Evaluation of the Xpert MTB/RIF test for the diagnosis of childhood pulmonary tuberculosis in Uganda: a cross-sectional diagnostic study

BMC Infectious Diseases

Philippa Musoke⁴  Sabrina Bakeera-Kitaka¹  Harriet Kisembo³  Willy Ssengooba²  Moses L Joloba²  Eric Wobudeya⁴  Moorine Penninah Sekadde¹ 

[1] Department of Paediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda;Department of Microbiology, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda;Department of Radiology, Mulago National Referral Hospital, Kampala, Uganda;Makerere University-John Hopkins University (MU-JHU) Research Collaboration, Kampala, Uganda

关键词: Xpert MTB/RIF;    Specificity;    Sensitivity;    Pulmonary tuberculosis;    Children;   

Others  :  1170989
DOI  :  10.1186/1471-2334-13-133

 received in 2012-11-27, accepted in 2013-03-06,  发布年份 2013

【 摘 要 】

Background

The diagnosis of childhood tuberculosis remains a challenge worldwide. The Xpert MTB/RIF test, a rapid mycobacteria tuberculosis diagnostic tool, was recommended for use in children based on data from adult studies. We evaluated the performance of the Xpert MTB/RIF test for the diagnosis of childhood pulmonary tuberculosis using one induced sputum sample and described clinical characteristics associated with a positive Xpert MTB/RIF test. The sputum culture on both Lowenstein-Jensen (LJ) and Mycobacteria Growth Indicator Tube (MGIT) was the gold standard.

Methods

We consecutively enrolled 250 Ugandan children aged 2 months to 12 years with suspected pulmonary tuberculosis between January 2011 and January 2012 into a cross-sectional diagnostic study at a tertiary care facility in Uganda.

Results

We excluded data from 15 children (13 contaminated culture and 2 indeterminate MTB/RIF test results) and analysed 235 records. The Xpert MTB/RIF test had a sensitivity of 79.4% (95% CI 63.2 - 89.7) and a specificity of 96.5% (95% CI 93 – 98.3). The Xpert MTB/RIF test identified 13 of the 14 (92.9%) smear positive-culture positive and 14 of the 20 (70%) smear negative -culture positive cases. The Xpert MTB/RIF identified twice as many cases as the smear microscopy (79.4% Vs 41.2%). Age > 5 years (OR 3.3, 95% CI 1.4 – 7.4, p value 0.005), a history of Tuberculosis (TB) contact (OR 2.4, 95% CI 1.1 – 5.2, p value 0.03), and a positive tuberculin skin test (OR 4.1, 95% CI 1.7 – 10, p value 0.02) was associated with a positive Xpert MTB/RIF test. The median time to TB detection was 49.5 days (IQR 38.4-61.2) for LJ, and 6 days (IQR 5 – 11.5) for MGIT culture and 2 hours for the Xpert MTB/RIF test.

Conclusion

The Xpert MTB/RIF test on one sputum sample rapidly and correctly identified the majority of children with culture confirmed pulmonary tuberculosis with high specificity.

【 授权许可】

   
2013 Sekadde et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Eamranond P, Jaramillo E: Tuberculosis in children: reassessing the need for improved diagnosis in global control strategies. Int J Tuberc Lung Dis 2001, 5(7):594-603.
• [2]Newton SM, Brent AJ, Anderson S, Whittaker E, Kampmann B: Paediatric tuberculosis. Lancet Infect Dis 2008, 8:498-510.
• [3]Shingadia D, Novelli V: Diagnosis and treatment of tuberculosis in children. Lancet Infect Dis 2003, 3:624-632.
• [4]Lighter J, Riguaud M: Diagnosing childhood tuberculosis: traditional and innovative modalities. Curr Probl Pediatr Adolesc Health Care 2009, 39:61-88.
• [5]Iriso R, Mudido PM, Karamagi C, Whalen C: The diagnosis of childhood tuberculosis in an HIV-endemic setting and the use of induced sputum. Int J Tuberc Lung Dis 2005, 9(7):716-726.
• [6]Oberhelman RA, Soto-Castellares G, Gilman RH, Caviedes L, Castillo ME, Kolevic L: Diagnostic approaches for paediatric tuberculosis by use of diff erent specimen types, culture methods, and PCR: a prospective case–control study. Lancet Infect Dis 2010, 10:612-620.
• [7]Cepheid: GeneXpert System. [cited 2012 October 1st]; Available from: http://www.cepheid.com/systems-and-software/genexpert-system webcite
• [8]World Health Organization: Automated Real-time Nucleic Acid Amplification Technology for Rapid and Simultaneous Detection of Tuberculosis and Rifampicin Resistance: Xpert MTB/RIF System2011. 2011. Contract No.: WHO/HTM/TB/2011.4. http://whqlibdoc.who.int/publications/2011/9789241501545_eng.pdf webcite
• [9]Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F: Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med 2010, 363(11):1005-1015.
• [10]Helb D, Jones M, Story E, Boehme C, Wallace E, Ho K: Rapid detection of Mycobacterium tuberculosis and rifampin-resistance 1 using on-demand, near patient technology. Clin Microbiol 2010, 48(1):229-237.
• [11]Nicol MP, Workman L, Isaacs W, Munro J, Black F, Eley B: Accuracy of the Xpert MTB/RIF test for the diagnosis of pulmonary tuberculosis in children admitted to hospital in Cape Town, South Africa: a descriptive study. Lancet 2011, 11:70167.
• [12]Rachow APC, Saathoff E, Mtafya B, Michael E, Ntinginya EN: Increased and expedited case detection by xpert MTB/RIF assay in childhood tuberculosis:a prospective cohort study. Clin Infect Dis 2012, 54(10):1388-1396.
• [13]World Health Organization: Guidance for national tuberculosis programmes on the management of tuberculosis in children. 2006. Contract No.: WHO/HTM/TB/2006.371. http://whqlibdoc.who.int/hq/2006/WHO_HTM_TB_2006.371_eng.pdf webcite
• [14]World Health Organization: Treatment of Tuberculosis Guidelines. 2009. Contract No.: WHO/HTM/TB/2009.420. http://whqlibdoc.who.int/publications/2010/9789241547833_eng.pdf webcite
• [15]World Health Organization: The WHO Child Growth Standards. 2013. http://www.who.int/childgrowth/en/index.html webcite
• [16]Marais BJ, Gie RP, Schaaf HS, Starke JR, Hesseling AC, Donald PR: A proposed radiological classification of childhood intra-thoracic tuberculosis. Pediatr Radiol 2004, 34(11):886-894.
• [17]Carley S, Dosman S, Jones SR, Harrison M: Simple nomograms to calculate sample size in diagnostic studies. Emerg Med J 2005, 22:180-181.
• [18]Fagan TJ: Normogram for Bayes's theorem. N Engl J Med 1975, 293(5):257.
• [19]Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R: Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet Infect Dis 2011, 377(9776):1495-1505.
• [20]Marais BJ, Gie RP, Schaaf HS, Hesseling AC, Obihara CC, Starke JJ: The natural history of childhood inta-thoracic tuberculosis:a critical review of literature from the pre-chemotherapy era. Int J Tuberc Lung Dis 2004, 8(4):392-402.
• [21]Theron G, Peter J, van Zyl-Smit R, Mishra H, Streicher E, Murray S: Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med 2011, 184(1):132-140.