USER MANUAL - NHS Lothian Laboratory Medicine
Contents
1. 2009 Special Report Policy A review of human carcinogens part B biological agents Lancet Oncol10 4 321 322 Schiffman et al 2009 Classification of weakly carcinogenic Human Papillomavirus types addressing the limits of epidemiology at the borderline Infectious Agents and Cancer 4 8 Bernard et al 2010 Classification of papillomaviruses based on 189 PV types and proposal of taxonomic amendments Virology 401 70 79 Li et al 2011 Human Papillomavirus type distribution in 30 848 invasive cervical cancers worldwide variation by geographical refion histological type and year of publication International Journal of Cancer 128 927 935 Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 gt OO ms 10 REPORTING OF RESULTS Written reports are issued and sent to the requesting consultant via the Royal Mail Transfer of scanned reports via email can be arranged provided the account is appropriate for secure transfer eg nhs net Transfer of surveillance results will be performed directly through ECOSS If requested results can be telephoned in advance of the report by a senior member of SHPVRL For advice and interpretation please contact Dr Kate Cuschieri or Dr Ingo Johannesen using contact details in Section 3 HPV results associated with test of cure SCSP are disseminated through the national IT management tool for cervical screening the Scottish Cer2. R HPVGYNREQF Version 3 Issue date 19 06 12 Review date 19 06 14 Human Papillomavirus HPV Test Request Form for GYNAE Scottish Human Papillomavirus Reference Laboratory Specialist Virology Centre Royal Infirmary of Edinburgh 51 Little France Crescent Edinburgh EH16 4SA FROM Sending Laboratory Consultant Name Address Tel PATIENT DETAILS Name Date of Birth CHI Sex M F Hospital Laboratory reference number Date amp time sample taken Date posted SPECIMEN TEST REQUIRED LJ Cervical liquid based cytology sample L High risk HPV screening Genotyping L12 x 10 um section of fixed biopsy L Genotyping Biopsy site PLEASE NOTE THAT OTHER BIOSPECIMEN TYPES CAN ONLY BE ACCEPTED AFTER PRIOR DISCUSSION WITH SHPVRL REASON FOR REQUEST Referral from routine screening due to problems with cervical cytology Q Older 9 who have not exited the SCSP at 60 years because of continuing LG disease O Patients where there is difficulty obtaining a Liquid based cytology sample e g Immunosuppression Al disease Referral following problems associated with colposcopy visits O Persistent LG BNA or mild abnormality after 22 treatments amp where fertility conservation is an issue O Postmenopausal with persistent LG smears attending Colposcopy given HRT if colp inadequate difficulty identifying SCJ where LETZ shown no histological abnormality amp vaginal colposcopic assessment
3. Roche depending on number genotyping of requests Cervical LBC samples HPV type InnoLipa HPV Genotyping Test Weekly to fortnightly 15 days specific Innogenetics depending on number genotyping of requests Biopsy Samples HPV type Multimetrix Multiplex HPV Weekly to fortnightly 15 days specific Genotyping Kit Progen depending on number genotyping of requests Biopsy Samples Turnaround time excludes weekends and public holidays a Detection Range 16 18 31 33 35 39 45 51 52 56 58 59 68 b Detection range HPV 6 11 1618 26 31 33 35 39 40 42 45 51 52 53 54 55 56 58 59 61 62 64 66 67 68 69 70 71 72 73 81 82 83 84 HPVIS38 HPV CP6108 c Detection range 6 11 16 18 26 31 33 35 39 40 43 44 45 51 52 53 54 56 58 59 66 68 69 70 71 73 74 d Detection range 6 11 16 18 26 31 33 35 39 42 43 44 45 51 52 53 56 58 59 66 68 70 73 82 Depending on the nature of the request HPV typing on biopsy samples may be performed using a combination of the InnoLipa and or the Multimetrix HPV test For risk status associated with the types please see section 9 Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 7 FACTORS AFFECTING PERFORMANCE OF HPV TEST The yield and quality of nucleic acid in cervical liquid based cytology samples collected in PreservCyt is high Degradation fragmentation of nucleic acid can however impair th
4. be accepted after prior discussion with a senior member of SHPVHL High risk HPV detection consensus testing or screening HPV genotyping type specific detection Cervical Liquid Based Cytology LBC sample in PreservCyt amp Media in original LBC container According to preference of the sending lab if cytological assessment is to be performed on the LBC sample a 5 ml prequot can be removed prior to cytology processing and placed in separate screw cap sterile container For biopsies 2 10 um sections of Formalin Fixed Paraffin Embedded Material placed in 2 separate sterile 2 ml screw cap tubes OR Cervical Liquid Based Cytology sample in PreservCyt Media in original LBC container According to preference of the sending lab if cytological assessment is to be performed onthe LBC sample a 5 ml prequot can be removed prior to cytology processing and placed in separate screw cap sterile container If the original LBC container is sent please ensure it is not required for any aspect of the cytopathology process at the sending laboratory SHPVRL is not responsible for returning original LBC samples to the sending laboratory If prequot is sent for an individual clinical request ensure container is labelled according to section 5 2 If sending paraffin sections it is essential to refer to Protocol for sectioning paraffin blocks at source laboratory in this user manual Paraffin sectio
5. is negative O HIV ve patients with persistent LG abnormalities where knowledge of HR HPV ve status would allow expectant observational management Exceptional cases not included above where knowledge of HPV status will influence management these cases must be discussed at Colposcopy MDT Discussed Date For further information please contact Dr Kate Cuschieri on 0131 242 6039 or Dr Ingo Johannessen on 0131 242 6003 SHPVRL LAB USE ONLY Date Received Comments Test code s Author K Cuschieri Page Author K Cuschieri amp C Moore PD MOL R LUSERHBK HPV Version 3 3 Issue date 19 06 12 APPENDIX 2 Review date 19 08 14 PD MIC R HPVNONGYNREQF Version 3 Issue date 19 06 12 Review date 19 06 14 Human Papilloma Virus HPV Test Request Form for non GYNAE Scottish Human Papillomavirus Reference Laboratory Specialist Virology Centre Royal Infirmary of Edinburgh 51 Little France Crescent Edinburgh EH16 4SA FROM Sending Laboratory Consultant Name Address Tel PATIENT DETAILS Name Date of Birth CHI Sex M F Hospital Laboratory reference number Date time sample taken Date posted SPECIMEN TEST REQUIRED 2x 10 um section of fixed biopsy High risk HPV screening Genotyping Is this an Oropharyngeal Biopsy Yes No If not an Oropharyngeal Biopsy specify site Please note that biopsies from outside the oropharynx should
6. 4800 HPV test Roche and the PreTect HPV Proofer Most HPV tests are DNA based consensus assays but the APTIMA assay is an mRNA based screening assay and the PreTect Proofer is a type specific mRNA assay All new tests are subjected to validation of the technology evaluation of performance and effectiveness for specific service requirements Users would be informed of any changes made in tests relating to service in advance of the next version of this user manual Costs associated with HPV testing For NHS Boards in Scotland Finite funding has been allocated for diagnostic HPV tests relating to requests from NHS Boards in Scotland Thus tests are free for referrals from NHS Boards in Scotland until the allocation which is reviewed on a yearly basis is fully utilised For NHS Boards outwith Scotland and for Private Institutions Costs have been calculated for non Scottish NHS Boards and private providers Hequests for undertaking HPV testing in these situations must be discussed with Dr Cuschieri before sending specimens Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 5 SUBMISSION OF SPECIMENS Individual Clinical Requests 5 1 Request form All specimens must be accompanied by the appropriate request form Please complete the relevant SHPVRL request form for either gynaecological or non gynaecological requests Both forms can be found in appendix 1 and 2 of
7. Cook F Hogg L Robertson C and Cubie H 2011 Urine testing as a surveillance tool to monitor the impact of HPV immunization programs Journal of Medical Virology 83 11 1983 7 O Leary MC Sinka K Robertson C Cuschieri K Lyman R Lacey M Potts A Cubie HA Donaghy M HPV type specific prevalence using a urine assay in unvaccinated male and female 11 to 18 year olds in Scotland Br J Cancer 2011 104 1221 1226 Kitchener HC Blanks R Cubie H Desai M Dunn G Legood R Gray A Sadique Z Moss S MAVARIC Trial Study Group MAVARIC a comparison of automation assisted and manual cervical screening a randomised controlled trial Health Technol Assess 2011 15 8 ii iv xxi 1 170 Kitchener HC Blanks R Dunn G Gunn L Desai M Albrow R Mather J Rana DN Cubie H Moore C Legood R Gray A Moss S Automation assisted versus manual reading of cervical cytology MAVARIC a randomised controlled trial Lancet Oncol 2011 12 56 84 Fagan EJ Moore C Jenkins C Rossouw A Cubie HA James VL External quality assessment for molecular detection of human papillomaviruses J Clin Virol 2010 48 251 254 Cuschieri K Brewster DH Williams AR Millan D Murray G Nicoll S Imrie J Hardie A Graham C Cubie HA Distribution of HPV types associated with cervical cancers in Scotland and implications for the impact of HPV vaccines Br J Cancer 2010 102 930 932 Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issu
8. PD MOL R USERHBK_HPV Version 3 Issue date 19 06 12 Review date 19 06 14 Scottish HPV Reference Laboratory SHPVRL Author K Cuschieri amp C Moore NHS Lothian E ir M i T T E mo locur hich is uncontrolled n printed i UE p pp CONTENTS Glossary Purpose Scope of service Contact details amp hours of work HPV tests offered Submission of specimens HPV types detected with different HPV tests Factors affecting performance of HPV test Additional tests Definition of high risk and low risk HPV types Reporting of results Laboratory accreditation External quality assurance schemes SHPVRL and research and development Selected publications Appendix 1 Appendix 2 Appendix 3 PD MOL R USERHBK HPV Version 3 Iss date 19 06 12 Rev date 19 06 14 Page 2 Page 3 Page 3 Page 4 Page 5 Page 7 Page 9 Page 10 Page 11 Page 12 Page 15 Page 15 Page 15 Page 16 Page 17 Page 19 Page 20 Page 21 Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Iss ate 19 06 12 jate 19 06 14 Re GLOSSARY HPV HPS LBC SCSP ECOSS NATS SCCRS FFPE NEQGAS QCMD FDA CE IARC PV Human Papillomavirus Health Protection Scotland Liquid Based Cytology Scottish Cervical Screening Programme Electronic Communication of Surveillance in Scotland Nucleic Acid tests Scottish Cervical Call Recall System Formalin Fixed Paraffin Embedded Natio
9. Probably high risk or query high risk High risk High risk High risk High risk Low risk Low risk Low risk Low risk High risk High risk High risk High risk or Probably high risk or query high risk Low risk Low risk High risk High risk High risk Low risk Low risk High risk or Probably high risk or query high risk High risk or Probably high risk or query high risk High risk or Probably high risk or query high risk Most potent type Risk of cancer an order of magnitude higher compared to other Group 1 high risk types Subtype of HPV 44 Subtype of 34 Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 Table 3 Continued Probably High risk 69 5 Possibly High risk or Probably high risk or query high risk 70 7 Possibly High risk or Probably high risk or query high risk 71 14 Unlikely Low risk 72 3 Unlikely Low risk 73 11 Possibly High risk or Probably high risk or query high risk 74 10 Unlikely Low risk 81 3 Unlikely Low risk 82 5 Possibly High risk or Probably high risk or query high risk 83 3 Unlikely Low risk 84 3 Unlikely Low risk HPVIS1 5 Possibly High risk or Probably high risk or Subtype of HPV 82 39 query high risk HPV 3 Unlikely Low risk or query risk Candidate HPV 89 CP6108 The table has been constructed from the following sources De Villiers et al 2004 Classification of papillomavirus Virology 324 17 27 Bouvard V et al
10. be discussed with SHPVRL prior to submission p16 Status of specimen Pos Neg Unclear Not done Will p16 Staining be performed Yes No If p16 staining is to be performed please let SHPVRL know the result when available REASON FOR REQUEST All cases must be discussed at multi disciplinary team meet Discussed Date For further information please contact Dr Kate Cuschieri on 0131 242 6039 or Dr Johannessen on 0131 242 6003 SHPVRL LAB USE ONLY Date Received Comments Test Code Author K Cuschieri Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Q APPENDIX 3 T Protocol for sectioning paraffin blocks at source laboratory 1 Ensure microtome and surrounding area are cleaned thoroughly recommended cleaner microsol wipes and that howie coat and gloves are worn throughout the procedure Select the relevant FFPE block and face up to ensure even surface Using a fresh blade take 10 um section and place into a 2 ml DNAse RNAse free screw cap tube eg sarstedt tube or eppendorf Using a new blade take and additional 10 um section and place into a second Screw cap sarstedt tube Tubes containing the section should be labelled with Surname Forename CHI and DOB as instructed in section 5 2 If sending a section to SHPVRL for the first time use an additional third new blade to section a blank paraffin block containing no tissue a
11. cal disease prevention are available and address future service delivery e Assay evaluation and development in conjunction with NHS academic and industrial partners Acting as clinical laboratory partners for external basic research collaborations In pursuit of the above staff at SHPVRL work closely with the HPV Research Group in the University of Edinburgh which hosts the National HPV archive for research related to cervical cancer prevention SHPVHL was actively involved in the founding of the Scottish HPV Investigators Network SHINe and in its continuing activities SHINe is a cross disciplinary forum aimed to engender and deliver collaborative research on HPV For further details please see the SHINe Website www shine mvm ed ac uk Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 amp 14 SELECTED PUBLICATIONS Junor E Kerr G Oniscu A Campbell S Kouzeli I Gourley C and Cuschieri K 2012 Benefit of chemotherapy as part of treatment for HPV DNA positive but p16 negative squamous cell carcinoma of the oropharynx British Journal of Cancer 106 2 358 65 Sinka K Lacey M Robertson C Kavanagh K Cuschieri K Nicholson D and Donaghy M 2011 Acceptability and response to a postal survey using self taken samples for HPV vaccine impact monitoring Sexually Transmitted Infections 87 7 548 52 Cuschieri K Nandwani R McGough P
12. e date 19 06 12 Review date 19 06 14 Mesher D Szarewski A Cadman L Cubie H Kitchener H Luesley D Menon U Hulman G Desai M Ho L Terry G Williams A Sasieni P Cuzick J Long term follow up of cervical disease in women screened by cytology and HPV testing results from the HART study Br J Cancer 2010 27 1405 1410 Cairms N Cuschieri KS Cubie HA Cruickshank ME High risk HPV genotyping in the follow up of women treated conservatively for microinvasive cervical cancer Int J Gynecol Cancer 2010 Jan 20 1 154 7 Hardie A Moore C Patnick J Cuschieri K Graham C Beadling C Ellis K Frew V Cubie HA High risk HPV detection in specimens collected in SurePath preservative fluid comparison of ambient and refrigerated storage Cytopathology 2009 20 235 241 Cuschieri K Wentzensen N Human papillomavirus mRNA and p16 detection as biomarkers for the improved diagnosis of cervical neoplasia Cancer Epidemiol Biomarkers Prev 2008 17 2536 2545 Review Kitchener H Nelson L Adams J Mesher D Sasieni P Cubie H Moore C Heard Agarossi A Casolati E Denny L Bradbeer C Lyons F Beattie G Niemiec T Colposcopy is not necessary to assess the risk to the cervix in HIV positive women an international cohort study of cervical pathology in HIV 1 positive women Int J Cancer 2007 121 2484 2491 Author K Cuschieri amp C Moore PD MOL R LUSERHBK HPV Version 3 qud Issue date 19 06 12 7 j Review date 19 06 14 PD MIC
13. e performance of the HPV NATs Degradation is more associated with paraffin embedded material than with liquid based cytology samples particularly where these have been stored in excess of 2 years The genotyping assays used by SHPVRL incorporates amplification of a human DNA gene to control for sample quality Thus if a sample tests HPV negative and is also negative for the human DNA gene a result of invalid is generated The Hybrid Capture 2 screening test does not incorporate a human cellular control For laboratories sending paraffin sections it is essential to refer to the protocol for sectioning paraffin blocks at source laboratory See Appendix 4 As the downstream HPV test used for FFPE sections is very sensitive we ask laboratories to send a section from a blank block if sending a section for diagnostic HPV testing to SHPVRL for the first time to monitor any potential environmental contamination Testing of blank sections is monitored to inform frequency of additional requests for blank sections Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 8 ADDITIONAL TESTS SHPVRL decision SHPVRL may perform a confirmatory HPV test on a specimen beyond that requested by the user if we consider that it would aid interpretation and be of benefit to the user An example would be performing an HPV genotyping test on a sample we received for high risk HPV
14. h Cervical Screening Programme SCSP To this end SHPVRL currently performs HPV testing as a test of cure of treatment Following an early implementation phase across part of Scotland test of cure was rolled out from the 30th April in 2012 Standard Operating Procedures for the delivery of HPV testing services for test of cure service have been developed between SHVPRL and the Scottish Cytology Laboratories For further information on this service please contact SHPVRL page 4 SHPVRL collaborates with partners including UK NEGAS and the English Cervical Screening Programme in the preparation of material for HPV quality assurance and validation schemes Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 amp 3 CONTACT DETAILS AND HOURS OF WORK Please contact Dr Kate Cuschieri for advice on HPV testing For administration purposes please contact Mrs Evelyn Wallace Name and Designation Director Dr Kate Cuschieri Medical Consultant Dr Ingo Johannessen Advanced Biomedical Scientist Mrs Catherine Moore Specialist Biomedical Scientist Miss Alison Fleming Associate Clinical Scientist Dr Christopher Ward Biomedical Support Worker Mr Norman Stenhouse Administrator Mrs Evelyn Wallace Departmental confidential fax Royal Mail Postal Address Telephone numbers and Email address 0131 242 6039 Kate Cuschieri luht scot nhs uk 0131 242 6003 Ingo Joha
15. nal External Quality Assurance Scheme Quality Control in Molecular Diagnostics Food and Drug Administration Certificate European International Agency of Research on Cancer Papillomavirus Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 amp 1 PURPOSE The Scottish Human Papillomavirus Reference Laboratory SHPVRL is commissioned by Health Protection Scotland HPS to provide a comprehensive service for screening and typing of Human Papillomavirus HPV amp 2 SCOPE OF SERVICE To provide testing services to evaluate the impact of the HPV immunisation programme on the incidence and prevalence of HPV related disease and HPV infection in the Scottish population To provide a specialist diagnostic and expert advice service in relation to HPV for specific clinical cases where it could help inform clinical management To provide education and training for the wider service and develop and validate new HPV technologies carry out quality control and external quality assurance and act as a base for research and development To contribute to the data and knowledge of changing epidemiology of HPV associated disease to help inform the future organisation of services to prevent cervical disease and cancer Other elements HPV testing for the Scottish Cervical Screening Programme SCSP SHPVRL also provides information advice and testing services for the Scottis
16. nd place in a separate tube This will be tested to exclude potential environmental contamination If a regular requestor you may be asked to send additional blank sections intermittently SHPVRL will contact you with details Author K Cuschieri amp C Moore
17. nnessen luht scot nhs uk 0131 242 6005 Catherine Moore luht scot nhs uk 0131 242 6020 Alison Fleming luht scot nhs uk 0131 242 6020 ChristopherWard nhslothian scot nhs uk 0131 242 6020 Norman StenhouseGluht scot nhs uk 0131 242 6010 Evelyn Wallaceenhslothian scot nhs uk 0131 242 6008 Scottish Human Papillomavirus Reference Laboratory SHPVRL Division of Laboratory Medicine Microbiology Department Edinburgh Royal Infirmary 51 Little France Crescent Edinburgh EH16 4SA Hays DX Address Dx number 6231202 Exchange depot Edinburgh 96 EH Hours of work Core laboratory hours are 9am 5pm Monday to Friday SHPVRL does not currently offer an out of hours service Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 4 HPV TESTS OFFERED 44 For diagnostic testing SHPVRL can perform HPV screening and or genotyping where an HPV result would be clinically relevant and influence individual patient management All detection assays used currently at SHPVRL are nucleic acid tests NATS see section 6 Table 2 Current assays used for diagnostic testing are For high risk HPV detection consensus testing of a group of high risk types Digene Hybrid Capture 2 HPV Test Qiagen This assay is approved by the US Food and Drug Administration and is CE marked For type specific genotyping Roche linear array HPV Genotyping Test Roche Molecular Systems i
18. ns of tissue in other fixatives eg Bouin s solution and fresh tissue are not accepted for HPV testing If the original LBC container is sent please ensure it is not required for any aspect of the cytopathology process at the sending laboratory SHPVRL is not responsible for returning original LBC samples to the sending laboratory If prequot is sent for an individual clinical request ensure container is labelled according to section 5 2 Please note that regarding samples associated with the national test of cure service SHPVRL do not require a request form these samples come directly from scottish cytology laboratories with whom standard protocols have been set up Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 6 HPV TYPES DETECTED WITH DIFFERENT HPV TESTS Different commercial HPV tests are designed to detect a specific range of HPV types dependent on the technology used and the primer probe range incorporated These are detailed in Table 2 Table 2 Type ranges of HPV tests performed High risk Digene Hybrid Capture 2 HPV 1 2 x Weekly 10 working days HPV test This is a CE marked FDA individual clinical detection approved assay which detects requests consensus 13 high risk HPV types in testing aggregate 5 working days cervical LBC test of cure samples HPV type Linear Array HPV Genotyping Weekly to fortnightly 15 days specific test
19. s to accrue and as a consequence the classifications refine In addition attribution of risk for rare types is challenging 9 2 Categorisation of HPV types according to standardised grouping system for human carcinogens In 2009 an expert working group at the International Agency for Research on Cancer IARC endeavoured to categorise HPV types according to a standardised grouping system for human carcinogens thus Group 1 Carcinogenic to humans Group 2A Probably carcinogenic to humans Group 2B Possibly carcinogenic to humans Group 3 Not classifiable as to its carcinogenicity in humans Table 3 shows the HPV types incorporated into the genotyping assays used at SHPVRL their associated carcinogenic group according to IARC and risk status according to current evidence expert opinion Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 Table 3 Carcinogenic potential risk status of HPV types detected in assays used at 11 16 18 26 31 33 35 39 40 42 41 43 45 51 52 53 54 55 56 58 59 61 62 64 66 67 SHPVRL 6 10 10 9 uo aN o 0 2 0 N O O O o o o N eres sn pes qe lal Unlikely Unlikely Yes Yes Possibly Unlikely Unlikely Unlikely Unlikely Possibly Unlikely Unlikely Unlikely Unlikely Possibly Possibly Possibly Low risk Low risk High risk High risk High risk or
20. s used This assay is CE marked and is used for genotyping of liquid based cytology samples For biopsy samples the test used will be according to the nature of the request but could incorporate the Innogenetics Innolipa HPV test and or the Multimetix Multiplex HPV Genotyping test Progen Detailed information on characteristics of tests and appropriate bio specimens for submission can be found in Tables 1 and 2 respectively For further information on HPV risk status please see Section 9 4 2 Assays used for Surveillance Testing SHPVRL performs HPV genotyping of biopsy material cervical liquid based cytology samples and self collected specimens using a luminex multiplex assay in line with the National Surveillance System for HPV infection and related disease in Scotland d 15th October 2008 Results of surveillance testing are communicated directly to Health Protection Scotland via ECOSS Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 4 3 Assays Under Evaluation SHPVRL has a role in evaluating the performance of new HPV tests with a mind to establishing which may be suitable for clinical use and or research and development going forward Consequently several in house amp commercial HPV tests are under evaluation including In house real tine PCR the rtHPV assay Abbott the APTIMA HPV assay GenProbe the CerVista HPV assay Hologic the cobas
21. screening which screened positive For these cases results would be aggregated in one report User requests For users who wish to organise an additional examination on a sample these may may not be possible depending on the nature of the request and the amount of residual specimen remaining There is no defined time limit for requesting additional examinations but if the request is possible their performance may affect the stated turnaround table 2 Turnaround is based on when the specimen request was initially received All additional assays whether generated in house or requested by users will be adjudicated on a case by case basis by a senior member of SHPVRL Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 9 DEFINITION OF HIGH RISK AND LOW RISK HPV TYPES dde A 91 Overview of classification HPV types are often categorised as high or low risk according to the strength of their association with cancer All HPV genotypes that are known to be cervical carcinogens belong to the alpha genus Within the alpha genus species groups which unite related types which have been found to contain high risk types are alpha 5 alpha 6 alpha 7 alpha 9 and alpha 11 The evidence base which has informed the risk classifications is drawn from worldwide surveys of HPV type distribution in high grade cervical lesions and cancers This evidence base continue
22. this user manual and are also included on separate PDFs on the website Where possible request forms should be printed from the website but can be provided by SHPVHL upon request Please use a separate request form for each patient ensuring that all relevant fields are completed As a minimum we require Patient s Identification Surname amp Forename CHI number Patient s date of birth and gender Specimen type site Consultant to whom a report should be addressed Location and contact details of sender Relevant clinical information 5 2 Specimen Labelling All specimens should be labelled with the following information Surname amp Forename CHI number for Scottish Referrals Date of birth A specimen and or associated request form with insufficient accompanying information as outlined above could result in a delay in the sample being tested or the sample not being tested 5 3 Courier transit instructions All specimens should be sent in accordance with UN 3373 Biological Substance category B transport regulations and conform to packing instructions 650 PI650 The courier HAYS DX can be used to transport samples to SHPVHL see section 3 Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 5 4 Specimen types appropriate for clinical requests Table 1 Appropriate specimens for diagnostic HPV testing Other types of samples can only
23. vical Call Recall System SCCRS ae amp 11 LABORATORY ACCREDITATION SHPVRL is situated within the Directorate of Laboratory Medicine Microbiology Laboratory which was accredited by CPA CPA Reference Number 2496 in 2008 and found to be in compliance with Standards for the Medical Laboratory incorporating ISO 15189 2003 qaa 12 EXTERNAL QUALITY ASSURANCE SCHEMES National External Quality Assurance NEGAS SHPVRL takes part in the HPV UK NEGAS scheme this involves the testing of a panel of 4 unknown clinical samples distributed three times per year The scheme interrogates the screening performance of assays and is designed to support clinical testing Quality Control for Molecular Diagnostics GCMD SHPVRL takes part in the HPV GCMD scheme which involves the testing of a panel of 10 samples distributed once per year The scheme interrogates the screening performance of assays WHO HPV LabNet SHPVHL take part in the WHO LabNet EGA scheme The scheme interrogates the type specific performance of assays Author K Cuschieri amp C Moore PD MOL R USERHBK HPV Version 3 Issue date 19 06 12 Review date 19 06 14 e 13 SHPVRL AND RESEARCH AND DEVELOPMENT SHPVRL has a keen interest and commitment to research and development Particular areas of interest are Working with public health the cervical screening programme and academia to ensure that optimal systems for both HPV surveillance and cervi
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