Sentinel Diagnostics Has Developed a Ready-to-Use Real-Time PCR Mix for the Detection of Novel Coronavirus Disease

Sentinel Diagnostics, an Italian company focused on the development and production of in vitro diagnostics for the most advanced clinical chemistry, immunochemistry, and molecular diagnostics platforms, recently announced that its new assay for the detection of novel Coronavirus disease (COVID-19) is ready. This test has been developed together with the most important hospital lab for the detection and treatment of coronavirus in Italy.

Sentinel Diagnostics has more than 35 years of experience in the development and production of IVD products designed for use in medical analysis labs and health care structures. In the last 12 years, the company has grown in the molecular diagnostics sector and has developed the proprietary technology STAT-NAT, able to stabilize the activity of PCR mix, allowing room temperature transport and storage, performance improvement, and long shelf life. STAT-NAT can be customized for all NAT systems, from POC to central laboratory.

Sentinel Diagnostics’ STAT-NAT COVID-19 assay is a freeze-dried ready-to-use Real-Time PCR mix for the detection of novel Coronavirus disease (COVID-19) in human respiratory tract specimens in about 90 minutes. The company developed two versions of this kit, which follow two international protocols for the highest sensitivity and specificity. STAT-NAT COVID-19 HK kit is based on the Hong Kong protocol, while STAT-NAT COVID-19 B assay follows the Berlin protocol. Both these kits are validated on the most common PCR instruments and have been tested on human respiratory tract specimens found positive.

“The R&D NAT team has developed and tested the COVID-19 assay by working side by side with one of the reference hospital labs for the detection and treatment of coronavirus in Italy,” explains Maurizio Gramegna, chief technology officer at Sentinel Diagnostics. “Both STAT-NAT COVID-19 HK and B are compliant with the international protocols and are able to detect the relevant genetic variants of Coronavirus COVID-19. We are always in touch with KOLs, in order to keep the assays up to date and even update them in case of any virus mutation.”

STAT-NAT COVID-19 assay isn’t the only news in the offer of the company. Sentinel Diagnostics has just enlarged its Molecular Diagnostics portfolio with a wide number of Real-Time PCR tests. The new assays are available for a wide variety of clinical applications in virology, posttransplant monitoring, hospital-acquired infection detection, and pharmacogenetics applications.

In the fourth quarter of 2020, Sentinel Diagnostics is also going to launch SENTiNAT200, a new end-to-end fully automated solution for PCR-based molecular diagnostics. SENTiNAT200 is going to be a flexible, fast, compact robotic workstation to efficiently automate sample preparation and will include two real time thermal cyclers to manage all the steps: from sample to the final result. The STAT-NAT COVID-19 kit, as well as all the on-market STAT-NAT assays, will be available on this system.

Source: Sentinel Diagnostics