Section 3: Specimens

This section deals with the specimen collection requirements for practitioner and self-collected tests and the requirements for retention of specimens for both screening and non-screening tests.

S3.1 The laboratory must advise requesting practitioners that the specimen must be identified as a screening specimen, follow-up specimen, specimen from a symptomatic woman, post-treatment specimen or a self-collected specimen.

The laboratory must advise the requesting practitioner that the specimen must be identified as a screening specimen, follow-up specimen, specimen from a symptomatic woman, post-treatment specimen or a self-collected specimen. Information about MBS item numbers and Descriptors and information for requesting practitioners may be found at link in Section 7.
The HPV NAT material must be retained in accordance with S5.5. S5.5 requires laboratories to compare their rate of detection of HPV with the national detection reference range most recently reported by the NCSR. If the laboratory’s rate of HPV positivity falls outside the national reference range published by the NCSR then the laboratory must take steps to investigate the reason for the difference. Specimens must therefore be retained appropriately such that they can be retested if required. (See Section 5.5.) More information may be found in the “Guidelines for handling HPV positivity rate quality management process” available on the NCSR website at https://www.ncsr.gov.au/content/ncsr/en/hpv-positivity-rates.html. The most recent reference range may also be found at this link and includes funnel plot and tables for different sample sizes.

S3.2 The laboratory must provide advice for practitioners on the collection of satisfactory cervical specimens, such that:

  1. The collection of the specimen from the cervix should be under direct vision so that the specimen for HPV NAT is suitable for reflex LBC.2, 3
  2. Expiry dates, storage and transportation requirements as recommended by the suppliers of the collection medium are adhered to.

S3.3 The collection medium/ device used by practitioners to collect the cervical sample must be suitable and validated for use with both the HPV NAT offered and the LBC test, as intended by the manufacturer.

S3.4 To avoid re-collection there must be sufficient residual specimen present for reflex LBC before additional samples are removed for other microbiological tests, such as Chlamydia, that may be performed subsequently on the screening sample.

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S3.5 The HPV NAT material must be retained in accordance with S5.5.††

S3.6 The residual sample, where LBC has been performed, must be retained in accordance with the manufacturer’s instructions, for a period of at least one month after the report is validated in accordance with S5.5 and with the Requirements for the Retention of Laboratory Records and Diagnostic Materials.

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S3.7 The specimens for HPV NAT and LBC must be retained in accordance with the Requirements for the Retention of Laboratory Records and Diagnostic Materials.

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S3.8 Self-collected specimens must be clearly identified as such.

S3.9 The laboratory must provide instructions for self-sampling.

S3.10 The collection device and collection medium if used, must be suitable and validated for use with the HPV NAT method.

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S3.11 The self-collected HPV NAT material must be retained in accordance with the Requirements for the Retention of Laboratory Records and Diagnostic Materials.

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