Dear LabPulse.com Member,

As SARS-CoV-2 variants continue to emerge, public health authorities worldwide are deploying next-generation sequencing (NGS) to discern unknown variants. But NGS is expensive and can take weeks to yield results. Only a fraction of test samples are sequenced overall; around 5% are sequenced in the U.S., according to the National Institutes of Health.

To enable broader testing for variants, however, laboratorians can now leverage a low-cost, high-volume RT-PCR technique used by thousands of U.S. labs. Using the new method, laboratories could develop new assays and get them into labs about two weeks after identifying a new variant, according to the authors of a new study.

Meanwhile, the U.S. Food and Drug Administration (FDA) recognizes the value of sequencing in the pandemic and has recently issued an emergency use authorization for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS test on the PacBio Sequel II sequencing system. According to the FDA, the Labcorp VirSeq SARS-CoV-2 NGS Test is the first COVID-19 assay to identify and differentiate SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages.

New COVID testing tools

For day-to-day SARS-CoV-2 testing, RT-PCR and antigen assays remain the go-to modalities, largely because they detect an active infection. Antibody tests that detect an infection that has already passed have had limited uptake compared to molecular tests, but laboratories are conducting millions of antibody tests per month during the pandemic. For example, national laboratory firm Quest Diagnostics reported performing 8.4 million antibody tests for COVID-19 in May.

Researchers and companies continue to develop such tests, and last week University of Tokyo researchers noted that the detection of IgM and IgG can provide useful information about the approximate course of the COVID-19 infection. They believe the use of needles to draw blood for an antibody test may be limiting adoption, so to remove this barrier they have developed a less-invasive microneedle patch and associated test.

We recently reported on another tool under development that also aims to improve on COVID-19 diagnostics. According to the developers, a wearable tracking tool and machine learning algorithm could augment molecular testing for COVID-19 and other conditions and provide an early warning that an infection is on the way before symptoms begin.

Outside COVID

A study published on Tuesday in the Annals of Internal Medicine is alerting laboratorians to a substantial discrepancy in test results related to glomerular filtration rates used to assess and monitor kidney function. There's a substantial discrepancy in the results that are estimated compared to those that are measured directly, and laboratories reporting estimated glomerular filtration (eGFR) rates for individuals should consider including the extent of the discrepancy, according to the study. The corresponding author told us that the concerns associated with eGFR may drive an increase in adoption of emerging methods for direct measurement.

While you are on LabPulse.com, check out these recent stories about infectious disease diagnostics developments unrelated to COVID-19:

  • Labcorp will begin testing for monkeypox using the U.S. Centers for Disease Control and Prevention's (CDC) orthopoxvirus assay.
  • Boehringer Ingelheim, Evotec, and BioMérieux announced a joint venture to develop the next generation of antimicrobial medications and diagnostic tests to fight antimicrobial resistance.

2022 AACC Annual Scientific Meeting & Clinical Lab Expo

Looking ahead, Erika Cheung and Tyler Shultz, two of the whistleblowers who helped bring down Theranos, will speak in a fireside chat at the 2022 AACC Annual Scientific Meeting & Clinical Lab Expo which will be held in Chicago from July 24 to July 28.

Bluejay Diagnostics on Wednesday announced the completion of clinical studies for its Symphony IL-6 Test for sepsis triage, saying it will present the study results at the AACC meeting.

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