Diagnostic Tools for the Direct Detection of Orientia Tsutsugamushi

Screening and enrolment

The study team will screen patients presenting with fever at the out- and inpatient departments of study sites. A scrub typhus rapid diagnostic test (RDT) will be performed at all sites (e.g. Scrub Typhus IgM RDT, InBios International; Scrub Typhus IgM/IgA/IgG RDT, SDBioline; STANDARD Q Tsutsugamushi IgM/IgG, SDBiosensor) and insulated isothermal polymerase chain reaction (iiPCR) will be performed at Chiang Rai Clinical Research Unit (CCRU) central laboratories. Before being screened with any of the above tests for study purposes, potential participants will be asked to pre-consent to the screening test.

If participants have a positive screening test following an order form the treating physician as part of standard management (not for study purposes), this will be considered equivalent to a positive screening test; those subjects will be asked then to provide informed consent to participate in the study.

Eligible patients who agree to participate and/or their legal guardians will take part in the informed consent procedure. If the RDT or iiPCR test is positive for scrub typhus (one positive test is sufficient) or the patient has a fever and an eschar, the patient is formally enrolled into the study.

Every screened patient will receive a screening number and details are recorded into a screening log. Screening rejection is defined as patients who have been screened but are not enrolled into the study. Reasons for rejection may include any exclusion criteria, non-conformity with the inclusion criteria, or failure to obtain informed consent. Reasons will be recorded in the screening log. Patients who do not progress from screening to trial recruitment will not be assigned with a study number or have clinical data recorded in the screening log.