Effectiveness of RT-PCR as a diagnostic tool for detecting tuberculosis in patients at the General Hospital of Macas, year 2025
Abstract
Tuberculosis is a disease with significant public health impact worldwide and in Ecuador, making it imperative to identify diagnostic methods with higher performance that enable early treatment. The objective was to analyze the effectiveness of RT-PCR as a diagnostic tool in patients at the General Hospital of Macas – 2025. This was a descriptive, cross-sectional, and prospective study. The sample consisted of 308 patients selected based on specific criteria. The positivity rate with RT-PCR was 3.2%, significantly higher (p=0.033) than the cases detected by Mycobacterium tuberculosis culture (1.6%). The diagnostic sensitivity and specificity of RT-PCR were both 100.0%, demonstrating significantly superior sensitivity (p<0.0001) compared to culture, which achieved 100.0% specificity and 50% sensitivity. Statistical association was found using the Chi-square test among the evaluated effectiveness indicators, particularly regarding time to diagnosis (p<0.05), initiation of treatment (p<0.05), and the ability to detect resistance (p<0.0001), as evidenced by RT-PCR. The higher performance of RT-PCR optimizes the clinical pathway, reduces the transmission window, and demonstrates its diagnostic effectiveness for tuberculosis in patients at the General Hospital of Macas
References
Anes E, Pires D, Mandal M, Azevedo-Pereira JM. ESAT-6 a Major Virulence Factor of Mycobacterium tuberculosis. Biomolecules [Internet]. 2023;13(6). Disponible en: https://www.mdpi.com/2218-273X/13/6/968 DOI: 10.3390/biom13060968 PMID 37371548 PMCID PMC10296275
GBD 2021 Tuberculosis Collaborators. Global, regional, and national age-specific progress towards the 2020 milestones of the WHO End TB Strategy: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Infect Dis [Internet]. 2024;24(7):698-725. Disponible en: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(24)00007-0/fulltext DOI: 10.1016/S1473-3099(24)00007-0 PMID 38518787 PMCID PMC11187709
Miggiano R, Rizzi M, Ferraris DM. Mycobacterium tuberculosis Pathogenesis, Infection Prevention and Treatment. Pathogens (Basel, Switzerland) [Internet]. 2020;9(5):385. Disponible en: https://www.mdpi.com/2076-0817/9/5/385 DOI: 10.3390/pathogens9050385 PMID 32443469 PMCID PMC7281116
Espinosa-Yépez KR, Viteri-Hinojosa AS, García-Cevallos MP, Rivera-Mora LF, Avalos-Vega GS. Carga de enfermedad por tuberculosis en Ecuador, 2018-2022. Rev Chil infectología [Internet]. 2025;42(2):99-106. Disponible en: https://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0716-10182025000200099&lng=en&nrm=iso&tlng=en DOI: 10.4067/s0716-10182025000200116
Getial Armijos L, Segovia Izurieta P, Véliz Castro T. La tuberculosis pulmonar y la calidad de vida en la población mundial. Rev Científica Arbitr Multidiscip PENTACIENCIAS [Internet]. 2023;5(1):606-18. Disponible en: https://editorialalema.org/index.php/pentaciencias/article/view/475
Matteo MJ, Latini MC, Martinovic DN, Bottiglieri M. Update of diagnostic methods in tuberculosis (TB). Rev Argent Microbiol [Internet]. 2025;57(1):49-53. Disponible en: https://www.sciencedirect.com/science/article/pii/S0325754124001640?via%3Dihub DOI: 10.1016/j.ram.2024.12.008 PMID 39828451
Mohammadnabi N, Shamseddin J, Emadi M, Bodaghi AB, Varseh M, Shariati A, et al. Mycobacterium tuberculosis: The Mechanism of Pathogenicity, Immune Responses, and Diagnostic Challenges. J Clin Lab Anal [Internet]. 2024;38(23):e25122. Disponible en: https://onlinelibrary.wiley.com/doi/10.1002/jcla.25122 DOI: 10.1002/jcla.25122 PMID 39593272 PMCID PMC11632860
Fang T, Peng L, Yang T, Cai Q, Li H, Li H, et al. Development and evaluation of multiplex real-time PCR for rapid identifying major pathogenic mycobacteria from pulmonary and extrapulmonary clinical samples in eastern China. Heliyon [Internet]. 2025;11(1):e41384. Disponible en: https://www.cell.com/heliyon/fulltext/S2405-8440(24)17415-4?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS2405844024174154%3Fshowall%3Dtrue DOI 10.1016/j.heliyon.2024.e41384 PMID 39844976 PMCID PMC11750471
Valdez Montenegro MP, Gerardo Ortiz J. Frecuencia de Mycobacterium tuberculosis en pacientes del centro de salud infa de la ciudad de macas 2019-2023. Anatomía Digit [Internet]. 2024;7(2.1):46-59. Disponible en: https://cienciadigital.org/revistacienciadigital2/index.php/AnatomiaDigital/article/view/3040 DOI 10.33262/anatomiadigital.v7i2.1.3040
Trajman A, Campbell JR, Kunor T, Ruslami R, Amanullah F, Behr MA, et al. Tuberculosis. Lancet [Internet]. 2025;405(10481):850-66. Disponible en: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02479-6/abstract DOI: 10.1016/S0140-6736(24)02479-6 PMID 40057344
Acharya B, Acharya A, Gautam S, Ghimire SP, Mishra G, Parajuli N, et al. Advances in diagnosis of Tuberculosis: an update into molecular diagnosis of Mycobacterium tuberculosis. Mol Biol Rep [Internet]. 2020;47(5):4065-75. Disponible en: https://link.springer.com/article/10.1007/s11033-020-05413-7 DOI 10.1007/s11033-020-05413-7 PMID 32248381
Parwati I, Chaidir L, Yunus M, Montain MM, Budhiarko D, Selasih SF, et al. Evaluation of a real-time PCR assay performance to detect Mycobacterium tuberculosis, rifampicin, and isoniazid resistance in sputum specimens: a multicenter study in two major cities of Indonesia. Front Microbiol [Internet]. 2024;15:1372647. Disponible en: https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2024.1372647/full DOI 10.3389/fmicb.2024.1372647 PMID 38800757 PMCID PMC11123600
Bajgai J, Cho C-H, Lee J-H. Diagnostic Accuracy of AdvanSure(TM) and PowerChek(TM) Real-Time PCR Assays for the Detection of Mycobacterium tuberculosis and Nontuberculous Mycobacteria. Diagnostics (Basel, Switzerland) [Internet]. 2025;15(14). Disponible en: https://www.mdpi.com/2075-4418/15/14/1776 DOI 10.3390/diagnostics15141776 PMID 40722525 PMCID PMC12293586
Ministerio de Salud Pública Ecuador. Subsecretaria de Vigilancia, Prevención y Control de la Salud. Dirección Nacional de Vigilancia. Epidemiológica. Enfermedades Respiratorias y Tuberculosis. Semana Epidemiológica 22 de 2025. Disponible en: https://www.salud.gob.ec/wp-content/uploads/2025/02/Eventos-Tuberculosis-DNVE-SE-05.pdf
Ministerio de Salud Pública Ecuador. Número total de casos de tuberculosis con tratamiento. SinfoTB. Semana Epidemiológica 14 de 2025. Disponible en: https://www.salud.gob.ec/wp-content/uploads/2025/04/Eventos-TUBERCULOSIS-DNVE-SE-14.pdf
Organización Mundial de la Salud. Informe mundial sobre la tuberculosis 2022. Disponible en: https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2022
Manterola C, Quiroz G, Salazar P, García N. Metodología de los tipos y diseños de estudio más frecuentemente utilizados en investigación clínica. Rev Médica Clínica Las Condes [Internet]. 2019;30(1):36-49. Disponible en: https://www.sciencedirect.com/science/article/pii/S0716864019300057 DOI: 10.1016/j.rmclc.2018.11.005
Fernández-Matias R. El Cálculo del Tamaño Muestral en Ciencias de la Salud: Recomendaciones y Guía Práctica. J MOVE Ther Sci [Internet]. 2023;5(1):481-503. Disponible en: https://publicaciones.lasallecampus.es/index.php/MOVE/article/view/915 DOI: 10.37382/jomts.v5i1.915
Cepheid Xpert MTB/RIF Assay: Package Insert (Rev. G) 2020. Disponible en: https://www.cepheid.com/content/dam/www-cepheid-com/documents/package-insert-files/Xpert-MTB-RIF-PORTUGUESE-Package-Insert-301-1404-PT-Rev-G.pdf
Khehra N, Padda IS, Zubair M. Polymerase Chain Reaction (PCR). En: StatPearls. Treasure Island (FL): StatPearls Publishing; enero de 2025. Disponible en: https://www.ncbi.nlm.nih.gov/books/NBK589663/.
Franco-Sotomayor G, Rivera-Olivero IA, Leon-Benitez M, Uruchima-Campoverde SE, Cardenas-Franco G, Perdomo-Castro ME, et al. Fast, Simple, and Cheap: the Kudoh-Ogawa Swab Method as an Alternative to the Petroff-Lowenstein-Jensen Method for Culturing of Mycobacterium tuberculosis. J Clin Microbiol [Internet]. 2020;58(4). Disponible en: https://journals.asm.org/doi/10.1128/jcm.01424-19?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed DOI: 10.1128/JCM.01424-19 PMID 32024726 PMCID PMC7098767
Hongler J, Musaazi J, Ledergerber B, Eberhard N, Sekaggya-Wiltshire C, Keller PM, et al. Comparison of Löwenstein-Jensen and BACTEC MGIT 960 culture for Mycobacterium tuberculosis in people living with HIV. HIV Med [Internet]. 2018;19(9):654-61. Disponible en: https://onlinelibrary.wiley.com/doi/10.1111/hiv.12635 DOI 10.1111/hiv.12635 PMID 29971898
Ministerio de Salud Pública del Ecuador. Manual: Gestión interna de los residuos y desechos generados en los establecimientos de salud. Disponible en: https://aplicaciones.msp.gob.ec/salud/archivosdigitales/documentosDirecciones/dnn/archivos/AC00036-2019.pdf
Vizcaíno-Salazar GJ. Importancia del cálculo de la sensibilidad, la especificidad y otros parámetros estadísticos en el uso de las pruebas de diagnóstico clínico y de laboratorio. Med y Lab [Internet]. 2017;23(7-8):365-86. Disponible en: https://www.medigraphic.com/cgi-bin/new/resumen.cgi?IDARTICULO=99323
Asamblea Nacional del Ecuador. Ley Orgánica de Protección de Datos Personales. 2021. Disponible en: https://www.telecomunicaciones.gob.ec/wp-content/uploads/2021/06/Ley-Organica-de-Datos-Personales.pdf
World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA [Internet]. 2013;310(20):2191-4. Disponible en: https://doi.org/10.1001/jama.2013.281053 DOI: 10.1001/jama.2013.281053 PMID 24141714
Ministerio de Salud Pública del Ecuador. Reglamento sustitutivo del reglamento para la aprobación y seguimiento de Comités de Ética de Investigación en Seres Humanos (CEISH) y Comités de Ética Asistenciales para la Salud (CEAS). Acuerdo Ministerial 00005-2022. Quinto Suplemento Nº 118-Registro Oficial. Disponible en: https://ceish.itsup.edu.ec/acuerdo.php
Daneshi S, Mehni EB, Kamali M, Barfar E, Barahouei FB, Hushmandi K, et al. Prevalence and contributing factors of drug-resistant tuberculosis (DR-TB) in Iran: a systematic review. BMC Infect Dis [Internet]. 2025;25(1):1004. Disponible en: https://link.springer.com/article/10.1186/s12879-025-11439-8 DOI 10.1186/s12879-025-11439-8 PMID 40781658 PMCID PMC12335167
Castro-Rodriguez B, Franco-Sotomayor G, Benitez-Medina JM, Cardenas-Franco G, Jiménez-Pizarro N, Cardenas-Franco C, et al. Prevalence, drug resistance, and genotypic diversity of the RD(Rio) subfamily of Mycobacterium tuberculosis in Ecuador: a retrospective analysis for years 2012-2016. Front public Heal [Internet]. 2024;12:1337357. Disponible en: https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1337357/full DOI 10.3389/fpubh.2024.1337357 PMID 38689770 PMCID PMC11060180
Mora-Pinargote C, Garzon-Chavez D, Franco-Sotomayor G, Leon-Benitez M, Granda-Pardo JC, Trueba G, et al. Country-wide rapid screening for the Mycobacterium tuberculosis Beijing sublineage in Ecuador using a single-nucleotide polymorphism-polymerase chain reaction method. Int J mycobacteriology. 2019;8(4):366-70 DOI 10.4103/ijmy.ijmy_132_19 PMID 31793507
Blanco FC, Queval CJ, Araujo FR, De Waard JH. Editorial: Recent Advances in Bovine Tuberculosis. Front Vet Sci [Internet]. 2022;9:907353. Disponible en: https://www.frontiersin.org/journals/veterinary-science/articles/10.3389/fvets.2022.907353/full DOI 10.3389/fvets.2022.907353 PMID 35615249 PMCID PMC9126120
Wu S, Ge L, Zheng S, Ma X, Liang R, Zhang B. A comparative study using Xpert MTB/RIF and culture methods evaluates MassARRAY technology for rapid detection of Mycobacterium tuberculosis and drug resistance. Front Cell Infect Microbiol [Internet]. 2025;15:1539240. Disponible en: https://www.frontiersin.org/journals/cellular-and-infection-microbiology/articles/10.3389/fcimb.2025.1539240/full DOI 10.3389/fcimb.2025.1539240 PMID 40703669 PMCID PMC12283603
Dong Z, Wang Q-Q, Yu S-C, Huang F, Liu J-J, Yao H-Y, et al. Age-period-cohort analysis of pulmonary tuberculosis reported incidence, China, 2006-2020. Infect Dis poverty [Internet]. 2022;11(1):85. Disponible en: https://link.springer.com/article/10.1186/s40249-022-01009-4 DOI: 10.1186/s40249-022-01009-4 PMID 35902982 PMCID PMC9331155
Fernández-Blázquez A, Leal-Negredo Á, Sabater-Cabrera C, Arias-Guillén M, García-García J-M, Palacios Gutiérrez JJ. Molecular assays for the initial diagnosis of tuberculosis in a low-prevalence setting: A comparative study. Enfermedades Infecc y Microbiol Clin (English ed) [Internet]. 2025;43(5):272-6. Disponible en: https://www.sciencedirect.com/science/article/abs/pii/S2529993X25000917?via%3Dihub DOI 10.1016/j.eimce.2024.11.006 PMID 40340036
Sawatpanich A, Petsong S, Tumwasorn S, Rotcheewaphan S. Diagnostic performance of the Anyplex MTB/NTM real-time PCR in detection of Mycobacterium tuberculosis complex and nontuberculous mycobacteria from pulmonary and extrapulmonary specimens. Heliyon [Internet]. 2022;8(12):e11935. Disponible en: https://www.cell.com/heliyon/fulltext/S2405-8440(22)03223-6?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS2405844022032236%3Fshowall%3Dtrue DOI 10.1016/j.heliyon.2022.e11935 PMID 36471833 PMCID PMC9719018
Córdoba C, Luna L, Triana DM, Perez F, López L. Factors associated with delays in pulmonary tuberculosis diagnosis and treatment initiation in Cali, Colombia. Rev Panam Salud Publica. 2019;43:e14. DOI 10.26633/RPSP.2019.14 PMID 31093238 PMCID PMC6519662
Luukinen B, Aittoniemi J, Miikkulainen-Lahti T, Mentula S, Pätäri-Sampo A. Evaluation of the STANDARD M10 MDR-TB and MTB/NTM assays for the detection of Mycobacterium tuberculosis, rifampicin and isoniazid resistance, and nontuberculous mycobacteria in a low-incidence setting. J Clin Microbiol [Internet]. 2024;62(10):e0040224. Disponible en: https://journals.asm.org/doi/10.1128/jcm.00402-24?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed DOI 10.1128/jcm.00402-24 PMID 39297626 PMCID PMC11481502
Ahmadi Ghezeldasht S, Mosavat A, Soleimanpour S, Rezaee SA, Derakhshan M. Screening of tuberculosis suspected subjects using real-time PCR, TaqMan method; Northeastern Iran. J Infect Public Health [Internet]. 2025;18(11):102932. Disponible en: https://www.sciencedirect.com/science/article/pii/S1876034125002813?via%3Dihub DOI: 10.1016/j.jiph.2025.102932 PMID 40829439
Castro-Rodriguez B, Franco-Sotomayor G, Orlando SA, Garcia-Bereguiain MÁ. Molecular epidemiology of Mycobacterium tuberculosis in Ecuador: Recent advances and future challenges. J Clin Tuberc other Mycobact Dis [Internet]. 2024;37:100465. Disponible en: https://www.sciencedirect.com/science/article/pii/S2405579424000524?via%3Dihub DOI 10.1016/j.jctube.2024.100465 PMID 39184342 PMCID PMC11342892
Rodriguez-Pazmiño AS, Castro-Rodríguez B, Cardenas-Franco GE, Franco-Sotomayor G, Carvajal E, Calderon J, et al. Conventional DNA Extraction Followed by Real-Time PCR Had Higher Sensitivity for Detection of Mycobacterium Tuberculosis in Clinical Samples Compared to Standard Methods. Am J Trop Med Hyg [Internet]. 2025;112(6):1260-3. Disponible en: https://www.ajtmh.org/view/journals/tpmd/112/6/article-p1260.xml DOI 10.4269/ajtmh.24-0797 PMID 40168976 PMCID PMC12139567
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