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June 10, 2021

Promega’s SARS-CoV-2 immunoassay obtains CE mark

The test could aid labs in reducing the use of resources through an add-incubate-read workflow that requires no wash steps.

Promega’s Lumit Dx SARS-CoV-2 Immunoassay has obtained CE mark for qualitative in vitro diagnostic detection of antibodies to SARS-CoV-2 in a serum sample.

The new bioluminescent immunoassay is currently available in Europe, the company noted.

Based on Promega NanoBiT bioluminescence complementation technology, the assay emits a glowing signal on detecting SARS-CoV-2 antibodies.

The scalable test is designed to aid laboratories in identifying antibodies against the receptor-binding domain antigen within the virus’ spike protein in serum in under an hour at room temperature.

Furthermore, the test facilitates labs to reduce the use of resources by offering an easy add-incubate-read workflow that requires no wash steps.

It also helps labs speed up the testing of vast populations by modifying the assay to high throughput on several automated platforms.

Promega chief medical officer Ashley Anderson said: “Bioluminescence, when applied to antibody detection, offers laboratories several advantages including a simple and fast workflow.”

Apart from Europe, the assay is available in the US under a policy that permits serological test developers to offer them with pending US Food and Drug Administration approval.

The Centers for Disease Control and Prevention added Promega’s amplification reagent GoTaq Probe 1-Step RT-qPCR System to its Covid-19 diagnostic protocol for emergency use in April last year.

In a separate development, Infinity BiologiX (IBX) has launched a new test for evaluating Covid-19 severity in adults.

The COVID-19 Risk Test uses genetic and clinical data to offer a risk score, which can be used by people to assess their risk of contracting a serious form of the disease and make decisions.

Employers, governments and other public health organisations can utilise the test data to adopt informed decisions on Covid-19 disease risk, options of treatment and vaccination choices.

In addition, this data will help in implementing steps required to lower disease exposure and handle the pandemic situation.

In partnership with Genetic Technologies’ (Gene) Vault Health, IBX has made the test available in the US. Vault Health will distribute and market the test in the country.

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