New Pregnancy Test Resource Offers Procurers Guidance on Quality

22nd May 2017

A new resource offers procurement groups guidance on quality standards and performance specifications for pregnancy tests. The document, “Quality and Performance Guidance on Selection of Pregnancy Tests for Procurement,” was developed by FHI 360 under the USAID-funded Envision FP project, in consultation with experts through a workstream of RHSC’s Market Development Approaches working group.

Ensuring access to low-cost, high quality, pregnancy tests has been shown to increase same-day provision of family planning, and aid in the timely provision of antenatal care. In many settings, non-menstruating women are denied same-day provision of family planning services due to a concern among healthcare providers that they may be pregnant. Use of the Pregnancy Checklist, a job aid with simple questions that a provider can ask a client to rule out pregnancy, can also help address this barrier. New clinical guidance is available for healthcare providers which offers guidance on when the Pregnancy Checklist versus a pregnancy test should be used.

In 2015, FHI 360 and Marie Stopes International led a multi-country assessment funded by the RHSC Innovation Fund to evaluate the accessibility and affordability of pregnancy tests. The assessment found concern among country stakeholders about the quality of pregnancy tests, and a need for guidance on ensuring that the tests meet performance standards. The new resource fills a gap in knowledge; it outlines requirements for quality and performance specifications derived primarily from the ISO standards, EU and U.S. FDA requirements for marketing clearance, and IMDRF/GHTF and WHO normative documents.

For more information about the new guidance document or to join the MDA workstream, please email Julia White at In addition, FHI 360 is developing a detailed test methods manual that will allow laboratories to evaluate the quality of pregnancy tests; for more information, contact To learn more about the potential impact of increasing access to pregnancy tests in family planning programs, watch this short video

Category: Market Development Approaches Working Group

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