title: The clinical usefulness of the SD Bioline Influenza Antigen Test® for detecting the 2009 influenza A (H1N1) virus.
abstract: Though the 2009 worldwide influenza A (H1N1) pandemic has been declared to have ended, the influenza virus is expected to continue to circulate from some years as a seasonal influenza. A rapid antigen test (RAT) can aid in rapid diagnosis and allow for early antiviral treatment. We evaluated the clinical usefulness of RAT using SD Bioline Influenza Antigen Test® kit to detect the influenza virus, considering various factors. From August 1, 2009 to October 10, 2009, a total of 938 patients who visited the outpatient clinic at Korea University Guro Hospital with influenza-like illnesses were enrolled in the study. Throat or nasopharyngeal swab specimens were obtained from each of the patients. Using these specimens, we evaluated the influenza detection rate by rapid antigen test based on the real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) method. In comparison with rRT-PCR, the sensitivity and specificity of the RAT were 44.0% and 99.9%, respectively. The cyclic threshold values of RAT negative specimens were higher than RAT positive specimens (30.1±3.1 vs. 28.3±3.9, p=0.031). The sensitivity of the RAT kit was higher in patients who visited clinics within two days of symptom onset (60.4% vs. 11.1%, p=0.026). The results of this study show that the RAT cannot be recommended for general use in all patients with influenza-like illness because of its low sensitivity. The RAT may be used, only in the settings with limited diagnostic resources, for patients who visit a clinic within two days of symptom onse.
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Guro-dong, Guro-gu, Seoul 152-703, Korea.
authors.forename: Won Suk
authors.initials: WS
authors.lastname: Choi
authors.forename: Ji Yun
authors.initials: JY
authors.lastname: Noh
authors.forename: Joong Yeon
authors.initials: JY
authors.lastname: Huh
authors.forename: Sae Yoon
authors.initials: SY
authors.lastname: Kee
authors.forename: Hye Won
authors.initials: HW
authors.lastname: Jeong
authors.forename: Jacob
authors.initials: J
authors.lastname: Lee
authors.forename: Joon Young
authors.initials: JY
authors.lastname: Song
authors.forename: Hee Jin
authors.initials: HJ
authors.lastname: Cheong
authors.forename: Woo Joo
authors.initials: WJ
authors.lastname: Kim
mesh_terms: D000956:Antigens, Viral / Q000235:genetics; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology; D011933:Reagent Kits, Diagnostic; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D000956:Antigens, Viral; D011933:Reagent Kits, Diagnostic