Assessment of Test Performance and Potential for Environmental Contamination Associated with a Point-of-Care Molecular Assay for Group A Streptococcus in an End-User Setting.

Related Articles

Assessment of Test Performance and Potential for Environmental Contamination Associated with a Point-of-Care Molecular Assay for Group A Streptococcus in an End-User Setting.

J Clin Microbiol. 2018 Dec 05;:

Authors: Donato LJ, Myhre NK, Murray MA, McDonah MR, Myers JF, Maxson JA, Meek AM, Espy MJ, Furst JW, Karon BS, Binnicker MJ

Abstract
Although FDA-approved and CLIA-waived point-of-care (POC) molecular systems are being implemented in routine clinical practice, instrument reliability, test performance in the hands of end-users, and the potential for environmental contamination resulting from use of POC molecular systems have not been extensively evaluated. We performed a prospective evaluation of the Roche cobas Liat group A streptococcus (GAS) assay compared to routine real-time PCR. We evaluated test accuracy, instrument failure rate, and monitored for environmental contamination when testing was performed by minimally trained end users in an Express Care Clinic environment. The overall concordance of the Liat GAS assay with routine testing was 97.2% (455/468). The average Liat failure rate across three analyzers was 6.6% (33/501) (range: 3.7 - 11.6%), and no environmental contamination was detected during the course of the study. The cobas Liat platform and GAS assay demonstrated reliable performance in the end-user setting and may serve as a rapid, POC option for routine diagnostic testing for certain infectious diseases, including GAS.

PMID: 30518542 [PubMed - as supplied by publisher]

from PubMed via alexandrossfakianakis on Inoreader https://ift.tt/2zQdGGu