Quality and Performance Guidance on Selection of Pregnancy Tests for Procurement

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Ensuring access to low-cost, high quality, pregnancy tests1 has been shown to increase same- day provision of family planning, and aid in the timely provision of antenatal care (19-22). However, in many settings, pregnancy tests are not routinely available for clients, are marked up to unaffordable prices, are of questionable quality and/or of variable performance. In 2015, FHI 360 partnered with Marie Stopes International to conduct an assessment in Kenya, Malawi and Mali to document the availability, affordability and quality of pregnancy tests. This project was completed with support from the Reproductive Health Supplies Coalition through an Innovation Fund grant. The assessment noted:

  • Concerns about falsified products or falsely CE- marked pregnancy tests entering markets;
  • A lack of knowledge among consumers, providers, importers, distributors, pharmacists and regulatory personnel on internationally recognized quality standards for pregnancy tests, including what existing standards mean and how they can be used to ensure that only pregnancy tests meeting quality and performance standards enter national markets;
  • No publicly available protocol for product qualification or pre-and post-shipment lot verification testing customized for pregnancy tests;
  • Limited visibility for procurers on the supply side (e.g., limited information about suppliers’ prior performance); and
  • A lack of focus and harmonization around quality and performance specifications to be used when selecting pregnancy tests for procurement.

Concurrently, FHI 360 carried out an exploratory evaluation of a small number of pregnancy tests, collected from low-resource settings over a two-year period, to develop an understanding of prevailing quality status based on labeling criteria. Preliminary results from this analysis, as summarized in Annex 2, illustrate significant quality, performance and operational gaps in labeling, such as inadequate instructions for use, absence of performance characteristics and standard quality assessment by recognized regulatory authorities.