ICMR and CDSCO Invite Stakeholder Comments on Standard IVD Performance Evaluation Protocols for Scrub Typhus

ICMR and CDSCO have jointly developed standard performance evaluation protocols for Scrub Typhus in-vitro diagnostic (IVD) kits to facilitate quality-assured diagnostics and establish uniformity in IVD performance evaluation in India. The draft protocols cover the Scrub Typhus IgM RDT and the Scrub Typhus IgM ELISA and are intended to verify manufacturers’ performance claims independently.

Key points include:

1. Two protocols have been developed: Performance Evaluation Protocol for Scrub Typhus IgM RDT and Performance Evaluation Protocol for Scrub Typhus IgM ELISA.
2. Evaluation is designed as a diagnostic accuracy study using irreversibly de-identified leftover archived or spiked clinical samples.
3. The protocols specify requirements for evaluation laboratories, reference assays, characterized sample panels, staff competency, testing procedures, data handling, and confidentiality.
4. For the IgM RDT protocol, the minimum evaluation panel is 150 positive and 80 negative samples, with 255 negative samples recommended for more robust assessment of cross-reactivity and specificity.
5. The RDT acceptance criteria include ≥90% sensitivity, ≥95% specificity, minimal cross-reactivity, and an invalid test rate of ≤5%.
6. The ELISA protocol specifies a minimum of 80 positive and 80 negative samples, with 255 negative samples recommended for robust evaluation.
7. The protocols also address repeatability, reproducibility, lot-to-lot variability, operator variability, day-to-day variability, and, where applicable, machine-to-machine variability.
8. The documents have been placed in the public domain for stakeholder comments. Comments must be submitted by 25 August 2026 using the prescribed format to ivdevaluation@gmail.com.