bringing innovations that can impact the management of patients and patient-care outcomes, influenced by the highest level of specificity and sensitivity of our kits.

With stable design and a rich database of more than 200 pathogens, we can direct our knowledge, skills, and capabilities to the changing needs of business, industry, and healthcare.

This means that we were able to draw on the design expertise and experience behind the range to pivot development and address the COVID-19 pandemic. The genesig® Real-Time PCR COVID-19 (CE) kits can detect nucleic acids from SARS-CoV-2 in different sample types. genesig® 1-gene and 2-gene use nasopharyngeal and oropharyngeal swabs with sputum; the new genesig® 3-gene uses nasopharyngeal and oropharyngeal swabs with saliva. They offer rapid detection and results in under 3 hours, without compromising on high sensitivity, specificity, and accuracy.

Being able to apply the same technologies to pandemic management led to the launch of our most recent genesig® products – the three gene version of the COVID-19 CE IVD test, and COVID-19 HT 2.0, our next-generation high-throughput PCR test for COVID-19.

The three-gene test, developed to acknowledge the changing testing needs from SARS-CoV-2 virus mutations, complements the company’s existing one-gene and two-gene tests, and demonstrates Novacyt’s flexibility and agility in response to the evolving COVID-19 pandemic. It was developed in recognition of rapidly changing testing needs dictated by SARS-CoV-2 mutations and complements our existing genesig® products by providing an ideal solution to meet the needs of the travel market.

Our comprehensive genesig® COVID-19 real-time PCR portfolio is known for its high priming efficiency, with accurate controls to confirm extraction and assay validity, and lyophilised components for ambient shipping. The genesig range of kits is designed to work perfectly with any real time PCR machine available on the market, delivering results in under three hours.

The success of our COVID-19 PCR assays has been built around robust design principles and our real-time bioinformatics surveillance programme to monitor new SARS-CoV-2 genome sequences. As a result, our genesig® COVID-19 portfolio is highly accurate, despite virus mutations.