Clinical Evaluation of the SD Bioline Influenza Virus Antigen Test for Rapid Detection of Influenza Viruses A and B in Children and Adults during the Influenza Season

Abstract

The performance of the SD Bioline rapid antigen test kit for influenza virus detection was evaluated with 295 respiratory specimens during the influenza season. The overall sensitivity and specificity of the SD Bioline test were 61.9% and 96.8% for the influenza A virus antigen and 54.5% and 100% for the influenza B virus antigen, respectively. The results were consistent with peak influenza activities.Influenza viruses are responsible for epidemics resulting in morbidity and excess mortality among the very young, the elderly, and those with chronic illness (10, 11). The rapid and accurate detection of influenza viruses is essential for appropriate antiviral therapy early in the illness and contributes to the reduction of medical costs and the lengths of hospital stays (5).Recently developed rapid influenza tests have had a positive impact on medical management by decreasing the need for ancillary tests and the use of antibiotics in children evaluated for an influenza-like illness in an emergency department (4, 12). Furthermore, they have increasingly become a useful tool for the surveillance of influenza activity (7,13,16).Several rapid influenza antigen detection kits using enzyme, optical, or chromatographic immunoassays provide a result in 15 to 30 min, with reported sensitivities ranging from 62% to 85% and specificities ranging from 79.5% to 99% compared to viral cultures (1,14).A newly developed SD Bioline rapid influenza test (Standard Diagnostics, Inc., Suwon, Korea) is a lateral-flow immunoassay that uses influenza virus-specific monoclonal antibodies on a strip for the qualitative detection of influenza A and B virus antigens, separately. However, the performance of the test has not been determined to date. In this study, we compared the performance of the SD Bioline test with that of the QuickVue test (Quidel Corp., San Diego, CA), a nontyping lateral-flow immunoassay (3) which is currently the only rapid influenza test available in Korea, and further evaluated its clinical usefulness during the influenza season.The study population was comprised of 295 Korean children and adults who were admitted to or visited the outpatient clinics at Korea University Anam Hospital with symptoms of acute respiratory tract illness during the 2005-to-2006 influenza season. Demographic and clinical data were collected using case report forms. Written informed consent to participate in the study was obtained from patients or their parents. The study protocol was approved by the hospital ethics committee (approval no. AN0560).Three anterior nasal or throat swab specimens per adult patient were collected. One swab, for virus culture, was transferred in standard refrigerated HH medium (Hanks' balanced salt solution with 0.88% sodium bicarbonate, 0.2% bovine serum albumin [Sigma], 30 mM HEPES buffer, and 50 g/ml gentamicin [9]), and the other two swabs were used for rapid influenza virus antigen testing. Nasopharyngeal aspirates and two throat swabs collected from each pediatric patient were used for virus culture and the ...

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