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[From the perspective of the Japan Association of Clinical Reagents Industries].

Simple testing conducted in the hospital laboratory and the Commercial Lab is not considered "time-consuming testing" but prompt testing that enables obtaining data near the patient. In the field of medical care, the need for POCT(Point-of-Care Testing) which can test in prompt and minimally invasive ways has been increasing. In a related move, new techniques are being developing one after another to meet those needs. In the future, we will need to appropriately provide intensive service at the central laboratory and prompt service at the bedside while increasing economic efficiency. Because the 21st century is being promoted as the age of self-responsibility, we need to create systems and an environment for patients to manage their own health. In terms of the reduction of medical service fees, it seems that the method of payment directs forward like DRG definitely. Therefore, cooperation among industry and academia is needed to promote OTC test agents as testing before getting a disease and take an active part enlightening the importance of home testing. Currently, long-term medication is administered for an increasing number of chronic ailments going with the aging population. It seems desirable to develop and popularize easy home tests for monitoring chronic ailment and easy test agents for the checking side effects by drug.

Drug Industry↗

A new scale for in-home test-weighing for mothers of preterm and high risk infants.

The purposes of this research were to describe the accuracy of test-weighing with the BabyWeigh, a new infant scale suitable for use in the home, and to determine whether mothers and investigators could estimate intake accurately during breastfeeding sessions, using clinical cues that are recommended for this purpose. Within five days of projected NICU discharge, 30 preterm and/or high risk infants and their mothers were studied during a single breastfeeding session. A member of the research team performed test-weights with the Smart Model 20 infant scale, and mothers performed test-weights with the BabyWeigh scale. The mothers and investigators each estimated volume of intake for the breastfeeding session using clinical cues. Mothers and investigators were blind to each others' test-weights and clinical estimates. Results revealed that the BabyWeigh scale provided an accurate estimate of intake during breastfeeding across a large range of infant weights and intake volumes. In contrast, investigator and maternal estimates of intake were not sufficiently accurate.

Adult↗

Sterility testing of home and inpatient parenteral nutrition solutions.

The microbial contamination rate was compared for parenteral nutrition solutions prepared by patients for home use and by pharmacy personnel for inpatient use. Phase I validated the Ivex 0.22-micron inline filter as a tool for microbiological testing by inoculating small numbers of organisms in 5% dextrose injection and testing for recovery. Phase II validated the same method for determining microbial contamination of total parenteral nutrition (TPN) solutions. Phase III compared inpatient and home TPN microbial contamination rates using the methodology validated in phase II. Test organism inocula used in phase I and II were Candida albicans, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, Proteus vulgaris, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus pyogenes. All contaminated solutions in phase I showed visual turbidity within 48 hr, and all test organisms were recovered and identified. All phase II-contaminated TPN solutions showed visual turbidity after 96 hr, and all test organisms were recovered and identified. One hundred postinfusion TPN samples were collected randomly during phase III from inpatient parenteral nutrition patients. Six patients and two hospitals participated in the study. None of the 44 home parenteral nutrition samples and none of the 56 inpatient TPN samples developed visible turbidity. Subcultures of each sample on blood agar were negative for microbial growth. This described methodology offers an effective means to establish contamination rates of parenteral nutrition solutions after administration.

Adolescent↗

Respiratory health and indoor air pollution at high elevation.

In this research, the authors sought to provide experimental data on indoor air quality, and the resulting respiratory impact, for a high-elevation (4550 m), rural community in Ladakh, India. This community is of interest because the primarily nomadic residents burn biomass inside the home for heating and cooking. The concentrations of particulate matter (PM), endotoxin, and carbon monoxide were determined for 6 homes. Lung function data and induced sputum samples were collected for 9 female test-home subjects. In addition, lung function data were collected for 84 additional Ladakhi highlanders at this location. Sputum from 3 visiting scientists (sojourners) was collected and analyzed as well. The average PM concentration ranged from 2 mg/m3 to 7 mg/m3, with 85% of the sampled PM sized as respirable. The average endotoxin concentration ranged from 2.4 ng/m3 to 19 ng/m3, and average carbon monoxide levels ranged from 50 ppm to 120 ppm. Lung function values for the highlander population and the test-home subjects were equal to or greater than predicted, despite the highlanders' significant exposure to indoor pollutants. An induced sputum analysis revealed a significantly greater total inflammatory cell count (M +/- SD, 10(5) cell/mg) in the Ladakhi natives than in the sojourners (107.5 +/- 75.2 vs 7.1 +/- 8.1, p < .01). Although the high levels of indoor pollutants did not correlate with significant decrements in lung function, the induced sputum analysis revealed marked airway inflammation dominated by macrophages and neutrophils. It appears that augmented lung mechanics of this high-altitude population are adaptive to reduce the work of breathing; thus, decrements in lung function go undetected because the true predicted values are greater than expected.

Adolescent↗

Comparison of home occult blood tests and interaction of tests with ibuprofen.

The interaction of ibuprofen with home tests for occult blood was evaluated, and the accuracy of these tests was determined by validating the results with a specific quantitative assay of stool blood. Three home occult blood tests were evaluated: Early Detector, Fleet Detecatest, and CS-T Coloscreen Self Test. Fourteen men 19 to 35 years of age were instructed on how to use the tests and to record each day their dietary intake and stool consistency, the color of test control areas, the results, and the times of ibuprofen administration. The study consisted of a control period (days 0-5) and short-term (days 6-9) and long-term (days 10-14) ibuprofen periods. Each subject took two 200-mg tablets of ibuprofen three times daily beginning on day 6 and ending on day 14. During each study period, one stool sample was collected on each of three consecutive days. All three tests were performed on each sample, in addition to specific quantitative analysis with HemoQuant. All samples in the control period were negative for occult blood. Three positive results were reported by subject 4 in the short-term ibuprofen period, one with Fleet Detecatest and two with Early Detector. Subject 6 reported two positive Fleet Detecatest results and three positive Early Detector results during the long-term drug period. No positive results were detected with CS-T Coloscreen Self Test. The HemoQuant values showed that Early Detector produced one false-negative and two false-positive results.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Neurobehavioral development of two mouse lines commonly used in transgenic studies.

The present study was aimed at establishing the differences in the neurodevelopmental profile between two F2 lines derived from two F1 hybrid mouse strains (129 x C57BL/6 and C57BL/6 x SJL). The choice of the given strains was based on the frequent use of these mice in transgenic research. For the neurodevelopment phenotyping, we employed a test battery consisting of 23 somatometric, sensorial and motor tests. Significant variations between the strains were established in different functional domains. Some specific delays in the appearance of developmental landmarks were observed in F2 mice derived from crosses of F1 C57BL/6 x 129, whereas they acquired early developmental functions, such as the righting reflex, sooner than C57BL/6 x SJL-derived mice. C57BL/6 x 129 F2 offspring were spontaneously hypoactive, and their poorer motor performance was confirmed by low performance in the negative geotaxis test. However, there were no differences in the general psychomotor development as shown by the good performance in the homing test in both F2 lines. Both strains were susceptible to the handling procedures used, presenting a similar alteration in the response observed in the homing test as compared to nonhandled control mice. In conclusion, our work highlights the importance of the genetic background for transgenesis experiments and also the need for well-established testing protocols to obtain sufficient information at the first stage of behavioral screening of genetically modified mice.

Animals↗

Pad test by mail for home evaluation of urinary incontinence.

AIMS: To present a simple, cost-effective, and convenient method of home pad test using the mail system and evaluating change in pad weight over time. MATERIALS AND METHODS: A series of nine kinds of commonly available commercial brands of urinary incontinence pads ranging from thin liners less than 10 g in dry weight to large diapers weighing over 100 g each were assembled. Two or three of each variety were individually weighed on an OHAUS LS2000 Portable Standard scale accurate to +/- 1 g. The pads were then wet uniformly with 20 cc of saline, placed individually in sealable plastic bags, sealed, and reweighed. Random groups of three pads were mailed by standard 1st class mail to the Urocenter of New York. The sealed pads were reweighed at 8 and 14 days from the original wetting. Concurrently, ten incontinence pads soiled with urine were similarly examined to confirm that there would be no detectable difference between urine and saline for the purpose of the study. In the second part of the study, 20 pads of the same type (13 inch-long pads with absorbent gel) were divided into 4 groups of 5 pads; each group was uniformly wet with 5, 10, 20, or 50 g of saline. These pads were mailed and reweighed at 7 and 14 days from the initial wetting. RESULTS: Twenty-four pads were used in the first part of the study. The dry weights of 22/24 (92%) of the pads were within 2 g of the average weight for their brand. At the first reweighing, 22 pads (92%) weighed within 2 g of their initial wet weights (Fig. 1). Only two pads on day 8 differed substantially from their initial weights: one pad appeared to have lost 4 g and another one 9 g. On day 14, 23/24 pads remained within 1 g of their day 8 weight and 1 differed by 2 g, and the total weight of the 24 pads on day 14 was only 4 g different from their initial weight (P = 0.71, Fig. 1). The soiled pads exhibited weight changes that were indistinguishable from the saline pads. The average cost of mailing the pads by 1st class mail was $4 and the average length of time in the mail was 5 days +/- 1 day. In the second part of the study, 18/20 pads had lost less than 1 g at 1 week, and at 2 weeks, 19/20 had lost less than 2 g when compared to their initial weights (Fig. 2). One pad had lost 3 g. Pads in the low volume groups (5 and 10 g) lost an average of 1.4 and 1.2 g, respectively, while pads in the high volume groups (20, 50 g) lost an average of 1.8 and 2 g at 2 weeks. CONCLUSIONS: Dry pads of any single brand have a relatively standard weight that varies insignificantly between pads. Up to 2 weeks of delay in the weighing of individually sealed pads does not significantly affect the clinical measurement of weight at a variety of low (5 g) or high (50 g) volumes of simulated incontinence. Home pad test using the mail system is a feasible, inexpensive, and clinically accurate method of evaluating incontinence. Patients can be instructed in techniques for home pad test, allowing for greater compliance, and convenience for both physicians and patients.

Humans↗

A comparison of the effect of conventional and filter vacuum cleaners on airborne house dust mite allergen.

The efficiency (dust collection and recirculation) of a conventional upright vacuum cleaner with a prototype vacuum bag (I) with pore size of 0.1 micron was compared with a standard vacuum cleaner bag (II), in the homes of 11 atopic asthmatic subjects with a known allergy to house dust mite. Four filter vacuum cleaners were assessed in pairs-the Vax 2000 with the Vorwerk VK121 ET340 (in 10 homes), and the Nilfisk GS90 'Allergy Vac' with the Bosch maxima 43 (in nine homes). All of the selected homes were vacuumed throughout (carpets and soft furnishings) for a 15 min period with each of the cleaners, and air was sampled simultaneously at 21 min-1 (Casella personal sampler). The weight of dust retrieved was recorded, and a sample of sieved dust (2 g) and the air filters were extracted to determine the concentrations of the major allergen, Der pI, by ELISA (ALK). No significant difference was observed in either total weight of dust, or airborne and dust concentrations of Der pI between using the conventional cleaner with vacuum bags I, or vacuum bags II. The Vax and the Vorwerk filter vacuum cleaners produced no measurable airborne Der pI concentrations during use in any of the 10 homes tested, whilst the Nilfisk produced airborne Der pI in two, and the Bosch in one of the nine homes tested. The Vorwerk retrieved significantly more dust from the floors than the Vax (P < 0.002). There was no significant difference in dust retrieval between the Nilfisk and the Bosch. All of the filter vacuum cleaners investigated produced lower concentrations of airborne Der pI, compared to the conventional cleaner with or without a special dust bag. However, the amount of dust and concentration/amount of Der pI that these cleaners actually retrieved, varied and the Vorwerk appeared most effective overall.

Air Pollution, Indoor↗

Prospective evaluation of accuracy, precision, and reproducibility of an at-home hemoglobin A1c sampling kit.

BACKGROUND: The measurement of hemoglobin A1c (HbA1c) is critical to the optimal therapeutic management of diabetes. To be most useful, the HbA1c value should be available at the clinical visit. Recently, a number of at-home sampling kits have been developed that facilitate the timely availability of HbA1c results. This is a report of the accuracy, precision (among-subject), and reproducibility (within-subject) of one such kit, B-D A1c, At-Home-Test, which combines a filter paper technique for spotting capillary blood with an immunoturbidometric assay (a variation of the Cobas Integra Hemoglobin A1c method also referred to as Roche Unimate). METHODS: The B-D A1c At-Home test kit was evaluated in a clinical trial using 1625 dried blood spot samples from 59 subjects diagnosed with type 1 or type 2 diabetes collected in an in-clinic setting. Data for replicate samples were compared against those from the standard Cobas Integra Hemoglobin A1c assay and from the BioRad Variant high-performance liquid chromatography [HPLC] assay. The effects of subjecting the dried spotted blood samples to prolonged elevated temperatures was evaluated in a separate laboratory analysis. RESULTS: The B-D A1c At-Home results, which are highly correlated with the standard Cobas Integra Hemoglobin A1c assay, (r2 = 94.7%), demonstrate excellent within-subject reproducibility for 3- to 10-day-old samples (coefficient of variation = 2.7%), and provide a coefficient of variation for among-subjects that is 3.9%. There were no clinically significant differences (i.e., < 0.3 units) in samples aged 3 to 10 days, between venous or capillary blood samples, or from freezing and thawing or prolonged exposure of B-D A1c At-Home dried blood samples to elevated temperatures before assay. CONCLUSIONS: The B-D A1c At-Home kit combines the accuracy, precision, and reproducibility of a clinical laboratory test with the convenience of at-home sample collection. This product may add to the convenience of both patient and health care provider by making it easier for patients to obtain their HbA1c values and have them available at their visit to the clinician.

Adult↗

Postnatal development of rat pups is altered by prenatal methamphetamine exposure.

There are studies showing that drug abuse during pregnancy may have impairing effect on progeny of drug-abusing mothers. Methamphetamine (MA) is one of the most common illicit drugs throughout the world. The purpose of the present study was to assess the effect of prenatal MA exposure on postnatal development of rat pups before the time of separation from their mothers. Female rats were injected with MA (5 mg/kg daily) for the duration of their pregnancy. Pups were then tested throughout the lactation period. They were weighed daily and the ano-genital distance was measured on postnatal day (PD) 1. Development of postural motor reaction was tested by righting reflex on surface between PD 1 and 12, and righting reflex in mid-air after PD 12 until successfully accomplished. On PD 15 homing test was examined as a test of pup acute learning. On PD 23 sensory-motor coordination was examined using the rotarod and bar-holding tests. Additionally, the markers of physical maturation, such as eye opening, testes descent in males and vaginal opening in females were also recorded. The birth weight in prenatally MA-exposed pups was lower than in controls or saline-exposed pups regardless of sex. There were no changes induced by prenatal MA exposure in weight gain or in sexual maturation. In righting reflexes, we demonstrated that pups exposed prenatally to MA were slower in righting reflex on surface and that they accomplished the test of righting reflex in mid-air later than controls or saline-exposed pups. The performance of homing test was not affected by prenatal drug exposure. The sensory-motor coordination was impaired in prenatally MA-exposed pups when testing in the rotarod test. Also, the number of falls in the bar-holding test was higher in MA-exposed pups than in controls. There were no sex differences in any measures. Thus, the present study demonstrated that prenatal MA exposure impairs development of postural motor movements of rat pups during the first 3 weeks after birth, while not affecting physical or sexual maturation.

Analysis of Variance↗

5,7-dihydroxytryptamine lesions of dorsal and median raphé nuclei and performance in the social interaction test of anxiety and in a home-cage aggression test.

Micro-injections of the neurotoxin 5,7-dihydroxytryptamine into the dorsal raphe nucleus produced a behavioural profile in the social interaction test of anxiety similar to that seen in rats treated chronically with benzodiazepines. Neurotoxin injections into the median raphé nucleus did not produce a profile significantly different from that of the controls. In the control rats and in the rats with lesions of the median raphé nucleus, ACTH1-24 (corticotrophin) significantly reduced active social interactions, whereas it was without effect on the rats with lesions of the dorsal raphé nucleus. In the home-cage intruder test, the median raphé-lesioned rats submitted less to the intruder and stood and jumped on him more often than did the controls. The dorsal raphé-lesioned rats showed significantly fewer interactions of all kinds, compared with control rats when an intruder was placed in their home cages.

5,7-Dihydroxytryptamine↗

Measuring preferences for health care interventions using conjoint analysis: an application to HIV testing.

OBJECTIVE: To examine preferences for HIV test methods using conjoint analysis, a method used to measure economic preferences (utilities). DATA SOURCES: Self-administered surveys at four publicly funded HIV testing locations in San Francisco, California, between November 1999 and February 2000 (n = 365, 96 percent response rate). STUDY DESIGN: We defined six important attributes of HIV tests and their levels (location, price, ease of collection, timeliness/accuracy, privacy/anonymity, and counseling). A fractional factorial design was used to develop scenarios that consisted of combinations of attribute levels. Respondents were asked 11 questions about whether they would choose "Test A or B" based on these scenarios. DATA ANALYSIS: We used random effects probit models to estimate utilities for testing attributes. Since price was included as an attribute, we were able to estimate willingness to pay, which provides a standardized measure for use in economic evaluations. We used extensive analyses to examine the reliability and validity of the results, including analyses of: (1) preference consistency, (2) willingness to trade among attributes, and (3) consistency with theoretical predictions. PRINCIPAL FINDINGS: Respondents most preferred tests that were accurate/timely and private/anonymous, whereas they had relatively lower preferences for in-person counseling. Respondents were willing to pay an additional $35 for immediate, highly accurate results; however, they had a strong disutility for receiving immediate but less accurate results. By using conjoint analysis to analyze new combinations of attributes, we found that respondents would most prefer instant, highly accurate home tests, even though they are not currently available in the U.S. Respondents were willing to pay $39 for a highly accurate, instant home test. CONCLUSIONS: The method of conjoint analysis enabled us to estimate utilities for specific attributes of HIV tests as well as the overall utility obtained from various HIV tests, including tests that are under consideration but not yet available. Conjoint analysis offers an approach that can be useful for measuring and understanding the value of other health care goods, services, and interventions.

AIDS Serodiagnosis↗

Differential effects of prenatal protein malnutrition and prenatal cocaine on a test of homing behavior in rat pups.

The effects of prenatal cocaine exposure and protein malnutrition on orientation to home nest material was assessed in rat pups. Sprague-Dawley dams were fed a diet of low protein content (6% casein), and isocaloric diet of adequate protein content (25% casein, control), or a laboratory chow diet prior to mating and throughout pregnancy. Within each diet group, rats received either cocaine injections (30 mg/kg IP 2 times per week prior to mating and the 30 mg/kg SC daily from day 3 to 18 of pregnancy) or saline injections. All litters were fostered on the day of birth to control mothers fed an adequate diet. On postnatal days 7, 9, and 11, a single pup from each litter (n = 11-15 per treatment) was tested repeatedly in a clean test cage for the rapidity of approach, and level of attraction to their own home (nest) bedding compared with fresh bedding. Prenatal malnutrition and prenatal cocaine exposure each gave rise to independent effects on performance, based upon factor analysis. Prenatal malnutrition, but not prenatal cocaine increased the time taken for rat pups to approach their nest bedding, reduced the time spent on this bedding, decreased the number of entries into the sector containing the home bedding and reduced pup weight. Prenatal cocaine, but not prenatal malnutrition, produced a reduction in activity, but had no effect on pup weight. The lower activity level was most pronounced on postnatal day 7. Surprisingly, interactive effects of prenatal cocaine and prenatal malnutrition were not observed on any behavior examined. Nevertheless, the co-existence of drug addiction and malnutrition in human populations raises the possibility that some of the effects generally attributed to drug exposure may, in fact, be due to malnutrition.

Animals↗

Spontaneously hypertensive rats (SHR) as a putative animal model of childhood hyperkinesis: SHR behavior compared to four other rat strains.

Childhood hyperkinesis or attention-deficit hyperactivity disorder (ADHD) is a behavior disorder of which the main symptoms are attention problems and hyperactivity. The main objective of the present study was to investigate whether the spontaneously hypertensive rat (SHR) strain is a useful animal model of ADHD. Five different rat strains were tested: SHR, Wistar-Kyoto (WKY), Wistar, Sprague-Dawley (SPRD), and PVG (hooded) rats. The protocol consisted of three different test procedures: 1) A 7.5-min free-exploration open-field test (home cage accessible), where the SHR was less active than Wistar and SPRD but more active than WKY; SHR showed longer latencies to leave the home cage than both Wistar and SPRD rats, spending less time in the field, ambulating and rearing less than Wistar and SPRD but more than WKY. Within session, the SHR tended to be more active at the end of the session than at the start, while the opposite tended to be the case in the other groups. 2) A 7.5-min forced exploration open-field test (home cage not accessible), where the results showed that the SHR is less active than both the Wistar and Sprague-Dawley strains, but more active than PVG and WKY. 3) A two-component multiple schedule of reinforcement with a fixed interval 2 min signalled by houselight on and a 5-min extinction signalled by houselight off. Lever pressing by SHR was markedly different from that of the other four strains, which were quite Except early in the interval, SHR pressed the lever more than any of the other groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

A 3 year retrospective review of intrauterine insemination, using cryopreserved donor spermatozoa and cycle monitoring by urinary or serum luteinizing hormone measurements.

Insemination with donor spermatozoa is an integral part of infertility treatment. For the last 3 years in our unit, intrauterine insemination with donor spermatozoa (IUID) has been used in preference to vaginal insemination. In this retrospective study, patients were offered an initial course of five single intrauterine inseminations with cryopreserved donor spermatozoa and treatment was then reviewed. A total of 389 patients received 1465 inseminations. In all, 1119 cycles were monitored using luteinizing hormone serum analyses and 346 cycles using the urine home test kits. The clinical pregnancy rate per insemination for the cycles monitored by the serum assay was 18.0% (202/1119) compared with the urine cycles (13.7%, 46/346) (P <05). The pregnancy loss rate was not significantly different (14.4%, 29/202 and 21.7%, 10/46) (serum and urine cycles respectively). The viable clinical pregnancy rate was significantly higher (P <03) for the serum cycles than for the cycles using the urinary monitoring (15.5%, 173/1119 and 10.4%, 36/346 respectively). The cycles monitored by serum assay had a significantly higher cumulative viable clinical pregnancy rate (P <0001) of 70.2% after nine inseminations compared with the urine monitored cycles of 54.8%. The majority of patients opted for the serum cycles, with a minority self-selecting the urine cycles mainly for travelling convenience. The explanation for the significant differences between the viable clinical pregnancy rates per insemination and the cumulative viable clinical pregnancy rates may be due to the sensitivity of the urine home test kit or the patients' interpretation of the result.

Cryopreservation↗