title: Multicenter Clinical Evaluation of the Novel Alere i Strep A Isothermal Nucleic Acid Amplification Test.
abstract: Rapid detection of group A beta-hemolytic streptococcus (GAS) is used routinely to help diagnose and treat pharyngitis. However, available rapid antigen detection tests for GAS have relatively low sensitivity, and backup testing is recommended in children. Newer assays are more sensitive yet require excessive time for practical point-of-care use as well as laboratory personnel. The Alere i strep A test is an isothermal nucleic acid amplification test designed to offer highly sensitive results at the point of care within 8 min when performed by nonlaboratory personnel. The performance of the Alere i strep A test was evaluated in a multicenter prospective trial in a Clinical Laboratory Improvement Amendments (CLIA)-waived setting in comparison to bacterial culture in 481 children and adults. Compared to culture, the Aleri i strep A test had 96.0% sensitivity and 94.6% specificity. Discrepant results were adjudicated by PCR and found the Alere i strep A test to have 98.7% sensitivity and 98.5% specificity. Overall, the Alere i strep A test could provide a one-step, rapid, point-of-care testing method for GAS pharyngitis and obviate backup testing on negative results.
authors.affiliation: Division of Emergency Medicine, Nationwide Children's Hospital, Columbus, Ohio, USA daniel.cohen@nationwidechildrens.org.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Cohen
authors.affiliation: Division of Emergency Medicine, Nationwide Children's Hospital, Columbus, Ohio, USA.
authors.forename: Michael E
authors.identifier: http://orcid.org/0000-0002-3692-4489
authors.initials: ME
authors.lastname: Russo
authors.affiliation: Section of Infectious Diseases, Nationwide Children's Hospital, Columbus, Ohio, USA.
authors.forename: Preeti
authors.initials: P
authors.lastname: Jaggi
authors.affiliation: Division of Emergency Medicine, Nationwide Children's Hospital, Columbus, Ohio, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Kline
authors.affiliation: FastER Urgent Care, Morris Plains, New Jersey, USA.
authors.forename: William
authors.initials: W
authors.lastname: Gluckman
authors.affiliation: New York Methodist Hospital, Brooklyn, New York, USA.
authors.forename: Amisha
authors.initials: A
authors.lastname: Parekh
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D010612:Pharyngitis / Q000175:diagnosis* / Q000382:microbiology; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013290:Streptococcal Infections / Q000175:diagnosis* / Q000382:microbiology; D055815:Young Adult