Emerging point of care tests for influenza: innovation or status quo

Abstract

Please cite this paper as: Tayo A et al. (2012) Emerging point of care tests for influenza: innovation or status quo. Influenza and Other Respiratory Viruses 6(4), 291–298. Background Point of care tests (POCTs) for influenza potentially offer earlier diagnosis, enabling specific treatment, infection control measures and greater patient convenience and satisfaction. Current POCTs have limited sensitivity, some cannot distinguish influenza types, none differentiate subtypes and are relatively expensive. Aims To identify and characterise influenza POCTs expected to be available for clinical use in the UK by mid‐2013, highlighting those with potential benefits over existing tests. Methods Potential developers of influenza POCTs were identified through known manufacturers’ websites, Medical Technology trade associations, the EuroScan International Network, an expert advisory group and by searching relevant online sources. Identified companies were asked to provide standard information on relevant technologies. Results Fifty‐six companies were identified, and 29 (52%) responded, identifying 57 potentially relevant technologies. Of these, 40 (70%) were already available or had undetermined status and 5 (9%) were excluded as time to results took over 60 minutes. Of the remaining 12 emerging POCTs, 10 (83%) reportedly enabled differentiation of influenza types and eight differentiation of A subtypes. Nasopharyngeal swabs were the most commonly acceptable sample type; the sample volume ranging from 80 μl to 1·4 ml. Discussion Most identified emerging influenza POCTs offered differentiation of influenza type and subtype. Tests claiming this capability include several incorporating reverse transcription polymerase chain reaction assays; though, these also had the longest time to result. However, whilst some identified POCTs exhibit high sensitivity and specificity, most lack published clinical data for assessment, and the overall costs of these technologies remains largely unknown.

Evaluation of the Sofia Influenza A + B fluorescent immunoassay for the rapid diagnosis of influenza A and B

“…A rapid diagnosis of influenza infection can facilitate the prescription of antivirals, obviate the need for unnecessary testing and antimicrobials, and allows the implementation of infection control measures [Tayo et al, ]. Although nucleic acid testing (NAT) is now the “gold standard” for diagnosis, the necessity for specialized equipment and staff and its relatively long turnaround times preclude NAT from being used as a point‐of‐care test [Playford and Dwyer, ].…”

Performance of the Molecular Alere i Influenza A&B Test Compared to That of the Xpert Flu A/B Assay

“…During the pandemic H1N1 outbreak of 2009, the performance of rapid antigen detection tests for influenza was shown to be inferior to the performance of molecular methods, with sensitivity ranging from 10% to 70% (1)(2)(3). Rapid molecular testing was not available in many hospitals, clinics, and physician offices due to either cost of equipment or cost of reagents, use of complex molecular diagnostics requiring skilled technologists to perform testing, and/or slow turnaround time to results (2,4,5). Recently, the Alere i influenza A&B assay (Alere, Scarborough, ME) became a FDA-cleared molecular test for detection of influenza viruses A and B.…”

Understanding user requirements to improve adoption of influenza diagnostics in clinical care within Metro Manila

“…While many of the new and emerging diagnostic tests for influenza offer superior performance to RIDTs, it not yet clear if these tests will adequately meet the needs of the end user. These needs may include supporting clinical case management, public health surveillance for seasonal influenza viruses, or emergency responses to pandemics . The cost, complexity, and turnaround times associated with these technologies often limit access outside of higher tier reference laboratories …”

“…These needs may include supporting clinical case management, public health surveillance for seasonal influenza viruses, or emergency responses to pandemics. 16 The cost, complexity, and turnaround times associated with these technologies often limit access outside of higher tier reference laboratories. 17,18 In both clinical case management and public health surveillance, as influenza diagnostics move closer to the patient and to the point of care (POC), the end user group also shifts, spurring a change in product design and development needs.…”