A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides

N/ACompletedNCT05899400

Diascopic, LLC400 enrolled

Overview

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Tuberculosis, Pulmonary

Interventions

Diascopic iON Image Analysis SystemDIAGNOSTIC_TEST

A scanning digital optical train that images sputum slides for automated analysis by a tuberculosis detecting algorithm

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Samples sourced from Makerere University's Joint Clinical Research Clinic (JCRC) and Laboratory Exclusion Criteria: * No samples from outside Makerere's Domain

Locations (1)

Makerere University

Kampala, Uganda

Outcomes

Primary Outcomes

Determined sensitivity and specificity of the iON device by comparing MTB slide results to their associated bacterial culture results from the same specimen(s).

Sensitivity, specificity, and average analysis time were determined. An image database of \>40,000 images was also created for internal use.

Time frame: Study completed over the grant period 2019 - 2022

Data from ClinicalTrials.gov

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