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. 2014 Feb 26;9(2):e89301.
doi: 10.1371/journal.pone.0089301. eCollection 2014.

Feasibility of decentralised deployment of Xpert MTB/RIF test at lower level of health system in India

Neeraj Raizada  1 , K S Sachdeva  2 , Achuthan Sreenivas  3 , Bhavin Vadera  1 , R S Gupta  2 , Malik Parmar  3 , Shubhangi Kulsange  1 , Ameet Babre  1 , Rahul Thakur  1 , Christen Gray  4 , Ranjani Ramachandran  3 , Umesh Alavadi  1 , Mayank Ghedia  3 , Balasangameshwara Vollepore  1 , Puneet Dewan  3 , Catharina Boehme  4 , C N Paramsivan  1
Affiliations

Feasibility of decentralised deployment of Xpert MTB/RIF test at lower level of health system in India

Neeraj Raizada et al. PLoS One. .

Abstract

Background: Xpert MTB/RIF is an automated cartridge-based nucleic acid amplification test that has demonstrated its potential to detect tuberculosis and rifampicin resistance with high accuracy. To assist scale-up decisions in India, a feasibility assessment of Xpert MTB/RIF implementation was conducted within microscopy centres of 18 RNTCP TB units.

Methods: As part of programme-based demonstration of Xpert MTB/RIF implementation, we recorded and analysed association between key implementation factors and the ability of test to produce valid results. Factors contributing to test failures were analysed from GeneXpert software data which provides 'failure codes' and causes for test failures.

Results: From March'12 to January'13, total 40,035 suspects were tested by Xpert MTB/RIF, and 39,680 (99.1%) received valid results (Cumulative: 37157 (92.8%) on first attempt, 39410 (98.4%) on second attempt, 39637 (99.0%) on third attempt and 39680 (99.1%) on more attempts). Overall initial test failure was 2,878 (7.2% (4%-17%)); of these, 2,594 (90.1%) were re-tested and produced valid results. Most frequent reason of test failure was inadequate sample processing or equipment malfunction (3.9%). Other reasons included power failure (1.1%), cartridge integrity/component failure (0.8%), device-computer communication error (0.5%), and temperature-related errors (0.08%). Significant variation was observed in failure rates both across instruments and over time; furthermore, substantial variation was observed in failure rate in two cartridges lots.

Conclusion: Installation required minimal infrastructure modifications and concerns about adequacy of human resources under public sector facilities and temperature extremes proved unfounded. Under routine conditions, Xpert MTB/RIF provided 99.1% valid results in TB suspects with low overall failure rates (7.2% initial failure, 0.9% final failure); devices provided valuable real-time feedback on reasons for test failure, which were used for rapid corrective action. High modular replacement (32%) and inter-lot cartridge performance variation remain sources of concern, and warrant close monitoring of failure rates as a key quality indicator.

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Conflict of interest statement

Competing Interests: I have read the journal's policy and have the following conflicts: NR, BV, SK, AB, RT, CG, UA, BV, CB and CNP are am employed by FIND, a non-profit organization that collaborates with industry partners,including Cepheid Inc., for the development and evaluation of new diagnostic tests. However, this doesnot alter our adherence to all the PLOS ONE policies on sharing data and materials. Further, none of the authors have any financial or market interest in the product being evaluated under the study.

Figures

Figure 1
Figure 1. Site Locations: Geographical locations of the 18 project sites across India.
Figure 2
Figure 2. Diagnostic Algorithm.
Figure 3
Figure 3. Reasons for test failure.
Figure 4
Figure 4. Trend in error rates of modules.
See this image and copyright information in PMC

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References

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