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1970-2003

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1970s

Two things came together in this period along with the so-called sexual revolution: increased research on reproductive health and a heightened desire (brought on by both improved prenatal care and legal abortion) to detect pregnancy as early as possible. Beginning in the 1970s, prenatal care and prenatal testing became more routine in the American health care system. 'A Preliminary screening test for pregnancy,' courtesy of the Food and Drug 

1970

Tests available to doctors and technicians included Wampole’s two-hour pregnancy test. The test could be done as early as four days after a missed period. In the packaging materials, the man pictured performing the test wore a laboratory coat, indicating that it was not intended for home use. Besides the equipment in the kit, (two test tubes, a plastic rack, a bottle of “control solution,” a bottle of “hCG-antiserum” and a bottle of “cell suspension”), testers would need a small funnel and filter paper or centrifuge, clean pipettes or syringes, and saline solution in addition to a urine sample.

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A preliminary screening test for pregnancy
"A preliminary screening test for pregnancy," courtesy of the Food and Drug Administration History Office

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Vaitukaitis, Braunstein, and Ross published their paper describing the hCG beta-subunit radioimmunoassay that could finally distinguish between hCG and LH, therefore making it potentially useful as an early test for pregnancy. See Vaitukaitis, J.L., Braunstein, G.D., and Ross, G.T. (1972) “A radioimmunoassay which specifically measures human chorionic gonadotropin in the presence of human luteinizing hormone.” American Journal of Obstetrics and Gynecology, 113, 751-8.

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1973

The first edition of Our Bodies, Ourselves, the women’s health manual written by the Boston Women’s Health Collective, noted that available pregnancy tests were most accurate if done two weeks after the missed period. Though the authors insisted that instructions for “collecting and submitting your urine are simple,” modern readers might disagree. “Drink no liquids after dinner the night before,” the text instructed, “then as soon as you awake in the morning collect a urine sample in a clean, dry, soap-free jar and take it to a laboratory.” Another possibility was sending the urine sample to a laboratory in North Carolina, after first writing to request the test kit.

Mid-1970s

Though the test was not yet widely available, NIH scientists spread the word about the new radioimmunoassay. At first, the test was found most useful for clinicians in testing and following patients being treated for hCG-secreting tumors. The sensitive radioimmunoassay could tell the doctors if the chemotherapy treatments had worked.

JV: We were doing assays for people all over the place. We felt ethically that we had to because it wasn’t available anyplace else. So we used to give out a lot of antiserums to research labs and show them how to set up the assays.

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From Directions and Technical Information on UCG-TEST, 1970, courtesy of Special Collections, Northwestern University Library
From Directions and Technical Information on UCG-TEST, 1970, courtesy of Special Collections, Northwestern University Library

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By the end of 1977, e.p.t was ready for the American market. (Because of requirements for the specific wording on packaging and other last-minute details, there is a lag time between FDA approval and wide availability of most medical devices.) In a “Dear Pharmacist” letter from Warner/Chilcott, drug stores were informed that “the e.p.t consumer advertising campaign has been designed to direct the consumer to their drug store to purchase e.p.t”


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1978

e.p.t was advertised in major women’s magazines including: Mademoiselle, McCall’s, Redbook, Family Circle, Ladies’ Home Journal, Good Housekeeping, and Vogue. Advertisements appeared later in the year for Predictor, Answer, and ACU-TEST.

The e.p.t test of 1978 was described to the public in Mademoiselle: “For your $10,” the article notes, “you get pre-measured ingredients consisting of a vial of purified water, a test tube containing, among other things, sheep red blood cells…as well as a medicine dropper and clear plastic support for the test tube, with an angled mirror at the bottom.” The test took two hours, and was more accurate for positive results (97%) than for negative (80%). Advantages, noted Mademoiselle, included “privacy and not having to wait several more weeks for a doctor’s confirmation, which gives you a chance, if pregnant, to start taking care of yourself…or to consider the possibility of early abortion.” (Mademoiselle, April 1978, p. 86)

McCall’s magazine claimed that “physicians we interviewed about the tests endorse the concept.” But the editors cautioned that women who get negative results and who still suspect pregnancy should not wait ten days to take the test again “but should seek medical help as soon as possible.” (McCall’s, March 1978, p. 46)

1979

Taking the test at home, noted a 1979 article in Family Planning Perspectives, both protected the privacy of a woman who might not want her doctor to know she is sexually active and gave women a new opportunity to take an active role in their own health care.

1980s

Research increased and educational campaigns were launched to identify the importance of folic acid in early pregnancy and to warn of the dangers of various environmental hazards and alcohol to a developing fetus.

1990s

Advances in the technology of pregnancy tests included the development of new types of antibodies and the use of enzyme labels in place of radioactive labels.

2003

The next generation of home pregnancy tests was ushered in with FDA approval of Clearblue Easy’s digital pregnancy test. In place of a thin blue line, the indicator screen will now display either “pregnant” or “not pregnant.”

JV: The home pregnancy test is probably the most widely used test besides the hematocrit and hemoglobin [the blood test to measure red blood cells and iron levels that is part of the blood workup done regularly at doctors’ offices].

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Advertisement for ACU-TEST, American Journal of Public Health, January 1979
Advertisement for ACU-TEST, American Journal of Public Health, January 1979.

'Dear Pharmacist' letter from Warner Chilcott, circa 1977. Courtesy of the National Museum of American History, Smithsonian Institution
"Dear Pharmacist" letter from Warner-Chilcott, c. 1977. Courtesy of the National Museum of American History, Smithsonian Institution

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