Will Molecular Diagnostics Work with the New COVID-19 Variants?

Posted on by Inta Veldre

In silico analysis demonstrates that Luminex SARS-CoV-2 assays can detect the current circulating variants

Virus mutations are common and SARS-CoV-2 is no exception. As new variants have begun emerging, the focus around COVID-19 has shifted to these new mutations as scientists work to understand if they will be covered by existing tests and vaccines.

At the moment, four main variants have developed in various populations and are of significant concern to public health experts:

  • B.1.1.7, first identified in the UK
  • B.1.351, first detected in South Africa (also known as S.501Y.V2)
  • P.1, originally found in Brazil
  • L452R, one of five recurring mutations that constitute the B.1.429/CAL.20C variant

The most pressing concern from a diagnostics standpoint is whether current SARS-CoV-2 molecular tests accurately detect these variants, or if these modified viral genomes can evade detection or result in false-negatives.

It’s important to note that molecular tests developed for clinical use—that is, to aid clinicians in determining a patient’s diagnosis and choosing the optimal treatment strategy—don’t typically differentiate between COVID-19 variants when reporting results, and current treatment guidelines for COVID-19 patients do not depend on which variant a patient has. Variant identification is typically performed using non-diagnostic technologies, and is most helpful for epidemiological purposes.

Nonetheless, the concern about the appearance of COVID-19 mutations was one our R&D Team considered during assay development, so we designed the assay probes in our tests to detect highly conserved regions of the viral genome to ensure that new mutations would be unlikely to escape detection.

Additionally, our currently available tests make a positive call based on multiple gene interrogations. Even if one gene mutated enough to avoid being detected, our tests should still report a positive result based on the detection of other included gene targets.

Thorough, accurate diagnostics lead to better patient outcomes

Recently, we compared the SARS-CoV-2-specific oligonucleotide sequences used in our assays to the genetic sequences of the SARS-CoV-2 variants available as of late January. According to in silico analysis, all of our commercially available assays that detect SARS-CoV-2 contain probes that can detect all four variant viruses.

As of February 2021, we have received FDA emergency use authorization for several COVID-19 tests:

For more information about our latest COVID-19 offerings, including CE-IVD tests for use in labs outside of the US, check out our website.

Learn More About Our Latest COVID-19 Offerings.

(EUA) In Vitro Diagnostic Use Under Emergency Use Authorization. This test has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by authorized laboratories.

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