Rapid detection of extensively drug-resistant tuberculosis in clinical samples using a novel tabletop platform: Protocol for a prospective clinical study
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HILLERY, Naomi, SEIFERT, Marva, CATANZARO, Donald G., MCKINNON, Symone, COLMAN, Rebecca E., CHILES, Peter G., CHESOV, Dumitru, CIOBANU, Nelly, HAGAN, Christopher, KRUDU, V., CATANZARO, Antonino, RODWELL, Timothy C.. Rapid detection of extensively drug-resistant tuberculosis in clinical samples using a novel tabletop platform: Protocol for a prospective clinical study. In: JMIR Research Protocols, 2021, nr. 7(10), pp. 1-10. ISSN -. DOI: https://doi.org/10.2196/26748
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JMIR Research Protocols
Numărul 7(10) / 2021 / ISSN - /ISSNe 1929-0748

Rapid detection of extensively drug-resistant tuberculosis in clinical samples using a novel tabletop platform: Protocol for a prospective clinical study

DOI: https://doi.org/10.2196/26748

Pag. 1-10

Hillery Naomi1, Seifert Marva1, Catanzaro Donald G.2, McKinnon Symone1, Colman Rebecca E.1, Chiles Peter G.1, Chesov Dumitru34, Ciobanu Nelly35, Hagan Christopher1, Krudu V.35, Catanzaro Antonino1, Rodwell Timothy C.1
 
1 University of California, San Diego,
2 University of Arkansas,
3 ”Nicolae Testemițanu” State University of Medicine and Pharmacy,
4 Research Center Borstel,
5 Institute of Phtysiopneumology „Chiril Draganiuc”
 
Disponibil în IBN: 3 august 2021


Rezumat

Background: The lack of accurate and efficient diagnostic devices for extensively drug-resistant tuberculosis (XDR-TB) makes it a severe threat to global public health. A prospective clinical study in an intended-use cohort was designed to evaluate the Akonni Biosystems XDR-TB TruArray and lateral flow cell (XDR-LFC) to address this gap in tuberculosis diagnostics. Objective: This paper presents the protocol for a study that aims to document the conceptualization and design of this evaluation method for early dissemination while data collection and analysis are ongoing. Methods: The clinical study was conducted in three phases. The first phase was to observe changes in bacterial load and culture positivity in patient sputa over time and better understand the diversity of prospective clinical samples. The second phase was to prospectively collect clinical samples for sensitivity and specificity testing of the Akonni Biosystems XDR-LFC device. Lastly, the third phase was to explore the anti-TB drug concentrations in serum throughout the drug-resistant tuberculosis treatment. Results: The methodology described includes the study design, laboratory sample handling, data collection, and the protection elements of human subjects of this clinical study to evaluate a potential new XDR-TB diagnostic device. A total of 664 participants were enrolled across the three phases. The implemented complex systems facilitated a thorough clinical data collection for an objective evaluation of the device. The study is closed to recruitment. The follow-up data collection and analysis are in progress. Conclusions: This paper outlined a prospective cohort study protocol to evaluate a rapid XDR-TB detection device, which may be informative for other researchers with similar goals. © Naomi Hillery, Marva Seifert, Donald G Catanzaro, Symone McKinnon, Rebecca E Colman, Peter G Chiles, Dumitru Chesov, Nelly Ciobanu, Christopher Hagan, Valeriu Crudu, Antonino Catanzaro, Timothy C Rodwell. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 14.07.2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.



Cuvinte-cheie
diagnostic, drug susceptibility testing, Drug-resistant, Extensively drug-resistant, Prospective cohort study, protocol, Rapid treatment methods, tuberculosis