Category
Standard
Type
Standard
Version
1
Access
Open
Status
Active
Created
2019
This is the current version.
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)
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)
Access Requirements for validation of self-collected vaginal swabs for use in the National Cervical Screening Program
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