Bi-directional Diagnosis of Tuberculosis (TB) Using Xpert® MTB/RIF Ultra and Determine® TB-LAM Ag Testing Methodologies in a Parallel Algorithm: Pathway Towards Identifying the Nigerian Missing TB Cases.
DOI:
https://doi.org/10.71637/tnhj.v25i1.944Keywords:
Tuberculosis, Nigeria, Advanced HIV Disease, Lipoarabinomannan, Algorithm, Methodology, Extra-pulmonary TBAbstract
Background: The endemic nature of TB infection in Nigeria requires that the nation’s TB diagnostic tools and algorithms be reassessed towards meeting the current global trends in TB case-detection. Also, the incidence and prevalence of both Pulmonary tuberculosis (PTB) and Extra-Pulmonary tuberculosis (EPTB) needs to be well ascertained for Nigeria to know her true TB prevalence.
Methods: 365 presumptive and consenting TB clients participated in this cross-sectional study. Collected sputum and urine samples were tested with Xpert® MTB/RIF ultra and the Determine® TB-LAM Ag®; following standard laboratory operating processes. Obtained data were statistically analyzed using the student’s t-test, the Pearson’s correlation statistics, and simple percentages with the Excel® Data Analysis ToolPak.
Results: 30.4% (111/365) combined Mtb cases were detected in this study. Using Student’s t-test at 95% CL, the obtained p-value (P 0.018104), and a calculated correlation coefficient (r=1) obtained reveals a significantly strong association and a perfect positive correlation between the bi-directional diagnosis of TB using this parallel TB screening methodologies, and an increased Mtb cases detection.
Conclusion: In this study, the high sensitivity of the Xpert® MTB/RIF Ultra at detecting PTB and the high specificity of the Determine® TB-LAM Ag® at detecting EPTB has been synergized in a parallel algorithm. It is believed that the application of this testing methodology in a parallel algorithm would help to optimize Mtb cases detection and TB diagnosis in Nigeria.
Downloads
References
1. Dye C, Scheele S, Dolin P, Pathania V, Raviglione MC. Consensus statement. Global burden of tuberculosis: estimated incidence, prevalence, and mortality by country. WHO Global Surveillance and Monitoring Project. Journal of the American Medical Association 1999; 282:677-86.
2. World Health Organization. Global tuberculosis control. Geneva: World Health Organization; 2001. Unpublished document WHO/CDS/TB/2001.287. Available at https://www.who.int/publications/i/item/WHO-CDS-TB-2001.287
3. World Health Organization. Tuberculosis Facts Check 2023. Geneva: World Health Organization; 2023. Available at https://www.who.int/news-room/fact-sheets/detail/tuberculosis
4. Molalign S, Wencheko E. Risk factors of mortality in patients with multi-drug-resistant TB. The Ethiopian Journal of Health Development. 2015;29(2).
5. World Health Organization. Intensifying new initiatives for TB Case-finding in Nigeria. World Health Organization; 2023. Available at https://www.afro.who.int/countries/nigeria/news/intensifying-new-initiatives-tb-case-finding-nigeria
6. Brown, S., Leavy, J. E., & Jancey, J. (2021). Implementation of GeneXpert for TB testing in low-and middle-income countries: A systematic review. Global Health: Science and Practice, 9(3), 698-710.
7. Moussa, H. S., Bayoumi, F. S., & Ali, A. M. (2016). Evaluation of GeneXpert MTB/RIF assay for direct diagnosis of pulmonary tuberculosis. Saudi medical journal, 37(10), 1076.
8. National Tuberculosis, Leprosy and Buruli Ulcer Control Program (NTBLCP). Desk Guide for Prevention, Diagnosis and Treatment of Tuberculosis in Children and Adolescents in Nigeria. NTBLCP; 2023. Available at https://ntblcp.org.ng/content/uploads/2023/06/desk-guide-for-prevention-diagnosis-and-treatment-of-tuberculosis-in-children-and-adolescents-in-nigeria.pdf
9. Malik M, Malik MI, Khan JK, Ashraf Z. Yield of Xpert MTB/RIF Assay in Extra Pulmonary specimens of patients at tertiary care hospital. Pakistan Journal of Chest Medicine. 2020 Sep 9;26(1):03-7.
10. World Health Organization. Lateral flow urine lipoarabinomannan assay (LF-LAM) for the diagnosis of active tuberculosis in people living with HIV. Policy updates 2019. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Available at https://www.who.int/publications/i/item/9789241550604
11. Bjerrum S, Schiller I, Dendukuri N, Kohli M, Nathavitharana RR, Zwerling AA, Denkinger CM, Steingart KR, Shah M. Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in people living with HIV. Cochrane Database of Systematic Reviews. 2019(10).
12. Suwanpimolkul, G., Kawkitinarong, K., Manosuthi, W., Sophonphan, J., Gatechompol, S., Ohata, P. J., ... & Ruxrungtham, K. Utility of urine lipoarabinomannan (LAM) in diagnosing tuberculosis and predicting mortality with and without HIV: prospective TB cohort from the Thailand Big City TB Research Network. International Journal of Infectious Diseases, 2017; 59, 96-102.
13. Hertz D, Schneider B. Sex differences in tuberculosis. In Seminars in immunopathology. Springer Berlin Heidelberg. Mar 15, 2019 (Vol. 41, pp. 225-237).
14. Thorson A. Gender issues in tuberculosis. In Sex and gender differences in infection and treatments for infectious diseases. Cham: Springer International Publishing. Aug 8, 2015 (pp. 231-253).
15. Marçôa R, Ribeiro AI, Zão I, Duarte R. Tuberculosis and Gender-Factors influencing the risk of tuberculosis among men and women by age group. Pulmonology. 2018 May-Jun; 24 (3): 199-202.
16. Shah M, Hanrahan C, Wang ZY, Dendukuri N, Lawn SD, Denkinger CM, Steingart KR. Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in HIV‐positive adults. Cochrane Database of Systematic Reviews. 2016(5).
17. Shah M, Ssengooba W, Armstrong D, Nakiyingi L, Holshouser M, Ellner JJ, Joloba M, Manabe YC, Dorman SE. Comparative performance of urinary lipoarabinomannan assays and Xpert MTB/RIF in HIV-infected individuals. Aids. 2014 Jun 1;28(9):1307-14.
18. Bulterys MA, Wagner B, Redard-Jacot M, Suresh A, Pollock NR, Moreau E, Denkinger CM, Drain PK, Broger T. Point-of-care urine LAM tests for tuberculosis diagnosis: a status update. Journal of clinical medicine. 2019 Dec 31;9(1):111.
19. Rasool G, Khan AM, Mohy-Ud-Din R, Riaz M. Detection of Mycobacterium tuberculosis in AFB smear-negative sputum specimens through MTB culture and GeneXpert® MTB/RIF assay. International journal of immunopathology and pharmacology. 2019 Feb; 33: 2058738419827174.
20. Shi J, Dong W, Ma Y, Liang Q, Shang Y, Wang F, Huang H, Pang Y. GeneXpert MTB/RIF outperforms mycobacterial culture in detecting mycobacterium tuberculosis from salivary sputum. BioMed Research International. 2018(1):1514381.
21. Ahmad S, Afzal S, Ullah A, Sheed A. Evaluation of GeneXpert MTB/RIF assay for detection of pulmonary tuberculosis on sputum samples. Journal of the College of Physicians and Surgeons Pakistan. 2019 Jan 1;29(1):66-9.
22. Zhang Q, Zhang Q, Sun BQ, Liu C, Su AN, Wang XH, Liu N, Zhang J, Kang J, Hou G. GeneXpert MTB/RIF for rapid diagnosis and rifampin resistance detection of endobronchial tuberculosis. Respirology. 2018 Oct; 23(10):950-5.
23. Nakiyingi L, Moodley VM, Manabe YC, Nicol MP, Holshouser M, Armstrong DT, Zemanay W, Sikhondze W, Mbabazi O, Nonyane BA, Shah M. Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2014 Jul 1;66(3):270-9.
24. Lawn SD, Kerkhoff AD, Vogt M, Wood R. Clinical significance of lipoarabinomannan detection in urine using a low-cost point-of-care diagnostic assay for HIV-associated tuberculosis. Aids. 2012 Aug 24;26(13):1635-43.
25. Chatla C, Mishra N, Jojula M, Adepu R, Puttala M. A systematic review of utility of urine lipoarabinomannan in detecting tuberculosis
among HIV-positive tuberculosis suspects. Lung India. 2021 Jan 1;38(1):64-73.
26. World Health Organization. National tuberculosis prevalence surveys 2007-2016. Geneva, 2021. Licence: CC BY-NC-SA 3.0 IGO. Available at https://iris.who.int/bitstream/handle/10665/341072/9789240022430-eng.pdf
27. Uplekar M, Raviglione M. WHO's End TB Strategy: From stopping to ending the global TB epidemic. Indian Journal of Tuberculosis. 2015 Oct 1;62(4):196-9.
28. Rath N, Nikam C, Seidel S, Sinha A, Arora VK. Yes, we have the power to end TB! Indian Journal of Tuberculosis. 2023 Jul 1;70(3):269-72.
Published
Issue
Section
License
Copyright (c) 2025 Adeniyi David Segun, Tongvwam Princewill John, Okonkwo Patrick Chikezie, Owolagba Femi Emmanuel, Ofuche Eke, Onwuatuelo Ifeyinwa, Samuels Jay Osi, Okonkwo Prosper
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
The Journal is owned, published and copyrighted by the Nigerian Medical Association, River state Branch. The copyright of papers published are vested in the journal and the publisher. In line with our open access policy and the Creative Commons Attribution License policy authors are allowed to share their work with an acknowledgement of the work's authorship and initial publication in this journal.
This is an open access journal which means that all content is freely available without charge to the user or his/her institution. Users are allowed to read, download, copy, distribute, print, search, or link to the full texts of the articles in this journal without asking prior permission from the publisher or the author.
The use of general descriptive names, trade names, trademarks, and so forth in this publication, even if not specifically identified, does not imply that these names are not protected by the relevant laws and regulations. While the advice and information in this journal are believed to be true and accurate on the date of its going to press, neither the authors, the editors, nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein.
TNHJ also supports open access archiving of articles published in the journal after three months of publication. Authors are permitted and encouraged to post their work online (e.g, in institutional repositories or on their website) within the stated period, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access). All requests for permission for open access archiving outside this period should be sent to the editor via email to editor@tnhjph.com.
