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Category
Standard
Type
Standard
Version
1
Access
Open
Status
Active
Created
2019
This document sets out the minimum requirements that a laboratory must meet in order to offer testing of self-collected vaginal swabs for human papillomavirus (HPV) as part of the National Cervical Screening Program as an in vitro diagnostic medical device.

Main sections:

- Risk management

- General requirements

- Validation performance requirements

- Stability

- Monitoring

- Performance measures

- Adverse event reporting

- Use of validation assessment material to verify analytical performance (normative)

- Evaluation of performance of testing of SCVS by applicant laboratories with clinical specimens (normative)

- Evaluation of stability (normative)