Luminex, Austin, Texas, has received FDA emergency use authorization for a new expanded version of its NxTAG Respiratory Pathogen Panel (RPP) that includes SARS-CoV-2 for high-throughput respiratory testing. The new test is a combination of the company’s original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, and SARS-CoV-2.
Respiratory infections such as covid-19 and influenza can be challenging to differentiate and diagnose because they often have overlapping symptoms. NxTAG RPP is a multiplex, high-throughput test designed to enable simultaneous detection of the most common respiratory pathogens for a fast, syndromic testing approach. Following the addition of the SARS-CoV-2 virus target, the panel now includes 19 viral and two bacterial targets, combining the most common respiratory pathogens in one panel to help facilitate the rapid identification of various individual and co-occurring infectious pathogens.
NxTAG RPP provides scalable throughput, allowing clinical labs to run up to 96 samples at a time—generating results in approximately four hours with minimal hands-on time. The test runs on Luminex’s easy-to-use, compact MAGPIX System and is designed for use in high-complexity molecular laboratories.
Importantly, the NxTAG RPP + SARS-CoV-2 Assay is expected to detect new variants of the coronavirus. An in silico analysis of molecular probes used in the assay compared to SARS-CoV-2 sequences available in the GISAID database as of February 11, 2021, determined that key sequences still match and should yield a positive result. The analysis included variants originally detected in the United Kingdom (B.1.1.7), South Africa (B.1.351 or 20H/501Y.V2), Brazil (P.1 lineage or 20J/501Y.V3), and California (one of five reoccurring mutations that constitute the B.1.429 lineage and CAL20C).
“Given the emergence of new respiratory pathogens and new variants of these pathogens, it will be increasingly challenging to identify and distinguish the presence and co-existence of SARS-CoV-2, influenza, and other common respiratory pathogens. As a highly accurate, low-cost, multiplex test, our NxTAG RPP + SARS-CoV-2 test delivers an ideal solution for this challenge,” says Nachum “Homi” Shamir, chairman, president and CEO of Luminex. “Clinical laboratories using the assay will be able to scale up their testing for both covid-19 and the flu with one high-capacity diagnostic platform that can provide much-needed information for appropriate patient treatment. This is especially important given that the symptoms for the flu, covid-19, and other respiratory illnesses can be very similar, but their treatment may be very different.”
A version of the assay, which also detects Legionella pneumophila and the 2009 H1N1 Flu A subtype, also just received a CE Mark, and was commercialized last month in Europe.
For more information, visit Luminex.