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Sample-to-Answer, Point-of-Care HPV DNA Test Feasible

Test requires six user steps and gives answer in 45 minutes

By Elana Gotkine HealthDay Reporter

TUESDAY, June 27, 2023 (HealthDay News) — A sample-to-answer, point-of-care human papillomavirus (HPV) DNA test is feasible and can be performed by minimally trained personnel, according to a study published online June 21 in Science Translational Medicine.

Kathryn A. Kundrod, Ph.D., from Rice University in Houston, and colleagues developed a prototype, sample-to-answer, point-of-care test for HPV16 and HPV18 DNA, relying on isothermal DNA amplification and lateral flow detection. All test components were integrated into a low-cost, manufacturable platform, and performance of the test was assessed with synthetic samples, provider-collected clinical samples in a high-resource setting in the United States, and self-collected samples from a low-resource setting in Mozambique.

The researchers found that the clinically relevant limit of detection was 1,000 HPV16 or HPV18 DNA copies per test. Six user steps were required for the test, and results were yielded in 45 minutes. The test can be performed using a benchtop instrument and minicentrifuge by personnel with minimal training. The projected costs were less than $5 per test and less than $1,000 for instrumentation.

“By demonstrating an effective solution to integrate sample preparation, isothermal amplification, and lateral flow detection that is appropriate for use in resource-limited settings, this work represents a major step toward a cervical cancer screening test that could be translated to clinical use in resource-limited settings and implemented at scale,” the authors write.

Two authors disclosed ties to the biopharmaceutical industry.

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