Projects

Vivalytic VRI Covid-19 Test System

Vivalytic VRI (viral respiratory tract infections) array is a universal test kit developed by Bosch Healthcare Solutions in collaboration with Randox Laboratories to rapidly detect a SARS-CoV-2 (Covid-19) virus infection in patients.

Project Type

COVID-19 rapid test kit

Developers

Bosch Healthcare Solutions and Randox Laboratories

Applications

Qualitative detection of SARS-CoV-2 (COVID-19) virus infection in patients

Expected Launch

Q2 2020

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Vivalytic VRI (viral respiratory tract infections) array is a universal test kit developed by Bosch Healthcare Solutions in collaboration with Randox Laboratories to rapidly detect a SARS-CoV-2 (Covid-19) virus infection in patients.

It can identify and distinguish lethal strain from the non-lethal strains of other respiratory infections such as influenza, Sarbecovirus or MERS with similar symptoms.

VRI test is one of the world’s first multiplex molecular diagnostic procedures, a fully automated platform produced by Bosch for Covid-19 testing.

The device targets the ORF1ab gene for Covid-19 and E-gene for Sarbecovirus representing high sensitivity and specificity.

VRI test results are automatically processed, made immediately available to the patients within 2.5 hours of diagnosis. The results offer an accuracy rate of up to 95% and comply with the Covid-19 testing recommendations of the World Health Organisation (WHO) and the Centres for Disease Control (CDC).

The test system will minimise the spread of the coronavirus by enabling the health authorities to break the transmission chain more rapidly.

The Vivalytic VRI test kit is expected for launch in the second quarter of 2020.

Vivalytic VRI Covid-19 test system features

Vivalytic VRI test can prevent the rapid spread of Covid-19 and can identify infectious patients with or without symptoms, performed in four simple steps in a fully contained environment for minimal contamination risk.

The test system supports all typical test procedures, including quantitative real-time polymerase chain reaction (PCR), melting curve analysis, end-point PCR and microarray technology.

Bosch Vivalytic test device can be used in various locations including hospitals, laboratories and clinics or doctor’s offices.

VRI test procedure is based on the principle of integration of sample preparation, detection of DNA amplification and single cartridge analysis. It applies nucleic acid-based testing for the direct identification of lethal Covid-19 viral pathogens.

The device provides a differential diagnosis of ten respiratory pathogens simultaneously, saving the additional time required for further testing, while offering a quick and successful diagnosis.

Details of Vivalytic VRI Covid-19 test system

The VRI test system features an open architecture comprising a sample platform, a cartridge containing all the required reagents and an automatic qualitative or quantitative analyser.

“VRI test results are automatically processed, made immediately available to the patients within 2.5 hours of diagnosis.”

A sample up to 2ml is drawn from the nose or throat of the patient using a cotton swab and placed on the cartridge without the need for any complex preparation.

The fully automatic analyser features the universal optical evaluation unit, which processes the cartridge containing the sample and up to nine required reagents.

Cartridges are fully isolated and have minimal risk of contamination during handling. The test can be rapidly and reliably performed at the site or point of care.

Operation of Vivalytic VRI Covid-19 test system

Vivalytic VRI test system initially scans the sample data, while the cartridge code is then scanned into the software. The sample is then placed on to the cartridge slot and the cartridge cap is closed.

The cartridge is then inserted into the system and the sample is analysed using qualitative and quantitative PCR procedures using three stable isothermal temperature zones to ensure high quality and reproducible results.

Embedded software with the device ensures the ultimate protection of sample material and data.

Safe and reliable test results will be displayed within 2.5 hours. The system is suitable for multiple types of test samples including blood smear, sputum, tissue fluid and stool.

VRI platform can also be used to analyse bacteria, fungi and viruses through two parallel processes independently from one another.

Vivalytic VRI device benefits

The test system requires a single nasal sample and an easy four-step process to be followed by the operator during the test.

User-friendly Vivalytic VRI test requires no special training for the operation of the test equipment. The touchscreen interface ensures the whole detection of samples and is completely sealed and hygienic.

VRI detection system connects to LIMS (Laboratory Information Management System) to improve the efficiency and reproducibility of the results obtained.

The Vivalytic system requires room temperature storage and is capable of conducting hi-plex, low-plex and single-plex testing.

A Bosch VRI analyser can perform up to 10 tests within 24 hours, requiring only 100 devices for conducting 1,000 tests a day.

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