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Clinical Chemistry, Vol 39, 53-59, Copyright © 1993 by American Association for Clinical Chemistry
J Daviaud, D Fournet, C Ballongue, GP Guillem, A Leblanc, C Casellas and B Pau
Laboratoire National de la Sante, Montpellier, France.
All 27 home-use tests sold in France in 1989 for the self-diagnosis of pregnancy were evaluated. The kits were first tested by qualified clinical chemistry technologists. Eleven kits with 100% specificity and 100% sensitivity were retained for the diagnostic study. Each of 638 laywomen was given a kit and asked to perform the assay with a coded urine specimen containing either no human chorionic gonadotropin (hCG) or an hCG concentration adjusted to the claimed detection limit (1 DL) or twice the detection limit (2 DL). After testing, each participant filled out a detailed questionnaire. The results showed a diagnostic specificity of 86-100% for 10 kits but a diagnostic sensitivity of 85- 100% for only 5 kits at 2 DL and for only 2 at 1 DL. Among the 478 positive urine samples distributed, 230 were falsely interpreted as negative. The main explanation for such a high percentage of false- negative results was difficulty in understanding the explanatory leaflets accompanying the kits and hence in reading the results, regardless of the socioeconomic situation of the participant. We conclude that pregnancy home-use tests should be subjected to rigorous analytical controls and evaluated by a panel of potential users before being released on the market.
The following articles in journals at HighWire Press have cited this article:
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  S. F Eichner and E. M Timpe Urinary-Based Ovulation and Pregnancy: Point-of-Care Testing Ann. Pharmacother., February 1, 2004; 38(2): 325 - 331. [Abstract] [Full Text] [PDF]
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 S. A. Butler, S. A. Khanlian, and L. A. Cole Detection of Early Pregnancy Forms of Human Chorionic Gonadotropin by Home Pregnancy Test Devices Clin. Chem., December 1, 2001; 47(12): 2131 - 2136. [Abstract] [Full Text] [PDF]
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 J. H. Skerritt and R. H. Heywood A Five-Minute Field Test for On-Farm Detection of Pre-Harvest Sprouting in Wheat Crop Sci., May 1, 2000; 40(3): 742 - 756. [Abstract] [Full Text]
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 B. C Delaney, C. J Hyde, R. J McManus, S. Wilson, D. A Fitzmaurice, S. Jowett, R. Tobias, G. H Thorpe, and F D R. Hobbs Systematic review of near patient test evaluations in primary care BMJ, September 25, 1999; 319(7213): 824 - 827. [Abstract] [Full Text]
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 L. A. Bastian, K. Nanda, V. Hasselblad, and D. L. Simel Diagnostic Efficiency of Home Pregnancy Test Kits: A Meta-analysis Arch Fam Med, September 1, 1998; 7(5): 465 - 469. [Abstract] [Full Text] [PDF]
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 L. A. Bastian and J. T. Piscitelli Is This Patient Pregnant? Can You Reliably Rule In or Rule Out Early Pregnancy by Clinical Examination? JAMA, August 20, 1997; 278(7): 586 - 591. [Abstract] [PDF]
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