1/27/2024 0 Comments Lbc package tracking number sample![]() ![]() 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. The automated TomCat ATS protocol is approved for routine processing of BD SurePath LBC samples. LBC transferred to an Aptima Specimen Tube should be tested on the Panther within 7 days. Primary HPV samples should be transferred to an Aptima Specimen Transfer tube within 7 days of collection. ![]() 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. 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). The Cepheid Xpert HPV test can be used with Hologic ThinPrep LBC samples performed on the Cepheid GeneXpert Dx System or GeneXpert Infinity System. 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. New BD SurePath LBC vials are yet to be approved for use with the Tecan Evo Freedom. 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.Ĭontact Abbott to arrange calibration of m2000 racks before using this method.Īutomated 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. 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)). The initial validation report must be submitted to the Chair of the Cervical Screening Laboratory Technology Subgroup via 2. Internal validation of a new test within the laboratory which elects to provide it is required for UKAS accreditation to ISO15189. Programme approved amendments to protocols are detailed below. Any amendments to protocols must be approved by the programme prior to use. ![]() ![]() HPV tests must be carried out according to protocols described in the manufacturer’s CE-IVD package insert. Only test kits detailed in this guidance can be purchased through the framework. NHS Supply Chain has published the contract prices for test kits in an NHS Framework. 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. 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. ![]()
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