The US Food and Drug Administration (FDA) has expanded ChromaCode’s HDPCR SARS-CoV-2 real-time PCR assay emergency use authorisation (EUA).
ChromaCode’s assay is designed for the detection of severe acute respiratory syndrome coronavirus 2 from nasopharyngeal swab specimens collected from individuals who are suspected of Covid-19 by their healthcare provider.
The expanded approval for the assay includes the addition of many new qPCR instruments, as well as the use of 384-well plates.
Now, the HDPCR SARS-CoV-2 assay is compatible with amplification and extraction systems.
The results from the assay are analysed in ChromaCode Cloud, the company’s HIPAA-compliant Cloud-based software.
ChromaCode Cloud provides an end-to-end solution for laboratories to streamline the test workflow and interpretation of results.
The Thermo Fisher Scientific Kingfisher Flex Purification System can be used alongside Thermo Fisher PCR instruments that include ABI 7500 Fast, ABI 7500 Fast Dx, QuantStudio 5, QuantStudio 7 and QuantStudio 12K Flex.
ChromaCode stated that the QuantStudio platform provides flexibility for labs to run either 96-well or 384-well plates to quadruple many Covid tests in a single run.
With this broad PCR instrumentation selection, labs will also be able to use known workflows and reagents to adopt the ChromaCode test.
ChromaCode co-founder and CEO Alex Dickinson said: “Our high-throughput PCR assay combined with our unique ChromaCode Cloud has enabled our customers to run massive test volumes with high reliability and confidence.
“The EUA authorisation for use with even more instrument platforms and 384-well plates will enable labs using ChromaCode’s assay to continue to rapidly scale and meet the demand for high-volume testing while delivering excellent accuracy and variant inclusivity.”