Health TrialsbyHealthPanel

Bioneer Q-RFIA Clinical Evaluation

ConditionTuberculosis, Multidrug-Resistant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFoundation for Innovative New Diagnostics, Switzerland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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.

Treatment groups

2,350 Participants
are divided into 1 treatment group
Group A: TB suspects1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy for MTB detection

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

Time frame
8 months
2

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.

Time frame
8 months

Secondary outcomes

1

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.

Estimate the difference in sensitivity and specificity between the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR and Xpert Ultra for MTB detection.

Time frame
3 months
2

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)

Estimate the difference in sensitivity and specificity between the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR and Xpert Ultra for RIF resistance detection.

Time frame
8 months
3

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

Estimate the difference in sensitivity and specificity between the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR and the GenoType MTBDRplus and MTBDRsl assays for resistance detection.

Time frame
8 months
4

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

Estimate the difference in sensitivity and specificity between the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR and Xpert MTB/XDR for resistance detection.

Time frame
8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Foundation for Innovative New Diagnostics, Switzerland

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
Apply now