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Home pregnancy tests detect human chorionic gonadotropin in urine with high early-detection accuracy.
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6 sources for · 0 against

The retrieved literature confirms that home pregnancy tests are designed to detect human chorionic gonadotropin in urine to identify early pregnancy, generally maintaining high manufacturer-claimed diagnostic accuracy near missed menses.

Evidence for · 6
1998 · cited by 42
<h4>Objective</h4>To assess the diagnostic efficiency of home pregnancy test (HPT) kits.<h4>Data sources</h4>A literature search of English-language studies was performed with MEDLINE and a review of bibliographies.<h4>Study selection</h4>Studies were included if HPT kits were compared with a criterion standard (laboratory testing), if they used appropriate controls, and if data were available to determine sensitivity and specificity.<h4>Data extraction</h4>Two investigators independently extracted data, and disagreement was resolved by consensus. Sensitivity, specificity, and an effectiveness score (a measure of the discriminatory power of the test, with higher scores implying greater effectiveness) were calculated.<h4>Data synthesis</h4>Five studies evaluating 16 HPT kits met the inclusion criteria. The range of sensitivities for HPT kits was 0.52 to 1.0. In studies where urine samples obtained by the investigators were tested by volunteers, sensitivity was 0.91 (95% confidence interval [CI], 0.84-0.96). However, the sensitivity was less in studies where subjects were actual patients who performed the test on their own urine samples (sensitivity, 0.75 [95% CI, 0.64-0.85]). The test effectiveness score was 2.75 (95% CI, 2.3-3.2) for studies where subjects were volunteers but deteriorated to 0.82 (95% CI, 0.4-1.2) for studies with actual patients.<h4>Conclusions</h4>The diagnostic efficiency of HPT kits is greatly affected by characteristics of the users. Despite the popularity of these kits, the relatively low effectiveness scores of these kits when used by actual patients are of concern. We suggest that manufacturers of HPT kits publish results of trials in actual patients before marketing them to the general public.
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More for · 5
2023 · cited by 1
Today, the home pregnancy test is the most frequently performed laboratory test for self-diagnosis (home diagnostic test). It is also the first laboratory test that has been adapted for self-use at home. This is probably because women have always wanted to know the answer to the question: "Am I pregnant or not?" and always preferred to know the answer to this question intimately and in a discreet way. The history of the pregnancy test is also an interesting example of how the discovery of antibodies and the development of in vitro diagnostic methods based on the antigen-antibody reaction were important for the development of laboratory and clinical diagnostics. Immunodiagnostic techniques (based on the antigen-antibody reaction) are currently the basis of modern specialist laboratory diagnostics, which is essential in clinical diagnosis. The history of the pregnancy test is an interesting one and dates back to ancient times. A pregnancy test is defined as a procedure intended to reveal the presence or absence of pregnancy. Nowadays, every pregnancy test is based on the detection of human chorionic gonadotropin (hCG) in urine or blood. Human chorionic gonadotropin is secreted by the placenta right after a fertilized egg cell implants in the uterus and can be detected in both the urine and blood of pregnant women. Urine pregnancy tests are convenient for self-use at home. Blood tests are performed in medical laboratories. Specialized laboratory methods not only detect hCG but also determine the concentration of this hormone. However, both of these methods are highly accurate and common. Throughout the ages, many different methods were used to detect pregnancy at the earliest stage. Grain, wine, and various small animals were used as research tools. These were both long-term and often unreliable; most were based on folk beliefs and superstitions. Animal pregnancy tests were the first biological tests used in this field. This was a significant advance in the accurate detection of relatively early pregnancy. Animal tests in modern times are considered cruel and inhumane, no matter how reliable their results can be. Their place is now taken by much more specific, more sensitive, and definitely more ethical immunochemical tests. The pregnancy test and the methods to find out whether a woman is pregnant have gone through massive transformations, from bioassays using plants to bioassays on animals to advanced immunochemical techniques and biosensors. Modern pregnancy tests are not invasive and are very sensitive. Nowadays, it takes only about 3 min to know the answer to the question: "Am I pregnant or not?". However, it was not always as simple as it is today. This manuscript aims to show the important role played by antibodies in the development of laboratory and clinical diagnostics in the example of the interesting history of the pregnancy test.
2021 · cited by 0
Over the past decades, paper-based lateral flow immunoassays (LFIAs) have been extensively developed for rapid, facile, and low-cost detection of a wide array of target analytes in a point-of-care manner. Conventional home pregnancy tests are the most significant example of LFAs, which detect elevated concentrations of human chorionic gonadotrophin (hCG) in body fluids to identify early pregnancy. In this work, we have upgraded these platforms to a higher version by developing a customized microfluidic paper-based analytical device (μPAD), as the new generation of paper-based point-of-care platforms, for colorimetric immunosensing. This will offer a cost-efficient and environmentally friendly alternative platform for paper-based immunosensing, eliminating the need for nitrocellulose (NC) membrane as the substrate material. The performance of the developed platform is demonstrated by detection of hCG (as a model case) in urine samples and subsequently indicating positive or negative pregnancy. A dual-functional silane-based composite was used to treat filter paper in order to enhance the colorimetric signal intensity in the detection zones of μPADs. In addition, microfluidic pathways were designed in a manner to provide the desired regulated fluid flow, generating sufficient incubation time (delays) at the designated detection zones, and consequently enhancing the obtained signal intensity. The presented approaches allow to overcome the existing limitations of μPADs in immunos
2014 · cited by 0
The first home pregnancy test was introduced in 1976. Since then, pregnancy tests have become the most common diagnostic assay used at home. Pregnancy tests use antibodies to detect human chorionic gonadotropin (hCG). It is an ideal marker of pregnancy since it rises rapidly and consistently in early pregnancy and can be detected in urine. The most advanced home pregnancy test currently available assesses the level of hCG found in urine and claims to provide women with reliable results within just a few weeks of pregnancy. Today, over 15 different types of home pregnancy test are available to buy over the counter in Germany. Many tests claim to be highly accurate and capable of detecting pregnancy before the next monthly period is due, although claims such as 8 days prior to menstruation are unrealistic. However, users and healthcare professionals should be aware that, although all are labelled as CE, there are currently no standard criteria for testing performance and claims. This review provides an overview of the development of home pregnancy tests and the data on their efficacy together with an analysis of published data on the accuracy of hCG for the detection of early pregnancy and studies on the use of home-based pregnancy tests. Preliminary data on some home pregnancy tests available in Germany are presented which indicate that many results do not match the claims made in the package insert. Healthcare professionals and women should be aware that some of the claims ma
cited by 0
(human chorionic gonadotropin (hCG)) in blood or urine using a pregnancy test kit, and scanning with ultrasonography. Testing blood for hCG results in the A pregnancy test is used to determine whether a woman is pregnant or not. The two primary methods are testing for the pregnancy hormone (human chorionic gonadotropin (hCG)) in blood or urine using a pregnancy test kit, and scanning with ultrasonography. Testing blood for hCG results in the earliest detection of pregnancy. Almost all pregnant women will have a positive urine pregnancy test one week A… Identified in the early 20th century, human chorionic gonadotropin (hCG) is a glycoprotein hormone that rises quickly in the first few weeks of pregnancy, typically reaching a peak at 8- to 10-weeks gestational age. hCG is produced by what will become the placenta. hCG testing can be performed with a blood (serum) sample (typically done in a medical facility) or with urine (which can be performed in a medical facility or at home). The assays used to detect the presence of hCG in blood or urine are generally reliable and inexpensive. Secretion of hCG can occur as soon as 6 days following ovulation and on average 8–10 days following ovulation; this is the earliest hCG can be detected in a blood sample. The hCG concentration in blood is higher than in urine. Therefore, a blood test can be positive while the urine test is still negative. Qualitative tests (yes/no or positive/negative results) look for the presence of the beta subunit of human chorionic gonadotropin in blood or urine. For a qualitative test the thresholds for a positive test are generally determined by an hCG cut-off where at least 95% of pregnant women would get a positive result on the day of their first missed period. Qualitative urine pregnancy tests vary in sensitivity. High-sensitivity tests are more common and typically detect hCG levels between 20 and 50 milli-international units/mL (mIU/mL). Low-sensitivity tests detect hCG levels between 1500 and 2000 mIU/mL and have unique clinical applications, including confirmation of medication abortion success. Qualitative urine tests available for home use are typically designed as lateral flow tests. Quantitative tests measure the exact amount of hCG in the sample. Blood tests can detect hCG levels as low as 1 mIU/mL, and typically clinicians will diagnose a positive pregnancy test at 5mIU/mL.
2025 · cited by 0
<h4>Background</h4>Women of childbearing age often require a nuanced and individualized approach to chronic pain management, especially when pregnancy is a possibility. Interventional procedures involving ionizing radiation, such as fluoroscopy-guided injections, raise specific concerns for fetal safety, including risks of embryo death, congenital anomalies, intellectual disability, and microcephaly. Despite national recommendations from organizations like the American College of Radiology (ACR), implementation of pregnancy screening in the pain management context remains limited.<h4>Methods</h4>This review synthesizes current literature and practice guidelines to assess the gaps in pregnancy screening protocols within chronic pain management settings. It highlights challenges in evaluating pregnancy status before initiating pharmacologic or fluoroscopic procedures, and it examines both biological testing limitations and procedural risks.<h4>Results</h4>Fluoroscopically guided procedures may exceed the teratogenic radiation threshold of 50 mGy, underscoring the critical need for reliable pregnancy screening. While urine and serum hCG tests are widely used, both are susceptible to false negatives and positives due to timing, hormone variants, and analytical interferences. Integrating clinical evaluation with menstrual history, point-of-care testing, and serum confirmation may improve diagnostic accuracy and ensure greater protection for the fetus.<h4>Conclusion and recommendations</h4>To address safety concerns, this review proposes a structured pregnancy screening algorithm tailored for chronic pain practices. Key recommendations include: routine screening of all reproductive-age women prior to procedures involving radiation or teratogenic medications, use of serum hCG testing when uncertainty exists, optimizing radiation exposure strategies, and clear, informed consent processes outlining fetal risks. Adoption of these best practices may improve clinical consistency and enhance patient safety.
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