[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448310":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":42,"studyPopulation":43,"armGroups":44,"interventions":50,"overallOfficials":39,"centralContacts":56,"locations":65,"responsibleParty":155,"collaborators":157,"id":168,"slug":169,"hasResults":170,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":39,"eligibilityCriteria":174,"healthyVolunteers":170,"sex":175,"minAge":176,"maxAge":39,"enrollmentInfo":177,"targetDuration":39,"studyType":180,"phases":39,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":68,"whyStopped":39,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"fullName":5,"class":6},"Foundation for Innovative New Diagnostics, Switzerland","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":39},[9,13],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":12},"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.",[17,21,24,27,30,33,36],{"measure":18,"description":19,"timeFrame":20},"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.","3 months",{"measure":22,"description":23,"timeFrame":12},"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.",{"measure":25,"description":26,"timeFrame":12},"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.",{"measure":28,"description":29,"timeFrame":12},"Compare the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for resistance detection to Xpert MTB\u002FXDR 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\u002FXDR for resistance detection.",{"measure":31,"description":32,"timeFrame":12},"Compare the diagnostic accuracy of the Bioneer IRONqPCR ™ RFIA Kit for resistance detection to the GenoType MTBDRplus and MTBDRsl assays","Estimate the difference in sensitivity and specificity between the Bioneer IRONqPCR ™ RFIA Kit and the GenoType MTBDRplus and MTBDRsl assays for resistance detection",{"measure":34,"description":35,"timeFrame":12},"Compare the diagnostic accuracy of the Bioneer IRONqPCR ™ RFIA Kit for resistance detection to Xpert MTB\u002FXDR","Estimate the difference in sensitivity and specificity between the Bioneer IRONqPCR ™ RFIA Kit and Xpert MTB\u002FXDR",{"measure":37,"description":38,"timeFrame":12},"Assess the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR technical performance, including non-determinant rates.","Percentage of invalid results, percentage of indeterminate results for MTB detection, and percentage of indeterminate results for resistance detection.",null,{"allocation":39,"interventionModel":39,"interventionModelDescription":39,"primaryPurpose":39,"observationalModel":41,"timePerspective":6,"maskingInfo":39},"COHORT","Multicentre Clinical Study to Assess the Performance of the Bioneer IRONqPCR ™ RFIA Kit for INH-, RIF-, FQ- and AG-Resistance Detection\n\nBackground and rationale Evidence of the clinical diagnostic accuracy and operational characteristics of the Bioneer IRONqPCR ™ RFIA Kit is needed to comprehensively evaluate Bioneer RFIA validity and inform global and national policy decision-making.\n\nThe Bioneer IRONqPCR ™ RFIA Kit. The Investigational Use Only (IUO) product is intended for the detection of MTB and mutations associated with RIF, INH, FQ and AMG drug resistance. The assay which is run as a kit cartridge physically consists of two parts; a nucleic extraction body part and the PCR plate. The cartridge is intended to be used with the IRON qPCR system.\n\nThe IRON qPCR system provided for this study should only be used for testing IUO product and study samples. The IRON qPCR instrument developed by Bioneer is intended to be used at lower healthcare systems. The instrument has a small footprint ((30.5(W) x 27(D) x 39.5(H) cm), weight (\\\u003C 15 kg) and can be operated on a battery charge. The system has the capability to fully automate the detection of 40 targets and to provide sample-to-result within 30 minutes.) The investigational product will be strictly accounted for, including receipt and inventory, storage, use during the trial, and return or disposal, as detailed in the Study Manual for this study.\n\nOther diagnostic tests (2nd comparators and reference tests) provided for use in this Trial are:\n\n* Xpert MTB\u002FRIF Ultra assay\n* Xpert MTB\u002FXDR assay\n* Hain MTBDRplus assay\n* Hain MTBDRsl assay Instructions for use of the investigational product(s) are provided in the IP package inserts.\n\nThe Bioneer IRONqPCR ™ RFIA Kit assay detects Mtb and mutations associated with INH, RIF, FQ and aminoglycoside resistance direct from sputum. In line with this intended use, clinical samples will be directly tested by the Bioneer Accupower Q-RFIA assay. However, the assay will also be used to test the culture isolate. This additional Bioneer IRONqPCR ™ RFIA Kit assay testing will allow for a comparison of performance and non-determinant rates between testing directly from the sample and testing from the culture isolate. It will also support resolution of potential discordant LPA and NGS results from the initial Bioneer IRONqPCR ™ RFIA Kit test result, as these tests will also be performed from the culture isolate (discordance may arise as a result of infections with a mix of different strains, with only one strain being grown out in culture). Furthermore, as all assays will be performed on the same culture, there is also no risk of any assay being tested on a different quality sample.\n\nIn order to efficiently assess the diagnostic performance of the Bioneer IRONqPCR ™ RFIA Kit on IRON qPCR, participants will be asked to provide ≥3ml of sputum (either a single sputum or two consecutively collected and pooled sputa). Spot sputa should be pooled and homogenized. For samples where only one specimen was collected from the participant, the sample needs to be homogenized. Briefly, following a mechanical homogenisation step the sputum sample will be split and the following tests will be performed:\n\n* Fluorescence smear microscopy (FM smear)\n* Xpert MTB\u002FRIF Ultra\n* Xpert MTB\u002FXDR assay\n* Bioneer Accupower Q-RFIA\n* Liquefaction\u002Fdecontamination by NALC-NaOH followed by re-suspension on PBS and inoculation on MGIT and Löwenstein-Jensen culture media\n\n  * MTB complex confirmation of positive cultures by either MPT64\u002FMPB64 antigen detection or PCR (GenoType) from each positive culture.\n  * Phenotypic DST to test INH, RIF, fluoroquinolone (moxifloxacin and levofloxacin), AMK, and KAN resistance will be done on the first culture positive for MTB complex per patient.\n  * Molecular testing from all MTB-complex confirmed cultures using GenoType MTBDRplus and MTBDRsl\n  * Whole genome sequencing will only be done from samples where the Bioneer result (from either the sputum or culture testing) is discordant with phenotypic DST\n  * Bioneer Accupower Q-RFIA from all MTBC confirmed cultures\n\nAll diagnostic test results (smear, Bioneer IRONqPCR ™ RFIA Kit on direct sample, Xpert MTB\u002FRIF Ultra on direct sample, Xpert MTB\u002FXDR on direct sample, MGIT, LJ, Bioneer Accupower RFIA on culture isolate, MTBDRplus, MTBDRsl, and phenotypic DST results) will be recorded by the laboratory technicians for each site on the laboratory CRF.\n\nRetrospective specimens selected from different biobanks will also be processed. In the event where routine testing has already been done on the retrospective specimens, FM smear and Xpert MTB\u002FRIF or Ultra does not have to be repeated. Prior to the study start the FIND study manager will evaluate the diagnostic data linked to each specimen to determine which testing needs to be done or repeated for each site. Xpert MTB\u002FXDR test will be performed for every selected specimen.\n\nReference Standard Test and Index Test Procedures Culture (LJ and MGIT), phenotypic DST and smear microscopy will be performed at the testing sites based on local SOPs. Whole genome sequencing will be done at a central location following a standardised protocol to be provided by FIND.\n\nEach participating laboratory will undergo a remote laboratory evaluation to assess the quality management system of the laboratory and more specifically to ensure standardized and high-quality performance of routine tests including smear, culture and DST. Results from reference standard testing will be recorded by technicians blinded to index test results, eliminating the risk of review bias. Presence of MTB complex will be confirmed for all patients from a positive culture using an MPT64-based rapid test or WHO-approved NAAT on the culture isolate.\n\nA culture reference standard may be imperfect in paucibacillary (smear-negative) TB. This can lead to bias in the accuracy estimates of the index test: (i) sensitivity may be overestimated when index test and reference standard both yield negative results in a patient with TB; and (ii) specificity may be underestimated when the index test gives a positive result in a patient with TB who tests negative with the reference standard. A biased sensitivity estimate is acceptable as it still represents a meaningful parameter (the proportion of culture-positive TB that is also detected by the index test). However, since near-perfect specificity is usually required of TB assays, bias in specificity can be problematic. To mitigate the risk of spurious index test \"false-positive\" results, a total of two cultures (one MGIT and one LJ culture) will be done in all cases.\n\nA composite reference standard of phenotypic DST and NGS will be used for resistance detection to ensure high confidence in the reference standard for this study. Using phenotypic DST as a reference standard may be imperfect for mutations with minimum inhibitory concentrations around the breakpoint of the respective drug. This can lead to bias in the accuracy estimates of the index test where (i) sensitivity may be overestimated when index test and reference standard both yield negative results for resistance; and (ii) specificity may be underestimated when the index test gives a positive result for resistance where phenotypic DST gives a negative result. To mitigate this risk sequencing will be done for all samples with a discrepant result between the index assay and phenotypic DST. As part of this study, sequencing results will only be available for results that are discordant between the index assay and pDST. Using sequencing only for discrepant samples can also lead to bias in the accuracy estimates for the index assay for cases where both the index and phenotypic DST results are negative for resistance and where sequencing would have shown the presence of a mutation. This risk is however minimal as clinically resistant mutations with a susceptible phenotype result is rare and their genotypic basis not well understood. In such cases the phenotypic DST result is still considered as the gold standard. Therefore, we considered use of the composite reference standard the approach with the lowest risk of bias overall and will use this for the primary analysis.\n\nPhenotypic MGIT DST will be done on the culture isolate for each clinical sample. MGIT DST will be done on site to determine culture drug-susceptibility to INH, RIF, moxifloxacin, levofloxacin, AMK, and KAN at the revised WHO critical concentrations15. Whole genome sequencing will be done for samples where the Bioneer assay result (from either the sputum or culture testing) is discordant with phenotypic DST. Whole genome sequencing will be done on DNA extracted from the cultured sample. The output for both phenotypic DST and NGS results are automated, and require no manual operator interpretation. Testing results, when obtained, will be input onto the laboratory CRF.\n\nThe index test will be performed on both the direct clinical sample as well as the positive culture, to ensure high Bioneer IRONqPCR ™ RFIA Kit diagnostic performance direct from sputum and to provide a basis for comparison if any discordants are seen between the initial Bioneer IRONqPCR ™ RFIA Kit result and the phenotypic DST and additional molecular test results (NGS and LPA). The output for the Bioneer IRONqPCR ™ RFIA Kit is automated and does not require manual interpretation. As with the reference test, all Bioneer IRONqPCR ™ RFIA Kit test results will be noted on the laboratory CRF.\n\nGCP statement This study will be conducted in compliance with the protocol, the Declaration of Helsinki, ICH-GCP E6 (R3) guidelines, ISO 20916:2019 and in compliance with all applicable regulations.","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.",[45],{"label":46,"type":39,"description":47,"interventionNames":48},"TB suspects","Sputum specimens will be collected from TB suspects enrolled in the study. The specimens will be tested with\n\n1. Bioneer Accupower Q-FRIA assay using the Iron q-PCR instrument (investigational product)\n2. Xpert MTB\u002FRIF Ultra and Xpert MTB\u002FXDR (comparators products)",[49],"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",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":39},"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","Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard.\n\nEstimate 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.",[46],[57,62],{"name":58,"role":59,"phone":60,"phoneExt":39,"email":61},"Vinzeigh Leukes, PhD","CONTACT","+27 84 419 9113","Vinzeigh.Leukes@finddx.org",{"name":63,"role":59,"phone":39,"phoneExt":39,"email":64},"Andres De la Rossa, PhD","Andres.DelaRossa@finddx.org",[66,84,106,120,136],{"facility":67,"status":68,"city":69,"state":70,"zip":39,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"KEMRI","RECRUITING","Nairobi","Nairobi County","Kenya","KE",{"type":74,"coordinates":75},"Point",[76,77],36.81667,-1.28333,{"lat":77,"lon":76},[80],{"name":81,"role":59,"phone":82,"phoneExt":39,"email":83},"Albert S Okumu, PhD","+254 722 497","alooks2@gmail.com",{"facility":85,"status":86,"city":87,"state":39,"zip":39,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Institute of Pneumology \"Chiril Draganiuc\"","NOT_YET_RECRUITING","Chisinau","Moldova","MD",{"type":74,"coordinates":91},[92,93],28.85938,47.00902,{"lat":93,"lon":92},[96,100,104],{"name":97,"role":59,"phone":98,"phoneExt":39,"email":99},"Valeriu Crudu, PhD","+373-22-572-245","valeriu.crudu@gmail.com",{"name":101,"role":59,"phone":102,"phoneExt":39,"email":103},"Nelly Ciobanu, PhD","+373-22-572-242","nellyka.ciobanu@gmail.com",{"name":97,"role":105,"phone":39,"phoneExt":39,"email":39},"PRINCIPAL_INVESTIGATOR",{"facility":107,"status":86,"city":108,"state":39,"zip":39,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia","Lima","Peru","PE",{"type":74,"coordinates":112},[113,114],-77.02824,-12.04318,{"lat":114,"lon":113},[117],{"name":118,"role":59,"phone":39,"phoneExt":39,"email":119},"Cesar Urgarte-Gil, PhD","cugartegil@yahoo.com",{"facility":121,"status":86,"city":122,"state":39,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"V.N Karazin Kharkiv National University","Kharkiv","61064","Ukraine","UA",{"type":74,"coordinates":127},[128,129],36.25475,49.98177,{"lat":129,"lon":128},[132],{"name":133,"role":59,"phone":134,"phoneExt":39,"email":135},"Olha Konstantynovska, PhD, MD","+380509244076","o.konstantynovska@karazin.ua",{"facility":137,"status":86,"city":138,"state":39,"zip":39,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Centre for Infectious Disease Research in Zambia","Lusaka","Zambia","ZM",{"type":74,"coordinates":142},[143,144],28.28713,-15.40669,{"lat":144,"lon":143},[147,151,154],{"name":148,"role":59,"phone":149,"phoneExt":39,"email":150},"Nsala Sanjase, MBChB","+260 0211.242 257\u002F8\u002F9","nsala.sanjase@cidrz.org",{"name":152,"role":59,"phone":149,"phoneExt":39,"email":153},"Monde Muyoyeta, PhD","Monde.Muyoyeta@cidrz.org",{"name":148,"role":105,"phone":39,"phoneExt":39,"email":39},{"type":156,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[158,160,162,164,167],{"name":159,"class":6},"V. N. Karazin Kharkiv National University",{"name":161,"class":6},"Kenya Medical Research Institute",{"name":163,"class":6},"Universidad Peruana Cayetano Heredia",{"name":165,"class":166},"BIONEER Corporation","INDUSTRY",{"name":137,"class":6},"100448310","bioneer-q-rfia-clinical-evaluation-100448310",false,"NCT05117788","Bioneer Q-RFIA Clinical Evaluation","Multicentre Clinical Study to Assess the Diagnostic Accuracy of the Bioneer Q-RFIA PCR Kit on IRON qPCR for the Detection of MTB and Resistance to Rifampicin, Isoniazid, Fluoroquinolones and Aminoglycosides.","Inclusion Criteria:\n\nPeople (aged ≥18 years) with clinical signs and symptoms of pulmonary TB including cough of any duration and ≥1 other symptom typical of pulmonary TB Exclusion criteria comprise absence of informed consent, insufficient sample volume or number, only extra-pulmonary TB signs \\& symptoms, and receipt of any dose of TB treatment within six months prior to enrolment (for objectives relating to MTB detection).\n\nExclusion Criteria:\n\nParticipants will be excluded from the study if any of the following apply:\n\n* Unwilling or unable to provide informed consent;\n* Unwilling to provide two sputum specimens at enrolment;\n* Presenting with only extra-pulmonary TB signs \\& symptoms;\n* Receipt of any TB treatment dose within the 6 months prior to enrolment.","ALL","18 Years",{"count":178,"type":179},2350,"ESTIMATED","OBSERVATIONAL","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.\n\nThe rapid diagnosis and appropriate treatment of M\u002FXDR-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.",[183],"Tuberculosis, Multidrug-Resistant",[185,186,187,188],"Bioneer assay","clinical performance","in-vitro diagnostic TB assay","Multi-drug resistant TB","2026-09-21",{"date":191,"type":192},"2026-09-23","ACTUAL",{"date":194,"type":192},"2026-06-30",{"date":196,"type":179},"2027-06-30",{"name":5,"class":6},5]