TEST-IT Trial

Trial Acronym	TEST-IT
Clinical Area	Critical Care
Description	Point Of Care Testing For Sepsis: A Diagnostic Accuracy Study
Status	Analysis and Reporting

RECRUITMENT

Date Opened to Recruitment	October 2016
Target Recruitment	4501 Samples
Recruitment to date	412 (Completed)
Date Closed to Recruitment	February 2018
No. of Sites	> 25

TRIAL DESIGN

Trial Design	A prospective, observational, multi-centre blinded accuracy study of a novel diagnostic.
Study Aim	To assess the diagnostic accuracy of the Randox point of care (POC) multiplex polymerase chain reaction (Multiplex PCR) test in critically ill patients with suspected sepsis.
	The primary objective of this study is measurement of the sensitivity, specificity, positive predictive value and negative predictive value of this novel test, in comparison with conventional culture, in critically ill adults with suspected sepsis.
	“The secondary objectives of this study are: (i) to estimate the true cost per test for conventional blood culture and for multiplex PCR (ii) to estimate the time to result for conventional blood culture and for multiplex PCR”

CHIEF INVESTIGATOR (CI)

Chief Investigator

Dr Ronan McMullan / Prof Danny McAuley

SPONSOR(s) & FUNDER(s)

Sponsors	Belfast Health and Social Care Trust
Funder	Innovate UK
Links	http://www.isrctn.com/ISRCTN97997760