LAB-Net was involved in the validation of ThermoFisher’s TaqPath Respiratory Viral Select Panel for the detection of adenovirus, parainfluenzavirus 1-4, human metapneumovirus, rhinovirus and enterovirus. The results of this validation were presented at the 25th ESCV meeting, P119, in Milano, Italy, 30/08-02/09/23.
Nucleic acid amplification techniques (NAAT) are now the gold standard for identification of viral respiratory tract infections due to their higher sensitivity and specificity when compared to traditional techniques. Multiplex formats solve the practical shortcoming of detecting only the infectious agent that is searched for. Here the evaluation of the TaqPathTM Respiratory Viral Select Panel (TP) for the detection of adenovirus (ADE), parainfluenza virus (PIV) type 1-4, human metapneumovirus (hMPV), rhinovirus and enterovirus (HRV/EV) against the RespiFinder 2Smart (R2S) is presented.
311 archived nasopharyngeal swabs (NPS), collected in the period from 2007-2019 in Europe previously found to be positive (GRACE and PREPARE project) for the presence of ADE, PIV 1-4, hMPV, HRV/EV and 100 negative archived NPS were tested in parallel with the TP assay (Thermo Fisher Scientific) and the R2S test (PathoFinder). FTD Respiratory Pathogens 21 assay (FTD) (Siemens Healthineers) was used to resolve discrepant results. All tests were performed according to their instructions for use. 5 samples were excluded from analysis due to invalid results or lack of sample volume. An expanded gold standard was used to calculate clinical sensitivity and specificity of both assays.
Positive and negative percent agreement varied between 66.0%-100%, and between 94.5%-98.4%, respectively. Seventy-four samples were resolved by the FTD assay: the majority of discrepant results were noticed for PIV1-4 (positive by TP, negative by R2S) and for HRV (negative by TP, positive by R2S). After discordant resolution, sensitivity of the TP assay for the detection of ADE, PIV1-4, hMPV and HRV/EV was 100%, 100%, 97.9% and 69.3%, while specificity was 99.5%, 99.7%, 99.7% and 99.3%, respectively. Sensitivity and specificity of the R2S were 96.0%, 91.6%, 87.1% and 76.6% and 99.0%, 100%, 100% and 99.7% for the detection of HRV/EV, hMPV, ADE and PIV1-4.
In conclusion, the TP assay has a very high specificity for all targets (>99%), and a very high sensitivity for ADE, PIV1-4 and hMPV (>97.8%). As the test is not designed for detection of all rhinovirus C species, the sensitivity observed for rhinovirus in this study could potentially be explained by proportion of this viral species in the positive cohort.
The poster can be accessed here.