However, there has not been a comparison of the NxTAG RPP to two widely used RPs in the United States, namely, BioFire RP and GenMark eSensor RVP. To date, the Luminex NxTAG RPP has been compared to Luminex xTAG RVP ( 9), Luminex xTAG RVP FAST v2 ( 10, – 12), BioFire RP ( 7, 13), RespiFinder-22 ( 14), Anyplex II RV16 ( 15), and laboratory-developed tests (LDTs) ( 12, 13, 16). Separate studies comparing one assay to another or to a reference method have generally found high levels of sensitivity and specificity ( 8). The three most inclusive respiratory pathogen panels (RPPs) cleared by the FDA at the time of this study are the FilmArray Respiratory Panel (RP) (BioFire Diagnostics, Salt Lake City, UT), the eSensor Respiratory Viral Panel (RVP) (GenMark Diagnostics, Carlsbad, CA), and the NxTAG RPP (Luminex Molecular Diagnostics, Austin, TX) ( 7).
The appeal to both the clinician and the laboratorian is understandable, as testing becomes more streamlined and results more comprehensive. Syndromic multiplexed molecular panels offer detection and identification of many of the most common viral (and in some cases bacterial) pathogens from a single patient sample. Diagnosis beyond influenza and respiratory syncytial virus (RSV) may predict the severity of the illness ( 5) and inform proper cohorting of patients ( 6). Accurate identification of the causative agent is important, because acute respiratory infections are the leading complaint for which antibiotics are prescribed for adults ( 4). Clinical differentiation of acute respiratory infections is difficult, because the overlap of signs and symptoms is significant. In the pre-COVID-19 era, viral infections were detected in 69% of adults and 90% of children hospitalized for community-associated pneumonia ( 2, 3). While overall mortality rates due to influenza and pneumonia have been decreasing ( 1), the burden of respiratory illness in the United States remains significant and will remain so as mitigation strategies, such as masking, decline from initial coronavirus disease 2019 (COVID-19) pandemic efforts.
GENMARK PRODUCTS DRIVERS
As new tests come to market, it is important to ascertain their performance characteristics, compared to other widely used in vitro diagnostic products.Īcute respiratory infections continue to be major drivers of health care visits in the United States. Here, the Luminex NxTAG RPP is compared to the BioFire FilmArray RP and GenMark eSensor RVP for overall and per-target accuracy.
IMPORTANCE Clinical laboratories have multiple choices when it is comes to syndromic respiratory testing. Increased false-positive results were seen with BioFire for the endemic coronaviruses and with GenMark for influenza B and the parainfluenza viruses. The three assays were equivalent for adenovirus, human metapneumovirus, influenza A, and respiratory syncytial virus.
Overall negative percent agreement values were high for all three assays, i.e., 99.9% for BioFire and Luminex and 99.5% for GenMark. The positive percent agreement of the BioFire RP assay was 94.1%, compared to 97.3% for GenMark RVP and 96.5% for Luminex RPP. There was no significant difference in the overall accuracies of BioFire and Luminex assays ( P = 0.6171) however, significant differences were found between BioFire and GenMark ( P = 0.0003) and between GenMark and Luminex ( P = 0.0009). We compared the three assays using nasopharyngeal swab samples ( n = 350) collected from symptomatic patients ( n = 329) in the pre-coronavirus disease 2019 (COVID-19) era. This study compares three of the most inclusive and widely used panels for respiratory syndromic testing in the United States, namely, Luminex NxTAG Respiratory Pathogen Panel (RPP), BioFire FilmArray Respiratory Panel (RP), and GenMark eSensor Respiratory Viral Panel (RVP).
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