Guidance

Cervical screening: acceptable HPV tests

Updated 24 November 2023

1. Introduction

The following high risk human papillomavirus (HPV) tests have been evaluated and accepted for use in the cervical screening programme for primary HPV screening and HPV triage of borderline and low grade abnormalities, and as a ’test of cure’ of treatment according to national protocols.

The HPV tests vary in terms of their level of automation and throughput, and laboratory providers will need to make an assessment of these factors relative to their requirements.

NHS Supply Chain has published the contract prices for test kits in an NHS Framework. Only test kits detailed in this guidance can be purchased through the framework.

HPV tests must be carried out according to protocols described in the manufacturer’s CE-IVD package insert. Any amendments to protocols must be approved by the programme prior to use. Programme approved amendments to protocols are detailed below.

Internal validation of a new test within the laboratory which elects to provide it is required for UKAS accreditation to ISO15189. The initial validation report must be submitted to the Chair of the Cervical Screening Laboratory Technology Subgroup via phe.screeninghelpdesk@nhs.net.

2. Abbott RealTime High-Risk HPV test

The Abbott RealTime High-Risk HPV test with the Abbott m2000 system can be used with Hologic ThinPrep LBC or BD SurePath LBC samples (either from the original SurePath collection vial or the remaining cell pellet sample after cytological processing, with the volume adjusted to 6ml using SurePath preservative – in accordance with the manufacturer’s instructions for use (IFU)). An alternative approved pre-processing method to that described in the manufacturer’s IFU involves placing the tube containing the cell pellet sample (volume adjusted to 6ml in the original gradient tube) directly on the m2000 system.

Contact Abbott to arrange calibration of m2000 racks before using this method.

Automated pre-processing of Hologic ThinPrep LBC samples and BD SurePath LBC samples using the Tecan Evo Freedom prior to the Abbott m2000 is also approved. New BD SurePath LBC vials are yet to be approved for use with the Tecan Evo Freedom.

3. BD Onclarity HPV test

The BD Onclarity HPV test can be used with BD SurePath LBC (sample from the original SurePath collection vial) or Hologic ThinPrep LBC samples performed on the BD Viper LT System or BD COR ^TM system

4. Cepheid Xpert HPV test

The Cepheid Xpert HPV test can be used with Hologic ThinPrep LBC samples performed on the Cepheid GeneXpert Dx System or GeneXpert Infinity System.

5. Hologic Aptima HPV test

The Hologic Aptima HPV test using the Panther system can be used with Hologic ThinPrep LBC or BD SurePath LBC (sample from the original SurePath collection vial). HPV triage and test of cure samples in BD Surepath LBC should be transferred to an Aptima Specimen Transfer tube within 28 days of collection. Primary HPV samples should be transferred to an Aptima Specimen Transfer tube within 7 days of collection. LBC transferred to an Aptima Specimen Tube should be tested on the Panther within 7 days.

The automated TomCat ATS protocol is approved for routine processing of BD SurePath LBC samples. The new BD SurePath vials, with the addition of a new plastic structure inside the vial and minor changes to the lid and container design, are not compatible with the TomCat. They are therefore not approved for use. The automated TomCat is approved for aliquoting Hologic ThinPrep LBC samples prior to testing on the Panther.

6. 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 Hologic ThinPrep LBC samples or the remaining BD SurePath LBC cell pellet obtained after cytological processing, using a 2 RLU cut-off. Sample preparation for BD SurePath LBC uses the manual method only in accordance with the manufacturer’s IFU.

The use of the Qiagen AXpH DNA kit or HPV Media Kit on the QIAsymphony for routine processing of Hologic ThinPrep LBC samples is approved for the Hybrid Capture 2 test. The automated QIAsymphony is not currently CE marked for processing BD SurePath LBC samples.

7. Roche Cobas 4800 HPV system

The Roche Cobas 4800 HPV test can be used with Hologic ThinPrep LBC or BD SurePath LBC samples (using sample from the original SurePath collection vial) in accordance with the manufacturer’s IFU.

Treatment of all SurePath HPV triage and test of cure samples with Cobas Sample Prep Buffer is required. This must be performed manually due to insufficient sample for the P480 pre-analytical system.

Treatment of all SurePath primary HPV samples with Cobas Sample Prep Buffer is required and can be performed on the Roche P480 pre-analytical system. Both new and old BD SurePath LBC vials are approved on the Roche P480.

The P480 is also approved for de-capping and capping of Hologic ThinPrep LBC samples which can then be directly placed on the Cobas 4800. Alternatively, the P480 can be used to aliquot ThinPrep into secondary tubes prior to testing on the Cobas 4800.

8. Roche Cobas 6800/8800 systems

The Roche Cobas 6800/8800 HPV test can be used with Hologic ThinPrep LBC samples or BD SurePath LBC samples (using sample from the original SurePath collection vial) in accordance with the manufacturer’s IFU.

The P480 is approved to aliquot ThinPrep into secondary tubes prior to testing on the Cobas 6800/8800.

Treatment of all SurePath HPV triage and test of cure samples with Cobas Sample Prep Buffer is required. This must be performed manually due to insufficient sample for the P480 pre-analytical system.

Treatment of all SurePath primary HPV samples with Cobas Sample Prep Buffer is required and can be performed on the Roche P480 pre-analytical system. Both new and old BD SurePath LBC vials are approved on the Roche P480.

9. Abbott Alinity m High-Risk HPV assay

The Abbott Alinity m High-Risk HPV assay can be used on the Alinity mp pre-analytical platform and the Alinity m system.