Added value of rapid respiratory syndromic testing at point of care versus central laboratory testing: a controlled clinical trial

Abstract

Background Virus-associated respiratory infections are in the spotlight with the emergence of SARS-CoV-2 and the expanding use of multiplex PCR (mPCR). The impact of molecular testing as a point-of-care test (POCT) in the emergency department (ED) is still unclear. Objectives To compare the impact of a syndromic test performed in the ED as a POCT and in the central laboratory on length of stay (LOS), antibiotic use and single-room assignment. Methods From 19 November 2019 to 9 March 2020, adults with acute respiratory illness seeking care in the ED of a large hospital were enrolled, with mPCR performed with a weekly alternation in the ED as a POCT (week A) or in the central laboratory (week B). Results 474 patients were analysed: 275 during A weeks and 199 during B weeks. Patient characteristics were similar. The hospital LOS (median 7 days during week A versus 7 days during week B, P = 0.29), the proportion of patients with ED-LOS <1 day (63% versus 60%, P = 0.57) and ED antibiotic prescription (59% versus 58%, P = 0.92) were not significantly different. Patients in the POCT arm were more frequently assigned a single room when having a positive PCR for influenza, respiratory syncytial virus and metapneumovirus [52/70 (74%) versus 19/38 (50%) in the central testing arm, P = 0.012]. Conclusions Syndromic testing performed in the ED compared with the central laboratory failed to reduce the LOS or antibiotic consumption in patients with acute respiratory illness, but was associated with an increased single-room assignment among patients in whom a significant respiratory pathogen was detected.

A Pragmatic Randomized Controlled Trial of Rapid On-site Influenza and Respiratory Syncytial Virus PCR Testing in Paediatric and Adult Populations

“…Finally, we found no signi cant difference between antibiotic prescriptions between the ROST and standard arm at either site. This is consistent with other published randomized trials in adult (8, 9,12,15) and paediatric (12) populations, in addition to non-randomized trials in paediatric (18, 21) and adult (26) populations. This highlights that rapid test results in and of themselves are unlikely to change antimicrobial prescribing practice (13).…”

“…Regarding our secondary outcomes, we found a signi cantly shorter TAT in the ROST arm with results reported in a mean 26 hours or more before the standard arm. Signi cantly reduced TAT with rapid testing is a consistent nding in rapid/ROST studies of various designs and quality (5,8,15,20,23,25).…”

“…In short, truly pragmatic studies within this context are desperately needed to fully address the impact of rapid respiratory NATs when implemented in a health care system. A notable exception is a study run by Bouzid et al, on emergency department (ED) adult patients where ED physicians ran the test however patients were randomized by the week and providers were not blinded to the arm (15). To address these gaps and Upon review, original secondary outcomes per study protocol were modi ed to address the most clinically relevant measures within the scope of the data collected.…”

The Biofire® Filmarray® Pneumonia Plus panel for management of lower respiratory tract infection in mechanically-ventilated patients in the COVID-19 era: a diagnostic and cost-benefit evaluation

“…A large number of studies have evaluated the diagnostic performance of FA-PP compared to standard culture in patients with suspected LRTBI [7] , [8] , [9] , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] ; nonetheless, cross-study comparison is not straightforward due to differences in potentially impactful parameters, such as patient's baseline clinical condition, hospitalization ward (ICU vs. non-ICU), LRTBI features (i.e., associated or not with MV), timing of FA-PP testing after hospital admission, specimens used (endotracheal aspirates vs. bronchoscopic specimens), and most importantly, whether or not EAT was in place at the time of testing. Despite these dissimilarities, all studies consistently showed the superior sensitivity of FA-PP for detection of all on-panel bacterial targets [7] , [8] , [9] , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] . In line with this, we found that, compared with culture, FA-PP increased the number of specimens reported as positive by approximately 70% and the total number of bacterial targets detected by around 120%, irrespective of their nature.…”

“…Standard semiquantitative culture-based and antimicrobial susceptibility testing procedures performed on endotracheal aspirates or bronchoscopic specimens are lengthy, returning results approximately 48–72 h after specimen reception. The use of molecular diagnostic approaches that allow rapid bacterial identification and documentation of the presence of genotypic resistance traits in the causative bacteria may provide clinically actionable results within 2 h. One such approach is the BioFire® FilmArray® Pneumonia/Pneumonia plus Panel (FA-PP) (BioFire Diagnostics, LLC, Salt Lake City, UT), a multiplex PCR panel that allows detection of 15 bacteria commonly involved in VA-LRTBI, providing semiquantitative estimates of bacterial load and seven genetic markers of antibiotic resistance (mecA/C and MREJ, blaCTX-M,blaKPC, blaVIM, blaOXA-48-like, blaIMP, blaNDM) This test has been extensively evaluated and proven to increase the diagnostic yield in LRTBI compared with standard culture-based methods [6] , [7] , [8] , [9] , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] . FA-PP shows great promise in improving the therapeutic management of VA-LRTBI, however, its positioning in laboratory diagnostic algorithms remains to be defined [22] .…”