Is it important to detect drug resistance at the time of

TB diagnosis?
Lessons from multi-centric study in India
Dr K S Sachdeva
Additional Deputy Director General
Central TB Division
Ministry of Health & Family Welfare
Government of India

Global and India TB Situation

Global

India

Estimated
Incidence
2013

Estimated
Number of deaths
2013

Estimated
Incidence 2013

Estimated
Number of
deaths 2013

Notification
under RNTCP
-2014 #

All forms of TB

90 lakh

11 lakh *

21 lakh

2.4 lakh *

14,43,942

HIV Associated
TB

11 lakh

3.6 Lakh

1.2 lakh

38,000

44171

480,000

210,000

61,000

Multi Drug
Resistant TB

Source: WHO Global Tuberculosis Report 2014

24,073

amongst
notified cases

Excluding deaths attributed to HIV/TB,

# (Annual TB Report-2015)

Introduction
Globally, India is the highest TB burden country, accounting for
1/5th of TB incidence
50% of global MDR-TB cases are estimated to be from China and India
Estimated number of DR-TB cases amongst cases notified under RNTCP in
2014: 61000
Approx. another 30000 DR-TB cases expected in the private sector

Globally, DST is offered to cases with high risk of resistant

This approach we could at best detect 2/3rd of estimates amongst notified
cases
Issues of operational losses in cases being tracked & specimen sent for DST

Decentralized deployment of GeneXpert could possibly, help

RNTCP achieving:
o Early and complete detection of all TB and DR-TB cases

Project Design
o 18 decentralized Xpert labs established at existing public sector microscopy centers
o Xpert: default Dx test for all presumptive TB cases; Each lab covered 0.5 million pop

Project Coverage

Project sites

Project implementation
Key Research questions: Impact assessment of upfront Xpert MTB/RIF testing on TB and Rif
resistant TB detection

Baseline Phase

Intervention Phase

No active intervention

Upfront Xpert MTB/RIF testing for all

pulmonary TB & DR- TB suspects

o TB & Rif resistant TB diagnosis as per RNTCP

diagnostic algorithm

Overall data captured

o Total 44.9 programme months data captured
(2.1- 5.1 months/site)
o Total 11,064 presumptive pulmonary TB & DRTB cases tested
o 10,832 TB
o 232 DR-TB
o 4 sites excluded from baseline & direct roll out
of intervention for early feasibility assessment

o Parallel smear microscopy for internal

comparison

Intervention
o Same day sputum specimen transportation to
Xpert lab
o Rx based on Xpert test results

Overall data captured

o Total 350.1 months data (16.4- 21.6 months/site)
o Total, 1,04,276 presumptive pulmonary TB & DRTB cases tested on CBNAAT
o 1,01,700 TB
o 2,576 DR-TB

Project Intervention: Upfront Xpert MTB/RIF testing of TB suspects

Xpert MTB/RIF additional

contribution of bacteriologicallyconfirmed cases and Rifampicin
resistant -TB cases

Xpert Positivity 20.3%

Smear Positivity 14.4%
Rif Resistant - 2301 (11.2%)

TB case detection: Baseline Vs Intervention phase

With upfront Xpert MTB/RIF test bacteriological TB case notification increased by:
11% for all forms of pulmonary TB
33% for Bacteriological TB cases

Xpert MTB/RIF performance among paediatric population

30-06-2015

Xpert MTB/RIF performance among HIV infected population

Rifampicin Resistant TB case detection

Category

Presumptive TB patients
New
Xpert Positive ; Smear-positive
Xpert positive; smear-neg/NA
Previously treated
Xpert positive; Smear-positive
Xpert positive; smear-neg/NA

Number
Detected Xpert RIF
with
resistance
Confirmed
additional prevalenc
PTB
Rifampici
e
Cases on
n
Xpert
resistanc
%
e
20587
2301
11.2
14539
841
5.8
9308
474
5.1
5231
367
7.0
6048
1460
24.1
3837
979
25.5
2211
481
21.8

Increased detection of DR-TB cases with upfront Xpert testing of TB suspects

Summary
This was a large scale demonstration at public health facilities
99.1% patients got valid test results on Xpert MTB/RIF
With upfront Xpert MTB/RIF testing, study demonstrated 33% increase in
proportion of bacteriologically confirmed TB cases diagnosed
> Two fold increase in detection rates in PLHA & Pediatric population

Upfront Xpert testing lead to five fold increase in Rifampicin resistant TB

case detection
Cost effectiveness assessment underway

Acknowledgment
FIND - Implementing partner

USAID Funding
WHO-India Country Office and technical support network
State TB officers, District TB officers, Medical Officers and respective
RNTCP staff from 18 study TUs.
National Reference Laboratories (NRL) and Intermediate reference
Laboratories (IRL) from all states participating in the study

AIGHD team