After reading the paragraphs below, answer the questions that follow.
Home pregnancy test kits can detect whether a woman is pregnant within 1 to 3 weeks of her egg being fertilized. The test kits include a short strip of paper that extends from a plastic case. After a woman urinates on the strip of paper and waits 3 to 5 minutes, a symbol is displayed on a small window in the plastic case. Some tests show a single line to indicate the woman is not pregnant (negative result) and two lines to indicate she is pregnant (positive result). Others show a minus or plus sign (or some other variation) to indicate negative and positive results.
The test reports a positive symbol if it detects the presence of HCG in the woman's urine. In order for HCG to be detected, it must be present in the urine at a concentration of at least 10 to 100 units per milliliter. Even though home pregnancy tests are well designed and have been tested extensively, false negative and false positive results do occur. A false positive occurs when a test tells a woman that she is pregnant when she really is not, and a false negative occurs when a test tells a woman that she is not pregnant when she really is. Most home pregnancy test kit manufacturers claim that their tests are over 99% accurate.
What would be the best experiment for a manufacturer to conduct in order to determine the false negative rate of its test kits?
◦ Have a group of women who are not pregnant use the test and count the number of false negative results.
◦ Have a group of women who are 32 weeks pregnant use the test and count the number of false negative results.
◦ Have a woman use the test before she is pregnant and again after she is pregnant and determine whether the tests were positive or negative.
◦ Have a group of women who are less than 5 weeks pregnant use the test and count the number of false negative results.
Hormonal Changes During Pregnancy
FDA Pregnancy Classifications
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