Multi-center evaluation of the cobas® Liat® Influenza A/B & RSV assay for rapid point of care diagnosis

被引:53
|
作者
Gibson, Jane [1 ]
Schechter-Perkins, Elissa M. [2 ]
Mitchell, Patricia [2 ]
Mace, Sharon [4 ,5 ]
Tian, Yu [3 ]
Williams, Kemi [3 ]
Luo, Robert [3 ]
Yen-Lieberman, Belinda [4 ,5 ]
机构
[1] Univ Cent Florida, Coll Med, Dept Clin Sci, Lake Nona Hlth Sci Campus,6850 Lake Nona Blvd, Orlando, FL 32827 USA
[2] Boston Univ, Sch Med, Dept Emergency Med, Boston Med Ctr, Boston, MA 02215 USA
[3] Roche Mol Syst, Pleasanton, CA USA
[4] Cleveland Clin, Emergency Dept, Cleveland, OH 44106 USA
[5] Dept Lab Med, Cleveland, OH USA
关键词
Influenza A; Influenza B; RSV; Point of care testing; EMERGENCY-DEPARTMENT; UNITED-STATES; PCR ASSAY; SEASON; IMPACT; VACCINE;
D O I
10.1016/j.jcv.2017.08.004
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
Point of Care Testing (POCT) provides the capability for rapid laboratory test results in patient care environments where a traditional clinical laboratory is not available. POCTs have shorter turn-around times (TATs), they may be performed by non-laboratory personnel, and the need for transport time is eliminated. The Food and Drug Administration (FDA) recently granted Clinical Laboratory Improvements Amendment (CLIA) waiver status to the cobas (R) Influenza A/B & RSV assay, a rapid, accurate point-of-care test for Influenza and respiratory syncytial virus (RSV) performed on the Liat (R) System. The performance characteristics of this test were determined though a multi-site study consisting of different point of care testing environments. Prospectively collected Nasopharyngeal (NP) swabs from 1361 patients seen at 8 primary care clinics and 4 emergency departments (EDs) and 295 retrospectively identified specimens were tested for Influenza A/B and RSV on the cobas (R) Liat (R) platform. Performance characteristics were determined through comparison to ProFlu+, a laboratory-based PCR test for Influenza A/B and RSV (reference test). Discordant specimens were adjudicated following bi-directional sequencing. The cobas (R) Influenza A/B and RSV assay showed sensitivities of 99.6%, 99.3%, and 96.8% for Influenza A, Influenza B, and RSV, respectively as determined from percent positive agreement (PPA) following comparison to the reference test. Sequencing confirmed cobas (R) Influenza A/B and RSV results in 49.2% of reference test discordant specimens, while crossing threshold data suggest increased sensitivity compared to the reference test. The cobas (R) Influenza A/B and RSV assay was found to be a rapid, sensitive POCT for the detection of these viruses, and provides laboratory-quality PCR-based diagnostic results in point of care settings.
引用
收藏
页码:5 / 9
页数:5
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