1970-2003
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.
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.
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.
Am I Pregnant?
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.
In a 1972 textbook on gonadotropins, Vaitukaitis and Ross noted that: “Common antigenic determinants [biological characteristics] among hCG, LH, FSH, and TSH have made the production of specific antisera for radioimmunoassay difficult.” However, the team was close: “the recent isolation and separation of subunits…have provided unique materials with which these questions could be explored.”
1972
Vaitukaitis, Braunstein, and Ross published their paperdescribing the hCG beta-subunit radioimmunoassay that could finally distinguish between hCG and LH, therefore making it potentially useful as an early test for pregnancy.
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.
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.
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.
1976
Several articles in the American Journal of Public Healthstated that public health would be better served if the average consumer could purchase a home pregnancy test and use it reliably in her own home.
1977
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”
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 inMademoiselle: “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, notedMademoiselle, 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.”
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.
1976
Several articles in the American Journal of Public Healthstated that public health would be better served if the average consumer could purchase a home pregnancy test and use it reliably in her own home.
1977
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”
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 inMademoiselle: “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, notedMademoiselle, 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.”
back to Pregnancy Test Kits
No comments:
Post a Comment