FDA grants EUA to Quidel’s Covid-19 molecular test

24 December 2020 (Last Updated December 24th, 2020 12:38)

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Quidel for marketing its Solana SARS-CoV-2 Assay for the qualitative detection of nucleic acid from SARS-CoV-2.

FDA grants EUA to Quidel’s Covid-19 molecular test
The assay can deliver results from up to 11 samples in 25 minutes. Credit: Ewa Urban from Pixabay.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Quidel for marketing its Solana SARS-CoV-2 Assay for the qualitative detection of nucleic acid from SARS-CoV-2.

The isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) assay detects nucleic acid from the virus in nasopharyngeal and nasal swab specimens in viral transport media from patients suspected of Covid-19 by their healthcare provider.

It offers a simple workflow with no sample extraction, a medium volume throughput design ideal for batch testing and enhanced lab efficiency, as well as fast, 25-minute run time for up to 11 samples.

The Solana test has two main steps, one being specimen preparation and the other amplification and identification of target sequences specific to SARS-CoV-2 using Quidel’s isothermal RT-HDA in the presence of target-specific fluorescence probes.

Designed for increased space efficiency and user friendliness, the Solana instrument evaluates and interprets a fluorescent signal, deliver the test results to the user on its display screen and can print the results through an integrated printer.

The instrument also has an interactive touchscreen and barcode scanner, Ethernet and USB ports and printing and compatibility with Dymo Label Writer systems.

Solana also has access to Quidel’s Virena data management and surveillance ecosystem, which delivers aggregated, de-identified testing data to public health officials 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.”

Earlier this week, the US FDA granted a EUA to Quidel’s QuickVue SARS Antigen test for Covid-19 testing.

In a separate development, the FDA has authorised marketing of Interscope’s EndoRotor System to resect and remove necrotic tissue for patients with walled-off pancreatic necrosis.

It has a power console, foot control, specimen trap and single-use catheter, and is used for direct endoscopic necrosectomy.