Clinical Validity and Utility of CRISPR-Based Diagnostics in HIV: Lessons for Population Screening and Policy Methods, Challenges, and Future Directions

Kungu Erisa

Faculty of Pharmacy Kampala International University Uganda

Email: erisa.kungu@studwc.kiu.ac.ug

ABSTRACT

CRISPR-based diagnostics represent a promising innovation in the detection of human immunodeficiency virus (HIV), with potential to improve early diagnosis, expand population screening, and strengthen public health responses. This paper examines the clinical validity and utility of CRISPR-based HIV diagnostics by analysing three interrelated domains: analytical performance, clinical performance, and operational utility. It reviews key analytical metrics such as limit of detection, precision, linearity, and robustness; clinical indicators including sensitivity, specificity, and predictive values across stages of infection; and operational considerations such as scalability, turnaround time, accessibility, and suitability for point-of-care deployment. The discussion highlights the advantages of CRISPR technologies in detecting viral RNA and DNA during acute infection and maintaining sensitivity despite HIV’s genetic diversity. At the same time, significant technical, regulatory, ethical, and health-system challenges remain, including validation standards, cost-effectiveness, data governance, and equitable access. Drawing lessons from existing population screening initiatives and diagnostic implementation frameworks, the paper underscores the importance of evidence-based policy design, sustainable financing, and integration with surveillance systems. Future directions include improving field readiness, user-centered design, digital reporting integration, and supportive regulatory pathways. Overall, CRISPR-based diagnostics could substantially enhance HIV screening strategies if their clinical performance, implementation feasibility, and policy alignment are systematically addressed.

Keywords: CRISPR-based diagnostics, HIV screening, Clinical validity and utility, Point-of-care testing and public health policy.

CITE AS: Kungu Erisa (2026). Clinical Validity and Utility of CRISPR-Based Diagnostics in HIV: Lessons for Population Screening and Policy Methods, Challenges, and Future Directions. RESEARCH INVENTION JOURNAL OF BIOLOGICAL AND APPLIED SCIENCES 6(1):1-7. https://doi.org/10.59298/RIJBAS/2026/611700