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15-minute COVID-19 test proves accurate at confirming infection

A new, fast COVID-19 test is found to be accurate at confirming disease in a new study. File photo by Twana Atkinson/U.S. Army/UPI
A new, fast COVID-19 test is found to be accurate at confirming disease in a new study. File photo by Twana Atkinson/U.S. Army/UPI | License Photo

May 8 (UPI) -- A new, point-of-care testing kit for COVID-19 that can deliver results in 15 minutes accurately diagnoses people more than 80 percent of time, according to an analysis published Friday in the journal Frontiers in Medicine.

The test, called Respi-Strip, was designed for use in doctor's offices and health clinics by the Belgium-based Coris BioConcept. It is a type of immunochromatographic assay, or lateral flow test, which detects the presence or absence of a particular substance -- similar to the function of a pregnancy test.

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Analysis of the testing kit was conducted by researchers at the Free University of Brussels, University of Leipzig, Karolinska Institute, KU Leuven, UZ Leuven, University of Liege, Luigi Sacco Hospital and University College London.

"The detection of viral infections in patients attending primary care centers would allow healthcare workers to rapidly identify new outbreak and define quarantine measures for ... suspect patients to limit the spread of the epidemic," researchers wrote in the study.

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To date, the U.S. Food and Drug Administration has approved one testing platform for use in doctor's offices and health clinics, the Cepheid for the Xpert Xpress SARS-CoV-2 test. That test also promises results in about 15 minutes.

Both the Xpert Xpress and the newer Respi-Strip test samples taken from the nose and back of the throat for the virus, just like the testing kits developed by the U.S. Centers for Disease Control and Prevention.

Problems in the manufacturing and distribution of the CDC testing kits, which use a method called PCR assays to identify the virus based on its genetic material, have been blamed for hindering the nation's response to the COVID-19 pandemic.

The CDC testing kits are designed to be more accurate than so-called point-of-care tests like Respi-Strip, but they require analysis at diagnostic labs and can take two to three days to process and yield results.

For COVID-19, the Respi-Strip uses a sample collected by a nasal and throat swab, which looks like a long, flexible Q-tip. The swab enters through one nostril and extends down the nasal passage close to a person's outer ear.

Once the sample is collected, the test looks for proteins found on the surface of SARS-CoV-2. If it finds the proteins, that means the virus is present.

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The test is based in part on a similar one developed for SARS-CoV-1, which caused the 2002-03 SARS epidemic, according to Coris BioConcept. The Respi-Strip is not intended to be a stand-alone test, but rather used as part of a broader testing strategy, the authors wrote.

The two-phase Frontiers in Medicine study assessed the sensitivity and specificity of the Respi-Strip test during its development stage in the lab and later on real-world biological samples from more than 300 patients who had COVID-19.

Researchers found the test's overall accuracy was 82 percent in these 300 patients, with an overall sensitivity -- or how often a test correctly generates a positive result -- of 58 percent and an overall specificity -- or how often a test correctly generates a negative result -- of 99.5 percent.

In other words, the test was able to correctly detect COVID-19 in roughly six of 10 people, and it was nearly perfect in determining when an infection was not present. The test was more sensitive in patients with higher viral loads, positively identifying an infection in roughly seven out of 10 people.

These findings indicate the test might be useful as part of a broader triage strategy for slowing down the pandemic by screening patients during peak periods, the authors said.

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Eventually, it could also be useful for screening higher-risk populations like healthcare workers, and could reduce the number of laboratory tests using PCR assays by more than 13 percent, they said.

The researchers said Respi-Strip could be especially useful "in the low- and middle-income countries, where molecular assays are available in very few laboratories, mainly only in capital cities."

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