The global SARS-CoV-2 pandemic is an emerging, rapidly evolving situation. Therefore, increasing the test capacity to detect a virus infection is of utmost importance. BioVariance GmbH helped to fortify the regulatory submission proposal of a globally acting in-vitro diagnostics company, to receive FDA (Food and Drug Administration) approval for a novel and rapid COVID-19 PCR test. This was achieved in record time by employing computer aided (in-silico) validation methods, and the dedication of our team of Data Specialists. Within the scope of this project, two main objectives were confirmed:
Primer and Probe Sensitivity
To confirm primer and probe sensitivity, alignments of the oligonucleotide sequences and all publicly available SARS-CoV-2 sequences were performed. Hits were prioritized by scoring criteria such as e-value, and mismatches were assessed and evaluated. Furthermore, the hits were further filtered for a potential formation of PCR products.
To predict potential cross-reactivity of the oligonucleotides, sequence homologies with the human genome, other coronaviruses and respiratory related pathogens were detected. This step was essential for ruling out false positive PCR results.
- Demonstration of analytical specificity and exclusivity of the oligonucleotides
- Fortification of regulatory submission proposals
- Reduced wet lab work time and resources
- Detection of mutations such as Single Nucleotide Polymorphisms (SNPs)
- Detailed report of scientific quality including compelling figures
Please do not hesitate to contact us if you are interested or have any further questions.
Helen Riessbeck | Sales and Distribution