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Use of Xpert MTB/RIF in Decentralized Public Health Settings and Its Effect on Pulmonary TB and DR-TB Case Finding in India.

Sachdeva KS, Raizada N, Sreenivas A, Van't Hoog AH, van den Hof S, Dewan PK, Thakur R, Gupta RS, Kulsange S, Vadera B, Babre A, Gray C, Parmar M, Ghedia M, Ramachandran R, Alavadi U, Arinaminpathy N, Denkinger C, Boehme C, Paramasivan CN - PLoS ONE (2015)

Bottom Line: The implementation of Xpert MTB/RIF was associated with increases in both notification rates of bacteriologically confirmed TB cases (adjusted incidence rate ratio [aIRR] 1.39; CI 1.18-1.64), and proportion of bacteriological confirmed TB cases among presumptive TB cases (adjusted risk ratio (aRR) 1.33; CI 1.6-1.52).Positive predictive value (PPV) of rifampicin resistance detected by Xpert MTB/RIF was 94.7% (CI 91.3-98.1), in comparison to conventional DST.Introduction of Xpert MTB/RIF as initial diagnostic test for TB in public health facilities significantly increased case-notification rates of all bacteriologically confirmed TB by 39% and rifampicin-resistant TB case notification by fivefold.

View Article: PubMed Central - PubMed

Affiliation: Central TB Division, Government of India, New Delhi, India.

ABSTRACT

Background: Xpert MTB/RIF, the first automated molecular test for tuberculosis, is transforming the diagnostic landscape in high-burden settings. This study assessed the impact of up-front Xpert MTB/RIF testing on detection of pulmonary tuberculosis (PTB) and rifampicin-resistant PTB (DR-TB) cases in India.

Methods: This demonstration study was implemented in 18 sub-district level TB programme units (TUs) in India in diverse geographic and demographic settings covering a population of 8.8 million. A baseline phase in 14 TUs captured programmatic baseline data, and an intervention phase in 18 TUs had Xpert MTB/RIF offered to all presumptive TB patients. We estimated changes in detection of TB and DR-TB, the former using binomial regression models to adjust for clustering and covariates.

Results: In the 14 study TUs, which participated in both phases, 10,675 and 70,556 presumptive TB patients were enrolled in the baseline and intervention phase, respectively, and 1,532 (14.4%) and 14,299 (20.3%) bacteriologically confirmed PTB cases were detected. The implementation of Xpert MTB/RIF was associated with increases in both notification rates of bacteriologically confirmed TB cases (adjusted incidence rate ratio [aIRR] 1.39; CI 1.18-1.64), and proportion of bacteriological confirmed TB cases among presumptive TB cases (adjusted risk ratio (aRR) 1.33; CI 1.6-1.52). Compared with the baseline strategy of selective drug-susceptibility testing only for PTB cases at high risk of drug-resistant TB, Xpert MTB/RIF implementation increased rifampicin resistant TB case detection by over fivefold. Among, 2765 rifampicin resistance cases detected, 1055 were retested with conventional drug susceptibility testing (DST). Positive predictive value (PPV) of rifampicin resistance detected by Xpert MTB/RIF was 94.7% (CI 91.3-98.1), in comparison to conventional DST.

Conclusion: Introduction of Xpert MTB/RIF as initial diagnostic test for TB in public health facilities significantly increased case-notification rates of all bacteriologically confirmed TB by 39% and rifampicin-resistant TB case notification by fivefold.

No MeSH data available.


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Enrollment of presumptive tuberculosis and drug resistant tuberculosis cases in baseline and intervention period of the study.
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pone.0126065.g002: Enrollment of presumptive tuberculosis and drug resistant tuberculosis cases in baseline and intervention period of the study.

Mentions: A total of 115,340 patients were approached under the study and all patients agreed to be enrolled across 18 study TUs. We excluded 562 (0.5%) from the analysis because of missing treatment history information. Of the remaining 114,778 patients, 111,969 (97.6%) were presumptive TB patients. In the 14 TUs with both baseline and intervention data, 10,675 (97.9%) of subjects enrolled in the baseline phase were presumptive TB patients and 232 (2.1%) were presumptive DR-TB patients. In the intervention phase 70,556 (98.1%) presumptive TB patients and 1,398 (1.9%) presumptive DR-TB patients were enrolled (Fig 2).


Use of Xpert MTB/RIF in Decentralized Public Health Settings and Its Effect on Pulmonary TB and DR-TB Case Finding in India.

Sachdeva KS, Raizada N, Sreenivas A, Van't Hoog AH, van den Hof S, Dewan PK, Thakur R, Gupta RS, Kulsange S, Vadera B, Babre A, Gray C, Parmar M, Ghedia M, Ramachandran R, Alavadi U, Arinaminpathy N, Denkinger C, Boehme C, Paramasivan CN - PLoS ONE (2015)

Enrollment of presumptive tuberculosis and drug resistant tuberculosis cases in baseline and intervention period of the study.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4440647&req=5

pone.0126065.g002: Enrollment of presumptive tuberculosis and drug resistant tuberculosis cases in baseline and intervention period of the study.
Mentions: A total of 115,340 patients were approached under the study and all patients agreed to be enrolled across 18 study TUs. We excluded 562 (0.5%) from the analysis because of missing treatment history information. Of the remaining 114,778 patients, 111,969 (97.6%) were presumptive TB patients. In the 14 TUs with both baseline and intervention data, 10,675 (97.9%) of subjects enrolled in the baseline phase were presumptive TB patients and 232 (2.1%) were presumptive DR-TB patients. In the intervention phase 70,556 (98.1%) presumptive TB patients and 1,398 (1.9%) presumptive DR-TB patients were enrolled (Fig 2).

Bottom Line: The implementation of Xpert MTB/RIF was associated with increases in both notification rates of bacteriologically confirmed TB cases (adjusted incidence rate ratio [aIRR] 1.39; CI 1.18-1.64), and proportion of bacteriological confirmed TB cases among presumptive TB cases (adjusted risk ratio (aRR) 1.33; CI 1.6-1.52).Positive predictive value (PPV) of rifampicin resistance detected by Xpert MTB/RIF was 94.7% (CI 91.3-98.1), in comparison to conventional DST.Introduction of Xpert MTB/RIF as initial diagnostic test for TB in public health facilities significantly increased case-notification rates of all bacteriologically confirmed TB by 39% and rifampicin-resistant TB case notification by fivefold.

View Article: PubMed Central - PubMed

Affiliation: Central TB Division, Government of India, New Delhi, India.

ABSTRACT

Background: Xpert MTB/RIF, the first automated molecular test for tuberculosis, is transforming the diagnostic landscape in high-burden settings. This study assessed the impact of up-front Xpert MTB/RIF testing on detection of pulmonary tuberculosis (PTB) and rifampicin-resistant PTB (DR-TB) cases in India.

Methods: This demonstration study was implemented in 18 sub-district level TB programme units (TUs) in India in diverse geographic and demographic settings covering a population of 8.8 million. A baseline phase in 14 TUs captured programmatic baseline data, and an intervention phase in 18 TUs had Xpert MTB/RIF offered to all presumptive TB patients. We estimated changes in detection of TB and DR-TB, the former using binomial regression models to adjust for clustering and covariates.

Results: In the 14 study TUs, which participated in both phases, 10,675 and 70,556 presumptive TB patients were enrolled in the baseline and intervention phase, respectively, and 1,532 (14.4%) and 14,299 (20.3%) bacteriologically confirmed PTB cases were detected. The implementation of Xpert MTB/RIF was associated with increases in both notification rates of bacteriologically confirmed TB cases (adjusted incidence rate ratio [aIRR] 1.39; CI 1.18-1.64), and proportion of bacteriological confirmed TB cases among presumptive TB cases (adjusted risk ratio (aRR) 1.33; CI 1.6-1.52). Compared with the baseline strategy of selective drug-susceptibility testing only for PTB cases at high risk of drug-resistant TB, Xpert MTB/RIF implementation increased rifampicin resistant TB case detection by over fivefold. Among, 2765 rifampicin resistance cases detected, 1055 were retested with conventional drug susceptibility testing (DST). Positive predictive value (PPV) of rifampicin resistance detected by Xpert MTB/RIF was 94.7% (CI 91.3-98.1), in comparison to conventional DST.

Conclusion: Introduction of Xpert MTB/RIF as initial diagnostic test for TB in public health facilities significantly increased case-notification rates of all bacteriologically confirmed TB by 39% and rifampicin-resistant TB case notification by fivefold.

No MeSH data available.


Related in: MedlinePlus