Guidance

Cervical screening: approved HPV tests for HPV triage and test of cure

The NHS Cervical Screening Programme (NHSCSP) considers these high risk HPV tests acceptable for use within screening for HPV triage and test of cure.

The NHS Cervical Screening Programme (NHSCSP) considers the high risk HPV tests listed here as acceptable for use within screening for HPV triage and test of cure.

HPV tests must be carried out according to the manufacturer’s CE-marked package insert. NHSCSP-approved amendments to a protocol are included below. Any additional amendments to a protocol must be first approved by NHSCSP.

Qiagen Hybrid Capture 2 High-Risk HPV DNA test

Use the Qiagen Hybrid Capture 2 High-Risk HPV DNA test (manual or Rapid Capture System) with ThinPrep LBC or remaining SurePath LBC cell pellet obtained after cytological processing, and using a 2 RLU cut-off. Sample preparation for SurePath LBC uses the manual method only as per kit insert. The automated QIAsymphony is not currently CE marked for SurePath. The use of the Qiagen AXpH DNA kit or HPV Media Kit on the QIAsymphony for routine processing of ThinPrep samples is now acceptable before the Hybrid Capture 2 test.

Abbott RealTime High-Risk HPV test

Use the Abbott RealTime High-Risk HPV test with the m2000sp/rt protocol with ThinPrep LBC or SurePath LBC (either from the original SurePath collection vial or the remaining cell pellet sample after cytological processing, volume adjusted to 6ml with SurePath preservative – as per kit insert). An alternative pre-processing method to that described in the kit insert and approved by NHSCSP is to place the tube containing the cell pellet sample (volume adjusted to 6ml in the original gradient tube) directly on the m2000sp instrument. Contact Abbott to arrange calibration of m2000sp racks before using this method. Automated pre-processing of SurePath samples using the Tecan Evo Freedom for the Abbott m2000 is also approved. New BD SurePath vials still require approval for use with the Tecan Evo Freedom.

Roche Cobas 4800 HPV system

Use the Roche Cobas 4800 HPV test with ThinPrep LBC or SurePath LBC (sample from the original SurePath collection vial), where SurePath samples have been transported and stored at 2 to 30°C for up to 42 days. Treatment of the sample with cobas Sample Prep Buffer is NOT required if samples are tested within 28 days. Manual treatment is required for samples tested between day 29 and 42. The P480 is approved for decapping and capping of ThinPrep and can be directly placed on the Cobas 4800.

Hologic Aptima HPV Assay

Use the Hologic Aptima HPV Assay using the Tigris or Panther system with ThinPrep LBC or SurePath LBC (sample from the original SurePath collection vial), where SurePath samples have been transported and stored at room temperature for up to 28 days. SurePath samples can be pre-treated using either the manual PACE 2 Fast Express kit prior to testing on the Tigris or the Aptima Transfer Solution (ATS) kit prior to testing on the Tigris or Panther. The automated TomCat ATS protocol is approved for routine processing of SurePath samples prior to testing on the Tigris or Panther. This does not include new BD SurePath vials. The automated TomCat is fully approved for aliquoting ThinPrep samples prior to using the Tigris or Panther.

Hologic Cervista HPV HR test

Use the Hologic Cervista HPV HR test with ThinPrep LBC samples on semi-automated platform

BD Onclarity HPV test.

Use the BD Onclarity HPV test with SurePath and ThinPrep samples performed on the BD Viper LT System.

Cepheid Xpert HPV assay

Use the Cepheid Xpert HPV assay with ThinPrep samples performed on the Cepheid GeneXpert Dx System or GeneXpert Infinity System.

NHS Supply Chain has published the contract prices for test kits in an NHS Framework. Only test kits with NHS CSP approval can be purchased through the framework.

Published 25 January 2017