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
Request for Proposals
22 MARCH 2017
The Prequalification Team is publishing a request for proposals for consultancy services relating to - developing and maintaining the Quality Management Systems (QMS) and assuming the responsibility for on-going system maintenance and effectiveness of operations within the Prequalification Team.
The services required by the World Health Organization (WHO) are more fully described in the below attached Terms of Reference and Request for Proposals.
Proposals should be submitted to WHO in writing no later than 5 April 2017 at 17:00 hours Geneva time ("the closing date"), by email at the following address: email@example.com
- 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
- First WHO prequalified hepatitis C rapid test opens the door to expanded treatment
- Two cutting-edge technologies for HIV detection in infants receive WHO prequalification
- New! Alternative performance evaluation mechanism
- New! Sample product dossier for public comment
- New! Guidance for manufacturers for public comment
New! Change of WHO recommendations on malaria RDT procurement
G6PD Prequalification: Public Announcement to Stakeholders
Guidance for post-market surveillance