TY  - JOUR
AU  - Hillery, Naomi
AU  - Seifert, Marva
AU  - Catanzaro, Donald G
AU  - McKinnon, Symone
AU  - Colman, Rebecca E
AU  - Chiles, Peter G
AU  - Chesov, Dumitru
AU  - Ciobanu, Nelly
AU  - Hagan, Christopher
AU  - Crudu, Valeriu
AU  - Catanzaro, Antonino
AU  - Rodwell, Timothy C
PY  - 2021
DA  - 2021/7/14
TI  - Rapid Detection of Extensively Drug-Resistant Tuberculosis in Clinical Samples Using a Novel Tabletop Platform: Protocol for a Prospective Clinical Study
JO  - JMIR Res Protoc
SP  - e26748
VL  - 10
IS  - 7
KW  - tuberculosis
KW  - drug-resistant
KW  - extensively drug-resistant
KW  - diagnostic
KW  - rapid treatment methods
KW  - protocol
KW  - drug susceptibility testing
KW  - prospective cohort study
AB  - 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. International Registered Report Identifier (IRRID): DERR1-10.2196/26748 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2021/7/e26748
UR  - https://doi.org/10.2196/26748
UR  - http://www.ncbi.nlm.nih.gov/pubmed/34259165
DO  - 10.2196/26748
ID  - info:doi/10.2196/26748
ER  -