Tuberculosis
Conditions
Interventions
Bioneer AccuPower Q RFIA PCR kit
Sponsors
Foundation for Innovative New Diagnostics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinical suspicion of pulmonary TB, defined as: Phase 1: Cough lasting at least 2 weeks, and at least one of the following additional symptoms Phase 2: Cough of any duration, and at least one of the following additional symptoms Fever Malaise Recent weight loss Night sweats Haemoptysis Chest pain Loss of appetite Supplemental Biobank specimens. Specimens may be included in the supplemental component if the originating participant met the following criteria: Symptoms suggestive of pulmonary TB, defined as persistent cough (generally =3 weeks or as per local definition of presumptive TB), and at least one of the following risk factors or clinical conditions: History of >1 month of treatment for a prior TB episode Failure of TB treatment, evidenced by positive sputum smear or culture after =3 months of a standard TB treatment Close contact with a known drug-resistant TB case Newly diagnosed with MDR-TB within the last 30 days Previously diagnosed with MDR-TB and failure of MDR-TB treatment, evidenced by a positive sputum smear or culture after =3 months of a standard MDR-TB treatment regimen
Exclusion criteria
Exclusion criteria: 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. or Phase 1, exclusion criteria were applied at the time of prospective enrolment For Phase 2, the same exclusion criteria will apply during ongoing participant recruitment at clinical sites. Supplemental biobank specimens will be excluded from the study if any of the following apply: Lack of documented informed consent from the originating participant for the use of the specimen in research. Absence of corresponding culture results or phenotypic drug susceptibility testing data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Point estimates of sensitivity and specificity with 95% confidence intervals (CI) for MTB detection using culture as reference standard. 2. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Estimate the difference in sensitivity and specificity between the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR and Xpert Ultra for MTB detection. 2. 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. | — |
Countries
Zambia
Contacts
Public ContactKachimba Shamaoma
Study Coordinator
Outcome results
None listed