EVALUATION OF THE TRUtm RSV TEST FOR RAPID DETECTION OF RESPIRATORY SYNCYTIAL VIRUS IN PEDIATRIC PATIENTS

Background:  Laboratory diagnosis of RSV infection in pediatric patients is useful for infection control and patient management. Although traditional methods of culture and DFA are commonly used for diagnosis, rapid detection of RSV protein antigens by a single use immunoassay device is valuable for diagnosis in select patient settings.

Objective:  In this study, a rapid RSV antigen test - the TRU™ RSV (Meridian Bioscience, Cincinnati, OH) was evaluated on respiratory tract samples collected during the 2006-07 respiratory virus season and compared to culture. TRU™ RSV is a lateral flow capture immunoassay utilizing monoclonal antibodies to detect both the RSV fusion and nucleoprotein antigens.

Methods:  A total of 281 samples submitted to Children’s Hospital Laboratory for RSV testing (typically DFA) per standard-of-care were evaluated – 207 nasal wash and 74 posterior NP swab samples, the latter submitted in 2.0 mL M4 viral transport medium.  Over 80% of samples were collected on patients less than 2 yr of age. About 65% of tests were performed on fresh, refrigerated samples within 72 hr of receipt (generally within 24 hr), while the remaining tests were run on frozen samples.  Culture was performed using a “shell-vial” assay and employed a fluorescent-labeled RSV-specific antibody. 

Results: Prevalence of RSV disease during the study period based on culture was 47.3%.

Performance characteristics of TRU™ RSV by specimen type are shown in the table.

Conclusions: The TRU™ RSV test (1) was easy to perform and interpret and (2) showed very good performance characteristics in our patient population during a high prevalence period for RSV disease. It should be considered for implementation in patient settings when a rapid turnaround time is needed for specific diagnosis of RSV disease.