Patients presenting to hospital with diarrhoea are routinely isolated as an infection control measure whilst awaiting results of laboratory stool tests which typically take several days. Novel rapid molecular testing platforms, which test comprehensively for gastrointestinal (GI) pathogens, generate a result in 1 hour, making them potentially deployable as point-of-care tests (POCT). Their use may therefore rationalise the use of isolation facilities.Methods
In this ongoing pragmatic, parallel group, open label, randomised controlled trial, adult patients presenting to hospital with acute diarrhoea (<14 days) were recruited and randomised 1:1 to receive either POCT with the FilmArray GI panel or to routine clinical care. Results of POCT were communicated to clinical and infection control teams. The primary outcome measure was duration of time in a side room and secondary outcome measures included turnaround time, proportion of patients with a pathogen detected, and proportion of patients correctly de-isolated. Statistical analysis was done using GraphPad Prism Version 7.Result
We performed an interim analysis using data collected from the first 100 patients. The groups (n=50) were well matched in terms of baseline characteristics. 34% of patients had inflammatory bowel disease. The median [IQR] turnaround time for results was 1.7 [1.6–2.3] hours in the POCT group and 61 [49–84] hours in the control group, p<0.0001. Pathogens were detected in 48% of patients in the POCT group and 20% in the control group, p=0.0057.The median duration of side room isolation was 2.1 [1.0–4.3] days in the POCT group (for those testing positive) compared to 2.7 [1.8–5.0] days in the control group, p=0.037. For those testing negative for pathogens, this was 1.4 [0.6–3.8] days in the POCT group versus 2.7 [1.8–4.9] days in the control group, p=0.0066. 62% of pathogen-negative patients were correctly de-isolated in the POCT group versus 20% in the control group, p=0.0012.Conclusion
POCT using the FilmArray GI panel resulted in a rapid turnaround time for results and an increase in the proportion of patients with pathogens detected. POCT was associated with a reduction in the duration of side room use. If these benefits are maintained in the full study and supported by health economic analysis, molecular POCT for GI pathogens should become standard of care.