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
The Qiagen Hybrid Capture 2 High-Risk HPV DNA test (manual or Rapid Capture System) can be used 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 HC2 test.
Abbott RealTime High Risk HPV test
The Abbott RealTime High Risk HPV test can be used 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 6mls 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 6 ml 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
You can use the Roche Cobas 4800 HPV system with ThinPrep LBC or SurePath LBC (sample from the original SurePath collection vial), where SurePath samples have been transported/stored at room temperature for up to 28 days. The pre-treatment step described by Roche is not needed when testing samples older than 14 days. The Cobas p480 is approved for decapping and capping of ThinPrep or SurePath before testing on the Cobas 4800. Only ThinPrep vials can be directly placed on the Cobas 4800.
Hologic Aptima HPV Assay
Hologic Aptima HPV Assay using the Tigris or Panther system can be used with ThinPrep LBC or SurePath LBC (sample from the original SurePath collection vial), where SurePath samples have been transported/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 use of the automated TomCat ATS protocol for routine processing of SurePath samples prior to testing on the Tigris or Panther has interim approval. The automated TomCat is fully approved for aliquoting ThinPrep samples prior to using the Tigris or Panther.
Hologic Cervista HPV HR test
You can use the Hologic Cervista HPV HR test with ThinPrep LBC samples on semi-automated platform
BD Onclarity HPV test.
You can use the BD Onclarity HPV test with SurePath samples performed on the BD Viper LT System.
Cepheid Xpert HPV assay
You can 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.