The new test kits consist of CE-IVD certified SARS-CoV-2 and Delta variant kit, and research use only (RUO) SARS-CoV-2, Delta, and Omicron kit
Medical device technology start-up Anitoa Systems has expanded its SARS-CoV2 rapid nucleic acid test portfolio with the addition of two new kits to detect Omicron and Delta mutations.
The World Health Organisation (WHO) has designated both Omicron and Delta mutations Covid-19 variants of concern (VOC).
Anitoa’s two new test kits consist of CE-IVD certified SARS-CoV-2 and Delta variant kit, and research use only (RUO) SARS-CoV-2, Delta, and Omicron kit.
For testing SARS-CoV-2 and variants, Anitoa integrates an in-house portable real time polymerase chain reaction (qPCR) instrument known as Maverick with its one-step reverse transcription qPCR (RT-qPCR) reagent.
According to the company, the solution helps to avoid the lengthy process of package and shipping of patient samples to a central lab and the additional steps of sample-prep prior to running RT-PCR.
Anitoa Systems CEO Dr Zhimin Ding said: “As a key supplier of equipment and materials for detecting SAR-Cov-2, Anitoa is closely monitoring all current and emerging variants of this deadly virus to ensure that our test solutions are relevant to the need of the people combating this disease.”
Due to the degradation of viral RNAs in the sample when shipped, Anitoa’s portable solution allows to avoid false-negative readings and deliver precise results.
Without freezing, shipping and thawing the samples in the lab, Anitoa’s solution enables to directly apply patient samples such as throat or nasal swaps to the portable instrument on-site.
The Maverick RT-qPCR device features an advanced four-plex optical multiplexing subsystem for the identification of multiple gene targets in one sample.
Powered by Anitoa’s advanced CMOS biosensor chip, the CE-marked and US FDA-registered device takes up to 45 minutes from sample to results.
The CMOS biosensors incorporates multiple sensing and processing functions required for qPCR in a single silicon chip.
In October last year, Anitoa secured US FDA registration and class II exempt device listing for its Maverick line of qPCR instruments.