Comparison of Colorimetric LAMP and PCR for High-risk HPV Detection: Implications for Cervical Cancer Screening.

OBJECTIVE: Cervical cancer, primarily caused by human papillomavirus (HPV) infection, is commonly detected using polymerase chain reaction (PCR)-based assays. However, these methods are time-consuming and require specialized instrumentation. This study evaluated the diagnostic performance of the loop-mediated isothermal amplification (LAMP) assay as a rapid alternative for HPV detection compared with conventional PCR testing. METHODS: This study included 933 nonpregnant women aged ≥19 years who underwent HPV testing for cervical cancer screening or follow-up. The HPV panel included 14 high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). Cervical swab samples underwent nucleic acid extraction followed by LAMP amplification using type-specific primers. Reactions were performed at 63 °C for 35 minutes, and results were interpreted colorimetrically (blue for positive, purple for negative). RESULTS: Compared with PCR, the LAMP assay showed a sensitivity of 97.8% (95% CI: 94.4-100.0) for HPV types 16 and 18 and 100.0% (95% CI: 98.8-100.0) for the remaining high-risk types. Specificity across all types was 100.0% (95% CI: 98.8-100.0). The overall diagnostic accuracy was 99.5% (95% CI: 99.0-100.0). When all 14 HPV types were analyzed collectively, clinical sensitivity and specificity were 99.4% and 100.0%, respectively. CONCLUSIONS: The LAMP assay provides a rapid, simple, and accurate method for HPV detection and may serve as a useful point-of-care screening tool, particularly in resource-limited settings.