Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact email@example.com.
Integrating Tuberculosis and COVID-19 Molecular Testing in Lima, Peru
20 Pages Posted: 27 Jul 2022More...
Background: Tuberculosis case notifications have plummeted since the COVID-19 pandemic began. Integrated molecular testing could be an opportunity to detect and provide care for both diseases. Many high tuberculosis burden countries have existing GeneXpert networks for tuberculosis testing using Xpert MTB/RIF Ultra (Ultra), and a GeneXpert SARS-CoV-2 assay, Xpert Xpress SARS-CoV-2 (Xpress), is also available. We assessed the feasibility of integrating tuberculosis and COVID-19 testing using one sputum specimen with Ultra and Xpress in Lima, Peru.
Methods: Between February 2021 and April 2022, we recruited adults presenting with clinical symptoms or history suggestive of tuberculosis and/or COVID-19. All participants provided one nasopharyngeal swab (NPS) and one sputum sample. For COVID-19, NPS and sputum were each tested on Xpress and another RT-PCR test; for tuberculosis, sputum was tested using culture and Ultra. Diagnostic accuracy of Xpress-sputum was compared to Xpress-NPS. Individuals with positive Xpress-NPS results were considered COVID-19 positive, while culture-positivity indicated tuberculosis. To assess testing integration, the proportion of cases identified in sputum by Xpress and Ultra were compared to Xpress-NPS and culture, respectively.
Findings: We included 600 participants. In-study prevalence of tuberculosis was 13% (80/600) and for SARS-CoV-2 was 35% (212/600). Among tuberculosis cases, concurrent SARS-CoV-2 positivity ranged from 0% to 14%, depending on the COVID-19 test and specimen used. Regarding integrated testing’s diagnostic yield, Ultra detected 96% of culture-confirmed tuberculosis cases, while Xpress-sputum detected 67% of COVID-19 cases identified by Xpress-NPS. Clinical and laboratory staff reported that integrated molecular testing was easy and acceptable.
Interpretation: The diagnostic yield of Xpress on sputum was moderate, but integrated testing for tuberculosis and COVID-19 using GeneXpert was feasible. However, systematic testing for both diseases may not be a worthwhile approach in everyone presenting with presumptive tuberculosis or COVID-19, as concurrently positive cases were rare. Further research may help determine when integrated testing is most worthwhile.
Funding Information: This project was funded by the Canadian Institutes of Health Research and International Development Research Centre (IDRC) [IDRC project #109554].
Declaration of Interests: None to declare.
Ethics Approval Statement: All participants provided written informed consent. This study received ethical approval from the Comité Institucional de Ética en Investigación at Universidad Peruana Cayetano Heredia (UPCH number SIDISI 202931) and the McGill University Health Centre Research Ethics Board. This study was registered in the PRISA repository at Instituto Nacional de Salud in Peru (number EI00000001484).
Keywords: Tuberculosis, SARS CoV2, COVID-19, Global Health, Diagnostics
Suggested Citation: Suggested Citation