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May 11, 2021

FDA grants EUA to Inova Diagnostics’ SARS-CoV-2 IgG test

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Inova Diagnostics’ Covid-19 assay.

Named QUANTA Flash SARS-CoV-2 IgG, the chemiluminescent immunoassay is indicated for the in vitro qualitative and semi-quantitative identification of immunoglobulin G (IgG) to the Covid-19 virus’s nucleocapsid and spike protein.

The test, which is carried out using human serum or citrated plasma, is authorised for use on the BIO-FLASH random access chemiluminescent analyser.

The BIO-FLASH system can process up to 60 samples in an hour with STAT capability and delivers a first result in 30 minutes.

Inova Diagnostics research and development vice-president Dr Michael Mahler said: “Based on the high performance of the assay and the high automation level of the BIO-FLASH system, QUANTA Flash SARS-CoV-2 IgG represents a promising solution to detect antibodies to SARS-CoV-2.”

The test has demonstrated a specificity of 100% in patients with confounding illnesses and sensitivity of 100% in Covid-19 patients after 15 days of a positive reverse transcription-polymerase chain reaction (RT-PCR) result.

In 2017, Inova received 510(k) clearance from the FDA for the use of its NOVA Lite kits with the NOVA View Immunofluorescence Assay microscope.

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In a separate development, FluroTech and its FluroTest Diagnostics Systems subsidiary are set to commence the next phase of the ongoing clinical trials for its high volume Covid-19 rapid antigen testing system, with partner Toolbox Medical Innovations.

The system can potentially aid in a quick and precise point of access testing based on robotics automation, biochemistry, fluorescence detection and Cloud computing.

The programme will enrol 600 symptomatic as well as asymptomatic subjects at six clinical sites in the US to analyse performance detection results as compared to a RT-PCR assay.

The results obtained from this trial and a future pilot programme with US-based Total Testing Solutions will be submitted to seek FDA EUA and an Interim Order Authorisation from Health Canada.

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