Diagnostics and Laboratory Technology

Prequalification of Diagnostics Laboratory Evaluation

Laboratory evaluation of the product will occur following a successful review of the product dossier. The laboratory evaluation to asses the operational and performance characteristics of the product is carried out by specified WHO collaborating Centre(s) under the instructions of WHO.

laboratory technician performing a diagnostic test

The assessment of the quality and the performance of commercially available test kits and technologies is a global requirement, however regulatory capacity is limited in many countries. The recent increase in diagnostic products manufactured and/or sold in markets without effective licensing and regulatory procedures is a cause of concern and warrants attention.

Types of tests
  • Simple/Rapids
  • Enzyme Linked Immuno Sorbent Assays (ELISAs)
  • Confirmatory Assays (such as Western Blot, line immuno assays)
  • CD4+ enumeration technologies
  • HIV monitoring, including viral load
Operational characteristics
  • Sensitivity
  • Specificity
  • Ease of Operation
  • Storage conditions

The results are published regularly in the form of Composite Reports, that are intended for use by health policy makers, blood bank directors, managers of national AIDS prevention and surveillance programmes. Data are used by WHO to select assays suitable for the bulk procurement.

Evaluations

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