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• Diagnostics and Laboratory Technology
• Contributions to universal access
• Prequalification of diagnostics and medical devices
• Procurement of diagnostics
• Quality assurance
• Guidance and training
• Country projects

WHO list of prequalified diagnostic products

The following products have been successfully prequalified:

• List of prequalified products
  pdf, 81kb

WHO Prequalification of Diagnostics programme public reports

• Public report for SD BIOLINE HIV-1/2 3.0, (PQDx 0027-012-00)
  pdf, 878kb

• Public report for Genscreen™ ULTRA HIV Ag-Ab, (PQDx 0096-031-00)
  pdf, 2.09Mb
• Public report for SD Bioline HIV Ag/Ab Combo, (PQDx 0069-012-00)
  pdf, 837kb

• Public report for Uni-Gold™ HIV, (PQDx 0149-052-00)
  pdf, 14.46Mb

• Public report for Pima™ CD4 Test, (PQDx 0099-032-00)
  pdf, 1.68Mb

• Public report for BD FACSCount™ Instrument System with FACSCount™ Control Kit and BD FACSCount™ Reagent Kit (Absolute CD4+, CD8+, and CD3+ Counts), (PQDx 0124-045-00)
  pdf, 2.96Mb

• Public report for BD FACSCountTM Instrument System with FACSCountTM Control Kit and BD FACSCountTM CD4 Reagent Kit (Absolute and Percentage CD4+ Counts), (PQDx 0133-045-00)
  pdf, 2.69Mb

• Public report for COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, version 2.0 (TaqMan 48) (PQDx 0126-046-00)
  pdf, 3.27Mb

• Public report for COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, version 2.0 (TaqMan 96) (PQDx 0147-046-00)
  pdf, 3.27Mb

• Public report for Alere Determine HIV-1/2 Ag/Ab Combo (PQDx 0034-013-00)
  pdf, 674kb

• Public report for VERSANT® HIV-1 RNA 1.0 Assay (kPCR) (PQDx 0115-041-00)
  pdf, 3.01Mb

• Public report for HIV 1/2 STAT-PAK® (PQDx 0007-006-00)
  pdf, 959kb

• Public report for NucliSENS EasyQ® HIV-1 v2.0 (Automated) (PQDx 0127-016-00)
  pdf, 2.85Mb

• Public report for NucliSENS EasyQ® HIV-1 v2.0 (Semi-Automated) (PQDx 0148-016-00)
  pdf, 5.67Mb

• Public report for Alere Determine HIV-1/2 (PQDx 0033-013-00)
  pdf, 456kb
• Public report for HIV 1/ 2 STAT-PAK® Dipstick (PQDx 0008-006-00)
  pdf, 702kb
• Public report for Pima CD4 test (PQDx 0099-032-00)
  pdf, 1.66Mb
• Public report for IMMUNOQUICK® Malaria Falciparum (PQDx 0045-018-00)
  pdf, 1.23Mb
• Public report for Abbott RealTime HIV-1 (Manual) (PQDx 0146-027-00)
  pdf, 7.85Mb
• Public report for Abbott RealTime HIV-1 (m2000sp) (PQDx 0145-027-00)
  pdf, 5.72Mb
• Public report for Abbott RealTime HIV-1 (m24sp) (PQDx 0083-027-00)
  pdf, 6.04Mb
• Public report for SD BIOLINE Malaria Ag P.f (PQDx 0031-012-00)
  pdf, 1.90Mb

Disclaimer

• Disclaimer for WHO list of prequalified diagnostic products

Malaria Rapid Diagnostic Test Performance - Results of WHO Product testing of malaria RDTs Round 3 (2010-2011) and Summary Rounds 1-3 (2008-2011)

• http://apps.who.int/tdr/svc/publications/tdr-research-publications/rdt_round3