TY - JOUR
T1 - Evaluation of Sofia fluorescent immunoassay analyzer for influenza A/B virus
AU - Lee, Chang Kyu
AU - Cho, Chi Hyun
AU - Woo, Mi Kyung
AU - Nyeck, Agnes E.
AU - Lim, Chae Seung
AU - Kim, Woo Joo
N1 - Funding Information:
This study was supported by a grant of the Korea Healthcare Technology R&D Project , Ministry of Health & Welfare, Republic of Korea (Grant No.: A103001 ).
PY - 2012/11
Y1 - 2012/11
N2 - Background: The influenza virus causes seasonal epidemics which are associated with high morbidity and mortality. Rapid diagnostics tests (RDT) are frequently used to make a quick influenza diagnosis to confirm the clinical suspicion, despite their low sensitivity. Objectives: Assess the performance of the Sofia Influenza A + B Fluorescence Immunoassay (Quidel, San Diego, CA). Study design: Nasopharyngeal swabs, taken from 241 patients (influenza A (n=73)/B (n=72), negative samples (n=96)) were analyzed using the Sofia Influenza A + B Fluorescence Immunoassay, BinaxNOW Influenza A/B antigen kit (Alere Inc., USA), Directigen EZ Flu A and B (Becton Dickinson, USA), real-time RT-PCR and an influenza virus culture. Results: There was a significant difference between the performance of rapid antigen tests and the Sofia FIA, when compared to the RT-PCR, in the detection of influenza strain A and B. Indeed, the Sofia FIA displayed sensitivities of 82.2% and 77.8% for strains A and B respectively, whereas sensitivities of BinaxNOW Influenza A/B antigen kit, and Directigen Flu A and B were 54.8%, and 68.5% for influenza A, and 62.5%, and 52.8% for influenza B respectively. The average RT-PCR threshold cycle (Ct) (±SD) for the Sofia Influenza A+B Fluorescence Immunoassay-positive specimens was higher than those of the BinaxNOW Influenza A/B antigen and the Directigen EZ Flu A and B kit positive specimens. Conclusion: Compared to other RDTs, the Sofia Influenza A + B Fluorescence Immunoassay is a sensitive, and rapid method for the detection and discrimination between influenza A and B.
AB - Background: The influenza virus causes seasonal epidemics which are associated with high morbidity and mortality. Rapid diagnostics tests (RDT) are frequently used to make a quick influenza diagnosis to confirm the clinical suspicion, despite their low sensitivity. Objectives: Assess the performance of the Sofia Influenza A + B Fluorescence Immunoassay (Quidel, San Diego, CA). Study design: Nasopharyngeal swabs, taken from 241 patients (influenza A (n=73)/B (n=72), negative samples (n=96)) were analyzed using the Sofia Influenza A + B Fluorescence Immunoassay, BinaxNOW Influenza A/B antigen kit (Alere Inc., USA), Directigen EZ Flu A and B (Becton Dickinson, USA), real-time RT-PCR and an influenza virus culture. Results: There was a significant difference between the performance of rapid antigen tests and the Sofia FIA, when compared to the RT-PCR, in the detection of influenza strain A and B. Indeed, the Sofia FIA displayed sensitivities of 82.2% and 77.8% for strains A and B respectively, whereas sensitivities of BinaxNOW Influenza A/B antigen kit, and Directigen Flu A and B were 54.8%, and 68.5% for influenza A, and 62.5%, and 52.8% for influenza B respectively. The average RT-PCR threshold cycle (Ct) (±SD) for the Sofia Influenza A+B Fluorescence Immunoassay-positive specimens was higher than those of the BinaxNOW Influenza A/B antigen and the Directigen EZ Flu A and B kit positive specimens. Conclusion: Compared to other RDTs, the Sofia Influenza A + B Fluorescence Immunoassay is a sensitive, and rapid method for the detection and discrimination between influenza A and B.
KW - Fluorescent immunoassay
KW - Influenza
KW - Rapid diagnostic test
KW - Virus culture
UR - http://www.scopus.com/inward/record.url?scp=84866402457&partnerID=8YFLogxK
U2 - 10.1016/j.jcv.2012.07.008
DO - 10.1016/j.jcv.2012.07.008
M3 - Article
C2 - 22871494
AN - SCOPUS:84866402457
SN - 1386-6532
VL - 55
SP - 239
EP - 243
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
IS - 3
ER -
