Abstract
As per national policy, all diagnosed tuberculosis patients in India are to be tested using Xpert® MTB/RIF assay at the district level to diagnose rifampicin resistance. Regardless of the result, samples are transported to the reference laboratories for further testing: first-line Line Probe Assay (FL-LPA) for rifampicin-sensitive samples and second-line LPA(SL-LPA) for rifampicin-resistant samples. Based on the results, samples undergo culture and phenotypic drug susceptibility testing. We assessed among patients diagnosed with tuberculosis at 13 selected Xpert laboratories of Karnataka state, India, i) the proportion whose samples reached the reference laboratories and among them, proportion who completed the diagnostic algorithm ii) factors associated with non-reaching and non-completion and iii) the delays involved. This was a cohort study involving review of programme records. For each TB patient diagnosed between 1st July and 31st August 2018 at the Xpert laboratory, we tracked the laboratory register at the linked reference laboratory until 30th September (censor date) using Nikshay ID (a unique patient identifier), phone number, name, age and sex. Of 1660 TB patients, 1208(73%) samples reached the reference laboratories and among those reached, 1124(93%) completed the algorithm. Of 1590 rifampicin-sensitive samples, 1170(74%) reached and 1104(94%) completed the algorithm. Of 64 rifampicin-resistant samples, only 35(55%) reached and 17(49%) completed the algorithm. Samples from rifampicin-resistant TB, extra-pulmonary TB and two districts were less likely to reach the reference laboratory. Non-completion was more likely among rifampicin-resistant TB and sputum-negative samples. The median time for conducting and reporting results of Xpert® MTB/RIF was one day, of FL-LPA 5 days and of SL-LPA16 days. These findings are encouraging given the complexity of the algorithm. High non-reaching and non-completion rates in rifampicin-resistant patients is a major concern. Future research should focus on understanding the reasons for the gaps identified using qualitative research methods.
Highlights
Tuberculosis (TB), an ancient disease whose cause was discovered nearly two centuries ago, still kills more people in the world, than any other infectious disease
We aimed to assess, among all the TB patients diagnosed at selected Xpert laboratories of Karnataka state, India, i) the proportion whose samples reached the reference laboratories and among them, the proportion who completed the diagnostic algorithm ii) demographic and clinical factors associated with non-reaching and non-completion of algorithm and iii) the delays involved at each step of the diagnostic cascade
A patient found to be Mtb detected in Xpert laboratory, who was documented to have received services in the reference laboratory was considered as having reached
Summary
Tuberculosis (TB), an ancient disease whose cause was discovered nearly two centuries ago, still kills more people in the world, than any other infectious disease. According to the World Health Organization (WHO), in 2018 an estimated 130,000 people in India developed rifampicin-resistant TB (RR-TB) or multidrug-resistant TB (MDR-TB) (defined as resistance to at-least isoniazid (H) and rifampicin (R), the two most effective first-line drugs). This accounts for one-fourth of the global burden of MDR/RR-TB [4]. All diagnosed tuberculosis patients in India are to be tested using Xpert® MTB/RIF assay at the district level to diagnose rifampicin resistance. We assessed among patients diagnosed with tuberculosis at 13 selected Xpert laboratories of Karnataka state, India, i) the proportion whose samples reached the reference laboratories and among them, proportion who completed the diagnostic algorithm ii) factors associated with non-reaching and non-completion and iii) the delays involved
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