Selecting and purchasing HIV, HBsAg and HCV in vitro diagnostics
Since 1988, WHO has performed assessments of commercially available diagnostics for HIV, hepatitis B, hepatitis C and Chagas disease. This programme provides independent comparative data on the performance and operational characteristics of diagnostics and forms the basis of recommendations for WHO procurement. Up to 2006, this process was called the WHO Test Kit Evaluation programme; it was the predecessor of the WHO Prequalification of Diagnostics Programme. Many of these assays have submitted an application and have been accepted into the WHO Prequalification of Diagnostics Programme. In the future, WHO prequalification will become a requirement for a product to be considered for WHO procurement.
Meanwhile products meeting the following product selection criteria based on data generated in the WHO Test Kit Evaluation programme are eligible to participate in the WHO process for establishing a long term agreement (LTA) for procurement by WHO through a request for proposal (RFP).
Product selection criteria
| Analyte | EIAs | Simple/rapid assays |
|---|---|---|
| anti-HIV-1/2 and/or HIV-1 p24 Ag | Sensitivity: 100% | Sensitivity. ≥ 99% |
| Specificity: ≥ 98% | Specificity: ≥ 98% | |
| Inter-reader variability: ≤5% | ||
| Invalid rate: ≤5% | ||
| anti-HCV | Sensitivity: 100% | Sensitivity. ≥ 98% |
| Specificity: ≥ 98% | Specificity: ≥ 97% | |
| Inter-reader variability: ≤5% | ||
| Invalid rate: ≤5% | ||
| HBsAg | Sensitivity: 100% | Sensitivity. ≥ 100% |
| Specificity: ≥ 98% | Specificity: ≥ 98% | |
| Inter-reader variability: ≤5% | ||
| Invalid rate: ≤5% |
WHO maintains a list of products for procurement based on performance data generated in the WHO Test Kit Evaluation programme in accordance with the above criteria.
Disclaimer
It is not in WHO’s mandate to issue any approvals, certificates or licenses for diagnostics. This responsibility lies with the regulatory authority of each country. Furthermore, WHO does not, as a matter of policy, endorse any specific commercial product over others. The purpose of the WHO prequalification of diagnostics process is to provide technical information to UN agencies, WHO Member States and other interested organizations. In this regard, please note that the results of the prequalification assessment, the participation in the WHO prequalification process, the inclusion of any product in the list of prequalified diagnostics or the WHO name and emblem, may not be used for commercial and/or promotional purposes. In keeping with WHO policy, WHO will not accept any liability or responsibility whatsoever for an injury, death, loss, damage or other prejudice of any kind that may arise as a result of, or in connection with the procurement, distribution and use of any product, as to which WHO has published the assessment results and/or which is included in the WHO list of prequalified diagnostics.