Product Evaluations

It is essential that POC IVDs are evaluated independently of the manufacturer for an unbiased assessment of their performance. To simplify processes, MOH partners and regulatory agencies are advised to use the results of product evaluations from other countries to grant regulatory approval in their own countries, accelerating the process for countries to approve and introduce new products.

For early infant diagnosis, one of the challenges is that while evaluations of new IVDs for EID are essential to inform national regulatory approval and implementation, the low incidence of HIV infection in infants limits the ability to have adequately-sized evaluation studies. To address this challenge and to generate evidence to support EID POC implementation, the EID Consortium was established as a multi-stakeholder effort to help accelerate the evaluation of EID POC IVDs through pooling data from field evaluations.

The EID Consortium has conducted pooled analyses of the field performance of POC HIV testing for early infant diagnosis across 6 countries in sub-Saharan Africa (Kenya, Malawi, Mozambique, Tanzania, South Africa and Zimbabwe). Analysis of the data shows that both the Alere q HIV-1/2 Detect (now m-Pima HIV - 1/2 Detect) and Cepheid Xpert HIV-1 qualitative assays perform well in the field with high sensitivity and specificity, and relatively low error rates (4-7%). In addition to informing national regulatory approval and registration, this pooled EID data, combined to the results of the WHO prequalification assessment and listing of these platforms can also help guide implementers, partners and healthcare workers as they plan for the introduction and roll out of POC IVDs.

Wherever an evaluation is required, scientifically sound evaluation protocols should be used for evaluations of new IVDs. The International Diagnostics Centre at the London School of Hygiene and Tropical Medicine contains various resources on diagnostic tools, including generic protocols for a POC EID Test Evaluation and POC HIV Viral Load Assay Evaluation.