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.