Page Comparison - Pregnancy Test Timeline (v.1 vs v.2)

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A. R. Midgley described the first radioimmunoassay for hCG, but the test still could not differentiate between hCG and luteinizing hormone. Several other laboratories reported improvements on this test, but did not solve this basic problem.

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

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

1970-1972

Scientists at NIH learned more about the properties of hCG. They were specifically interested in which parts of the hormone showed biologic activity. Using various methods, they identified two subunits of hCG and focused on the beta-subunit. They found that the beta-subunit is where the immunologic and biologic specificity of hCG resides (what makes it different from other hormones). Using animal models, they took advantage of this discovery to develop a specific antiserum for measuring the hormone in humans.

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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.

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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 Image Added

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

1976

FDA approval was sought by Warner-Chilcott for e.p.t, the “Early Pregnancy Test” later known as the “Error Proof Test.” e.p.t would become the first home pregnancy test kit on the market in the United States. The makers of e.p.t worked with the FDA to meet all the requirements of the 1976 Medical Devices Act. (The new regulations divided medical devices into three classes depending on potential for harm and misuse.) Approval was also granted to three other tests that were deemed “Substantially equivalent:” Predictor, ACU-TEST, and Answer.

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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.

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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:

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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].

Note
Note: Quotations labeled “JV” are from an interview with Judith Vaitukaitis, August 18, 2003. Quotations labeled “GB” are from a telephone conversation with Glenn Braunstein, October 3, 2003.

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

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