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J Clin Microbiol. 2013 Jul 12. [Epub ahead of print]
Duplex influenza A/B molecular diagnostic assay intended for point-of-care use.
Wu LT, Thomas I, Curran MD, Ellis JS, Parmar S, Goel N, Sharma P, Allain JP, Lee HH.
Source
Diagnostics Development Unit (DDU), Department of Haematology, University of Cambridge, Cambridge CB2 2PT, United Kingdom.
Abstract
Early diagnosis and management of influenza virus infection directly correlates with the effectiveness in disease control. Current molecular influenza virus tests were designed for use in the diagnostic testing facilities, where sophisticated equipments and highly-trained technicians are available. A longer turnaround time of the centralized testing compared to testing near the sample source could delay the initiation of medical intervention, thereby reducing the efficacy of antiviral treatment. The new assay, SAMBA (Simple AMplification Based Assay) Flu duplex test, is a dipstick-based molecular assay developed to provide a simple, accurate and cost-effective solution for the diagnosis of influenza A/B viruses intended for near-patient testing. The test presents an alternative format of influenza molecular testing utilizing isothermal amplification and visual detection of nucleic acid on a test strip. The entire test procedure (extraction, amplification and detection) was integrated into an enclosed semi-automated system. Analytically, the SAMBA Flu duplex test detects 95 and 85 copies of viral genomes for influenza A and B viruses, respectively, with no cross-reactivity observed against other common respiratory pathogens. The clinical performance was established by blind testing 328 nasal/throat and nasopharyngeal swab specimens from the UK and Belgium and comparing with the qRT-PCR routinely used in two public health laboratories. SAMBA Flu duplex test showed a clinical sensitivity and specificity of 100% and 97.9% for flu A and 100% and 100% for flu B. The test provides a new technology that could facilitate simple and timely identification of influenza infection, potentially resulting in a more efficient control measure.
PMID:
23850955
[PubMed - as supplied by publisher]
Duplex influenza A/B molecular diagnostic assay intended for point-of-care use.
Wu LT, Thomas I, Curran MD, Ellis JS, Parmar S, Goel N, Sharma P, Allain JP, Lee HH.
Source
Diagnostics Development Unit (DDU), Department of Haematology, University of Cambridge, Cambridge CB2 2PT, United Kingdom.
Abstract
Early diagnosis and management of influenza virus infection directly correlates with the effectiveness in disease control. Current molecular influenza virus tests were designed for use in the diagnostic testing facilities, where sophisticated equipments and highly-trained technicians are available. A longer turnaround time of the centralized testing compared to testing near the sample source could delay the initiation of medical intervention, thereby reducing the efficacy of antiviral treatment. The new assay, SAMBA (Simple AMplification Based Assay) Flu duplex test, is a dipstick-based molecular assay developed to provide a simple, accurate and cost-effective solution for the diagnosis of influenza A/B viruses intended for near-patient testing. The test presents an alternative format of influenza molecular testing utilizing isothermal amplification and visual detection of nucleic acid on a test strip. The entire test procedure (extraction, amplification and detection) was integrated into an enclosed semi-automated system. Analytically, the SAMBA Flu duplex test detects 95 and 85 copies of viral genomes for influenza A and B viruses, respectively, with no cross-reactivity observed against other common respiratory pathogens. The clinical performance was established by blind testing 328 nasal/throat and nasopharyngeal swab specimens from the UK and Belgium and comparing with the qRT-PCR routinely used in two public health laboratories. SAMBA Flu duplex test showed a clinical sensitivity and specificity of 100% and 97.9% for flu A and 100% and 100% for flu B. The test provides a new technology that could facilitate simple and timely identification of influenza infection, potentially resulting in a more efficient control measure.
PMID:
23850955
[PubMed - as supplied by publisher]
