The Color HPV Test is a laboratory developed test (LDT) for HPV-testing in first-void urine. The test builds off of the FDA-approved BD OnclarityTM system, extending its use to self-collected first-void urine samples collected in the Novosanis Colli-pee urine collection device and DNA stabilization media. We’ve demonstrated through in vitro and clinical studies that this test is effective and reproducible in detecting and genotyping HPV high risk strains at the Color Diagnostics clinical laboratory.

Analytical validity: Color’s HPV test has been shown to be 94.4% accurate in detecting positive cases and 100% accurate in confirming negative results. This means that if you have a high risk strain of HPV, there's a 94.4% chance the test will detect it, and if you don't have a high risk strain of HPV, the test is 100% reliable in giving a negative result. See Color’s HPV Validation Report for further information.

Clinical validity: In 2014, a meta analysis found urine sampling to have a sensitivity of 89% and a specificity of 97% compared to HPV testing via cervical swabs.