Advanced Biological Laboratories (ABL) Releases the First & Unique Commercial CE-IVD Registered COVID-19 rRT-PCR Assay Validated also for Human Saliva Specimens

Single well rRT-PCR assay, including highly sensitive detection of 2 targets and housekeeping internal control, with full automation

 

Luxembourg (Luxembourg), Metz (France), — July 06 Advanced Biological Laboratories (ABL) announced today the CE-IVD marking of its UltraGene® Combo2Screen SARS-CoV-2 qPCR assay. It is the first qPCR detection kit now validated with SARS-CoV-2 RNA extracted from nasopharyngeal swabs and saliva. The collection of saliva samples is not invasive and allows easier and broader population testing and screening.

This optimization consisting in using saliva specimen as an input material for the SARS CoV-2 RNA extraction and qPCR detection, rather than traditional nasopharyngeal swabs, helps in improving the workflow, costs and convenience of the test together with the comfort of the patients. It allows to target asymptomatic patients, increase patients’ acceptance for testing and reduces workload and risk of infection for healthcare professionals performing nasopharyngeal or oropharyngeal collections. Patients collect saliva samples under healthcare professionals’ supervision under a simpler and painless collection protocol.

The UltraGene® Combo2Screen CE-IVD assay is targeting two highly conserved regions of the SARS-CoV-2 genome (Nucleocapsid (N) and Envelop (E) genes) in a multiplex format which includes an internal control. The test remains one of the most sensitive and easy to use assays from the market (~200 cp/mL) either with naso-oropharyngeal or saliva samples. It is compatible with most of the automated or manual RNA extraction methods, as well as with most of the qPCR instruments.

The instructions for use of the assay describes a saliva collection process which shall be adapted and validated by the laboratory according to its own accredited procedures (patient eligibility, patient’s skill, supervision or self-collection …).

“We are proud to enhance our COVID-19 line of solutions. Converting the assay into a non-invasive fluid saliva collection workflow should significantly help increasing the number of people being tested and ease the access to diagnostics to fragile population such as children or elderly patients and to asymptomatic patients” said Dr. Chalom Sayada, CEO of ABL. “Proactive saliva collection strategy at schools and business places shall be foreseen to monitor prospectively SARS-CoV-2 infection”

To learn more about UltraGene® Combo2Screen SARS-CoV-2 assay, please visit https://www.ablsa.com/laboratory-applications/ultragene-combo2screen/