HEALTH

ICMR Validation of Point of Care Assays for Sickle Cell Disease Screening

By TEAM CIRCULAR EXPRESS • 16 Aug 2026
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The Indian Council of Medical Research (ICMR) has released the validation results for two Point of Care (POC) assays used for screening Sickle Cell Disease. The assays validated are the LordsMed ShapeDx AI software-based system and the Genebio Health Pvt. Ltd. Sickle Cell Rapid POC device. Both devices were tested at ICMR-NIIH Mumbai and ICMR-CRMCH Chandrapur in 2024. The validation was conducted against the HPLC gold standard. The circular emphasizes the necessity of training laboratory staff to prevent technical errors during usage.
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purpose of issuance
To notify the validation status of specific Point of Care assays for Sickle Cell Disease screening.
Most Important Details
LordsMed ShapeDx AI (100% sensitivity, 100% specificity) and Genebio Health Sickle Cell Rapid POC Device (97% sensitivity, 100% specificity) have been validated by ICMR.

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ICMR Validation of Point of Care Assays for Sickle Cell Disease Screening

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