Home test system for HIV approved by FDA.
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AIDS Serodiagnosis↗
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Results for “home testing”
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HIV home test: you make the call.
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HIV Infections↗
Home testing for human immunodeficiency virus.
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Diagnostic Errors↗
[Evaluation of home pregnancy tests].
Three home pregnancy tests, Clearblue (Tjellesen), Clearblue one step (Tjellesen) and Predictor (Organon), were tested and compared with respect to sensitivity, specificity, prozone-phenomenon and convenience for use. In addition, they were compared with two well-known pregnancy tests, HCG-Novoclone (Novo) and HCG-Nostick (Organon), which are used in several hospitals and drugstores. All three home pregnancy tests were found to be in agreement with the instructions for use with regard to sensitivity and prozone phenomenon. One test, Clearblue one step, showed false positive results when LH was added. Clearblue was found to be laborious and unhygienic in performance. Predictor seems to be the test of choice.
Evaluation Studies as Topic↗
Development of the home pregnancy test.
The home pregnancy test works by measuring human chorionic gonadotropin (hCG) hormone in urine. This hormone was initially studied in NICHD intramural laboratories as a reliable marker of certain tumors. Refinement of the assay for hCG detection to enhance specificity enabled its ready application to pregnancy detection.
Chorionic Gonadotropin↗
Obtaining HIV test results with a home collection test kit in a community telephone sample.
OBJECTIVES: To test the feasibility of obtaining HIV test results by home collection kit from a probability telephone sample of men who have sex with men (MSM). METHODS: A quota sample of 615 MSM previously interviewed by the Urban Men's Health Study phone survey in Chicago, Los Angeles, New York City, and San Francisco were re-contacted and offered an HIV test using an oral specimen (Orasure) home collection kit. RESULTS: Eighty percent consented to be mailed a kit, and 84% returned a specimen, for a 67% participation rate. All self-reported HIV-positive persons tested positive (77 of 77); 4 of 266 (1.5%) with a prior negative test and 2 of 69 (2.9%) with no prior positive HIV test result. Participation was associated with self-reported prior HIV test status-HIV-positive (83%), HIV-negative (68%), or no prior HIV test result (54%)-and marginally associated with New York City residence after adjustment for HIV status (odds ratio = 0.7; 95% confidence interval, 0.4-1.1; p =.08). CONCLUSIONS: These results suggest that urban MSM identified and interviewed by telephone will participate in home collection HIV testing. This methodology could be used to produce population-based estimates of HIV seroprevalence and seroincidence in MSM and could probably be extended to other populations and other viral infections.
AIDS Serodiagnosis↗
Detection of early pregnancy forms of human chorionic gonadotropin by home pregnancy test devices.
BACKGROUND: Home pregnancy testing devices claim >99% diagnostic accuracy for pregnancy and utility on the first day of the missed menses or earlier. We investigated the forms of human chorionic gonadotropin (hCG) in early pregnancy urines, the diagnostic accuracy claim, and the abilities of 15 devices to detect the different forms of hCG. METHODS: We measured the concentrations of regular hCG and hyperglycosylated hCG (H-hCG, a large hCG variant) in 592 urines. Fifteen home devices were tested according to manufacturers' instructions with regular hCG and H-hCG diluted in urine. RESULTS: H-hCG was the principal hCG-related molecule in pregnancy urine in the 2 weeks following the missed menses (61% and 50% of total immunoreactivity in the 4th and 5th completed weeks of pregnancy, respectively). Of 15 home test devices, 2 had a detection limit of 6.3 IU/L for regular hCG, but poorer detection of H-hCG. Two devices detected 13 IU/L regular hCG, one with similar detection and one with poorer detection of H-hCG. Ten devices detected 25 IU/L regular hCG, 6 with poorer detection of H-hCG. One device detected 50 IU/L regular hCG, but better detected H-hCG. Overall, 9 of 15 devices did not detect H-hCG as well as regular hCG. CONCLUSIONS: H-hCG is the principal hCG immunoreactivity in early pregnancy urine. Home tests vary widely in detection limits for regular hCG (6.3-50 IU/L), and 9 of 15 devices (60%) had poorer detection limits for H-hCG than for hCG. The variation in analytical detection limits appears contradictory to the common claim for all devices of >99% detection of pregnancy on the first day of the missed menses or earlier. We suggest that manufacturers calibrate devices for both hCG and H-hCG and determine the detection rates for pregnancy rather than the proportion of positive results at arbitrary hCG concentrations.
Chorionic Gonadotropin↗
Quality assurance in home laboratory testing.
In review, one is compelled to the notion that a variety of the aforementioned thoughts become pre-eminent in assuring quality. The selection of the tests available for home testing is crucial. They should be divided into categories of single encounter tests and multiple use tests. The single encounter implies a test that has an extremely high degree of reliability and is likely to achieve an answer to the question asked. This should relate to a disease or process for which potential favorable treatment can be achieved or which may have a major favorable impact on public health. In this category one thinks in terms of the worldwide prevalence of hepatitis B and other infectious diseases that are particularly common in third world countries. Yet, these are not "markets" likely to be able to afford this testing. Similarly, these societies are not currently sophisticated in terms of application of preventive measures. On the other hand, major benefits could be projected from the other category of testing, namely, therapeutic monitoring in the hands of individuals who will repetitively test for the same substance in the same manner. This includes not only diabetes but other conditions that are monitored for drug therapy, including seizure disorders and bronchospasm. Inherent in this aspect is the requirement for meaningful and ongoing instruction in proper testing methodology and recording of results. The incorporation of some type of memory device to enforce this aspect of testing appears extremely desirable, if not mandatory. Finally, we must consider the potential for misuse of the single test type of device. One suspects that it would be highly desirable that any test made available for self-testing should also be mandated as accessible through certified laboratories at the request of an individual, which would at least provide reliable performance of the test with a quality result. The development of the concept of quality assurance in home testing is in its infancy and will require continuing evolution.
Aged↗
Evaluating the impact of a home screening test for streptococcal pharyngitis.
Home screening tests must be evaluated as an aid to self-referral to a physician and should not be judged as if they were diagnostic procedures, i.e. the sole determinants of a therapeutic decision. The performance characteristics of a test are properly compared to those of the patient or parent, operating in the absence of the test. For streptococcal pharyngitis there would be a net increase in the number of cases correctly treated whenever the sensitivity of the home test (multiplied by the probability that the patient will act upon the test results) exceeds the a priori probability that the patient will be seen by a physician in the absence of the test. Use of home screening tests is likely to increase the number of patient-physician contacts among persons with sore throats and will do so proportionately more frequently among those with streptococcal pharyngitis.
Home Nursing↗
Development and testing of formal protocols for oxygen prescribing.
The absence of standardized assessment protocols with well- defined measurement properties limits comparison of outcomes among those receiving long-term oxygen therapy (LTOT). We describe simple protocols for a hospital test, a simulated home test, and an actual home test, their reliability and relationship to each other. Stable patients with exercise hypoxemia participated. In 74 patients who completed four exercise tests, correlations between tests ranged from 0.85 to 0.78. Of these 27.0% had the same prescription from all four tests. In 46% prescriptions were within 1 L/ min and in 27% within 2 L/min. During exercise the hospital tests suggested slightly higher oxygen prescriptions than did the simulated home tests (2.5 L/min versus 2.0 L/min, p < 0.001). In 23 patients who participated in actual home assessments, the correlations between the home test, the hospital, and the simulated home tests were 0.22 (95% CI -0.24 to 0.67) and 0.27 (95% CI -0.18 to 0.72). In conclusion, standardizing tests for the assessment of LTOT is important. We describe simple hospital and simulated home tests that are reproducible, easy to carry out, and correlate well with each other.
Aged↗
Development of the Canadian Home Fitness Test.
The Canadian Home Fitness Test is a self-administered procedure in which the participant steps at an age- and sex-specific rhythm controlled by recorded music, then palpates the pulse immediately following activity. Validation of the test has shown a correlation of 0.72 with the results of a standard submaximum bicycle ergometer test, while the directly measured maximum oxygen intake is correlated even more closely (r = 0.88) with the attained stepping rate, body weight and recovery heart rate. Given modest training, subjects could measure their immediate postexercise heart rate (correlation with electro-cardiographic data, r = 0.94), although 10-second counts underestimated the true rate by an average of 7 beats/min. The safety of the test will be established ultimately by experience in its use in a large population; nevertheless, both theoretical considerations and results of trials in over 14 000 adults suggest the procedure can be self-administered without serious consequences. It is also well accepted by the general public and arouses considerable interest in most homes. The test can thus be recommended as providing an approximate measure of an individual's physical fitness in order to stimulate an increase in personal physical activity. It also has potential as a simple screening procedure that would allow paramedical personnel to record fitness levels and standardized exercise electrocardiograms in large segments of the population.
Adolescent↗
Present views on the Canadian Home Fitness Test.
The Canadian Home Fitness Test was conceived for the mass testing of fitness levels and as a motivational tool in exercise programs. A double step (such as in a domestic staircase) is climbed at an age- and sex-specific rhythm set by a long-playing record. Fitness is assessed from test duration and the radial or carotid pulse count immediately following exercise. To date, use of the procedure by almost 500,000 Canadians has given rise to no serious complications. The test inevitably has limited precision when taken at home, although most subjects can learn to count their pulse and to step in time with the music. The test has been well received and has achieved its prime objective of stimulating an interest in endurance activity. When supervised by a paramedical worker using an electrocardiograph to monitor the heart rate during exercise, the procedure yields as good an estimate of maximum oxygen intake as other submaximal tests. One current area of controversy is the interpretation of abnormal electrocardiograms. It is suggested that this problem could be resolved by the appropriate training and certification of interested family physicians and paramedical workers.
Allied Health Personnel↗
"Do-it-yourself" dementia testing: issues regarding an Alzheimer's home screening test.
The Early Alert Alzheimer's Home Screening Test (AHST) is a variant of the Smell Identification Test (SIT) and the Cross-Cultural Smell Identification Test (CC-SIT), and recently became available for purchase by the general public. The validity and the practical utility of routine screening for individuals with asymptomatic cognitive impairment has not been established. There are considerable specific methodological concerns regarding the use of the AHST including the association of olfactory impairment with (a) age in the absence of cognitive impairment, (b) numerous acute and/or chronic medical conditions, and (c) lifestyle habits and social and/or demographic variables. General public misunderstanding of the difference between a screening and a diagnostic test, primary care physicians' frequent confusion about follow-up mechanisms for newly diagnosed patients with dementia, the possible lack of perceived counseling options for those self-diagnosed, and abuse of test findings create distinct possibilities for misuse of this test. The marketing of the AHST and its general use without appropriate public health educational safeguards is inappropriate and may be unethical.
Aged↗
A sodium rodizonate lead testing kit for home use--valid for paint and soil samples?
BACKGROUND: The presence of lead in consumer products has become an important health issue. Lead Check is a home test kit promoted to detect lead on any surface at government action levels with 96.6% accuracy. Validation of this kit's sensitivity and specificity is necessary because false negatives may give the user a false sense of security, while false positives may result in unnecessary concern. METHODS: Aliquots of paint and soil samples submitted to a county health department were collected. Lead Check kits were used to analyze these samples in accordance with manufacturer's instructions. Each sample was tested with three reagent swabs; one stored at 56 degrees C (room temperature), and one swab each stored at 22 degrees C (cold) and 92 degrees C (hot) for 24 hours. Results were compared to quantitative results obtained from the health department's lead testing laboratory. RESULTS: The sensitivity of the swabs for testing lead in paint was 91.7% for all three temperatures with a specificity of 88.9% (22 degrees C), 77.8% (56 degrees C), and 88.9% (92 degrees C). The sensitivity of the swabs for testing lead in soil was significantly less: 28.6% at 22 degrees C, 28.6% at 56 degrees C (room temperature) and 85.7% at 110 degrees C. The specificity for testing lead in soil was 100% for all temperatures. CONCLUSIONS: The claim that Lead Check can detect lead in paint at government action levels (0.5% lead) appears to be accurate; however, the claim that this kit can reliably detect lead in soil at 1000 ppm was not verified. The swabs were found to maintain their ability to detect lead even if not stored under ideal conditions.
Environmental Exposure↗
Evaluation of the home pad test for quantifying incontinence.
The home pad test to quantify urinary incontinence is described. Patients conduct the test in their homes and bring the pad, in a self-sealing plastic bag, for weighing at their next clinic visit. The validity of the procedure was assessed by measuring evaporation loss from the pads and comparing the home with the standard hospital test. Evaporation loss was shown to be acceptable if the test was carried out within 72 h of weighing. There were no significant differences between home and hospital tests and 95% of home results were within 32% below to 16% above hospital results. This was at least as consistent as the "gold standard" hospital test as 95% of the hospital results were within 28% below to 44% above repeated test results. The principal advantages in performing the pad test at home are simplicity, cost effectiveness and the relaxed environment, which reproduces more accurately the conditions leading to incontinence when compared with the relatively unfamiliar hospital setting.
Female↗
A street intercept survey to assess HIV-testing attitudes and behaviors.
Nationally, it has been estimated that 44% of adults in the United States have been tested for HIV, with substantial individual and community-level variations in HIV-testing attitudes and behaviors. HIV-testing behaviors and intentions and attitudes toward HIV testing, particularly toward home tests, were assessed among 385 adults recruited in a street intercept survey from a gay-identified agency, a substance-abuse treatment program, and inner-city community venues (a shopping mall and community center). Across these Los Angeles sites, the proportion of persons reported being tested for HIV in their lifetime (77%) was higher than the national estimate. Gay-identified agency (88%) and substance-abuse treatment program participants (99%) were more likely to have been tested than were the community participants (67%). Participants from a gay-identified agency were more likely to have had an anonymous test (51%) than were those from a substance-abuse treatment program (25%) or community sites (24%). Attitudes toward HIV testing, including mail-in home-test kits and instant home tests, were very positive. Most participants were willing to pay about $20 for a home-test kit. Participants from the community sites (82%) and the substance-abuse treatment program participants (87%) endorsed notification of HIV status to health departments and sexual partners more than did participants from the gay identified agency (48%). The street intercept survey appears to be a quick and feasible method to assess HIV testing in urban areas.
Adolescent↗
Home STI testing: the adolescent female's opinion.
PURPOSE: To assess sexually active adolescent females' attitudes of home tests for sexually transmitted infections. METHODS: This study represents a follow-up to a study on adolescent attitudes toward different sampling methods for STI testing. In the initial study participants completed a pre-examination health survey, provided first void urine (FVU) and self-collected vaginal swab samples followed by a pelvic examination with STI screening by endocervical swabs. Participants' attitudes about the three collection techniques were assessed at the end of the visit. For the current study, this same group of ethnically diverse adolescents (13-20-years-old) was contacted by telephone 9 months after their initial clinic visit to re-assess their attitudes about the three specimen collection techniques and to evaluate their attitudes regarding the use of home STI testing. Friedman tests of mean ranks evaluated teens' rankings of STI sampling methods and multivariate regression analysis was used to identify predictors of home test preference. RESULTS: Home urine testing was the first choice for STI screening followed by the FVU, self-obtained vaginal swab and endocervical swab collected in a clinical setting. FVU was preferred to self-collected vaginal swabs (p = .01). Adolescents who worried about having an STI were more likely to favor home urine testing (OR 5.5, p = .01). Only 22% would seek any STI screening if asymptomatic. CONCLUSIONS: Because young women preferred home STI testing, this may be an additional option, as the foundation for such testing kits has progressed. Adolescent preferences may be heavily influenced by the pelvic examination experience. Because of the largely asymptomatic nature of CT infections, multiple screening options (clinical and home-based) need to be available to increase access to care.
Adolescent↗