Section 4: Equipment

This section details the requirements for the equipment and test methods used for HPV NAT testing within the NCSP.

S4.1 Laboratories must only use commercially supplied HPV NAT that are validated for primary population based screening.

To be fit for purpose, in the Australian population with a mix of vaccinated and unvaccinated women, the test method must be suitable for use as a primary screening test as per criteria set out in this section, which outlines the requirements to be considered in selecting the equipment for HPV NAT within the renewed NCSP. These criteria are more prescriptive and stringent than those required for HPV NAT as a “test-of-cure” within the previous NCSP, because test performance characteristics of a primary screening test are different to those of a diagnostic test.
Only commercially supplied HPV NAT validated for primary population screening and listed on the Australian Register of Therapeutic Goods (ARTG) may be used. HPV NAT assays used in primary screening must fulfil the strict criteria set out in this section and must include a control to monitor inhibition and/or assay failure as well as a control for cellularity. Note here re validation of self-collection devices and TGA.
In addition, performing an HPV NAT assay on a self-collected vaginal specimen has different regulatory arrangements to those collected on clinician collected cervical specimens. This is because at the time of writing none of the commercial HPV NAT assays currently listed on the ARTG have self-collected vaginal specimens as a validated specimen type specified in the manufacturer’s instructions for use which makes testing this specimen type an ‘in-house’ test. In-house IVDs have specific regulatory requirements. Further information on the regulatory requirements and development and use of in-house IVDs may be found from the TGA Regulatory requirements for in-house IVDs (available at https://www.tga.gov.au/publication/regulatory-requirements-house-ivds-australia ) and the NPAAC Requirements for the development and use of in-house in-vitro diagnostic medical devices (IVDs) (available at http://www.health.gov.au/internet/main/publishing.nsf/Content/health-npaac-dhaivd.htm ). In-house IVDs must be validated within a laboratory network and assessed by NATA. Any further questions on the regulatory requirements for in-house IVDs should be directed to the TGA.

C4.1 In selecting HPV NAT for use in the screening setting, in combination with the chosen collection medium, the laboratory must confirm that the manufacturer’s kit insert lists population based screening as an intended use.

S4.2 The HPV NAT method must test for HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68, and separately identify HPV 16 and HPV18.

S4.3 The test must be included on the Australian Register of Therapeutic Goods.

S4.4 HPV NAT assays used in primary screening as part of the National Cervical Screening Program must be demonstrated by the manufacturer, or in published studies to fulfil the following criteria:

  1. For HPV detection in a satisfactory sample, show proven non-inferiority to validated reference assays (e.g. Hybrid Capture 2 (HC2) in cross-sectional equivalence studies using guidelines for test requirements which were developed by an international consortium3.
  2. Have demonstrated clinical sensitivity for HSIL of not less than 90% of HC2 or an equivalent test which has been demonstrated to achieve this level of sensitivity in women of at least 25 years of age.
  3. Have a clinical specificity for HSIL not less than 98% of that of HC2 or an equivalent test which has been demonstrated to achieve this level of specificity in women of at least 25 years of age.
  4. Display intra-laboratory reproducibility and inter-laboratory agreement with a lower confidence bound of 87% to be tested on at least 500 samples of which 30% were HPV positive.
  5. Contain a control to monitor inhibition and/or assay failure.
  6. Contain a control for cellularity to detect inadequate or empty cervical samples.

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13-Mar-2019
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