Year: 2026 | Month: September | Volume: 16 | Issue: 9 | Pages: 71-82
DOI: https://doi.org/10.52403/ijhsr.20260909
Diagnostic Performance of a Gold Nanoparticle–Based Lateral Flow Assay Snake Venom Detection Kit: A Single-Centre Observational Pilot Study in Snakebite Victims
Dhirubhai Chhaganbhai Patel1, Shama Bhat2, Vivek Wayse3, Prabhakar B.4, Anil Yadav5, Hardik Nagar6, Nibedita Das7, Ziniya B. Mallick8, Ankit Pathak9
1Shree Sainath Surgical and Maternity Hospital, Valsad, Gujarat, India
2Bhat Biotech Pvt. Ltd., Bengaluru, Karnataka, India
3Biorad Medisys Pvt. Ltd., Pune, Maharashtra, India
4Sarsuag Enterprise, Bangalore, Karnataka, India
5Raut Serums India Pvt. Ltd., Pune, Maharashtra, India
6NAMO Medical Education and Research Institute, Silvassa, Dadra and Nagar Haveli, India
7Shree Sainath Surgical and Maternity Hospital, Valsad, Gujarat, India
8University of Calcutta, Kolkata, West Bengal, India
9WorkSure® India, New Delhi, Delhi, India
Corresponding Author: Vivek Wayse
ABSTRACT
Background: A gold nanoparticle–based lateral flow assay snake venom detection kit (SVDK) may provide a simple, rapid, point-of-care method for venom detection and timely clinical decision-making in resource-limited facilities. This study evaluated diagnostic performance of a SVDK in serum samples from snakebite victims by comparing it to physician-based primary reference standard (PRS).
Methodology: This single-centre, prospective, observational pilot study enrolled venomous and nonvenomous snakebite cases, as confirmed through clinical presentation, evidence of snakebite and laboratory investigations (on physician’s discretion) that served as the PRS. The SVDK testing was performed by an independent pathology service, blinded to PRS. Analysis of diagnostic performance of the SVDK was assessed by overall agreement (%) between SVDK and PRS for identification of venomous/nonvenomous cases.
Results: Forty snakebite cases were prospectively enrolled in this study, of whom 38 were included in the final analysis. Eighteen were venomous snakebite cases and 20 were nonvenomous snakebite cases, as per PRS. In analytical validation studies, the SVDK demonstrated a limit of detection of 10 ng/mL for Indian ‘big four’ snake venoms. Evaluation of the SVDK using serum samples from the enrolled patients showed complete concordance with the physician-based PRS (100% true positivity and true negativity).
Conclusion: The SVDK has shown high overall agreement vis-à-vis PRS in identifying venomous snakebite cases. Large population studies are required to determine its clinical utility as point-of-care diagnostic.
Key words: Anti-snake venom; Gold nanoparticles; Lateral flow assay; Snake envenomation; Snake venom detection kit; Rapid detection