Pregnancy Test Kits Research Articles

The feminist appropriation of pregnancy testing in 1970s Britain

ABSTRACTThis article restores pregnancy testing to its significant position in the history of the women’s liberation movement in 1970s Britain. It shows how feminists appropriated the pregnancy test kit, a medical technology which then resembled a small chemistry set, and used it as a political tool for demystifying medicine, empowering women and providing a more accessible, less judgmental alternative to the N.H.S. While the majority of testees were young women hoping for a negative result, many others were older, menopausal women as well as those anxious to conceive. By following the practice of pregnancy testing, I show that, at the grassroots level, local women’s centres were in the vanguard of not only access to contraception and abortion rights, but also awareness about infertility and menopause.

Cost-effectiveness analysis and mortality impact estimation of scaling-up pregnancy test kits in Madagascar, Ethiopia and Malawi.

Cost-effective, innovative approaches are needed to accelerate progress towards ending preventable infant, child and maternal mortality. To inform policy decisions, we conducted a cost-effectiveness analysis of adding urine pregnancy test kits to the maternal and reproductive services package offered at the community level in Madagascar, Ethiopia and Malawi. We used a decision tree model to compare the intervention with the status quo for each country. We also completed single factor sensitivity analyses and Monte Carlo simulations with 10 000 iterations to generate the probability distribution of the estimates and uncertainty limits. Among a hypothetical cohort of 100 000 women of reproductive age, we estimate that over a 1-year period, the intervention would save 26, 35 and 48 lives in Madagascar, Ethiopia, and Malawi, respectively. The Incremental Cost Effectiveness Ratio (ICER) for the cost per life saved varies by country: $2311 [95% Uncertainty Interval (UI): $1699; $3454] in Madagascar; $2969 [UI: $2260; $5041] in Ethiopia and $1228 [UI: $918; $1777] in Malawi. This equates to an average cost per Disability Adjusted Life Year (DALY) averted of $36.28, $47.95 and $21.92, respectively. Based on WHO criteria and a comparison with other maternal, newborn, and child health interventions, we conclude that the addition of urine pregnancy tests to an existing community health worker maternal and reproductive services package is highly cost-effective in all three countries. To optimize uptake of family planning and antenatal care services and, in turn, accelerate the reduction of mortality and DALYs, decision makers and program planners should consider adding urine pregnancy tests to the community-level package of services.

Proximity to major roadways and prospectively-measured time-to-pregnancy and infertility

We aimed to study the potential impact of proximity to major roadways on time-to-pregnancy and infertility in couples attempting pregnancy in the Longitudinal Investigation of Fertility and Environment (LIFE) study (2005–2009), a population-based, prospective cohort study. Couples attempting pregnancy (n=500) were enrolled and followed prospectively until pregnancy or 12months of trying and 393 couples (78%) had complete data and full follow-up. Time-to-pregnancy was based on a standard protocol using fertility monitors, tracking estrone-3-glucuonide and luteinizing hormone, and pregnancy test kits to detect human chorionic gonadotropin (hCG). The fecundability odds ratio (FOR) and 95% confidence interval (CI) were estimated using proportional odds models. Infertility was defined as 12months of trying to conceive without an hCG pregnancy and the relative risk (RR) and 95% CI were estimated with log-binomial regression. Final models were adjusted for age, parity, study site, and salivary alpha-amylase, a stress marker. Infertile couples (53/393; 14%) tended to live closer to major roadways on average than fertile couples (689m vs. 843m, respectively) but the difference was not statistically significant. The likelihood of pregnancy was increased 3% for every 200m further away the couples residence was from a major roadway (FOR=1.03; CI=1.01–1.06). Infertility also appeared elevated at moderate distances compared to 1000m or greater, but estimates lacked precision. Our findings suggest that proximity to major roadways may be related to reductions in fecundity. Prospective data from larger populations is warranted to corroborate these findings.

Preconception perfluoroalkyl and polyfluoroalkyl substances and incident pregnancy loss, LIFE Study.

Equivocal findings are reported for perfluoroalkyl and polyfluoroalkyl substances (PFASs) and self-reported pregnancy loss. We prospectively assessed PFASs and pregnancy loss in a cohort comprising 501 couples recruited preconception and followed daily through 7 post-conception weeks. Seven PFASs were quantified: 2-N-ethyl-perfluorooctane sulfonamide acetate (Et-PFOSA-AcOH); 2-N-methyl-perfluorooctane sulfonamido acetate (Me-PFOSA-AcOH); perfluorodecanoate (PFDeA); perfluorononanoate (PFNA); perfluorooctane sulfonamide (PFOSA); perfluorooctane sulfonate (PFOS); and perfluorooctanoate (PFOA). Women used home pregnancy test kits. Loss denoted conversion from a positive to a negative pregnancy test, onset of menses or clinical confirmation (n=98; 28%). Chemicals were log transformed and rescaled by their standard deviations to estimate adjusted hazard ratios (HRs) and 95% confidence intervals. No significantly elevated HRs were observed for any PFASs suggesting no association with loss: Et-PFOSA-AcOH (1.04; 0.87, 1.23), Me-PFOSA-AcOH (0.79; 0.61, 1.00; p<0.05), PFDeA (0.83; 0.66, 1.04), PFNA (0.86; 0.70, 1.06), PFOSA (0.74; 0.50, 1.09), PFOS (0.81; 0.65, 1.00), and PFOA (0.93; 0.75, 1.16).

Paternal exposures to environmental chemicals and time-to-pregnancy: overview of results from the LIFE study.

Published findings from the Longitudinal Investigation of Fertility and the Environment (LIFE) Study regarding the relation between environmental chemicals and couple fecundity, as measured by time-to-pregnancy (TTP), are reviewed with a particular focus on role of the male partner. The LIFE Study recruited 501 couples from 16 counties in two U.S. states upon discontinuing contraception for purposes of becoming pregnant. Upon enrollment, couples provided a blood and urine sample for the quantification of persistent and non-persistent environmental chemicals, respectively, and then completed daily journals until pregnant or up to one year of trying. Female partners used fertility monitors to aid the timing of intercourse relative to ovulation, and digital home pregnancy test kits on the day of expected menses. Chemical classes included: metals, persistent organic pollutants, environmental phenols, and phthalates that were quantified using inductively coupled plasma mass spectrometry or isotope dilution high-resolution or tandem mass spectrometry. Time-to-pregnancy (TTP) was defined as the number of prospectively observed menstrual cycles required for pregnancy. Fecundability odds ratios (FORs) and 95% confidence intervals (CIs) were estimated for each chemical and partner after adjusting for potential confounders and accounting for right censoring and time off contraception. FORs<1 are suggestive of diminished fecundity or a longer TTP. Significant reductions (ranging from 17-31%) in couple fecundity were observed for male partners' concentration of lead (0.83; 0.70, 0.98), 2,2',4,4'-tetrahydroxybenzophenone (0.69; 0.49, 0.97), monobenzyl (0.80; 0.67, 0.97), and monomethyl (0.81; 0.70, 0.94) phthalates after adjusting for the female partners' concentrations. Seven PCB congeners quantified in men's serum were associated with a 17-29% reduction in couple fecundity. Our findings underscore the importance of a couple-based exposure design, inclusive of the male partner, when assessing couple-dependent outcomes such as TTP to avoid misinterpretation of results based only upon the female partner.

Providing free pregnancy test kits to community health workers increases distribution of contraceptives: results from an impact evaluation in Madagascar

ObjectivesTo improve access to contraceptives in remote and rural areas, sub-Saharan African countries are allowing community health workers (CHWs) to distribute hormonal contraceptives. Before offering hormonal contraceptives, CHWs must determine pregnancy status but often lack a reliable way to do so. No studies have evaluated the impact of providing CHWs with urine pregnancy test kits. We assessed the impact of giving CHWs free pregnancy test kits on the number of new clients purchasing hormonal contraceptives from CHWs. Study designWe implemented a randomized experiment in Eastern Madagascar among CHWs who sell injectable and oral hormonal contraceptives. A total of 622 CHWs were stratified by region and randomly assigned at the individual level. Treatment-group CHWs were given free pregnancy tests to distribute (n analyzed=272) and control-group CHWs did not receive the tests (n analyzed=263). We estimated an ordinary least-squares regression model, with the monthly number of new hormonal contraceptive clients per CHW as our primary outcome. ResultsWe find that providing CHWs with free pregnancy test kits increases the number of new hormonal contraceptive clients. Treatment-group CHWs provide hormonal contraceptives to 3.1 new clients per month, compared to 2.5 in the control group. This difference of 0.7 clients per month (95% confidence interval 0.13–1.18; p=.014) represents a 26% increase. ConclusionsGiving CHWs free pregnancy tests is an effective way to increase distribution of hormonal contraceptives. As pregnancy tests become increasingly affordable for health-care systems in developing countries, community-based distribution programs should consider including the tests as a low-cost addition to CHWs’ services. ImplicationsNo study has evaluated the impact of giving CHWs free urine pregnancy test kits for distribution to improve provision of hormonal contraceptives. Giving CHWs free pregnancy test kits significantly increases the number of clients to whom they sell hormonal contraceptives. Community-based distribution programs should consider including these tests among CHWs’ services.

Lifestyle and pregnancy loss among women using home pregnancy test kits, life study

Recent cohorts of reproductive aged women now detect their pregnancies early using sensitive home pregnancy tests, replacing clinical diagnosis as the gold standard. This prompted us to assess whether the incidence or risk factors for pregnancy loss have changed relative to guidance based upon clinically recognized pregnancies.

The impact of tubal ectopic pregnancy in Papua New Guinea--a retrospective case review.

BackgroundEctopic pregnancy (EP) is an important cause of morbidity and mortality amongst women of reproductive age. Tubal EP is well described in industrialised countries, but less is known about its impact in low-resource countries, in particular in the South Pacific Region.MethodsWe undertook a retrospective review of women with tubal EP treated at a provincial referral hospital in coastal Papua New Guinea over a period of 56 months. Demographic and clinical variables were obtained from patients’ medical records and analysed. The institutional rate of tubal EP was calculated, and diagnosis and management reviewed. Potential risk factors for tubal EP were identified, and delays contributing to increased morbidity described.ResultsA total of 73 women had tubal EP. The institutional rate of tubal EP over the study period was 6.3 per 1,000 deliveries. There were no maternal deaths due to EP. The mean age of women was 31.5+/−5.7 years, 85% were parous, 67% were rural dwellers and 62% had a history of sub-fertility. The most commonly used diagnostic aid was culdocentesis. One third of women had clinical evidence of shock on arrival. All women with tubal EP were managed by open salpingectomy. Tubal rupture was confirmed for 48% of patients and was more common amongst rural dwellers. Forty-three percent of women had macroscopic evidence of pelvic infection. Two-thirds of patients received blood transfusions, and post-operative recovery lasted six days on average. Late presentation, lack of clinical suspicion, and delays with receiving appropriate treatments were observed.ConclusionsTubal EP is a common gynaecological emergency in a referral hospital in coastal PNG, and causes significant morbidity, in particular amongst women residing in rural areas. Sexually transmitted infections are likely to represent the most important risk factor for tubal EP in PNG. Interventions to reduce the morbidity due to tubal EP include the prevention, detection and treatment of sexually transmitted infections, identification and reduction of barriers to prompt presentation, increasing health workers’ awareness of ectopic pregnancy, providing pregnancy test kits to rural health centres, and strengthening hospital blood transfusion services, including facilities for autotransfusion.

Health consumption as work: The home pregnancy test as a domesticated health tool

A growing array of biomedical goods and services has become central to the North American experience of navigating illness and pursuing good health. Yet despite the utility of consumption as an analytical framework within the social sciences, the selection, purchase, and use of biomedical goods and services has been understudied. By using the home pregnancy test as a case study, we suggest new approaches to thinking about the consumption of these goods and services. We chose the home pregnancy test because it is the best-known example of a mass-produced diagnostic tool used by consumers. We draw on two sources of data for this qualitative analysis: a set of stories submitted between 2003 and 2005 by women and men to an online exhibit mounted by the National Institutes of Health called “A Thin Blue Line: The History of the Pregnancy Test Kit,” which we analysed between 2006 and 2007; and web sampling conducted in 2009 and 2010 of personal web and video logs of women and men who have posted stories and opinions about their experiences with contemporary home pregnancy testing products. We adapt the term “domestication” from Science and Technology Studies scholarship to describe the movement of diagnostic devices into homes for use by consumers. Specifically, we propose that the consumption of domesticated biomedical devices, goods, and services should be theorized as work performed by consumers, in two senses: as a form of tool use that allows non-experts to produce diagnostic knowledge about their own bodies and health; and as the ongoing biopolitical work that is expected of citizens to produce healthy bodies. Our paper draws attention to these understudied phenomena, while suggesting new approaches to theorizing the social and cultural elements of goods and services for health.

The diagnostic accuracy of strategies used to identify early pregnancy: a systematic review.

Review question/objective The objective of this review is to summarise and synthesise the evidence on the diagnostic accuracy of screening strategies used to identify early pregnancy in patients in the health care setting More specifically, the objectives are to identify the diagnostic accuracy of: 1. patient history to identify early pregnancy; including verbal questioning, written questionnaires and use of last menstrual period dates, and 2. pregnancy testing in identifying early pregnancy. Inclusion criteria Types of participants This review will consider studies that include adolescent and adult female patients in the health care setting of childbearing age. Focus of the review The focus of the review is the correct identification of early pregnancy. This review will consider studies that compare the diagnostic accuracy of screening strategies to identify early pregnancy compared to HCG pregnancy test. Types of outcomes This review will consider studies that report on the sensitivity, specificity and accuracy of medical history and/or physical examination (index test), and urine or serum HCG pregnancy test (reference test) to identify early stage pregnancy. Likelihood ratios and/or predictive values will be generated to further describe the diagnostic test accuracy.

The diagnostic accuracy of strategies used to identify early pregnancy: a systematic review.

The diagnostic accuracy of strategies used to identify early pregnancy: a systematic review.

Designing prospective cohort studies for assessing reproductive and developmental toxicity during sensitive windows of human reproduction and development – the LIFE Study

The relationship between the environment and human fecundity and fertility remains virtually unstudied from a couple-based perspective in which longitudinal exposure data and biospecimens are captured across sensitive windows. In response, we completed the LIFE Study with methodology that intended to empirically evaluate a priori purported methodological challenges: implementation of population-based sampling frameworks suitable for recruiting couples planning pregnancy; obtaining environmental data across sensitive windows of reproduction and development; home-based biospecimen collection; and development of a data management system for hierarchical exposome data. We used two sampling frameworks (i.e., fish/wildlife licence registry and a direct marketing database) for 16 targeted counties with presumed environmental exposures to persistent organochlorine chemicals to recruit 501 couples planning pregnancies for prospective longitudinal follow-up while trying to conceive and throughout pregnancy. Enrolment rates varied from <1% of the targeted population (n = 424,423) to 42% of eligible couples who were successfully screened; 84% of the targeted population could not be reached, while 36% refused screening. Among enrolled couples, ∼ 85% completed daily journals while trying; 82% of pregnant women completed daily early pregnancy journals, and 80% completed monthly pregnancy journals. All couples provided baseline blood/urine samples; 94% of men provided one or more semen samples and 98% of women provided one or more saliva samples. Women successfully used urinary fertility monitors for identifying ovulation and home pregnancy test kits. Couples can be recruited for preconception cohorts and will comply with intensive data collection across sensitive windows. However, appropriately sized sampling frameworks are critical, given the small percentage of couples contacted found eligible and reportedly planning pregnancy at any point in time.

Qualitative Determination of Pregnancy by Home Pregnancy Test Kit: A Survey on Purchase and Use of Kits in Saudi Community

Qualitative Determination of Pregnancy by Home Pregnancy Test Kit: A Survey on Purchase and Use of Kits in Saudi Community

Associations between blood metals and fecundity among women residing in New York State

Trace exposures to metals may affect female reproductive health. To assess the relation between trace concentrations of blood metals and female fecundity, 99 non-pregnant women discontinuing contraception for the purpose of becoming pregnant were prospectively followed. Participants completed a baseline interview and daily diaries until pregnant, or up to 12 menstrual cycles at risk for pregnancy; home pregnancy test kits were used. For 80 women, whole blood specimens were analyzed for arsenic, cadmium, lead, magnesium, nickel, selenium and zinc using inductively coupled plasma mass spectrometry (ICP–MS). Time to pregnancy was estimated using Cox proportional hazards models for discrete time. Metal concentrations were generally within population reference intervals. Adjusted models suggest a 51.5% increase in the probability for pregnancy per 3.60 μg/L increase in Mg ( P = 0.062), and a 27.7% decrease per 0.54 μg/L increase in Zn ( P = 0.114). Findings indicate that Mg and Zn may impact female fecundity, but in varying directions.

Stress reduces conception probabilities across the fertile window: evidence in support of relaxation

To assess salivary stress biomarkers (cortisol and α-amylase) and female fecundity. Prospective cohort design. United Kingdom. 274 women aged 18 to 40 years who were attempting pregnancy. Observation for six cycles or until pregnancy: women collected basal saliva samples on day 6 of each cycle, and used fertility monitors to identify ovulation and pregnancy test kits for pregnancy detection. Salivary cortisol (μg/dL) and α-amylase (U/mL) concentration measurements; fecundity measured by time-to-pregnancy and the probability of pregnancy during the fertile window as estimated from discrete-time survival and Bayesian modeling techniques, respectively. Alpha-amylase but not cortisol concentrations were negatively associated with fecundity in the first cycle (fecundity odds ratio=0.85; 95% confidence interval 0.67, 1.09) after adjusting for the couples' ages, intercourse frequency, and alcohol consumption. Statistically significant reductions in the probability of conception across the fertile window during the first cycle attempting pregnancy were observed for women whose salivary concentrations of α-amylase were in the upper quartiles in comparison with women in the lower quartiles (highest posterior density: -0.284; 95% interval -0.540, -0.029). Stress significantly reduced the probability of conception each day during the fertile window, possibly exerting its effect through the sympathetic medullar pathway.

How medical devices are regulated in the UK

Excluding medicines, most other healthcare products are medical devices.1 It is estimated that around 38 million people in the UK “have contact with” a medical device every day,2 and there...

Utilization of Home Pregnancy Testing Among Women at Risk for Unintended Pregnancy

We sought to determine whether a brief intervention increased home pregnancy test utilization among women at risk for unintended pregnancy. The intervention included education, consultation with a nurse, and the provision of a free home pregnancy test kit. Participants were 35 women aged 18-39 years from a Medicaid population who were having unprotected intercourse and who were not trying to conceive. The women received education on pregnancy testing and the importance of early recognition of pregnancy. All women received a free home pregnancy test kit. The main outcome measures were pregnancy test use and appropriateness of use. During the 3-month follow-up period, 62% of participants used the home pregnancy test kit, which was approximately 3 times higher than the self-reported testing rate before the study (p < .001). The most common reason for use was a late period (median 5 days late when test was done). Women also purchased additional kits to confirm the initial test result (median 2 kits per episode of use). The intervention increased utilization of home pregnancy test kits among women at risk of unintended pregnancy. All study participants used the test appropriately. These results can serve as a framework for interventions to improve early pregnancy recognition.

A Thin Blue Line: The History of the Pregnancy Test Kit (review)

A Thin Blue Line: The History of the Pregnancy Test Kit (review)

HOME-BASED COLLECTION OF BIOLOGICAL MEASUREMENTS AND SPECIMENS FROM WOMEN AND CHILDREN

ISEE-348 Abstract: Studies examining the relation between human health and either environmental exposures, lifestyle, or genetic predisposition require biologically-based data from selected human populations. Such data can be collected in the form of descriptive narrative (e.g., a questionnaire), a physiological measurement (e.g., height), or a biological specimen (biospecimen, e.g., blood). Biospecimens are particularly valuable in that they can both minimize misclassification bias associated with exposure and/or disease status, and also provide cellular and molecular data that can contribute towards an understanding of the physiological processes being impacted by a disease or exposure. However, a major complicating factor for studies utilizing biospecimens, especially those aiming to enroll large cohorts, is that sample collection can sometimes be encumbered by the difficult logistics and expense of obtaining them from study participants who live in a variety of locations and lead a variety of lifestyles. Privacy issues, both physical and personal, can also contribute to reduced levels of recruitment and retention. For example, some people are not comfortable providing certain biological measurements (such as those needed for Tanner staging of pubertal development) or undergoing certain procedures (such as cervical smearing); others may not participate because they feel stigmatized for inhabiting a certain area, living a certain lifestyle, or having a certain medical condition. One way in which to address these issues is to utilize home-based collection protocols that can be carried out by study participants with minimal to no oversight from study staff members. A number of biological measurements and specimens from women and children are amenable to this type of collection. Investigators have successfully utilized a range of technologies for home specimen collection including vaginal swabs for assessing infections, salivary kits for hormonal and cortisol measurement and urinary collection for fertility monitors and pregnancy test kits. Appropriate collection procedures and considerations for these endpoints and others will be discussed.

Inventions Leading to the Development of the Diagnostic Test Kit Industry – From the Modern Pregnancy Test to the Sandwich Assays

The universities are encouraged by the government nowadays to stimulate innovations and also to provide the proper machinery for assisting the protection and commercialisation of innovations. Abetter understanding of the innovation process may help to create an atmosphere suitable for inventions at the university. Examples can be taken from successful innovations previously made at the university.During the 1960's I made a series of inventions, which ultimately led to the development of the diagnostic test kit industry. The first, which I made as an undergraduate, was a simple and reliable test kit for diagnosis of pregnancy. This was followed by the solid phase radioimmunoassay and a solid phase assay for vitamin B12; next, the dual specific non-competitive sandwich assay and the in-vitro test for diagnosis of allergy, called RAST (Radioallergosorbent test). Organon in Holland with the pregnancy test kit, and Pharmacia in Sweden with test kits for radioimmunoassay, became pioneers among the diagnostic test kit industries. Pharmacia Diagnostics later became one of the leading diagnostic test kit companies in the world and has continued to be so in the field of allergy diagnosis.Each one of these inventions started with a few unique observations leading to a technical development. The pregnancy test as well as the allergy test emerged from the development of assay methods with unique qualities with the subsequent search for appropriate applications. The foreseeing of a commercial value on a future market was a very important step. This was followed by the search for a suitable industry interested to exploit the invention with its new business opportunity i.e. apply for a patent, produce and market the products, which in my case consisted of the necessary reagents and equipments for particular diagnostic tests. Finally, an agreement had to be settled between the entrepreneur and the inventors. This report describes these inventions and particularly discusses some crucial steps of the innovation processes.