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The unprecedented COVID-19 pandemic and its impact on public health, social and economic life worldwide, has created an urgent and pressing need for the development of therapeutics, vaccines and accurate diagnostic tests to combat the disease.
In the beginning of April, Biogazelle set up and validated its own SARS-CoV-2 RT-qPCR testing platform, independent from commercial testing kits. Since then, we have established a robust, high-throughput testing platform and have processed >300,000 patient samples in a diagnostic setting.
Biogazelle is ISO17025 accredited for qPCR test development and its use in clinical trials. We have wet-lab validated more than 100,000 qPCR assays, beyond industry standards, of which the SARS-CoV-2 assay is just one. Additionally, our founders have co-authored the MIQE guidelines for design, execution, analysis, and reporting of qPCR studies, with more than 10,000 citations.
We have validated both E (envelope) and N (nucleoprotein) gene assays for RT-qPCR. Applying both assays results in 99.99% coverage of known SARS-CoV-2 viral genomes, and also provides increased sensitivity. We have implemented multiple controls in our platform, namely an internal spike-in RNA to test the efficiency of RNA extraction and RT-qPCR of each sample, and 1 positive and negative workflow control per batch of 93 samples. Finally, we have introduced digital PCR as an orthogonal validation method and to calibrate our platform. For more details on our RT-qPCR testing workflow, please watch our webinar.
Additionally we have validated both the E and N gene assays in duplex for digital PCR, which provides absolute quantification of viral genomes and increased precision, particularly on samples with very low viral abundance.
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