MUMBAI, India, Aug. 10 -- Intellectual Property India has published a patent application (202641089584 A) filed by Nitte Deemed To Be University on July 23, 2026, for Recombinase Polymerase Amplification Primer, Crispr-Cas12a Guide Rna Construct For The Detection Of Hepatitis B Virus.
Inventors include Ms. Prerana Sharan; Ms. Shruthi Padavu; and Dr. Praveen Rai.
The application for the patent was published on July 31, 2026, under issue no. 31/2026.
Abstract: 7. ABSTRACT UNIQUE PRIMER SETS AND CAS12A GUIDE RNA SEQUENCES ENABLING RAPID ISOTHERMAL DETECTION OF HEPATITIS B VIRUS Hepatitis B virus (HBV) infection remains a major public health burden in India and worldwide, contributing significantly to chronic liver disease, cirrhosis, and hepatocellular carcinoma. Despite the high sensitivity and specificity of qPCR, its reliance on sophisticated instrumentation and trained personnel limits its deployment in resource-limited and point-of-care settings. To address this gap, we have developed a rapid and sensitive recombinase polymerase amplification (RPA) CRISPR- Cas12a-based assay for HBV DNA detection. The assay targets a conserved region of the HBV surface (S) gene, enabling broad detection across major HBV genotypes. Isothermal amplification was performed at a constant low temperature, followed by Cas12a-mediated collateral cleavage-based signal generation, allowing rapid visual and fluorescence readout without the need for complex equipment. The developed assay demonstrated a limit of detection of approximately 5 HBV DNA copies per reaction. Clinical validation using confirmed HBV-positive and HBV-negative serum samples showed 100% concordance with reference diagnostic methods, indicating high sensitivity and specificity. The simplicity, speed, and minimal instrumentation requirements of the RPA CRISPR-Cas12a assay make it a promising platform for early diagnosis, blood-bank screening, and decentralised HBV testing in low-resource settings.
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