A guidance document to assess quality of self-test pregnancy tests: A guide for procurers Public Deposited

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  • February 28, 2019
  • Fernando, Ashini
    • Affiliation: Gillings School of Global Public Health, Public Health Leadership Program
  • This paper describes the development of a guidance document for the procurement of high quality self-test pregnancy tests, intended for use in low resource settings. Pregnancy tests play a key role in sexual and reproductive health by facilitating rapid diagnosis of pregnancy status, and thereby enabling appropriate follow up care inclusive of family planning, antenatal or abortion services. Access to pregnancy tests, in terms of cost/affordability, availability, and quality, is a key factor required to streamline the provision of reproductive health related services. Although availability of pregnancy tests has increased and the cost has decreased over time, there remains a significant gap in regulatory control of the quality of these tests, which may lead to prevalence of spurious and counterfeit pregnancy tests in the low-income markets. This paper focuses on the role of pregnancy tests in family planning programs, provides preliminary evidence for current pregnancy test quality gaps, and introduces the content area covered by the new guidance document that was drafted in 2016. The draft guidance document covers applicable international quality standards and performance specifications, which would enable procurers to make informed decisions on selecting and maintaining high quality self-test pregnancy tests for improving family planning services and beyond.
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Rights statement
  • In Copyright
  • Paper type: Other
  • Track: Leadership
  • Ramaswamy, Rohit
  • Rademacher, Kate
  • Master of Public Health
Degree granting institution
  • University of North Carolina at Chapel Hill
Graduation year
  • 2016
Deposit record
  • 87a180ec-a427-4cc9-80c6-a0c19f531abe

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