Frequently asked questions
CD4+T-Cell counting technology
- What are CD4+ T-cells?
- What is the CD4+ T-cell count?
- How are CD4+ T-cells enumerated?
Viral load testing
- What is HIV-1 Viral Load?
- How are CD4 and HIV viral load used?
- How is Viral Load measured?
- What is an ELISA test?
- What is a Simple/Rapid test?
- What is the difference between a ELISA and a Simple/Rapid test?
- What is a Confirmatory Assay?
- What is the "window-period" and how long is it?
Alternative specimens- whole blood, oral fluid & urine
- Is urine or saliva feasible to use as a source of HIV detection?
- EBOLA IVDs
- 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
Invitation to manufacturers of in vitro diagnostics for Zika virus to submit an application for emergency use assessment and listing by WHO
ZIKA VIRUS: Emergency Use Assessment and Listing Procedure (EUAL) announcement
- Sample product dossier for an IVD intended for HIV self-testing (for public comments to be submitted to email@example.com no later than 29 February 2016)
- New Guidance for Manufacturers (TGS 1 & TGS 2) (for public comments to be submitted to firstname.lastname@example.org no later than 29 February 2016)
Newsletter Issue 12, Q4 2015
Guidance for post-market surveillance
Prioritization criteria expanded to HPV