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Background <p>Dengue fever presents a significant public health challenge in India, with approximately 289,235 reported cases and 485 deaths in 2023 and 233,519 cases and 297 deaths in 2024. Current diagnostic methods, including ELISA-based NS1 antigen tests and RT-PCR, have limitations in terms of accessibility, cost, and turnaround time, particularly in resource-limited settings. Rapid diagnostic tests (RDTs) offer potential solutions, however, they are currently excluded from national guidelines despite widespread private sector usage.</p> Methods <p>This comprehensive policy analysis employed a narrative review methodology to systematically examine peer-reviewed literature from PubMed, Scopus, and World Health Organization (WHO) databases (2018–2024). We analyzed current diagnostic practices, RDT performance characteristics, implementation challenges, and cost-effectiveness studies. Additional data sources included the National Center for Vector Borne Disease Control reports, WHO guidelines and regulatory documents from the Drug Controller General of India.</p> Results <p>The analysis revealed that current diagnostic methods have significant limitations in outbreak situations, with ELISA requiring 24–48&#xa0;h and RT-PCR taking 4–6&#xa0;h for results. RDTs showed variable performance, with sensitivity ranging from 27.1% to 97.7% and specificity from 50% to 100% across different manufacturers. Cost analysis indicated that RDTs ($0.58–$6.90 per test) are substantially more affordable than conventional methods. Key barriers to implementation include exclusion from national guidelines, quality control concerns, and cross-reactivity with other Flaviviruses.</p> Conclusions <p>RDTs have demonstrated significant potential as complementary diagnostic tools in India’s dengue control strategy, particularly for outbreak response and pre-vaccination screening. However, successful implementation requires the development of a comprehensive policy framework, quality assurance mechanisms, healthcare worker training, and integration into existing surveillance systems. A phased implementation approach, beginning with outbreak-prone areas, could provide valuable real-world evidence while building system’s capacity.</p>

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Assessing the readiness of rapid diagnostic tests for integration into the national dengue control strategy of India

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月15日

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  • Kunal H. Pise,
  • Snehal Chavan,
  • Yogesh Gurav

摘要

Background

Dengue fever presents a significant public health challenge in India, with approximately 289,235 reported cases and 485 deaths in 2023 and 233,519 cases and 297 deaths in 2024. Current diagnostic methods, including ELISA-based NS1 antigen tests and RT-PCR, have limitations in terms of accessibility, cost, and turnaround time, particularly in resource-limited settings. Rapid diagnostic tests (RDTs) offer potential solutions, however, they are currently excluded from national guidelines despite widespread private sector usage.

Methods

This comprehensive policy analysis employed a narrative review methodology to systematically examine peer-reviewed literature from PubMed, Scopus, and World Health Organization (WHO) databases (2018–2024). We analyzed current diagnostic practices, RDT performance characteristics, implementation challenges, and cost-effectiveness studies. Additional data sources included the National Center for Vector Borne Disease Control reports, WHO guidelines and regulatory documents from the Drug Controller General of India.

Results

The analysis revealed that current diagnostic methods have significant limitations in outbreak situations, with ELISA requiring 24–48 h and RT-PCR taking 4–6 h for results. RDTs showed variable performance, with sensitivity ranging from 27.1% to 97.7% and specificity from 50% to 100% across different manufacturers. Cost analysis indicated that RDTs ($0.58–$6.90 per test) are substantially more affordable than conventional methods. Key barriers to implementation include exclusion from national guidelines, quality control concerns, and cross-reactivity with other Flaviviruses.

Conclusions

RDTs have demonstrated significant potential as complementary diagnostic tools in India’s dengue control strategy, particularly for outbreak response and pre-vaccination screening. However, successful implementation requires the development of a comprehensive policy framework, quality assurance mechanisms, healthcare worker training, and integration into existing surveillance systems. A phased implementation approach, beginning with outbreak-prone areas, could provide valuable real-world evidence while building system’s capacity.