Clinical evaluation of the quidel solana flu a + b assay in a uk district general hospital laboratory
Year: 2020
Type: article
Abstract: Background and Purpose: Influenza remains a burden on the UK health service.Polymerase chain reaction (PCR)-based diagnostic platforms provide improved sensitivity versus antigen detection methods, and helicase-based isothermal PCR assays mitigate thermocycler-associated costs.We evaluate a helicase-based assay, Quidel Solana ® , versus established thermocycling platforms for the detection of influenza in samples from two UK district general hospitals and surrounding general practices.Methodology: Samples were selected from throat swabs tested for influenza in Hampshire Hospitals Foundation Trust microbiology laboratory November 2018-January 2019.After assaying with laboratory standard of care (SoC) testing platforms (Cepheid Xpert ® Flu, Xpress Flu and Bio Molecular Systems Mic qPCR), positive samples were additionally run on the Quidel Solana ® Influenza A + B assay, together with randomly selected negative samples obtained on the same dates.Results and discussions: 44 samples were analysed, of which 25 were positive for influenza A (19 confirmed H1N1, 4 untested); no samples tested positive for influenza B. Due to staffing/training limitations in the laboratory, 15 samples were run on the Solana ® outside the 48 hour window recommended by the swab manufacturer.11 samples were initially found to be discordant between the Solana ® and SoC.Following re-testing, one positive/negative pair of the discordant samples was ascribed to a labelling transposition during initial sample processing.3 discordant samples were tested > 48 hours after sampling, with two reported as invalid (one positive, one negative on SoC) and 1 false negative on Solana ® versus SoC; all 6 remaining discordant samples were false negatives versus SoC.Across all samples producing a valid result, we found sensitivity = 83.3% and specificity = 100% for Solana ® versus SoC.Conclusions: We found that the Solana ® had test characteristics and setup costs intermediate between most commercially available antigen-based assays and thermocycling PCR platforms; it may therefore be a suitable choice for selected clinical environments.
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,310
OpenAlex ID: W3005330786