Bioneer Q-RFIA Clinical Evaluation

NCT05117788 | Active Not Recruiting

• 1 other identifier: TB040
• Study Type: observational
• Target: 2,350
• Locations: 5 countries
• Sites: 5

Brief Summary

Robust evidence on the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR is required to comprehensively evaluate validity of the Bioneer RFIA assay to support both global and national policy decision-making. The rapid diagnosis and appropriate treatment of M/XDR-TB is essential to prevent significant morbidity, mortality and further transmission of disease. The FQ are key components of the new bedaquiline-containing 6-9 month regimen, and so it is necessary to rule-out resistance to these compounds prior to treating patients with the shorter regimen. Currently there are no WHO endorsed test that can diagnose MTB and identify resistance to both first and second-line drugs in a single assay cartridge with integrated sample preparation.

Conditions

Tuberculosis, Multidrug-Resistant

Keywords

Bioneer assay; clinical performance; in-vitro diagnostic TB assay; Multi-drug resistant TB

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy for MTB detection

  Point estimates of sensitivity and specificity with 95% confidence intervals (CI) for MTB detection using culture as reference standard.

  8 months

• Diagnostic accuracy for isoniazid (INH), rifampicin (RIF), fluoroquinolone (FQ) and aminoglycoside (AMG) resistance detection

  Point estimates of sensitivity and specificity with 95% CI for INH, RIF, FQ, and AMG resistance detection using phenotypic DST and sequencing as composite reference standard.

  8 months

Secondary Outcomes (7)

• Compare the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection to Xpert Ultra, using culture as the reference standard.

  3 months

• Compare the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for RIF resistance detection to Xpert Ultra using a composite reference standard comprising phenotypic DST and targeted sequencing (subset of culture positive specimens)

  8 months

• Diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for resistance detection to the GenoType MTBDRplus and MTBDRsl assays using composite reference standard comprising phenotypic DST and targeted sequencing, on the subset of culture

  8 months

• Compare the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for resistance detection to Xpert MTB/XDR using a composite reference standard comprising phenotypic

  8 months

• Compare the diagnostic accuracy of the Bioneer IRONqPCR ™ RFIA Kit for resistance detection to the GenoType MTBDRplus and MTBDRsl assays

  8 months

Study Arms (1)

TB suspects

Sputum specimens will be collected from TB suspects enrolled in the study. The specimens will be tested with 1. Bioneer Accupower Q-FRIA assay using the Iron q-PCR instrument (investigational product) 2. Xpert MTB/RIF Ultra and Xpert MTB/XDR (comparators products)

Diagnostic Test: Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard. Estimate the diagnostic accuracy of the Bioneer Ac

Interventions

Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard. Estimate the diagnostic accuracy of the Bioneer Ac DIAGNOSTIC_TEST

Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard. Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for isoniazid (INH), rifampicin (RIF), fluoroquinolone (FQ) and aminoglycoside (AMG) resistance detection using a composite reference standard comprising phenotypic DST and targeted sequencing.

TB suspects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants in whom pulmonary TB is suspected. Additionally, well-characterized samples from existing biobanks may be included in the study to supplement drug-resistant cases.

You may not qualify if:

• Participants will be excluded from the study if any of the following apply:
• Unwilling or unable to provide informed consent;
• Unwilling to provide two sputum specimens at enrolment;
• Presenting with only extra-pulmonary TB signs \& symptoms;
• Receipt of any TB treatment dose within the 6 months prior to enrolment.

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• V. N. Karazin Kharkiv National University: collaborator
• Kenya Medical Research Institute: collaborator
• Universidad Peruana Cayetano Heredia: collaborator
• Bioneer Corporation: collaborator
• Centre for Infectious Disease Research in Zambia (CIDRZ): collaborator
• Institute of Pneumology "Chiril Draganiuc" National TB Reference Laboratory: collaborator

Study Sites (5)

KEMRI

Nairobi, Nairobi County, Kenya

Location

Institute of Pneumology "Chiril Draganiuc"

Chisinau, Moldova

Location

Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia

Lima, Peru

Location

V.N Karazin Kharkiv National University

Kharkiv, 61064, Ukraine

Location

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

Location

Related Publications (1)

• Georghiou SB, de Vos M, Velen K, Miotto P, Colman RE, Cirillo DM, Ismail N, Rodwell TC, Suresh A, Ruhwald M. Designing molecular diagnostics for current tuberculosis drug regimens. Emerg Microbes Infect. 2023 Dec;12(1):2178243. doi: 10.1080/22221751.2023.2178243.

  PMID: 36752055 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Sputum specimens, M tuberculosis cultured isolates from patient specimens

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Adam Penn-Nicholson

  Find

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: February 23, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

MO (1); UA (1); ZA (1); KE (1); PE (1)