Validation of the TaqMan Influenza A Detection Kit and a rapid automated total nucleic acid extraction method to detect influenza A virus in nasopharyngeal specimens.
This study describes the validation of the TaqMan Influenza A Detection Kit v2.0 combined with an automated nucleic acid extraction method. The limit of detection of this assay was determined by probit regression (95% confidence interval) to be 2 influenza A/PR/8/34 (H1N1) virus particles per microlitre. One hundred and eleven specimens previously tested using the Seeplex RV assay and viral culture methods were tested using the TaqMan Influenza A Detection Kit. Compared to the aggregate gold-standard, the sensitivity and specificity of the TaqMan Influenza A Detection Kit were 100% (35/35) and 97% (74/76), respectively. Because of its accuracy, quick turn-around-time and lyophilized bead form, the TaqMan Influenza A Detection Kit, combined with the NucliSense easyMAG automated extraction method, constitutes a reliable protocol for influenza A diagnosis.
Ontario Public Health Laboratories, Molecular Diagnostics, Mount Sinai Hospital, 81 Resources Road, Etobiocoke, Ontario M9P 3T1, Canada. shelly.bolotin@ontario.ca
Shelly
S
Bolotin
Cedric
C
De Lima
Kam-Wing
KW
Choi
Ernesto
E
Lombos
Laura
L
Burton
Tony
T
Mazzulli
Steven J
SJ
Drews
D001331:Automation; D004279:DNA, Viral / Q000235:genetics* / Q000302:isolation & purification; D004196:Disease Outbreaks; D006801:Humans; D009980:Influenza A virus / Q000235:genetics / Q000254:growth & development / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000453:epidemiology; D009305:Nasopharynx / Q000821:virology*; D012367:RNA, Viral / Q000235:genetics* / Q000302:isolation & purification; D012044:Regression Analysis; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods; D012621:Seasons; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000592:standards
D004279:DNA, Viral; D012367:RNA, Viral