tetano
Editor, Senior Moderator
J Clin Microbiol. 2010 Jul 28. [Epub ahead of print]
Nucleic Acid Dipstick Test: Molecular Diagnosis of Pandemic H1N1.
Wu LT, Curran MD, Ellis J, Parmar S, Ritchie AV, Sharma PI, Allain JP, Jalal H, Zambon M, Lee HH.
Diagnostics Development Unit, Department of Haematology, University of Cambridge, Cambridge CB2 2PT, United Kingdom; Clinical Microbiology and Public Health Laboratory, Health Protection Agency, Addenbrooke's Hospital, Cambridge CB2 2QW, United Kingdom; Virus Reference Department, Centre for Infections, Health Protection Agency, Colindale, London NW9 5HT, United Kingdom; Department of Haematology, University of Cambridge, Cambridge CB2 2PT, United Kingdom.
Abstract
A new nucleic acid amplification-based rapid test for diagnosis of pandemic influenza (H1N1) 2009 was developed. The molecular test, SAMBA pandemic H1N1 test, is based on isothermal amplification and visual detection on dipstick characterized by high sensitivity, high specificity, short turnaround time, and minimal technical requirements. The amplification step is monitored with an internal control to ensure correct interpretation of test results. The clinical performance of this assay was evaluated using blinded RNA samples extracted from nasal/throat swabs of 262 patients exhibiting influenza-like illness. Compared with the UK National Standard Method based on qRT-PCR the sensitivity, specificity, positive predictive value, and negative predictive value of the new assay were 95.3% (95% confidence interval, 88.5 to 98.7%), 99.4% (96.9 to 99.9%), 98.8% (93.5 to 99.9%), and 97.8% (94.4 to 99.4%), respectively. The SAMBA pandemic H1N1 test provides a new technology that could potentially facilitate timely diagnosis and management of infected individuals, thereby informing decision-making with regard to patient isolation during a pandemic outbreak.
PMID: 20668123 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20668123
Nucleic Acid Dipstick Test: Molecular Diagnosis of Pandemic H1N1.
Wu LT, Curran MD, Ellis J, Parmar S, Ritchie AV, Sharma PI, Allain JP, Jalal H, Zambon M, Lee HH.
Diagnostics Development Unit, Department of Haematology, University of Cambridge, Cambridge CB2 2PT, United Kingdom; Clinical Microbiology and Public Health Laboratory, Health Protection Agency, Addenbrooke's Hospital, Cambridge CB2 2QW, United Kingdom; Virus Reference Department, Centre for Infections, Health Protection Agency, Colindale, London NW9 5HT, United Kingdom; Department of Haematology, University of Cambridge, Cambridge CB2 2PT, United Kingdom.
Abstract
A new nucleic acid amplification-based rapid test for diagnosis of pandemic influenza (H1N1) 2009 was developed. The molecular test, SAMBA pandemic H1N1 test, is based on isothermal amplification and visual detection on dipstick characterized by high sensitivity, high specificity, short turnaround time, and minimal technical requirements. The amplification step is monitored with an internal control to ensure correct interpretation of test results. The clinical performance of this assay was evaluated using blinded RNA samples extracted from nasal/throat swabs of 262 patients exhibiting influenza-like illness. Compared with the UK National Standard Method based on qRT-PCR the sensitivity, specificity, positive predictive value, and negative predictive value of the new assay were 95.3% (95% confidence interval, 88.5 to 98.7%), 99.4% (96.9 to 99.9%), 98.8% (93.5 to 99.9%), and 97.8% (94.4 to 99.4%), respectively. The SAMBA pandemic H1N1 test provides a new technology that could potentially facilitate timely diagnosis and management of infected individuals, thereby informing decision-making with regard to patient isolation during a pandemic outbreak.
PMID: 20668123 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20668123