Quidel has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Solana SARS-CoV-2 assay to diagnose Covid-19 patients.

Solana SARS molecular test is an isothermal reverse transcriptase – helicase-dependent amplification (RT-HDA) assay designed to facilitate the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens in viral transport media from suspected Covid-19 patients.

Quidel’s test offers a simple workflow with no sample extraction and also features medium volume throughput design that is suitable for batch testing. With improved laboratory efficiency, Solana SARS molecular test requires just a 25-minute run time for up to 11 samples.

The test comprises two crucial steps, of which the first one is specimen preparation. The second is the amplification and detection of target sequences specific to SARS-CoV-2 using the company’s RT-HDA in the presence of target-specific fluorescence probes.

Solana instrument is said to objectively measure and interpret a fluorescent signal. The instrument will show the test results to the user on its display screen and they can be printed using an integrated printer.

Compatible with Dymo Label Writer systems, the small-profile instrument is provided with an interactive touchscreen and barcode scanner for easy data entry, along with Ethernet and USB ports for data transfer and printing.

The instrument can also be connected with Quidel’s Virena data management and surveillance ecosystem, which offers aggregated and de-identified testing data to public health authorities in near real-time.

Quidel president and CEO Douglas Bryant said: “Joining our Lyra and Lyra Direct assays for SARS-CoV-2, we now offer another molecular weapon in the fight against Covid-19 to quickly diagnose symptomatic patient populations.

“The Solana SARS-CoV-2 Assay nicely complements our Sofia and QuickVue tests that are run at the point-of-care, for pre-symptomatic, asymptomatic and symptomatic patients.”

Recently, Quidel has also secured EUA status from the FDA for its QuickVue SARS rapid antigen test to diagnose Covid-19.