UltraGene Combo2Screen SARS-CoV-2 Assay Now Validated by the French National Laboratory Network

We did in March 2020 an external clinical validation with the French National Reference Centre for Covid-19 (CNR). The validation was in two phases. Clinical samples were tested both with the CNR’s RT-PCR reference method (IP2/IP4) and the UltraGene Combo2Screen SARS-CoV-2 Assay.
  • The two phases showed that the UltraGene Combo2Screen SARS-CoV-2 Assay and the CNR’s reference method have substantial agreement in the detection of the SARS-CoV-2 RNA : 100% for the first phase, between 84-89% for the second one.
  • The UltraGene Combo2Screen SARS-CoV-2 Assay detected and interpreted correctly samples with SARS-CoV-2 dilutions down to 10e-7.
  • On the usability aspects, the kit was evaluated as very easy to use with a turnaround time of 90 minutes on QuantStudio 5 (Applied BioSystems) after an extraction on EMAG (bioMérieux).
The CNR’s concluded that the UltraGene Combo2Screen SARS-CoV-2 Assay can be used for the detection of SARS-CoV-2 in France during the Covid-19 outbreak.
This external validation and the CE-IVD mark allows the test to be supplied to healthcare institutions, private hospitals, medical clinics and clinical laboratories in France and to be reimbursed by French Social Security Code (social welfare).
Full CNR report for ABL UltraGene Combo2Screen SARS-CoV-2 Assay  and other predicates for SARS-CoV-2 RNA detection available at : https://www.sfm-microbiologie.org/2020/04/03/covid-19/