HPV DNA PCR, Vaginal Self-Coll

HPVDNA

14263

1 ThinPrep® vial sample collected with COPAN FLOQSwab 552C.RM

1.5 mL

1 ThinPrep vial sample collected with Evalyn Brush

Patient should follow instructions provided with the self-collection device.

The collection device should be immediately transferred to ThinPrep following provided instructions.

ThinPrep® vial

Room temperature

Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable

Copan Swab not suspended in ThinPrep • Evalyn Brush not suspended in ThinPrep • SurePath™ pellet • Samples treated with Acetic Acid • Cervical sources • Samples from patients who have undergone hysterectomy • Swab in vial • Patients less than 21 years of age

All shifts Daily

2-5 days

This test is used for the detection of high-risk Human Papillomavirus in self-collected vaginal samples and can be used as part of an HPV primary screening algorithm. The test detects high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, which are reported out as HPV 16, HPV 18, and other high-risk HPV types which includes, but does not differentiate, the remaining 12 high- risk types. Interim guidance supports the use of an HPV primary screening algorithm, where high-risk HPV testing is used as a first line screen, in women ≥25 years of age [1].

In patients for whom cervical sampling is either contraindicated or a cervical sample cannot otherwise be obtained, vaginal samples can be self-collected within a healthcare setting where samples can be processed by trained personnel. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.

1. Huh WK, Ault KA, Chelmow D, et al. Use of primary high- risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol. 2015;125(2):330-337. doi:10.1097/AOG.0000000000000669