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An evaluation of the sensitivity of five home pregnancy tests to known concentrations of human chorionic gonadotropin

  • Joseph T. Hanlon
    Correspondence
    Reprint requests: Joseph T. Hanlon, M.S.Pharm., Division of Family Medicine, Duke University Medical Center, Durham, North Carolina 27710
    Affiliations
    School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina USA

    the Division of Biometry, Department of Community and Family Medicine, Duke University Medical Center, Durham, North Carolina USA

    the International Fertility Research Program, Research Triangle Park, North Carolina USA

    the Chapel Hill Fertility Services Chapel Hill, North Carolina USA
    Search for articles by this author
  • Stephen M. Caiola
    Affiliations
    School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina USA

    the Division of Biometry, Department of Community and Family Medicine, Duke University Medical Center, Durham, North Carolina USA

    the International Fertility Research Program, Research Triangle Park, North Carolina USA

    the Chapel Hill Fertility Services Chapel Hill, North Carolina USA
    Search for articles by this author
  • Lawrence H. Muhlbaier
    Affiliations
    School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina USA

    the Division of Biometry, Department of Community and Family Medicine, Duke University Medical Center, Durham, North Carolina USA

    the International Fertility Research Program, Research Triangle Park, North Carolina USA

    the Chapel Hill Fertility Services Chapel Hill, North Carolina USA
    Search for articles by this author
  • Betty H. Dennis
    Affiliations
    School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina USA

    the Division of Biometry, Department of Community and Family Medicine, Duke University Medical Center, Durham, North Carolina USA

    the International Fertility Research Program, Research Triangle Park, North Carolina USA

    the Chapel Hill Fertility Services Chapel Hill, North Carolina USA
    Search for articles by this author
  • David A. Edelman
    Affiliations
    School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina USA

    the Division of Biometry, Department of Community and Family Medicine, Duke University Medical Center, Durham, North Carolina USA

    the International Fertility Research Program, Research Triangle Park, North Carolina USA

    the Chapel Hill Fertility Services Chapel Hill, North Carolina USA
    Search for articles by this author
  • James R. Dingfelder
    Affiliations
    School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina USA

    the Division of Biometry, Department of Community and Family Medicine, Duke University Medical Center, Durham, North Carolina USA

    the International Fertility Research Program, Research Triangle Park, North Carolina USA

    the Chapel Hill Fertility Services Chapel Hill, North Carolina USA
    Search for articles by this author
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      Abstract

      A study was conducted to evaluate the sensitivity of the five commercially available home pregnancy testing kits. Known amounts of human chorionic gonadotropin (hCG) were diluted in pooled, sterile male urine. Varying concentrations of hCG were randomly assigned to 100 kits of each of the five brands. The test results were read independently by three individuals who were blinded to the hCG concentrations. Statistical analyses were based on the majority vote of the readers. The rank-ordered sensitivity of the five home pregnancy tests, expressed as the proportion of positive results for the range of hCG concentrations studied, was as follows: (1) Predictor, (2) e.p.t., (3) Acu-Test, (4) Answer, and (5) Daisy 2. Overall, Predictor and e.p.t. appear to be more accurate than Acu-Test or Answer. Only Daisy 2 was found to be significantly different from the other brands. However, the currently marketed Daisy 2 pregnancy test is manufactured by a different company.
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