Multi-site diagnostic accuracy evaluation of innovations for rapid TB diagnosis and screening (RAPID-TB)

Evaluating the diagnostic accuracy and performance of novel diagnostic and screening tools for TB disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202511696950960

Enrollment

8500

Registered

2025-11-18

Start date

2025-11-03

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

Assessing diagnostic accuracy and screening performance of several new TB tools

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults: Age 18+ years (or 21+ years); Children & adolescents: Age 12 months-17 (or 20) years; Screening for TB: A positive TB screen may include: the WHO-recommended four-symptom screen (W4SS) OR parenchymal abnormalities on chest radiography (CXR) OR Failure of antibiotics for pneumonia OR TB risk factor(s) including HIV-infection, history of TB treatment, at risk of undernutrition, at risk of alcohol use disorders or use of tobacco Willing to provide the specimens needed for testing. Written informed consent and agreement to follow-up after enrollment.

Exclusion criteria

Exclusion criteria: Current anti-TB treatment (counting from the third dose). Any anti-TB treatment within 60 days prior to enrollment and any TB preventive therapy within 6 months prior to enrollment. Lack of informed consent.

Design outcomes

Primary

Measure	Time frame
Point estimates of sensitivity and specificity with 95% confidence intervals of evaluated tools in HIV-positive and HIV-negative participants.	—

Secondary

Measure	Time frame
Crude and additional diagnosis yield of new tools compared to AlereLAM (urine) as well as smear, culture, and Xpert Ultra (sputum and urine) among all patients identified as having TB by extended microbiological reference standard . ;Diagnosis performance and accuracy of FujiLAM II with UCD in HIV-positive and HIV-negative adults and children. ;Secondary endpoints related to operational feasibility indicators such as turnaround time, repeatability, and rate of non-actionable results (indeterminate, error, etc). Endpoints for user preferences will be based on an aggregate acceptability score calculated from bespoke indicators within 8 constructs of Sekhon et al.’s acceptability framework for healthcare interventions. Health economic indicators include cost per specimen processed and cost per case detected.	—

Measure

Time frame

Crude and additional diagnosis yield of new tools compared to AlereLAM (urine) as well as smear, culture, and Xpert Ultra (sputum and urine) among all patients identified as having TB by extended microbiological reference standard . ;Diagnosis performance and accuracy of FujiLAM II with UCD in HIV-positive and HIV-negative adults and children. ;Secondary endpoints related to operational feasibility indicators such as turnaround time, repeatability, and rate of non-actionable results (indeterminate, error, etc). Endpoints for user preferences will be based on an aggregate acceptability score calculated from bespoke indicators within 8 constructs of Sekhon et al.’s acceptability framework for healthcare interventions. Health economic indicators include cost per specimen processed and cost per case detected.

—

Countries

Cameroon, Nigeria, Viet Nam

Contacts

Public ContactSarah Zaidi

Analyst Stop TB Partnership

sarahz@stoptb.org+41796516119

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026