Owing to advancements in molecular diagnostics, recent years have seen an increasing number of laboratories adopting respiratory viral panels to detect respiratory pathogens. In December 2015, the NxTAG respiratory pathogen panel (NxTAG RPP) was approved by the United States Food and Drug Administration. We compared the clinical performance of this new assay with that of the xTAG respiratory viral panel (xTAG RVP) FAST v2 using 142 clinical samples and 12 external quality assessment samples. Discordant results were resolved by using a laboratory-developed respiratory viral panel. The NxTAG RPP achieved 100% concordant negative results and 86.6% concordant positive results. It detected one coronavirus 229E and eight influenza A/H3N2 viruses that were missed by the xTAG RVP FAST v2. On the other hand, the NxTAG RPP missed one enterovirus/rhinovirus and one metapneumovirus that were detected by FAST v2. Both panels correctly identified all the pathogens in the 12 external quality assessment samples. Overall, the NxTAG RPP demonstrated good diagnostic performance. Of note, it was better able to subtype the influenza A/H3N2 viruses compared with the xTAG RVP FAST v2.
Coronavirus ; Hand ; Influenza, Human ; Metapneumovirus ; Pathology, Molecular ; Respiratory Tract Infections ; United States Food and Drug Administration

INTRODUCTIONSince the emergence of the pandemic influenza A/H1N1/2009 virus in April 2009, diagnostic testing in many countries has revealed the rapid displacement and then replacement of circulating seasonal influenza viruses by this novel virus.

MATERIALS AND METHODSIn-house seasonal and pandemic influenza-specific polymerase chain reaction assays were introduced and/or developed at the Molecular Diagnosis Centre (MDC) at the National University Hospital (NUH), Singapore. These assays have been used to test all samples received from in-patients, out-patients, staff and visitors for suspected pandemic influenza A/H1N1/2009 infection.

RESULTSPrior to the arrival of the pandemic A/H1N1/2009 virus in Singapore at the end of May 2009, seasonal influenza A/H3N2 predominated in this population, with very little seasonal influenza A/H1N1 and B viruses detected. Within about 1 month of its arrival in Singapore (mainly during June to July 2009), this pandemic virus rapidly displaced seasonal influenza A/H3N2 to become the predominant strain in the Singaporean population served by MDC/NUH.

CONCLUSIONSRealtime molecular techniques have allowed the prompt detection of different influenza subtypes during this current pandemic, which has revealed the displacement/replacement of previously circulating seasonal subtypes with A/H1N1/2009. Although some of this may be explained by immunological cross-reactivity between influenza subtypes, more studies are required.

Communicable Diseases, Emerging ; Cross Reactions ; Disease Outbreaks ; Humans ; Influenza A Virus, H1N1 Subtype ; isolation & purification ; Influenza B virus ; isolation & purification ; Influenza, Human ; classification ; diagnosis ; epidemiology ; Influenzavirus C ; isolation & purification ; Molecular Diagnostic Techniques ; Polymerase Chain Reaction ; Singapore ; epidemiology

BACKGROUND: Human herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) are responsible for a plethora of human diseases, of which cutaneous and mucocutaneous infections are the most prevalent. In its most severe form, HSV infection can cause meningitis/encephalitis. We compared the Luminex ARIES HSV 1&2 assay (Luminex Corp., Austin, TX, USA), an automated sample-to-result molecular solution, to two non-automated HSV DNA assays. METHODS: A total of 116 artificial controls were used to determine the analytical performance of the ARIES assay. Controls were prepared by spiking universal transport medium (UTM) and cerebrospinal fluid (CSF) samples from patients who tested negative for HSV by an in-house HSV-1 and -2 DNA assay with reference materials (SeraCare Life Sciences, MA, USA; ZeptoMetrix Corp., MA, USA). Another 117 clinical samples were then used to compare the clinical performance of the ARIES assay with those of an in-house assay and the FTD Neuro 9 assay (Fast Track Diagnostics, Junglinster, Luxembourg). RESULTS: The analytical sensitivity (95% limit of detection) of the ARIES assay was 318 copies/mL (UTM samples) and 935 copies/mL (CSF samples) for HSV-1 strain 96 and 253 copies/mL (UTM samples) and 821 copies/mL (CSF samples) for HSV-2 strain 09. No cross-reactivity was observed in samples spiked with 14 non-HSV microorganisms. Compared with the reference result (agreement between the in-house and FTD Neuro 9 results), the ARIES assay had overall concordance rates of 98.2% (111/113) and 100% (113/113) for HSV-1 and HSV-2, respectively. CONCLUSIONS: The ARIES assay appears to be an excellent alternative for rapid detection and differentiation of HSV in skin and genital infections, meningitis, and encephalitis.
Biological Science Disciplines ; Cerebrospinal Fluid ; DNA ; Encephalitis ; Herpes Simplex* ; Herpesvirus 1, Human ; Herpesvirus 2, Human ; Humans ; Meningitis ; Real-Time Polymerase Chain Reaction* ; Simplexvirus* ; Skin