Testing. FDA panel weighs benefits, risks of in-home HIV test.
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AIDS Serodiagnosis↗
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Evaluation of the Canadian Home Fitness Test in middle-aged men.
The Canadian Home Fitness Test (CHFT) and the Bruce treadmill test were performed by 230 men aged 45 to 69 years. Because of inaccuracies in the counting of heart rates, less was known about the fitness of the men after testing than before. In addition, inaccuracies in the test record and design were uncovered. A more accurate estimate of fitness could be obtained when the subjects' own rating of exertional intensity was substituted for heart rate counting. The CHFT is a marketing tool of Health and Welfare Canada that may be useful in selling fitness, but as a measure of fitness in Canadian homes it is likely to be misleading.
Aged↗
Some factors affecting accuracy of Canadian Home Fitness Test scores.
Factors affecting the accuracy of Canadian Home Fitness Test scores have been evaluated in male and female office workers. At a first attempt, the typical subject underestimates his 10 sec post-exercise pulse count by 1 beat, with a superimposed probable error of 2 beats. However, the modest experience of pulse counting gained in an employee fitness programme corrects the systematic error, while the probable random error is reduced to approximately 8 beats/min. Taking account also of variations in the fficiency of stepping, the probable error of an Astrand prediction of V O2(max) is approximately 10.3%. Comparison with directly measured values in a subsample of 22 men shows an actual random discrepancy of 9.5%, plus a systematic error of approximately 19% due to an increase of heart rate with anticipation of the maximum test. The Jetté prediction formula has a random discrepancy of approximately 8%, plus a systematic error of approximately 10.6%. Assuming the latter can be corrected by evaluation of a larger population, the fitness scores should give most people an indication of both their initial fitness and responses to a training regimen.
Adult↗
How frequently are home pregnancy tests used? Results from the 1988 National Maternal and Infant Health Survey.
Many women use commercially available home pregnancy tests to determine their pregnancy status before seeking professional health care. Despite the increasing popularity of these products, no national estimates have been reported to date on their frequency of use. We analyzed available data from the 1988 National Maternal and Infant Health Survey to determine the frequency of use of home pregnancy tests during recent pregnancies of women of varying sociodemographic backgrounds. Approximately 33 percent (N = 4700) of the women surveyed used such a device. Use was most frequent among women who were white, married, over age 39 years, highly educated, or had a high family income. We conclude that home pregnancy testing appears to be a frequent procedure, especially among women of high socioeconomic background.
Adolescent↗
Reliability and feasibility of pregnancy home-use tests: laboratory validation and diagnostic evaluation by 638 volunteers.
All 27 home-use tests sold in France in 1989 for the self-diagnosis of pregnancy were evaluated. The kits were first tested by qualified clinical chemistry technologists. Eleven kits with 100% specificity and 100% sensitivity were retained for the diagnostic study. Each of 638 laywomen was given a kit and asked to perform the assay with a coded urine specimen containing either no human chorionic gonadotropin (hCG) or an hCG concentration adjusted to the claimed detection limit (1 DL) or twice the detection limit (2 DL). After testing, each participant filled out a detailed questionnaire. The results showed a diagnostic specificity of 86-100% for 10 kits but a diagnostic sensitivity of 85-100% for only 5 kits at 2 DL and for only 2 at 1 DL. Among the 478 positive urine samples distributed, 230 were falsely interpreted as negative. The main explanation for such a high percentage of false-negative results was difficulty in understanding the explanatory leaflets accompanying the kits and hence in reading the results, regardless of the socioeconomic situation of the participant. We conclude that pregnancy home-use tests should be subjected to rigorous analytical controls and evaluated by a panel of potential users before being released on the market.
Adolescent↗
Good gene hunting: commercializing safety and efficacy of home genetic test kits.
The rapid advancement of genetic identification as a means of diagnosing or identifying the existence of a genetic trait for preventative and reproductive concerns should compel legal experts to determine whether there is sufficient safety and efficacy in genetic tests. Genetic testing has been used by physicians for a number of years to enhance their allopathic practice. Specifically, genetic tests are now being considered as aids in understanding the development and proliferation of certain diseases in society as a whole, and in specific ethnic and familial groups. The purposes of this paper are to: (1) articulate what genetic testing offers, by way of definition and scope; (2) identify statutory and regulatory limitations on the development, distribution, and use of genetic tests; and (3) consider whether the potential availability of home genetic tests should be made accessible to the American public. This paper will further provide a proposed regulation to encourage the development and distribution of home genetic tests.
Biotechnology↗
The limited clinical value of home urine testing by diabetic patients.
To investigate the value of home urine glucose testing in assessing chronic diabetic glucose control, the authors compared patients' glycosuria patterns with their mean blood glucose (MBG) levels calculated from glycosylated hemoglobin (Hb Alc). One hundred and twenty-one patients who regularly checked their urines reported on the frequencies of glycosuria over the preceding ten weeks. There was substantial overlap in the glycosuria patterns of patients at different levels of MBG. Glycosuria was not detectable in only 44% of patients with good control (MBG less than or equal to 150 mg/dl). The probability of such good control given no glycosuria was only 26%. Similarly, frequent glycosuria was reported by only 27% of patients with poor control (MGB greater than 250 mg/dl). The probability of such poor control given frequent glycosuria was only 34%. Because home urine testing cannot reliably identify good or poor control, it has a very limited role in assessing patients' chronic glucose control.
Adolescent↗
What happened to home HIV test collection kits? Intent to use kits, actual use, and barriers to use among persons at risk for HIV infection.
Through sequential cross-sectional surveys, we examined intent to use home HIV test collection kits, actual use and barriers to use among persons at high risk for HIV infection. Interest in kits was assessed in the 1995-96 HIV Testing Survey (HITS, n=1683). Kit use, knowledge of kits and barriers to use were assessed in the 1998-99 HITS (n=1788), after kits had become widely available. When asked to choose among future testing options, 19% of 1995-96 participants intended to use kits. Untested participants were more likely than previously tested HIV-negative participants to choose kits for their next HIV test (p < 0.001). Among 1998-99 participants, only 24 (1%) had used kits; 46% had never heard of kits. Predictors of not knowing about kits included never having been HIV tested and black or Latino race. Common reasons for not using kits among participants aware of home test kits were concerns about accuracy, lack of in-person counselling and cost. Despite high rates of anticipated use, kits have had minimal impact on the testing behaviour of persons at high risk for HIV infection. Increasing awareness of kits, reducing price and addressing concerns about kit testing procedures may increase kit use, leading to more HIV testing by at-risk individuals.
Cross-Sectional Studies↗
Evaluation of the home pad test in the investigation of female urinary incontinence.
OBJECTIVE: To evaluate the use of the home pad test in the management of patients with urinary dysfunction with reference to feasibility, normal data, reproducibility, compliance and accuracy when compared to video urodynamics. DESIGN: A prospective study to determine 1. the accuracy of weighing pads by healthcare workers compared to weighing by patients with a spring balance; 2. the effects of evaporation; 3. the pad weight increase in continent women; 4. the compliance over 194 tests in terms of acceptability and feasibility; 5. the reproducibility in 112 women for the 24 h and 48 h tests, 6. the comparison with video urodynamic studies in 149 patients. SETTING: A London teaching hospital. MAIN OUTCOME MEASURES: Coefficient of variation and mean deviation analysis were employed to determine the accuracy of measurement. Percentage changes in standardised wet pad weights over a period of 8 weeks were used to determine the rate of weight loss due to evaporation. The percentage of patients completing the test satisfactorily was documented. The increase in the weights of all pads worn during the test period was measured in continent volunteers and incontinent patients. Video urodynamic diagnoses were used as the Gold Standard for comparison. RESULTS: Twelve perineal pads were weighed by 15 healthcare workers with a resulting coefficient of variation equal to 1.55% (standard error = 0.09%). The mean deviation between patient-measured pad weights and staff-measured weights was 49% (SD = 132%). Pads wetted with saline showed no difference in weight after 1 week and less than 5% change in weight after 8 weeks, with the upper 95% confidence limit of less than 10% loss. The mean pad weight increase over 48 h in continent women was 7.13 g (SD = 4.32 g) giving a 95% upper confidence level of less than 15 g. Compliance was reasonably high with 161 (83%) carrying out the test perfectly. Test-retest analysis of the 24 h and 48 h tests showed a strong relationship with correlation coefficients of 0.90 and 0.94 respectively. The reproducibility was also good, with differences as a percentage of the mean between the first and second test being 6.9% and 1.6% for the 24 h and 48 h tests respectively. There was good concordance when the urodynamic study data was compared with pad weight data in terms of incontinence compared with no incontinence (kappa = 0.65), but a high false positive rate was detected for the pads. When eight of these patients with a false positive pad test had repeat video urodynamic studies, six were found to have detrusor instability on the second study. CONCLUSIONS: The home pad test combined with frequency volume chart documentation is an easy test to perform. It is quite robust and reasonably reproducible. This test should be added to complement the routine urodynamic tests and may have a role in detecting occult detrusor instability.
Female↗
Dynamics of urinary levels of hCG during early pregnancy and accuracy of the home pregnancy test.
The paper ‘Dynamics of urinary levels of hCG during early pregnancy and accuracy of the home pregnancy test’ has been retracted at the request of the authors. Since initiating the work 3 years ago improvements have been made to home pregnancy tests, and the device used in the study is no longer commercially available. The authors are conducting a similar study with a new pregnancy test device which suggests that some of the conclusions drawn in the retracted paper could now be misleading to health professionals and consumers.
Retraction of Publication as Topic↗
Evaluation of home pregnancy test kits.
Nine pregnancy test kits intended for home use were evaluated for optimal accuracy, sensitivity, ease of operation, and definitude of results. Tests of the kits on samples of urine from healthy male volunteers previously spiked with known concentrations of human chorionic gonadotropin showed wide variations among the kits in all characteristics examined. Specific values are given for the kits tested.
Adult↗
An evaluation of the sensitivity of five home pregnancy tests to known concentrations of human chorionic gonadotropin.
A study was conducted to evaluate the sensitivity of the five commercially available home pregnancy testing kits. Known amounts of human chorionic gonadotropin (hCG) were diluted in pooled, sterile male urine. Varying concentrations of hCG were randomly assigned to 100 kits of each of the five brands. The test results were read independently by three individuals who were blinded to the hCG concentrations. Statistical analysis were based on the majority vote of the readers. The rank-ordered sensitivity of the five home pregnancy tests, expressed as the proportion of positive results for the range of hCG concentrations studied, was as follows: (1) Predictor, (2) e.p.t., (3) Acu-Test, (4) Answer, and (5) Daisy 2. Overall, Predictor and e.p.t. appear to be more accurate than Acu-Test or Answer. Only Daisy 2 was found to be significantly different from the other brands. However, the currently marketed Daisy 2 pregnancy test is manufactured by a different company.
Chorionic Gonadotropin↗
Clinical efficacy of LH-color: a new home ovulation test.
In this study we evaluate the efficacy of a new home ovulation test to identify LH surge (LH-Color, Organon). Fifty-five spontaneously ovulating women were followed during their cycles with twice daily urinary LH testing as well as daily ultrasound and BBT charts. In 39 (70.91%) of the 55 patients, ovulation occurred within 24 h after the decoloration of the LH-Color. Follicular collapse as visualized by ultrasonography, took place in all patients within 36 h after the decoloration of the LH-Color. Thus a good correlation was found between urinary LH surge and ultrasound. We conclude that the rapid LH test was able to predict impending ovulation.
Adult↗
Human semen analysis.
Rapid developments have occurred in the management of couple infertility due to a male factor. These have stimulated renewed interest in semen analysis, which has become more correct, more reliable and more informative. The so-called basic semen analysis, which includes subjective estimation of sperm concentration, motility and morphology, has largely become obsolete. It has been replaced by several alternative techniques such as the home testing of semen by the man himself, the elaboration of methods and equipments for the exact assessment of conventional sperm characteristics, and the measurement of new parameters evaluating the functional state and capacity of spermatozoa, accessory sex glands and seminiferous epithelium. The present paper covers the following items: (i) conventional methods of semen analysis, (ii) the resazurin test and home fertility scoring, (iii) advanced methods for the objective assessment of conventional sperm characteristics and motility parameters.
Coloring Agents↗
Economical test methods for developmental neurobehavioral toxicity.
The assessment of behavioral changes produced by prenatal or early postnatal exposure to potentially noxious agents requires both the designing of ad hoc tests and the adaptation of tests for adult animals to the characteristics of successive developmental stages. The experience in designing tests is still more limited than in the adaptation of tests, but several tests have already proven their usefulness; some examples are the suckling test, the homing test, and evaluations of dam-pup and pup-pup interactions. Functional observational batteries can exploit the development at specified postnatal ages of several reflexes and responses that are absent at birth in altricial rodent species with a short pregnancy such as the rat and the mouse. In neonates, the assessment of early treatment effects can rely not only on deviations from normal responding but also on changes in the time of appearance of otherwise normal response patterns. The same applies to other end points such as responses to pain and various types of spontaneous motor/exploratory activities, including reactivity to a variety of drug challenges that can provide information on the regulatory systems whose development may be affected by early treatments. In particular, the analysis of ontogenetic dissociations (i.e., differential early treatment effects depending jointly on developmental stage at the time of exposure, age of testing, and response end point) can be of considerable value in the study of treatments' mechanisms of action. Overall, it appears that behavioral teratological assessments can be effectively used both proactively, i.e., in risk assessment prior to any human exposure, and reactively. In the latter case, these assessments could have special value in the face of agents suspected to produce borderline changes in developing humans, whose innocuousness or noxiousness can be difficult to establish in the absence of hard evidence of teratogenicity.
Animals↗
Salivary markers of systemic disease: noninvasive diagnosis of disease and monitoring of general health.
Because of interest in the link between oral and general health, clinicians are increasingly using salivary analyses to diagnose systemic disease and to monitor general health. The reason for this interest lies in the ability of new diagnostic tools, such as sensitive enzyme-linked immunosorbent assays, as well as other technologies, to distinguish a range of salivary components that are biomarkers for changes in the body's health. The noninvasive nature of salivary testing has made it an attractive and effective alternative to blood and urine testing, and home testing kits have made it possible for people to monitor their own health using this diagnostic medium. This paper explores what saliva can reveal about general health, drawing examples from recent research on salivary biomarkers of systemic illness and highlighting the current use, and potential clinical and research applications, of diagnostics based on oral fluids.
Biomarkers↗
[The current method of handling of test samples and medical reimbursement for POCT in Japan].
Point of care testing(POCT) is defined as clinical testing done at or near the site of patient treatment and care in the medical field, and includes all clinical test other than those performed at hospital laboratories and outside testing centers. Home testing is also a form of POCT relating to residential medical care. The ratio of clinical tests based on POCT has not tended to increase as rapidly in Japan, although such tests are greatly increasing in the US while clinical tests performed at hospital laboratories are decreasing. POCT products are generally applied to direct analysis of test samples obtained from patients. Since storage, transportation or pretreatment after sampling is not necessary in POCT, test data can be obtained in real time. Therefore, it is important to complete testing immediately after obtaining samples without transporting or storing them, when handling POCT samples. Consideration of POCT as a part of health care services covered by health insurance is the same as in the case of conventional testing. Recent technological innovation has provided a wide variety of POCT products that do not require medical equipment or reagents. Further development of novel, innovative POCT procedures in the near future is promising.
Autoanalysis↗
Development of a novel home sperm test.
BACKGROUND: The majority of men find the production of a semen sample an embarrassing and stressful experience. Consequently, the availability of an over-the-counter home sperm test, which would reliably and accurately allow the patient to obtain an assessment of fertility potential at their convenience, would be a major benefit. Our objective was to develop and evaluate a home sperm test that provides a visual estimate of the concentration of progressively motile sperm in a semen sample. METHODS: Three particular challenges are described (i) developing a visualization system; (ii) optimization of the detection limit; and (iii) controlling variation due to changes in ambient temperature. The accuracy of the device was tested against two reference methods: computer-assisted sperm analysis (CASA) and a hyaluronate migration test (HMT). RESULTS: In 129 semen samples, where both reference methods agreed (positive or negative), the accuracy of the device was 95%. The observed likelihood ratio of 8.8 indicated that a sample showing a red line in the device was over eight times more likely to have a positive (normal) result in CASA and HMT than a sample without a red line. CONCLUSIONS: The final device provides a visual estimate of the concentration of progressively motile sperm in a semen sample using a test that is completed within approximately 1 h of production of the sample and can be used by the man in the comfort of his own home.
Humans↗