Recent Activities - 2016
August 2016: Technical Working Group on Product Selection for HIV, HIV-related and Viral Hepatitis IVDs
On 24 and 25 August, NRL staff Kim Wilson and Sue Best participated in the Technical Working Group on Product Selection for HIV, HIV-related and Viral Hepatitis IVDs, which was held at WHO Headquarters, Geneva. This technical working group was convened to assist WHO in development of guidance for Member States on IVD product selection that mitigates the risks should selected products be unavailable. The objective of the planned guidance is to provide simpler methodology for validation of testing algorithms, and strategies to mitigate the effect of test kit stock-outs.
The meeting was attended by representatives from a number Member States including Pakistan, Malawi, Mozambique, Rwanda, Ethiopia, Nigeria, Viet Nam, The Philippines, and Senegal. Also attending were organisations involved with providing support and guidance on IVD product selection including the US Centers for Disease Control, Medecins Sans Frontiere, the Clinton Health Access Initiative, USAID, UNICEF and the Global Fund to Fight AIDS, TB and Malaria.
WHO recommends that standardised testing algorithms are used within countries. The countries have to decide which tests to use in the standardised algorithms, how to validate the sensitivity and specificity of the algorithm (as opposed to the sensitivity and specificity of each test in the algorithm, which are established through WHO pre-qualification) and how to build flexibility into the algorithm should any of their identified test kits be unavailable. At the meeting, validation of testing algorithms was reported to be particularly challenging, in some countries more so than others. The challenges included access to adequate volume of appropriate specimens for validation, accurate characterisation and access to temperature controlled storage of the specimens.
These topics were discussed at length, including suggestions for a globally or regionally sourced panel of challenging specimens for validation, stored appropriately at regional reference laboratory(ies) and made available to countries at their request.
As outcomes of the meeting, the potential for development of a challenging panel of validation specimens will be explored and a protocol for simplified verification of test kits for use in countries will be developed. It was also recognised that significant information is already available about WHO pre-qualified test kits, and tools to interrogate this information would be helpful for IVD product selection.