This article was downloaded by: [New York University] On: 07 May 2015, At: 10:28 Publisher: Routledge Informa Ltd Registered in England and Wales Registered Number: 1072954 Registered office: Mortimer House, 37-41 Mortimer Street, London W1T 3JH, UK
Journal of American College Health Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/vach20
The Use of Pregnancy Test Kits by College Students a
b
Stephen Joel Coons PhD , Lance Churchill MA, MT(ASCP) & Mary L. Brinkman MA a
Division of Pharmacy Administration Practice , University of Kentucky College of Pharmacy , Lexington, USA b
University Health Service Published online: 09 Jul 2010.
To cite this article: Stephen Joel Coons PhD , Lance Churchill MA, MT(ASCP) & Mary L. Brinkman MA (1990) The Use of Pregnancy Test Kits by College Students, Journal of American College Health, 38:4, 171-175, DOI: 10.1080/07448481.1990.9938438 To link to this article: http://dx.doi.org/10.1080/07448481.1990.9938438
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http://www.tandfonline.com/page/termsand-conditions
The Use of Pregnancy Test Kits by College Students
Downloaded by [New York University] at 10:28 07 May 2015
STEPHEN JOEL COONS, PhD, LANCE CHURCHILL, MA, MT(ASCP), and MARY L. BRINKMAN, M A
The self-testing product market is experiencing tremendous growth. Technical breakthroughs are allowing tests to be conducted in the home that at one time were possible only in a clinical laboratory. One of the nmre rapidly expanding components of the self-testing market is home pregnancy test kits. We conducted a study to obtain information about the use of home pregnancy test kits by college students. Questionnaires were distributed to 1,OOO women entering the student health service between October 1 and November 4, 1987. A total of 761 (76.1 %) questionnaireswere completed and returned. Results indicated that approximately 1 out of 6 respondents (17.2%) had used a pregnancy test kit at least once. Of those who had used a test kit, the majority did so because of the speed or confidentiality of obtaining results. The magnitude of test kit use by this sample suggests that college women should be encouraged to use self-testing products as a supplement to but not as a substitute for professional medical care.
A new era of self-reliance in healthcare has emerged. Consumers are assuming an increasing amount of responsibility for their own care and health maintenance. Self-care in health has emerged as a major social trend. One aspect of self-care is self-assessment or self-diagnosis, which increasingly involves the use of self-testing products. Because of this, the self-testing product market is experiencing tremendous growth. Sales of products in this market are projected to increase from approximately $515 million in 1986 to $1.4 billion at retail by 1992, with an average annual growth rate of 18% over the next 5 years.’ Innovations in biotechnology are setting the stage for new self-testing product development. Technical breakthroughs are allowing tests to be completed in the home that at one time were possible only in a clinical laboratory.
Stephen JoelCoons is an assistant professor in the Division of Pharmacy Administration and Practice at the University of Kentucky College of Pharmacy, Lexington, where lance Churchill is clinical service coordinator for the University Health Service, and Mary 1. Brinkman is coordinator of health education.
VOL 38, IANUARY 1990
The explosive growth is expected to continue as consumers seek to reduce their healthcare expenditures by assuming more and more diagnostic responsibility. Several other elements are also leading to an expansion of the market, including an aging population, a regulatory environment favoring home healthcare, and new and more sophisticated distribution channels.* As recent research findings show, self-diagnostic tests are being performed in more than 20% of surveyed household^.^ Some of the products currently on the market or expected to enter the consumer market in the near future are tests or monitors for blood pressure, blood and urine glucose, fecal occult blood, Papanicolaou smear, impotence, pregnancy, predicting ovulation, Strep-A (strep throat), urinary tract infections, and visual acuity.”’ This list illustrates the extent of diagnostic and monitoring capability that is shifting from the clinical laboratory or physician’s office to the home. One of the most rapidly expanding components of the self-testing market is home pregnancy test kits. Sales of these products reached $72 million in 1987, up from about $35 million in 1984.a,’ Almost one third of pregnant women, according to research reports, may use a pregnancy test kit at least once during their pregnancy.” Warner-Lambert created this market in 1977 when it introduced the first consumer product of its kind: e.p.t.@ it has been estimated that Ortho Pharmaceuticals and WarnerLambed, the two sales leaders in the home pregnancy test kit market, spent a combined total of $8 million on consumer advertising campaigns for their kits in 1986.’ Pregnancy test kits are based on the detection of human chorionic gonadotropin (HCG) in the urine.’’ Production of HCG by certain cells (trophoblasts)in the’embryo occurs between 5 and 8 days after fertilization.’* For several of the test kits, it has been demonstrated that the concentration (0.2 I U h L or greater) of HCG necessary to provide highly sensitive prediction of pregnancy is reached14 to 15 daysafter conception, typicallythe day of the missed mense~.’~ The FDA requires that all self-testing kits have a 95Oh or greater accuracy rate when performed correctly. Ac-
171
Downloaded by [New York University] at 10:28 07 May 2015
COLLEGE HEALTH curacy is defined as agreement of the test results with actual status of the individual, ie, pregnant, not pregnant.14 Accuracy, therefore, is a combination of the sensitivity and specificity of the test kit. The sensitivity of a pregnancy test is the percentage of pregnant women who obtain positive results on it (true positives); the specificity is the percentage of women who are not pregnant and o b tain rregative results (true negatives). The labels on all pregnancy test kit packages available to consumers claim an accuracy of greater than 99%. Several of the kit manufacturers would not provide data regarding the actual specificity and sensitivity of their product or products, as determined through laboratory and clinical testing. One firm that provided extensive information reported that, in laboratory tests, their product demonstrated a specificity of 100% on negative clinical samples and a sensitivity of 99.5% on clinical samples with HCG levels of 0.1 I U h L or greater, for an overall accuracy of 99.7%. In consumer studies using untrained nontechnical women to perform the test at home, the test kit demonstrated a specificity of 99.2% in detecting negative samples and a sensitivity of 98.9% in detecting 0.1 I U h L HCG, for an overall consumer accuracy of 99.1'10.'~ Because of the similarities in the labeled accuracy rates of all the other pregnancy test kits available to con-
sumers, it is expected that their specificities and sensitivities would be comparable to those above. Overall, because of the monoclonal antibody technology used in the current generation of kits, the tests are less prone to false results. False positives have been reported with the newer kits in women with staphylococcal urinary tract infections; false negatives may occur if the reagents in the test kit or the urine are chilled,"' or, of course, if the test is done too early. Table 1 lists the majority of the home pregnancy test kits currently on the market. It also lists two differences among the testing products that are especially important for the user to be familiar with: (1) how soon after the missed menses the test can be run and (2) how long the test takes to show a positive result. In order to obtain information regarding the selection, purchase, and use of pregnancy test kits by college women, we developed a project to determine the proportion of women entering the student health service who had used a home pregnancy test kit; the students' primary reasons for using home pregnancy tests rather than another source of pregnancy testing; the major factors influencing students' choice of a specific brand of home pregnancy test kit;
TABLE 1 Home Pregnancy Testst
Product (manufacturer) Advance Test (Advanced Care ProductslOrtho) Answer Answer I I (two tests in kit) (Carter Products) Answer Plus (Carter Products) Clearblue (VLU Daisy 2 (two tests in kit) (Advanced Care ProductslOrtho) e.p.t. Stick Test (Warner-Lambert) e.p.t. Plus (Warner-Lambert) Fact (Advanced Care ProductslOrtho) First Response (Tambrands)
Q Test
Days after missed menses
Minutes between test and results
1
30
3
60
1
15
1
30
3
45
1
10 to 30
1
10 to 30
1
45
Day of missed period 1
10
5 to 15
(Becton Dickinson) tAdapted with permission of the Medical Economics Company. In Quattrocchi E: Helping patients understand home testing devices. Drug Topics 1988;132(9):65.
7 72
PREGNANCY TEST KITS the level of confidence users have with the results of the test kits; and the students’ reasons for thinking that they might be pregnant.
TABLE 3 Most Important Factors in the Selection of a Specific Brand of the Home Pregnancy Test Kit
METHOD We collected data using a questionnaire specifically developed for this project. Women entering the student health service between October 1 and November 4, 1987, were requested to complete the questionnaire and return it to one of the collection boxes in the waiting rooms. All subjects were assured that their participation was voluntary, the questionnaire was completely anonymous, and their responses would in no way affect the services or care they received.
RESULTS AND DISCUSSION
Downloaded by [New York University] at 10:28 07 May 2015
Of the 1,OOO questionnaires distributed during the data collection period, 761 (76.1%) were completed and returned. One hundred thirty-one (17.2%) of the subjects had used a pregnancy test kit; a majority (64.3%) of those had done so only once. Twenty-five of the subjects had used a home pregnancy test within the 3 months immediately preceding their participation in the project. The mean age of the women who had used a test kit was 22.3 years, with a range from 17 to 40 years of age. The mean age of all women who used the student health service during the study period was 22.9 years. The students’ primary reasons for using a home pregnancy test kit rather than, or in addition to, having the test done in a physician’s office, health clinic, or clinical lab are shown in Table 2. The most frequently cited reason was “speed in obtaining results,” with ”confidentiality” ranking second, and “convenience,” third. Although the student health service provides pregnancy testing free of charge, these factors may have overridden the cost incentive for students. In addition, some of the home pregnancy tests were performed while school was not in session. “Cost” and “accuracy“ were not reported as significant factors for the majority of the subjects.
TABLE 2 Primary Reason for Using a Home Pregnancy Test Kit ~
Reason
Speed in obtaining results Confidentiality Convenience cost Accuracy
Other
Subjects (N n 68 40 22 7
5 3
=
131)t %
51.9
30.5 16.8 5.3 3.8 2.3
tSome subjects selected more than one response. The columns, therefore, add up to a number greater than the sample size and to more than 100%.
VOL 38, )ANUARV 1990
Subiects (N n
Factor
Information from side of box Price Advertisements Recommendation of the pharmacist Recommendation of family member or friend Recommendation of other health professional Other
=
131H %
53
40.5
38
29.0
27
20.5
9
6.9
9
6.9
3
2.3
4
3.1
tSome subjects selected more than one response. The cotumns, therefore, add up to a number greater than the sample size and to more than 100%.
More than 80% of the subjects bought their test kits in a “pharmacyldrugstore” or “pharmacy in grocery store,” but pharmacists and other health professionals did not play a key role in the selection of a specific brand of home pregnancy test (see Table 3). The most important consideration was the subjects’ evaluation of the product on the basis of the information on the test kit package. Advertising and price were also important factors in product selection. When students were asked whether or not the directions enclosed with the pregnancy test kit were sufficient to enable them to perform the test with the confidence that they were doing it properly, 119 (90.8%) stated yes. The subjects’ confidence regarding the accuracy of the results that they obtained with the test kits was also high. More than two thirds said they felt confident of the results of the test 75% to 99% or more of the time. Approximately 52% of the users of a test kit had the results verified by a test other than a kit. We did not ask whether their original results were confirmed or disproved by the subsequent test, nor were students asked about the outcome of the test (ie, whether they were pregnant or not). The respondents’ reasons for thinking they might be pregnant are shown in Table 4. In 50 cases (40.3%), more than one response was given (that is, the student had a cluster of symptoms). More than two thirds (67.2%) of the subjects had missed a period. The second most frequently cited reason, “had intercourse and worried/ wondered,“ was selected by about one quarter (25.2%) of the subjects; almost 1 in 5 (19.1%) indicated they had not used or had misused birth control measures.
CONCLUSIONS Our results show that health professionals are playing only a minor role in college women’s use of home preg-
173
COLLEGE HEALTH TABLE 4
Subjects’ Reasons for Thinking They Might Be Pregnant
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Subjects (N
=
131)t
Reason
n
%
Missed a period Had intercourse and worriedlwondered Breast tenderness Did not use or misused birth control method Nausea Missed two or more periods Other
88 33
67.2 25.2
28 25
21.4 19.1
17 7
13.0 5.3
2
1.5
tSome sqbjects selected more than one response. The COIL umns, therefore, add up to a number greater than the sample size and to more than 100%.
nancy tests. This may be partly because the young women value the confidentiality afforded by these products and wish to make purchase decisions on their own. It may also be an indication that health professionals are hesitant to become involved in this process. Some of this hesitancy ‘may be because the professionals lack knowledge about the test kits; some may be due to a perceived reluctance on the part of the consumer to involve others in the decision-making process. Although the majority did not indicate any problems, almost 10% of the subjeqs i n this study said they did not think the directions enclosed in the pregnancy test kit were adequate. The magnitude of use suggests the need for further inquiry into the physical and emotional impact of pregnancy test kit results on women. Depending on the woman’s perspective, a pregnancy test kit result could be traumatic. Some women who wish to become pregnant but have difficulty doing so can find it a terribly frustrating experience, especially if they obtain a false positive and believe it to be true. Others, who do not want t o become pregnant but obtain positive results (either false or true positive) on a test kit may be emotionally devastated, even to a point that affects their physical health. An additional concern is that a false negative result may lead to a delay in the critical decision-making process appropriate for someone who is ~ r e g n a n t . ’ ~ Although this sample may not be representative of all women on campus, the results provide evidence of the need for educational efforts about birth control. Our finding that almost 20% of the sample thought they might be pregnant because they had not used or had misused a birth control method suggests that more can be done in this area. Overall, self-testing has the potential to improve health and save costs. If used inappropriately, however, selftesting could waste money, provide no health benefit, or possibly endanger health by incorrect interpretation of
.
7 74
the results or through overreliance on the products as infallible diagnostic techniques. One of the most crucial limitations of self-testing is the knowledge and competence of the user. It is, therefore, essential to provide the necessary information and skills to enable individuals to involve themselves appropriately in self-testing activities. Health professionals should encourage their patients to use these tests as a supplement to professional care, not as a substitute. Home pregnancy tests are only one component of the expanding self-testing product market. Staff of student health services need to be aware of the many different types of self-testing products aiailable and encourage their proper use. In an effort to promote self-testing safety and effectiveness, the FDA has provided a list of general precautions to be considered when using one of the
product^.^ When purchasing a test kit, note the expiration date. Don’t buy or use a test kit if the date is past. Consider whether the product needs protection from heat or cold. Follow storage directions. Study the package insert. Really study the instructions and pictures until you fully understand each step. If something isn’t clear, don’t guess: Consult a pharmacist or other health professional, or check the insert for a toll-free “800” number to call. Learn what the test is intended to do and what its limitations are. Remember: The tests are not 100% accurate. If color is a part of the test and you’re colorblind, be sure someone who can discern color interprets the results. Note special precautions, such as avoiding physical activity or certain foods and drugs before testing. Follow instructions exactly; do not skip any sfeps. When collecting a urine specimen-unless you use a container from a kit-wash the container thoroughly and rinse out all soap traces, preferably with distilled water. When a step is timed, be precise. As with medications, keep test kits out of the reach of children. Promptly discard used test materials as directed . INDEX TERMS pregnancy, pregnancy test kits, self-testing products
NOTE Results of this study were presented at the 66th Annual Meeting of the American College Health Association in Denver, May 1988.
REFERENCES 1. Home test market expected to top $1 billion by 1992. Drug Topics 1987;131(18):58.
IACH
PREGNANCY TEST KITS 2. Self-diagnostic products market to reach $736 million
by 1989. Medical Marketing & Media 1985;20:38(10):38.
Downloaded by [New York University] at 10:28 07 May 2015
3. Two of every ten households now use home diagnostic tests. Am Pharm 1987;NS27(1):15. 4. Farley D. Do-it-yourself medical testing. FDA Consumer 1986;(February):24. 5. Chi J. What’s new in home test kits. Drug Topics 1986; 130(15):28-34. 6. Home Pap smear test looks promising. Am Pharm 1986; NS26(7):487. 7. Rosendahl I . Self-care continues to fuel OTC drug market. Drug Topics 1986;130(9):60-63. 8. Rosendahl I, Mysiewicz T. What’s happening in OTCs and HBAs. Drug Topics 1988;132(8):36-60. 9. Winters P. W-L, Ortho vie for home-pregnancy-test lead. Advertising Age 1986;(March 10):4. 10. Valanis BG, Perlman CS. Home pregnancy testing kits: Prevalence of use, false-negative results, and compliance with
The computer system for InternationalTravel Advice
IMUNIZATIONALERT
IM
P.O. Box406 Dept. B Storrs, CT 06268 203/487-0422 Telex via WI 2907868
What it is: A computer program which contains health information for travelers on over 200 countries Who is using Immunization Alert?: 0 physicians in primary care 0 specialists in Infectious Diseases 0 state and local health departments 0 travel clinics 0 group practices and HMOs 0 corporations whose employees must travel 0 medical libraries
VOL 38, IANUARY 1990
instructions. Am / Public Health 1982;72(9):1034-1036. 11. CarreireLewandowski E. Pregnancy testing: Detection of human chorionic gonadotropin (HCG). / Med Techno/ 1986; 3(9):473-476. 12. Braunstein GD, Rasor J, Adler D, et al. Serum human chorionic gonadotropin levels throughout normal pregnancy. Am / Obstet Cynecol 1976;126(6):678-681. 13. Asch RH, Asch 6, Asch G,et al. Performance and sensitivity of modern home pregnancy tests. Int / Fertil 1988;33(3): 154- 161 . 14. Doshi ML. Accuracy of consumer performed in-home tests for early pregnancy detection. Am / Public Health 1986; 76(5):512-51 4. 15. Seigel M (Becton Dickinson Consumer Products). Personal Communication. November 1, 1988. 16. Koffer KF, Cerbino PP. Home laboratory testing (Part 2). American Druggist 1986; 193(4):103-108.
What it does: I.Produces reports for individual travelers to any number of countries; includes a summary statement of all preventive,measures 2. Preparesa master print-out of over 200 countries which can be reprinted as needed to remain current 3. Provides immediate access on the computer screen to all recommendations; especially useful for settings in which telephone advice is given and printed reports are not needed (clinics and health departments) Is it current?: The master program is updated daily as needed to reflect changes in world conditions; new diskettes can be mailed weekly, bi-weekly, monthly or quarterly, as desired. Both CDC and WHO are used as references. For these computers: IBM PC, PC-XT (MS-DOS 2.0) Tandy 2000 (and others compatible with these systems)
1 7.5
Journal of American College Health Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/vach20
The Use of Pregnancy Test Kits by College Students a
b
Stephen Joel Coons PhD , Lance Churchill MA, MT(ASCP) & Mary L. Brinkman MA a
Division of Pharmacy Administration Practice , University of Kentucky College of Pharmacy , Lexington, USA b
University Health Service Published online: 09 Jul 2010.
To cite this article: Stephen Joel Coons PhD , Lance Churchill MA, MT(ASCP) & Mary L. Brinkman MA (1990) The Use of Pregnancy Test Kits by College Students, Journal of American College Health, 38:4, 171-175, DOI: 10.1080/07448481.1990.9938438 To link to this article: http://dx.doi.org/10.1080/07448481.1990.9938438
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http://www.tandfonline.com/page/termsand-conditions
The Use of Pregnancy Test Kits by College Students
Downloaded by [New York University] at 10:28 07 May 2015
STEPHEN JOEL COONS, PhD, LANCE CHURCHILL, MA, MT(ASCP), and MARY L. BRINKMAN, M A
The self-testing product market is experiencing tremendous growth. Technical breakthroughs are allowing tests to be conducted in the home that at one time were possible only in a clinical laboratory. One of the nmre rapidly expanding components of the self-testing market is home pregnancy test kits. We conducted a study to obtain information about the use of home pregnancy test kits by college students. Questionnaires were distributed to 1,OOO women entering the student health service between October 1 and November 4, 1987. A total of 761 (76.1 %) questionnaireswere completed and returned. Results indicated that approximately 1 out of 6 respondents (17.2%) had used a pregnancy test kit at least once. Of those who had used a test kit, the majority did so because of the speed or confidentiality of obtaining results. The magnitude of test kit use by this sample suggests that college women should be encouraged to use self-testing products as a supplement to but not as a substitute for professional medical care.
A new era of self-reliance in healthcare has emerged. Consumers are assuming an increasing amount of responsibility for their own care and health maintenance. Self-care in health has emerged as a major social trend. One aspect of self-care is self-assessment or self-diagnosis, which increasingly involves the use of self-testing products. Because of this, the self-testing product market is experiencing tremendous growth. Sales of products in this market are projected to increase from approximately $515 million in 1986 to $1.4 billion at retail by 1992, with an average annual growth rate of 18% over the next 5 years.’ Innovations in biotechnology are setting the stage for new self-testing product development. Technical breakthroughs are allowing tests to be completed in the home that at one time were possible only in a clinical laboratory.
Stephen JoelCoons is an assistant professor in the Division of Pharmacy Administration and Practice at the University of Kentucky College of Pharmacy, Lexington, where lance Churchill is clinical service coordinator for the University Health Service, and Mary 1. Brinkman is coordinator of health education.
VOL 38, IANUARY 1990
The explosive growth is expected to continue as consumers seek to reduce their healthcare expenditures by assuming more and more diagnostic responsibility. Several other elements are also leading to an expansion of the market, including an aging population, a regulatory environment favoring home healthcare, and new and more sophisticated distribution channels.* As recent research findings show, self-diagnostic tests are being performed in more than 20% of surveyed household^.^ Some of the products currently on the market or expected to enter the consumer market in the near future are tests or monitors for blood pressure, blood and urine glucose, fecal occult blood, Papanicolaou smear, impotence, pregnancy, predicting ovulation, Strep-A (strep throat), urinary tract infections, and visual acuity.”’ This list illustrates the extent of diagnostic and monitoring capability that is shifting from the clinical laboratory or physician’s office to the home. One of the most rapidly expanding components of the self-testing market is home pregnancy test kits. Sales of these products reached $72 million in 1987, up from about $35 million in 1984.a,’ Almost one third of pregnant women, according to research reports, may use a pregnancy test kit at least once during their pregnancy.” Warner-Lambert created this market in 1977 when it introduced the first consumer product of its kind: e.p.t.@ it has been estimated that Ortho Pharmaceuticals and WarnerLambed, the two sales leaders in the home pregnancy test kit market, spent a combined total of $8 million on consumer advertising campaigns for their kits in 1986.’ Pregnancy test kits are based on the detection of human chorionic gonadotropin (HCG) in the urine.’’ Production of HCG by certain cells (trophoblasts)in the’embryo occurs between 5 and 8 days after fertilization.’* For several of the test kits, it has been demonstrated that the concentration (0.2 I U h L or greater) of HCG necessary to provide highly sensitive prediction of pregnancy is reached14 to 15 daysafter conception, typicallythe day of the missed mense~.’~ The FDA requires that all self-testing kits have a 95Oh or greater accuracy rate when performed correctly. Ac-
171
Downloaded by [New York University] at 10:28 07 May 2015
COLLEGE HEALTH curacy is defined as agreement of the test results with actual status of the individual, ie, pregnant, not pregnant.14 Accuracy, therefore, is a combination of the sensitivity and specificity of the test kit. The sensitivity of a pregnancy test is the percentage of pregnant women who obtain positive results on it (true positives); the specificity is the percentage of women who are not pregnant and o b tain rregative results (true negatives). The labels on all pregnancy test kit packages available to consumers claim an accuracy of greater than 99%. Several of the kit manufacturers would not provide data regarding the actual specificity and sensitivity of their product or products, as determined through laboratory and clinical testing. One firm that provided extensive information reported that, in laboratory tests, their product demonstrated a specificity of 100% on negative clinical samples and a sensitivity of 99.5% on clinical samples with HCG levels of 0.1 I U h L or greater, for an overall accuracy of 99.7%. In consumer studies using untrained nontechnical women to perform the test at home, the test kit demonstrated a specificity of 99.2% in detecting negative samples and a sensitivity of 98.9% in detecting 0.1 I U h L HCG, for an overall consumer accuracy of 99.1'10.'~ Because of the similarities in the labeled accuracy rates of all the other pregnancy test kits available to con-
sumers, it is expected that their specificities and sensitivities would be comparable to those above. Overall, because of the monoclonal antibody technology used in the current generation of kits, the tests are less prone to false results. False positives have been reported with the newer kits in women with staphylococcal urinary tract infections; false negatives may occur if the reagents in the test kit or the urine are chilled,"' or, of course, if the test is done too early. Table 1 lists the majority of the home pregnancy test kits currently on the market. It also lists two differences among the testing products that are especially important for the user to be familiar with: (1) how soon after the missed menses the test can be run and (2) how long the test takes to show a positive result. In order to obtain information regarding the selection, purchase, and use of pregnancy test kits by college women, we developed a project to determine the proportion of women entering the student health service who had used a home pregnancy test kit; the students' primary reasons for using home pregnancy tests rather than another source of pregnancy testing; the major factors influencing students' choice of a specific brand of home pregnancy test kit;
TABLE 1 Home Pregnancy Testst
Product (manufacturer) Advance Test (Advanced Care ProductslOrtho) Answer Answer I I (two tests in kit) (Carter Products) Answer Plus (Carter Products) Clearblue (VLU Daisy 2 (two tests in kit) (Advanced Care ProductslOrtho) e.p.t. Stick Test (Warner-Lambert) e.p.t. Plus (Warner-Lambert) Fact (Advanced Care ProductslOrtho) First Response (Tambrands)
Q Test
Days after missed menses
Minutes between test and results
1
30
3
60
1
15
1
30
3
45
1
10 to 30
1
10 to 30
1
45
Day of missed period 1
10
5 to 15
(Becton Dickinson) tAdapted with permission of the Medical Economics Company. In Quattrocchi E: Helping patients understand home testing devices. Drug Topics 1988;132(9):65.
7 72
PREGNANCY TEST KITS the level of confidence users have with the results of the test kits; and the students’ reasons for thinking that they might be pregnant.
TABLE 3 Most Important Factors in the Selection of a Specific Brand of the Home Pregnancy Test Kit
METHOD We collected data using a questionnaire specifically developed for this project. Women entering the student health service between October 1 and November 4, 1987, were requested to complete the questionnaire and return it to one of the collection boxes in the waiting rooms. All subjects were assured that their participation was voluntary, the questionnaire was completely anonymous, and their responses would in no way affect the services or care they received.
RESULTS AND DISCUSSION
Downloaded by [New York University] at 10:28 07 May 2015
Of the 1,OOO questionnaires distributed during the data collection period, 761 (76.1%) were completed and returned. One hundred thirty-one (17.2%) of the subjects had used a pregnancy test kit; a majority (64.3%) of those had done so only once. Twenty-five of the subjects had used a home pregnancy test within the 3 months immediately preceding their participation in the project. The mean age of the women who had used a test kit was 22.3 years, with a range from 17 to 40 years of age. The mean age of all women who used the student health service during the study period was 22.9 years. The students’ primary reasons for using a home pregnancy test kit rather than, or in addition to, having the test done in a physician’s office, health clinic, or clinical lab are shown in Table 2. The most frequently cited reason was “speed in obtaining results,” with ”confidentiality” ranking second, and “convenience,” third. Although the student health service provides pregnancy testing free of charge, these factors may have overridden the cost incentive for students. In addition, some of the home pregnancy tests were performed while school was not in session. “Cost” and “accuracy“ were not reported as significant factors for the majority of the subjects.
TABLE 2 Primary Reason for Using a Home Pregnancy Test Kit ~
Reason
Speed in obtaining results Confidentiality Convenience cost Accuracy
Other
Subjects (N n 68 40 22 7
5 3
=
131)t %
51.9
30.5 16.8 5.3 3.8 2.3
tSome subjects selected more than one response. The columns, therefore, add up to a number greater than the sample size and to more than 100%.
VOL 38, )ANUARV 1990
Subiects (N n
Factor
Information from side of box Price Advertisements Recommendation of the pharmacist Recommendation of family member or friend Recommendation of other health professional Other
=
131H %
53
40.5
38
29.0
27
20.5
9
6.9
9
6.9
3
2.3
4
3.1
tSome subjects selected more than one response. The cotumns, therefore, add up to a number greater than the sample size and to more than 100%.
More than 80% of the subjects bought their test kits in a “pharmacyldrugstore” or “pharmacy in grocery store,” but pharmacists and other health professionals did not play a key role in the selection of a specific brand of home pregnancy test (see Table 3). The most important consideration was the subjects’ evaluation of the product on the basis of the information on the test kit package. Advertising and price were also important factors in product selection. When students were asked whether or not the directions enclosed with the pregnancy test kit were sufficient to enable them to perform the test with the confidence that they were doing it properly, 119 (90.8%) stated yes. The subjects’ confidence regarding the accuracy of the results that they obtained with the test kits was also high. More than two thirds said they felt confident of the results of the test 75% to 99% or more of the time. Approximately 52% of the users of a test kit had the results verified by a test other than a kit. We did not ask whether their original results were confirmed or disproved by the subsequent test, nor were students asked about the outcome of the test (ie, whether they were pregnant or not). The respondents’ reasons for thinking they might be pregnant are shown in Table 4. In 50 cases (40.3%), more than one response was given (that is, the student had a cluster of symptoms). More than two thirds (67.2%) of the subjects had missed a period. The second most frequently cited reason, “had intercourse and worried/ wondered,“ was selected by about one quarter (25.2%) of the subjects; almost 1 in 5 (19.1%) indicated they had not used or had misused birth control measures.
CONCLUSIONS Our results show that health professionals are playing only a minor role in college women’s use of home preg-
173
COLLEGE HEALTH TABLE 4
Subjects’ Reasons for Thinking They Might Be Pregnant
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Subjects (N
=
131)t
Reason
n
%
Missed a period Had intercourse and worriedlwondered Breast tenderness Did not use or misused birth control method Nausea Missed two or more periods Other
88 33
67.2 25.2
28 25
21.4 19.1
17 7
13.0 5.3
2
1.5
tSome sqbjects selected more than one response. The COIL umns, therefore, add up to a number greater than the sample size and to more than 100%.
nancy tests. This may be partly because the young women value the confidentiality afforded by these products and wish to make purchase decisions on their own. It may also be an indication that health professionals are hesitant to become involved in this process. Some of this hesitancy ‘may be because the professionals lack knowledge about the test kits; some may be due to a perceived reluctance on the part of the consumer to involve others in the decision-making process. Although the majority did not indicate any problems, almost 10% of the subjeqs i n this study said they did not think the directions enclosed in the pregnancy test kit were adequate. The magnitude of use suggests the need for further inquiry into the physical and emotional impact of pregnancy test kit results on women. Depending on the woman’s perspective, a pregnancy test kit result could be traumatic. Some women who wish to become pregnant but have difficulty doing so can find it a terribly frustrating experience, especially if they obtain a false positive and believe it to be true. Others, who do not want t o become pregnant but obtain positive results (either false or true positive) on a test kit may be emotionally devastated, even to a point that affects their physical health. An additional concern is that a false negative result may lead to a delay in the critical decision-making process appropriate for someone who is ~ r e g n a n t . ’ ~ Although this sample may not be representative of all women on campus, the results provide evidence of the need for educational efforts about birth control. Our finding that almost 20% of the sample thought they might be pregnant because they had not used or had misused a birth control method suggests that more can be done in this area. Overall, self-testing has the potential to improve health and save costs. If used inappropriately, however, selftesting could waste money, provide no health benefit, or possibly endanger health by incorrect interpretation of
.
7 74
the results or through overreliance on the products as infallible diagnostic techniques. One of the most crucial limitations of self-testing is the knowledge and competence of the user. It is, therefore, essential to provide the necessary information and skills to enable individuals to involve themselves appropriately in self-testing activities. Health professionals should encourage their patients to use these tests as a supplement to professional care, not as a substitute. Home pregnancy tests are only one component of the expanding self-testing product market. Staff of student health services need to be aware of the many different types of self-testing products aiailable and encourage their proper use. In an effort to promote self-testing safety and effectiveness, the FDA has provided a list of general precautions to be considered when using one of the
product^.^ When purchasing a test kit, note the expiration date. Don’t buy or use a test kit if the date is past. Consider whether the product needs protection from heat or cold. Follow storage directions. Study the package insert. Really study the instructions and pictures until you fully understand each step. If something isn’t clear, don’t guess: Consult a pharmacist or other health professional, or check the insert for a toll-free “800” number to call. Learn what the test is intended to do and what its limitations are. Remember: The tests are not 100% accurate. If color is a part of the test and you’re colorblind, be sure someone who can discern color interprets the results. Note special precautions, such as avoiding physical activity or certain foods and drugs before testing. Follow instructions exactly; do not skip any sfeps. When collecting a urine specimen-unless you use a container from a kit-wash the container thoroughly and rinse out all soap traces, preferably with distilled water. When a step is timed, be precise. As with medications, keep test kits out of the reach of children. Promptly discard used test materials as directed . INDEX TERMS pregnancy, pregnancy test kits, self-testing products
NOTE Results of this study were presented at the 66th Annual Meeting of the American College Health Association in Denver, May 1988.
REFERENCES 1. Home test market expected to top $1 billion by 1992. Drug Topics 1987;131(18):58.
IACH
PREGNANCY TEST KITS 2. Self-diagnostic products market to reach $736 million
by 1989. Medical Marketing & Media 1985;20:38(10):38.
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3. Two of every ten households now use home diagnostic tests. Am Pharm 1987;NS27(1):15. 4. Farley D. Do-it-yourself medical testing. FDA Consumer 1986;(February):24. 5. Chi J. What’s new in home test kits. Drug Topics 1986; 130(15):28-34. 6. Home Pap smear test looks promising. Am Pharm 1986; NS26(7):487. 7. Rosendahl I . Self-care continues to fuel OTC drug market. Drug Topics 1986;130(9):60-63. 8. Rosendahl I, Mysiewicz T. What’s happening in OTCs and HBAs. Drug Topics 1988;132(8):36-60. 9. Winters P. W-L, Ortho vie for home-pregnancy-test lead. Advertising Age 1986;(March 10):4. 10. Valanis BG, Perlman CS. Home pregnancy testing kits: Prevalence of use, false-negative results, and compliance with
The computer system for InternationalTravel Advice
IMUNIZATIONALERT
IM
P.O. Box406 Dept. B Storrs, CT 06268 203/487-0422 Telex via WI 2907868
What it is: A computer program which contains health information for travelers on over 200 countries Who is using Immunization Alert?: 0 physicians in primary care 0 specialists in Infectious Diseases 0 state and local health departments 0 travel clinics 0 group practices and HMOs 0 corporations whose employees must travel 0 medical libraries
VOL 38, IANUARY 1990
instructions. Am / Public Health 1982;72(9):1034-1036. 11. CarreireLewandowski E. Pregnancy testing: Detection of human chorionic gonadotropin (HCG). / Med Techno/ 1986; 3(9):473-476. 12. Braunstein GD, Rasor J, Adler D, et al. Serum human chorionic gonadotropin levels throughout normal pregnancy. Am / Obstet Cynecol 1976;126(6):678-681. 13. Asch RH, Asch 6, Asch G,et al. Performance and sensitivity of modern home pregnancy tests. Int / Fertil 1988;33(3): 154- 161 . 14. Doshi ML. Accuracy of consumer performed in-home tests for early pregnancy detection. Am / Public Health 1986; 76(5):512-51 4. 15. Seigel M (Becton Dickinson Consumer Products). Personal Communication. November 1, 1988. 16. Koffer KF, Cerbino PP. Home laboratory testing (Part 2). American Druggist 1986; 193(4):103-108.
What it does: I.Produces reports for individual travelers to any number of countries; includes a summary statement of all preventive,measures 2. Preparesa master print-out of over 200 countries which can be reprinted as needed to remain current 3. Provides immediate access on the computer screen to all recommendations; especially useful for settings in which telephone advice is given and printed reports are not needed (clinics and health departments) Is it current?: The master program is updated daily as needed to reflect changes in world conditions; new diskettes can be mailed weekly, bi-weekly, monthly or quarterly, as desired. Both CDC and WHO are used as references. For these computers: IBM PC, PC-XT (MS-DOS 2.0) Tandy 2000 (and others compatible with these systems)
1 7.5
