

The Centre for Infectious Disease Research in Zambia (CIDRZ) has successfully conducted a Site Initiation Visit (SIV) for the Bioneer AccuPower Q‑RFIA PCR Clinical Evaluation Study, a new tuberculosis (TB) diagnostic research study at the Chawama Clinical Research Site in Lusaka.
The study will evaluate the Bioneer AccuPower Q‑RFIA PCR system, a molecular test designed to detect TB bacteria and identify drug-resistant strains, including resistance to Rifampicin, Isoniazid, Fluoroquinolones, and Aminoglycosides.
Speaking on the milestone, CIDRZ Research Medical Officer Dr Nsala Sanjase explained that this Multicentre Diagnostic Accuracy Study is sponsored by the Foundation for Innovative New Diagnostics (FIND), while the investigational device was developed by Bioneer.
Dr Sanjase highlighted that the SIV ensured alignment across the clinical, laboratory, and data teams on all protocol requirements, workflows, quality systems, and safety reporting, laying a foundation for the commencement of Phase 2 prospective enrollment in Zambia.
She stated that the study will contribute to strengthening evidence for rapid, accessible diagnostics for both drug‑sensitive and drug‑resistant tuberculosis in high‑burden settings.

