Solutions



We’re committed to long-term solutions in disease management

ABL has three platform solutions for COVID-19 diagnostic testing:

  • Molecular: UltraGene® Combo2Screen SARS-CoV-2 Assay

    Early detection of COVID-19 through a qPCR molecular assay (now available). Click here for a PDF with more details.

  • Genotype: DeepChek® 8-plex SARS-CoV-2 Genotyping Assay

    (now available for Research Use Only. Not for use in diagnostic procedures). Click here for a PDF with more details.

  • Serology: SARS-CoV-2 Antibody Test
    (More information coming soon.)
We’re committed to long-term solutions in disease management
UltraGene® Combo2Screen SARS-CoV-2 Assay
ABLDx has submitted an EUA application to the FDA for this first COVID-19 test.

UltraGene® Combo2Screen SARS-CoV-2 Assay

The UltraGene® Combo2Screen SARS-CoV-2 Assay is a real-time RT-PCR nucleic acid technique intended to be used for the qualitative detection of nucleic acids from patients with acute respiratory syndrome-associated coronavirus 2 (SARS-CoV2) and directed against the E and N genes of SARS-CoV-2 virus.

ACCURACY
Dual target assay, with specific targets unique to SARS-Cov-2 (COVID-19 Coronavirus) and directed against the E and N genes.

CLINICAL PERFORMANCE
Specificity: 100% in clinical evaluations (95% CI: 84.56%-100%)
Sensitivity: 100% in clinical evaluations (95% CI: 84.56%-100%)
Clinical Reproducibility: 100% obtained via QCMD 2020 Coronavirus Outbreak Preparedness EQA reference study (Ref# QAV204214_1)

MULTI-PLATFORM
Compatible with main standard qPCR platforms

HANDS-ON TIME
Simple workflow / estimated turnaround time 1 hour 45 minutes

THROUGHPUT
Standard throughput per platform between 300-500 samples per shift

Registration Status

ABLDx has submitted an EUA application to the FDA for clinical use of the UltraGene® Combo2Screen SARS-CoV-2 Assay as a test for COVID-19.

Click here to download the product sheet, including performance.

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