Seegene-Anyplex™ II HPV HR test

Aim: Compatibility of the Seegene Anyplex™ II HPV HR test for testing first-void urine specimens

Partners: Seegene, University of Antwerp (VAXINFECTIO), Novosanis nv

Results from the Proof of Concept study will be presented via a poster at the HPV conference, February 2017, Cape Town

Samples from the IWT study: 22 HPV-positive women were included and each collected 8 UCM-preserved urine samples on 4 consecutive days (morning and late afternoon), using either the Colli-Pee™ or a regular urine cup. Therefore, 172 first-void urine samples were obtained, of which 88 Colli-Pee™ and 88 urine cup. DNA was extracted in-house and analyzed in-house (HPV 16 and human DNA TS qPCR), at AML (TS qPCR), at Heidelberg (HPV genotyping DiaMex), and using the Seegene AnyplexTM II HPV HR test.

Main results included:

• AnyplexTM II HPV HR assay detected each high-risk HPV without an invalidation using first-void urine as sample
• Good to very good agreement for high-risk HPV DNA positivity between the three analytical methods
  
  • AML/Anyplex TM II: agreement 86%, kappa 0.68 (CI95%0.56-0.80)
  • DiaMex/AnyplexTM II: agreement 93%, kappa 0.817 (CI95%0.72-0.92)

It was concluded that the AnyplexTM HPV HR assay is compatible with self-collected first-void urine.

Future studies will focus on clinical cut-off determination and demonstration of assay performance in larger populations.