Report for Human Papilloma Virus DNA Quality Assurance Pilot Studies

1st April 2008 – Milestone 2 Report - Progress and Preparation for Pilot Study One

Page last updated: 01 November 2008

    Current Status of the Project

  • 20 participating laboratories were chosen to participate in the two Pilot Studies. A demonstrated willingness to give feedback and remain in regular communication with the SQAP was the most important criteria but also laboratories that already had HPV DNA testing established were chosen above those who were still in the introductory phase.
  • 20 sets of PreservCyt specimens and 10 sets of dry swabs specimens were prepared by Assoc. Prof. Sepehr Tabrizi (Senior Research Scientist, Department of Microbiology, The Royal Women's Hospital, Melbourne) and sent to the SQAP for distribution to the participating laboratories.
  • Each of the chosen participating laboratories was asked to provide their methodology and their preferred medium (for example, swab or PreservCyt solution).
  • The questionnaire was drafted and sent to Sepehr Tabrizi to provide advice / input into the questions asked and the overall format of the questionnaire, including protocols for testing both specimen types.
  • Once the questionnaire was finalised, the web programmer was engaged to prepare the data entry screens; it was then trialed on a number of occasions before the survey open date.
  • Participants were notified of their Participant Number (specific to the study for some laboratories) and their website login password.
  • Specimens were dispatched and questionnaires emailed on the opening day of the survey and given 18 days to return their results (due date 11/4/08).
    Objective of Pilot Study One
    The main objective is to establish the best material and preparation method for specimens to issue to laboratories as a means of assessing laboratory performance.
    Participating Laboratories
    20 participants were recruited via a flyer in the SQAP Newsletter for the first Pilot Study. 17 participants were recruited from the Serology QA Program; one was recruited from the Victorian Cytology Service, another was recruited from the “on-site” Cytopathology Department at Symbion Laverty Pathology and one from a laboratory that had been conducting in-house testing for HPV DNA for some time.

    The 20 participants are from the following locations:
    New Zealand - 2
    New South Wales - 8
    Queensland - 2
    South Australia - 2
    Tasmania - 1
    Victoria - 3
    Western Australia - 2

    Participants were asked to provide email addresses and a contact name, with address, fax and telephone numbers. Participants were then asked: the method in use for HPV DNA testing, whether they screen for high risk / low risk or type specimens, the number of specimens processed per month, the number of years that they have performed HPV DNA testing and the type of specimens (dry swab or Thin Prep) being evaluated. This information will be evaluated together with the returned results.Top of page

    All laboratories were sent a set of 8 PreservCyt specimens and those that indicated a willingness to test the dry swabs were sent a set of 8 swabs. Some of the laboratories were concerned because their method had not been validated for dry swabs but they were assured that it was not an assessment of their performance but an evaluation to establish the best material for the purpose. Instructions were provided by Sepehr Tabrizi for preparing the specimens for testing.

    After distribution one participant notified the SQAP that their laboratory was withdrawing the HPV test and therefore, they could not participate in the Pilot Study. At this stage this set of PreservCyt specimens have not been re-distributed. The withdrawing laboratory had also been sent dry swab specimens and this set of dry swabs, together with another set from a laboratory that was unwilling to test the dry swab specimens, were re-dispatched to another two participants who were willing to test them.
    Specimen Preparation
    Sepehr Tabrizi prepared the PreservCyt specimens from specimens obtained from the Victorian Cytology Service (VCS). High value specimens were required and as VCS were unable to meet the required number Symbion Laverty Pathology in Sydney were asked to provide high value specimens. These were provided promptly and used for the final set of specimens that were distributed.

    There is no established method for either the PreservCyt specimens or the dry swabs and so Sepehr has spent some time evaluating different methodologies to ensure that the dispatched specimens were appropriate.
    The questionnaire was prepared by the SQAP and sent to Sepehr as a draft. Sepehr edited and suggested some changes and this then became the final version.
    Website Data Entry
    All participants were enrolled as website participants; results and related data are entered by the participant at the website rather than completing a paperwork questionnaire.

    Participants have been asked to provide feedback / suggestions to both the questionnaire and website data entry screens. Each data entry screen on the website has a ‘Feedback’ box for participants to make an immediate comment.

    Participants have been given a number and password specific for the HPV DNA Pilot Study. Emails and letters have been sent to participants ensuring that they are informed throughout the process.
    Timeline Progress
    A worked methodology for preparing PreservCyt specimens for Quality Assurance was promised by a third party, but due to the non-arrival of the method it was decided that Sepehr would proceed and develop his own method for sample preparation. Negotiations and waiting for the method to be delivered caused an extensive delay in the starting date of the project.
    Changes to Original Proposal
    When this HPV DNA Project was being planned it was anticipated that the specimens would need to be sent out on dry ice. This entails specially designed courier boxes, shipping as ‘Dangerous Goods’ and high courier costs. Both the dry swabs and the PreservCyt specimens were shipped at ambient temperature and therefore the costs of packaging and shipping have been considerably lower than anticipated.

    Stability studies will be ongoing to confirm that shipping specimens at ambient temperature does not affect the integrity of the specimens.
    Imminent Processes
  • The closing date for the first Pilot Study is the 11th April 2008.
  • Generic reports will be prepared and issued as Preliminary Reports so that all participants see the results immediately.
  • Members of the committee will be sent the Preliminary Report and requested to review the results and provide comments / discussion. This information will then be added to the report which will be issued as a Final Report.
  • The committee will meet to discuss the results and review participant feedback in order to make changes (if required) for the second Pilot Study.
  • Automated personalised Assessment Reports generated through the website will be developed for HPV DNA after results have been received from the first Pilot Study. Participant feedback will guide development. This means that the web-based Assessment Report will be available after the second Pilot Study and will include results from the first Pilot Study.
    The project is progressing well although it is slightly behind the proposed timelines due to a set-back with promised specimen protocols. However, since it was decided to proceed with Sepehr developing the methodology, the Pilot Study has progressed as envisaged.
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