Comprehensive assessment of invalid and indeterminate results in Truenat MTB-RIF testing across sites under the national TB elimination program of India.

Introduction: Truenat MTB-RIF assay (Truenat), a nucleic acid amplification test (NAAT), is a real-time polymerase chain reaction (RT-PCR) chip-based assay that can detect Mycobacterium tuberculosis (Mtb) and rifampicin (RIF) drug resistance using portable, battery-operated devices. The National TB Elimination Program (NTEP) in India introduced this novel tool at the district and subdistrict level in 2020. This study aimed to assess the level and causes of inconclusive results (invalid results, errors, and indeterminate results) in MTB and RIF testing at NTEP sites and the root causes of these in the programmatic setting. Methods: Truenat testing data from 1,690 functional Truenat sites under the NTEP from April to June 2021 were analyzed to assess the rates of errors, invalid MTB results, and indeterminate RIF results. Following this analysis, 12 Truenat sites were selected based on site performance in Truenat testing, diversity of climatic conditions, and geographical terrain. These sites were visited to assess the root causes of their high and low rates of inconclusive results using a structured checklist. Results: A total of 327,649 Truenat tests performed for MTB and RIF testing were analyzed. The rate of invalid MTB results was 5.2% [95% confidence interval (CI): 5.11-5.26; n = 16,998] and the rate of errors was 2.5% (95% CI: 2.46-2.57; n = 8,240) in Truenat MTB chip testing. For Mtb-positive samples tested using the Truenat RIF chip for detection of RIF resistance (n = 40,926), the rate of indeterminate results was 15.3% (95% CI: 14.97-15.67; n = 6,267) and the rate of errors was 1.6% (95% CI: 1.53-1.78; n = 675). There was a 40.1% retesting gap for Mtb testing and a 78.2% gap for inconclusive RR results. Among the inconclusive results retested, 27.9% (95% CI: 27.23-28.66; n = 4,222) were Mtb-positive, and 9.2% (95% CI: 7.84-10.76; n = 139) were detected as RR. Conclusion: The main causes affecting Truenat testing performance include suboptimal adherence to standard operating procedures (SOPs), inadequate training, improper storage of testing kits, inadequate sputum quality, lack of quality control, and delays in the rectification of machine issues. Root cause analysis identified that strengthening of training, external quality control, and supervision could improve the rate of inconclusive results. Ensuring hands-on training of technicians for Truenat testing and retesting of samples with inconclusive results are major recommendations while planning for Truenat scale-up. The recommendations from the study were consolidated into technical guidance documents and videos and disseminated to laboratory staff working at the tiered network of TB laboratories under the NTEP in order to improve Truenat MTB-RIF testing performance.

Strategies to overcome vaccine hesitancy: a systematic review.

BACKGROUND: Vaccination, albeit a necessity in the prevention of infectious diseases, requires appropriate strategies for addressing vaccine hesitancy at an individual and community level. However, there remains a glaring scarcity of available literature in that regard. Therefore, this review aims to scrutinize globally tested interventions to increase the vaccination uptake by addressing vaccine hesitancy at various stages of these interventions across the globe and help policy makers in implementing appropriate strategies to address the issue. METHODS: A systematic review of descriptive and analytic studies was conducted using specific key word searches to identify literature containing information about interventions directed at vaccine hesitancy. The search was done using PubMed, Global Health, and Science Direct databases. Data extraction was based on study characteristics such as author details; study design; and type, duration, and outcome of an intervention. RESULTS: A total of 105 studies were identified of which 33 studies were included in the final review. Community-based interventions, monetary incentives, and technology-based health literacy demonstrated significant improvement in the utilization of immunization services. On the other hand, media-based intervention studies did not bring about a desired change in overcoming vaccine hesitancy. CONCLUSION: This study indicates that the strategies should be based on the need and reasons for vaccine hesitancy for the targeted population. A multidimensional approach involving community members, families, and individuals is required to address this challenging issue.

Return on investment of the electronic vaccine intelligence network in India.

The electronic vaccine intelligence network (eVIN) was introduced by India's Ministry of Health and Family Welfare in 12 states and was implemented by the United Nations Development Programme through the Gavi health system strengthening support during 2014-17 to replace the traditional paper-based cold-chain management system with an electronic vaccine logistics management system. An economic assessment was conducted as part of the overall assessment of eVIN. The objective of the economic assessment was to conduct a return on investment analysis of eVIN implementation. Return on investment was defined as the ratio of total benefits (savings) from eVIN to total investment in eVIN. All costs were calculated in 2020 prices and reported in Indian rupees (1 US dollar = INR 74.132). A one-rupee investment in eVIN led to a return of INR 0.52 for traditional vaccines. The highest cost savings from eVIN was from better vaccine stock management. When same percentage of savings from the new vaccines were incorporated into the analysis, one-rupee investment in eVIN led to a return of INR 1.41. In the future, when only recurrent costs will exist, the return from eVIN will be even higher: a one-rupee investment in eVIN will yield a return of INR 2.93. The assessment of eVIN showed promising results in streamlining the vaccine flow network and ensuring equity in vaccine stock management along with good return on investment; hence, there was a rapid expansion of eVIN in all 731 districts across 36 states and union territories in the country.

Programmatic assessment of electronic Vaccine Intelligence Network (eVIN).

eVIN is a technology system that digitizes vaccine stocks through a smartphone application and builds the capacity of program managers and cold chain handlers to integrate technology in their regular work. To effectively manage the vaccine logistics, in 2015, this technology was rolled-out in 12 states of India. This study assessed the programmatic usefulness of eVIN implementation in the areas of vaccine utilization, vaccine stock and distribution management and documentation across selected cold chain points. A pre-post study design was used, where cold chain points (CCPs) were selected using two-stage sampling technique in eVIN states. Pre-post comparative analysis was carried out on the identified indicators using both primary and secondary data sources. The vaccine utilization data reflects that the utilization had reduced from 305.3 million doses in pre-eVIN period to 215.0 million doses in post-eVIN period across 12 eVIN states, resulting into savings of approximately 90 million doses of vaccines. Number of facilities having stock-out of any vaccine showed a significant reduction by 30.4% in post-eVIN period (p<0.001). There was a 4.0% drop in facilities reporting minimum stock of any vaccine after implementation of eVIN. Facilities with maximum stock of any vaccine had increased from 37.4% in pre-eVIN to 39.2% in post-eVIN. During the pre-eVIN period, only 38.6% facilities updated vaccine stock on a daily basis, while in post-eVIN period, 53.5% facilities updated vaccine stock on daily basis. The completeness of records in the vaccine stock registers, indent form and temperature logbook have been substantially improved in the post-eVIN period (p<0.001). eVIN had helped in streamlining the vaccine flow network and ensured equity through better vaccine management practices. It is a powerful contribution to strengthen the vaccine supply chain and management. Upscaling eVIN in the remaining states of India will be crucial in improving the efficacy of vaccines and cold chain management.