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:
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.
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.
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.
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.
Contain a control to monitor inhibition and/or assay failure.
Contain a control for cellularity to detect inadequate or empty cervical samples.
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