1976
DOI: 10.2105/ajph.66.2.166
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Evaluation of a 'do-it-yourself' pregnancy test.

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Cited by 9 publications
(4 citation statements)
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“…The remaining 10 articles (Table 1) were then analyzed and 5 more were excluded. 5,16,[18][19][20][21][22][23][24][25] The additional exclusions were because the study had no control group of nonpregnant patients, 5 there were insufficient data for determining sensitivity and specificity, 18,19 the kit was no longer available because of its demonstrated poor performance, 20 or the study had an inadequate sample size. 21…”
Section: Study Selectionmentioning
confidence: 99%
“…The remaining 10 articles (Table 1) were then analyzed and 5 more were excluded. 5,16,[18][19][20][21][22][23][24][25] The additional exclusions were because the study had no control group of nonpregnant patients, 5 there were insufficient data for determining sensitivity and specificity, 18,19 the kit was no longer available because of its demonstrated poor performance, 20 or the study had an inadequate sample size. 21…”
Section: Study Selectionmentioning
confidence: 99%
“…Just four months later, in December 1972, the FDA took the drastic measure of recalling Ova II, stating that the tests were 'inaccurate, unreliable, and prone to give false results' (Lyons, 1972). A spokesperson from Faraday Laboratories countered that the tests were 'accurate and reliable when used as directed', but agreed to recall the kits, though the spokesperson questioned the jurisdiction of the FDA to regulate the product premarket because it was not a drug (Baker et al, 1976;Lyons, 1972). Perhaps further preventing FDA action was that under the law at that time, the FDA could recall (postmarket) 'harmful or ineffective' devices, which were defined as 'instruments, apparatus, and contrivances, intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in man or affect the structure or any function of the body of man or other animals' (USC, 1972: 21 USC §321(h), emphasis added).…”
Section: Is Pregnancy a Disease? Regulatory Creep And The Limits Of Fda Jurisdictionmentioning
confidence: 99%
“…On a practical level, they judged the tests 'convenient for the user' and 'less expensive than laboratory tests' (Hunt, 1975: 122). Earlier diagnosis could be possible, making possible both earlier prenatal care and earlier abortions (Baker et al, 1976).…”
Section: Translating the Technical To The Publicmentioning
confidence: 99%
“…One of the expected advantages of home pregnancy tests was "allowing a woman to be the first person to know that she is pregnant" (Baker et al 1976). This view ignores the fact that in the past women were the first to know, albeit via different means.…”
Section: History Of the Home Pregnancy Testmentioning
confidence: 99%