SeqOnce Biosciences has launched its new AzureSeq One-Step Universal RT-qPCR kit, which can be used for detecting the N501Y variant of SARS-CoV-2.
The kit uses a single-tube reaction targeting the N1 nucleocapsid gene, both alleles of S gene N501Y (A23063T) and has RNaseP as a control.
The test, which does not need viral RNA extraction, has a fast cycling protocol option, providing samples to answer results in under 30 minutes.
Furthermore, it uses common qPCR instruments with detection channels of FAM, HEX, Cy5, and ROX.
SeqOnce CSO Joe Dunham said: “The AzureSeq N501Y assay provides health officials, CLIA labs and hospitals the ability to quickly identify and monitor this important SARS-CoV-2 variant.
“We decided to also target the N1 gene so the assay can be used in front-line detection, as well as identification of samples that have previously tested positive.”
In a separate development, molecular diagnostics company Co-Diagnostics has submitted to the US Food and Drug Administration (FDA) for an emergency use authorisation (EUA) of its Covid-19 polymerase chain reaction (PCR) diagnostic saliva test.
The Logix Smart SARS-CoV-2 DS (Direct Saliva) test can identify the presence of SARS-CoV-2 in human saliva samples without needing RNA extraction of the sample.
These extracted samples are then analysed for the presence of the target pathogen using PCR technology.
As compared to other PCR tests, which need a costly, time-consuming process for extracting genetic material from the cells in the sample, the latest test detects SARS-CoV-2 directly from minimally processed saliva samples.
The company noted that removing the extraction process can potentially boost throughput and lower costs of Covid-19 testing, without compromising on quality or accuracy.
Co-Diagnostics CEO Dwight Egan said: “Our new extraction-free saliva test has been developed as part of our ongoing commitment to providing improved Covid-19 diagnostics for high-throughput laboratory settings, using technology with additional potential point-of-care applications.”
Last April, Co-Diagnostics signed an agreement with Promega for additional manufacturing capacity for the urgent production of its Logix Smart Covid-19 test.