CDSCO Issues Guidelines and Protocols for Performance Evaluation of In-Vitro Diagnostic Kits

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Dated: 20.09.2025

CDSCO Issues Guidelines and Protocols for Performance Evaluation of In-Vitro Diagnostic Kits

The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly developed standardized performance evaluation protocols for in-vitro diagnostic (IVD) kits. These protocols aim to ensure the accuracy, reliability, and quality of diagnostic kits used for detecting various pathogens, including respiratory viruses, arboviruses, and other infectious agents.

Introduction

The COVID-19 pandemic underscored the importance of robust diagnostic systems for accurate and timely disease detection. In response, ICMR and CDSCO collaborated to create standardized protocols to independently verify manufacturers’ claims regarding the performance of diagnostic kits, ensuring their suitability for use in India.

Objectives

The primary objectives of the protocols include:

Validation of Diagnostic Kits: Evaluating sensitivity, specificity, repeatability, and reproducibility.
Cross-Reactivity Analysis: Ensuring kits do not produce false positives due to cross-reactivity with other pathogens.
Standardization: Establishing uniform testing protocols for consistent and reliable results.
Regulatory Compliance: Aligning diagnostic kits with national and international standards for global competitiveness.

Scope

The protocols cover the evaluation of IVD kits for:

Respiratory Viruses: Influenza A & B, SARS-CoV-2, RSV, and Human Metapneumovirus.
Arboviruses: Dengue, Chikungunya, Zika, and related viruses.
Multiplex Assays: Kits capable of detecting multiple pathogens simultaneously.

Key Features of the Protocols

Sample Panel Development: Use of well-characterized clinical samples categorized by Ct values and cross-reactivity panels.
Ethical Approvals: Exemption from ethics approval for irreversibly de-identified leftover clinical samples.
Evaluation Parameters: Sensitivity, specificity, cross-reactivity, repeatability, and reproducibility.
Acceptance Criteria: Minimum sensitivity and specificity set at ≥95% and ≥98%, respectively, with invalid test rates ≤5%.
Blinding of Laboratory Staff: Ensuring unbiased results through blinded evaluations.
Publication Rights: Principal investigators retain rights to publish findings for transparency and scientific integrity.

Protocols for Specific Pathogens 

Respiratory Viruses: Kits are evaluated for Influenza subtyping, SARS-CoV-2 detection, RSV differentiation, and Human Metapneumovirus specificity.
Arboviruses: Separate protocols for Dengue NS1, IgM, and IgG detection, Chikungunya IgM and RNA detection, and Zika RNA detection.
Multiplex Assays: Framework for evaluating kits detecting multiple pathogens simultaneously.

Significance

The protocols enhance diagnostic accuracy, support public health by enabling timely disease detection, and promote global competitiveness by aligning Indian diagnostic kits with international standards.

Challenges in Performance Evaluation

Sample Availability: Difficulty in obtaining well-characterized samples for rare pathogens.
Cross-Reactivity: Extensive testing required to minimize false positives.
Ethical Compliance: Adhering to guidelines while using clinical samples.

Conclusion

The ICMR-CDSCO Standard Performance Evaluation Protocols represent a significant step forward in strengthening India’s diagnostic ecosystem. By ensuring the quality and reliability of IVD kits, these guidelines contribute to affordable, accessible, and high-quality healthcare for all.

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Source: CDSCO

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