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

ObjectivesTo estimate the diagnostic accuracy of HAT Sero K-SeT for the field diagnosis of second-stage human African trypanosomiasis (HAT).DesignA 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.SettingRural hospital in the Democratic Republic of the Congo.ParticipantsAll patients above five years old presenting at Mosango hospital with a neurological problem of recent onset at the exclusion of trauma.Interventionsn.a.Main Outcome MeasuresSensitivity and specificity of HAT Sero K-SeT test.ResultsThe sensitivity of the HAT Sero K-SeT was 8/8 or 100.0% (95% confidence interval: 67.6 to 100.0%) and the specificity was 258/266 or 97.0% (94.2% to 98.5%).ConclusionThe high sensitivity of the HAT Sero K-SeT is in line with previously published estimates, though the sample of HAT cases in this study was small. The specificity estimate was very high and precise. This test, when negative, allows the clinician to rule out HAT in a clinical suspect in a hospital setting in this endemic region.

NTD Diagnostics for Disease Elimination: A Review

“…The years covered by the scoping review coincide with a highly productive period for HAT diagnostic development, with the review papers documenting the development and validation of "first" generation (based on native antigens) and "second' generation" (based on recombinant antigens) rapid diagnostic tests for screening [45][46][47][48][49][50][51][52][53][54][55]. Two "first" generation tests are already commercially available (Standard Diagnostics, Alere, Suwan, S. Korea; Coris Bioconcept, Gembloux, Belguim).…”

Where there is no brain imaging: Safety and diagnostic value of lumbar puncture in patients with neurological disorders in a rural hospital of Central Africa

“…Additional diagnostic information was immediately provided by other CSF analyses in the study hospital for 25 of these 52 cases (48. As shown in Table 1, the features associated with CSF pleocytosis in bivariate analysis with a p-value < 0.02 were: prior exposure to antibiotics and to antibiotics and/or antimalarials, altered consciousness and Glasgow Coma Scale < 15, moderate/severe dehydration, fever as reported by patient and fever documented at admission, neck stiffness, vomiting, anorexia, confirmed HIV infection (defined as reactivity to three different brands of HIV RDTS used sequentially in the diagnostic panel/national control program), positive RDT for HAT (HAT Sero K-SeT, Coris, Gembloux, Belgium [16] and positive Card Agglutination Trypanosoma Test (CATT) result. Blood WBC count above 10,000/µL and hyperglycemia (≥ 6.66 mmol/L) were also associated with CSF pleocytosis but as these test results were not available for all study patients because of technical reasons at the local hospital laboratory, we did not retain these two features in the multivariable analysis.…”

High frequency of Taenia solium antigen positivity in patients admitted for neurological disorders in the Rural Hospital of Mosango, Democratic Republic of Congo.

“…This exploratory study has many limitations, most of which were largely acknowledged in previous publications [14,20,21]. The use of patients rather than a sample of the general population is one of the limitations of the study as it does not enable the magnitude of the underlying problem to be estimated.…”