In vitro diagnostics and laboratory technology

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.

Related links

WHO Collaborating Centre web sites

Emergency Use Assessment And Listing (EUAL) Procedure


Contact us

Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
World Health Organization
20 Avenue Appia
1211, Geneva 27