A Phase III Diagnostic Accuracy Study of a Rapid Diagnostic Test for Diagnosis of Second-Stage Human African Trypanosomiasis in the Democratic Republic of the Congo.

ABSTRACT:

Objectives

To estimate the diagnostic accuracy of HAT Sero K-SeT for the field diagnosis of second-stage human African trypanosomiasis (HAT).

Design

A phase III diagnostic accuracy design. Consecutive patients with symptoms clinically suggestive of HAT were prospectively enrolled. We compared results of the index test HAT Sero K-SeT with those of a composite reference standard: demonstration of trypanosomes in cerebrospinal fluid (CSF), or trypanosomes detected in any other body fluid AND white blood cell count in CSF >5/μl.

Setting

Rural hospital in the Democratic Republic of the Congo.

Participants

All patients above five years old presenting at Mosango hospital with a neurological problem of recent onset at the exclusion of trauma.

Interventions

n.a.<

SUBMITTER: Boelaert M 

PROVIDER: S-EPMC5828295 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature