Journal of Clinical Virology 44 (2009) 173–175 Contents lists available at ScienceDirect Journal of Clinical Virology journal homepage: www.elsevier.com/locate/jcv Short communication Performance of a new immunochromatographic assay for detection of adenoviruses in children  Fatma Levent a , Jewel M. Greer a,b , Malorie Snider a,c , Gail J. Demmler-Harrison a,b,* a Baylor College of Medicine, Department of Pediatrics, Section of Infectious Diseases, Houston, TX, United States b Diagnostic Virology Laboratory, Texas Children’s Hospital, Houston, TX, United States c Harvard University, Boston, MA, United States article info Article history: Received 17 June 2008 Received in revised form 3 November 2008 Accepted 4 November 2008 Keywords: Rapid assay Adenovirus Diagnosis Children abstract Background: Adenoviruses are a prominent cause of respiratory, ocular, gastrointestinal, and disseminated diseases in healthy and immunocompromised children. An accurate rapid diagnostic assay may impact clinical decision-making. Objectives: Evaluate the performance of a new rapid assay for detection of adenoviruses directly in pedi- atric clinical specimens. Study design: The rapid assay was performed on adenovirus culture-positive original samples and on an equal number of culture-negative samples matched by patient age and specimen type. Discrepant results were resolved using a polymerase chain reaction (PCR) assay. Results: 200 adenovirus culture-positive and 200 adenovirus culture-negative samples were evaluated from 315 different patients. Overall sensitivity was 55% and specificity was 98.9%. The assay was most sensitive in children 5 years old and younger and most specific in respiratory samples. Conclusions: The rapid assay was highly specific for detecting adenovirus infections in children. However, since this rapid assay had only moderate to low sensitivity, samples with negative rapid assay results should have additional testing for adenovirus performed by either viral culture or PCR. © 2008 Elsevier B.V. All rights reserved. 1. Introduction Adenoviruses are a prominent cause of respiratory, ocu- lar, gastrointestinal, and disseminated diseases in healthy and immunocompromised infants, children and adults. 1–4 Infection with adenoviruses can mimic Kawasaki disease and bacterial infec- tions, leading to unnecessary treatments if not properly diagnosed. 5 Community and health-care associated outbreaks also occur and prompt isolation of infected patients is critical for outbreak containment. 3,6,7 Adenovirus may be detected using viral culture, direct fluo- rescence assay (DFA), or molecular methods, all of which require special expertise or equipment to perform and hours to days to provide final results. 8–13 Furthermore, DFA and even the newer res- piratory virus panels or multiplex PCR assays may not be sensitive methods for detection of many common serotypes of adenovirus. 13  Presented in part at Infectious Diseases Society of America 45th Annual Meeting, San Diego, CA, October 4–7, 2007. * Corresponding author at: Texas Children’s Hospital, Mail Code 3-2371, 6621 Fannin Street, Houston, TX 77030-2399, United States. Tel.: +1 713 436 9572; fax: +1 713 798 7249. E-mail addresses: levent@bcm.edu (F. Levent), jmgreer@texaschildrenshospital.org (J.M. Greer), snider@bcm.edu (M. Snider), gdemmler@bcm.edu (G.J. Demmler-Harrison). A new qualitative in vitro immunochromatographic membrane- based assay that utilizes a specific monoclonal antibody against the group-reactive hexon antigen common to all known serotypes of human adenovirus was evaluated. Adenovirus antigen was detected directly in clinical samples, in as little as 15min, 14 timely enough to potentially influence clinical decision-making. 2. Methods Specimens submitted to the Diagnostic Virology Laboratory at Texas Children’s Hospital from January through December 2006 for virology testing were evaluated using the SAS Rapid Adeno test (SAScientific, San Antonio, TX, USA) 200 adenovirus culture posi- tive and 200 adenovirus culture negative samples obtained from 315 pediatric patients were evaluated. The rapid assay was performed per manufacturer’s instructions 15 and results were interpreted by the presence or absence of visually detectable colored lines (Fig. 1). Following a brief extraction step using a buffer containing 0.1% sodium azide, the sample was added to a sample well in a plastic device. An immobilized capture antibody on a membrane formed a colored line at the specimen “S line” if the specimen contained adenovirus antigen. An internal control line C, containing anti- mouse antibody that captured the colored conjugate antibody, was also built into the device to serve as a procedural quality 1386-6532/$ – see front matter © 2008 Elsevier B.V. All rights reserved. doi:10.1016/j.jcv.2008.11.002