title: Accurate Detection of Streptococcus pyogenes at the Point of Care Using the cobas Liat Strep A Nucleic Acid Test.
abstract: The performance of a polymerase chain reaction-based point-of-care assay, the cobas Strep A Nucleic Acid Test for use on the cobas Liat System (cobas Liat Strep A assay), for the detection of group A Streptococcus bacteria was evaluated in primary care settings. Throat swab specimens from 427 patients were tested with the cobas Liat Strep A assay and a rapid antigen detection test (RADT) by existing medical staff at 5 primary care clinics, and results were compared with bacterial culture. The cobas Liat Strep A assay demonstrated equivalent sensitivity (97.7%) and specificity (93.3%) to reference culture with a 15-minute turnaround time. In comparison to RADTs, the cobas Liat Strep A assay showed improved sensitivity (97.7% Liat vs 84.5% RADT). The Clinical Laboratory Improvement Amendments-waived cobas Liat Strep A assay demonstrated the ease of use and improved turnaround time of RADTs along with the sensitivity of culture.
authors.affiliation: 1 Roche Molecular Systems, Marlborough, MA, USA.
authors.forename: Fangnian
authors.initials: F
authors.lastname: Wang
authors.affiliation: 1 Roche Molecular Systems, Marlborough, MA, USA.
authors.forename: Yu
authors.initials: Y
authors.lastname: Tian
authors.affiliation: 1 Roche Molecular Systems, Marlborough, MA, USA.
authors.forename: Lingjun
authors.initials: L
authors.lastname: Chen
authors.affiliation: 2 Roche Molecular Systems, Pleasanton, CA, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Luo
authors.affiliation: 2 Roche Molecular Systems, Pleasanton, CA, USA.
authors.forename: Joanna
authors.initials: J
authors.lastname: Sickler
authors.affiliation: 2 Roche Molecular Systems, Pleasanton, CA, USA.
authors.forename: Oliver
authors.initials: O
authors.lastname: Liesenfeld
authors.affiliation: 1 Roche Molecular Systems, Marlborough, MA, USA.
authors.forename: Shuqi
authors.initials: S
authors.lastname: Chen
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D009696:Nucleic Acids; D019095:Point-of-Care Systems / Q000706:statistics & numerical data*; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000706:statistics & numerical data*; D011446:Prospective Studies; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013290:Streptococcal Infections / Q000175:diagnosis*; D013297:Streptococcus pyogenes / Q000302:isolation & purification*; D055815:Young Adult
chemical_list: D009696:Nucleic Acids
keywords: cobas Liat Strep A assay; group A Streptococcus; point-of-care (POC); polymerase chain reaction (PCR); rapid antigen detection test