Quality control samples
In order to assure that a test run is valid and results are reliable, Quality Control Samples should be used in the performance of each assay.
The Quality Control Samples should be treated in the exact same manner as the test samples and are used to validate the test run. Each laboratory should develop a criteria for run acceptance based on guidance from the manufacturer's kit insert and in-lab validation of an external QC sample.
- Kit Controls –the negative and positive control provided with the kit
- Quality Control Sample –a low positive externally produced sample
WHO's QC programmes
WHO Collaborating Centre, the National Serology Reference Laboratory, Australia produces and distributes HIV QC samples to laboratories in the South East Asian, Western Pacific and African regions.
WHO Collaborating Centre web sites
- WHO list of prequalified in vitro diagnostic products
- Status of active applications to the prequalification of in vitro diagnostics
- Complaints and Product Alerts
- Streamlining of the Prequalification of Diagnostics
- WHO Prequalification of Male Circumcision Devices
- Procurement of in vitro diagnostics
- HIV incidence assay working group
- Information resources
G6PD Prequalification: Public Announcement to Stakeholders
- Sample product dossier for an IVD intended for HIV self-testing (for public comments to be submitted to firstname.lastname@example.org no later than 29 February 2016)
- New Guidance for Manufacturers (TGS 1 & TGS 2) (for public comments to be submitted to email@example.com no later than 29 February 2016)
Newsletter Issue 13, Q1 2016
Guidance for post-market surveillance
Prioritization criteria expanded to HPV