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A simple, efficient and inexpensive program for preventing prematurity.

Prevention of prematurity and of low birth weight is--because of the associated increased risk of mortality and morbidity--one of the most urgent tasks of perinatal medicine. Whereas the rate of prematures all over the world does not vary very much (5-10%), the rate of infants born with low birth weight lies between 3.6% and 10% in the industrial countries and between 9.8% and 43% in the developing countries, where the main cause of low birth weight is intrauterine malnutrition. As there are different causes for prematurity and low birth weight, but also because various countries have different resources and have therefore to set their priorities differently, there is no global solution. The situation in each country must be considered individually. However, as far as basic means are available for the majority--such as basic health care, monitoring the nutritional state of the mothers and acting to prevent infectious diseases (malaria in particular can cause prematurity)--determined prevention of prematurity should take the form of screening and the treatment of disturbances of the vaginal milieu or genital infections. This policy can be recommended because one of the most important avoidable causes of prematurity is ascending genital infection (mostly combined with bacterial vaginosis), which very frequently starts with a disturbance of the vaginal milieu and then often takes its course asymptomatically. Regular screening for signs of such a disturbance using vaginal pH-measurements (and if necessary further diagnostics and therapy) makes possible the detection of an "early marker" to prevent prematurity in an effective and inexpensive way. Our prematurity-prevention-program, which has been successful for many years, is based on an anamnestic assessment of prematurity risk, the early detection of warning signs (including regular measurement of the vaginal pH) and, if necessary, the appropriate therapeutic measures. In cases of disturbance of the vaginal milieu, the latter consists of a therapy with lactobacillus preparations or in a combination of lactobacillus preparation with an acidifying therapy which may lead to earlier normalization of the vaginal milieu. In cases of bacterial vaginosis local therapy, for example with metronidazol or clindamycin, is undertaken, and in other infections specific treatment. It is encouraging to note that particularly the rate of the very small prematures is reduced when pregnant patients take part in our self-care-program, measuring their own vaginal pH-value twice a week, and also searching for any other warning signs. In this way in our collective the rate of very small low birth weight infants could be reduced from 7.8% in the immediate previous pregnancy to 1.3%. In a prospective study performed in Erfurt the rate of very early premature births (< 32 + 0 gw) amounted to only 0.3% in contrast to 3.3% in a control group who had not taken part in the self-care activity. According to a differentiated classification of the control group the success of the self-care activity was even clearer: In patients who did not take part because their doctors did not support the self-care activity, the rate of very early premature births amounted to 4.1%. In patients who did not take part in the self-care activity, but who were in the care of doctors who were interested and had taken part in the prevention-program, the rate was 2.2%; in the group with active participation in the self-care activity it was only 0.3%. To date measurement of the vaginal pH-value was performed intravaginally using either indicator strips or pH-measuring test gloves. A short time ago we developed a panty liner coated with an indicator strip, which enables reading of the pH-value by just checking the indicator on the panty liner. First results with this panty liner are very promising.

Abortion, Spontaneous↗

Crevicular fluid myeloperoxidase--an indicator of acute gingival inflammation.

Paper strips inserted into 100 gingival sulci or periodontal pockets in 9 patients for 3 minutes in each case were assayed for polymorphonuclear (PMN) leukocyte-derived myeloperoxidase (MP) activity. This activity was then analysed in relation to the simultaneously recorded gingival index, probing depth and bleeding on probing. MP activity was always very low if the gingiva was clinically healthy, with no bleeding or signs of loss of attachment. However, sites at which the marginal gingiva was inflamed and bleeding and/or the pocket depth was greater than or equal to 6 mm exhibited MP activities ranging from very low to very high. The wide variation most likely reflects differing numbers of PMN cells in these crevices and is, therefore, probably indicative of acute or chronic periodontal disease at any particular site. The assays of the paper strips resulted in values linear with respect to the actual concentrations of purified, PMN cell-derived MP in the strips. Our method is a relatively simple way to quantitate the products of PMN cells at a single periodontal site and, in this way, to possibly identify the acute phases of the disease.

Adult↗

[Evaluation of the lithogenic risk in renal lithiasis. Value of urine density measurement].

OBJECTIVE: Measuring specific gravity of urine is a simple means of self-monitoring for urolithiasis patients. METHODS: We evaluated the reliability of two test strips (N-Multistix and Combur-Stix) and determined the relationship between urine specific gravity and crystal formation in first morning urine in 179 patients with calcium oxalate lithiasis. Urine hydrometry was used as the reference method. RESULTS: There was a good correlation between urine density read on the test strips and hydrometry (r = 0.733 for N-Multistix and 0.697 for Combur-Stix). Hydrometry showed little pH effect but the test strips gave results correlated with urine pH (r = 0.764 and 0.813 respectively). When urine pH was below 6.5, the specific gravity of the urine was overestimated; inversely for pH > 7, it was underestimated. Correction factors were obtained by comparing test strip values with specific gravity measurements for pH level between 4.5 and 8. There were crystals in 66% of the urine samples with a density > or = 1012 g/l. In contrast, 75% of the samples below this value were crystal free. There was a close relationship between 24-hour urine volume and specific gravity (n = 124; r = 0.778): a specific gravity of 1.012 corresponded to 2100 ml urine output. For 24% of the patients, specific gravity of the morning urine was > or = 1.012 despite a 24-h urine output > or = 2100 ml, indicating insufficient urine dilution during the night. CONCLUSION: Measurement of specific gravity with test strips with correction for pH can be a simple way to measure the specific gravity of urine and assess whether urine dilution is sufficient to reduce the risk of crystal formation, the main risk factor in urolithiasis patients.

Humans↗

[Evaluation of the effectiveness of metabolic self-control through direct dispensation of diagnostic strips to type 2 diabetic patients].

OBJECTIVE: To perform an evaluation of the effectiveness of diagnostic strips in metabolic control by type 2 diabetics. DESIGN: A crossover, observational study. SETTING: Primary Health Care. PATIENTS: A sample of 400 histories at a Primary Care Centre (PCC), representative of Diabetes 2 patients who used reactive strips directly dispensed at PCCs as a method of home self-analysis of their disease, was evaluated. They were monitored in 1995 and 1996 in the seven health districts in the Primary Care region of Tortosa. MEASUREMENTS AND MAIN RESULTS: The use of reactive strips was considered effective if the data recorded in the PCC histories satisfied the criteria for acceptable metabolic control, as defined by the GEDAPS, for the previous year of monitoring, or for at least three months if the period of use of the strips was under a year. Mean annual cost and consumption per diabetic, and the evolution of these over the study period, were calculated. CONCLUSIONS: Direct dispensing of reactive strips led to an important annual increase in cost (+46.59%) and consumption (+89.25%), but acceptable effectiveness was not demonstrated (1.10%).

Aged↗

Regional influences on the dispensing of glucose test strips in Dutch community pharmacies.

BACKGROUND: Pharmacy practice guidelines promote the role of community pharmacies in self-monitoring of blood glucose. However, variations between Dutch pharmacies exist in the proportion of patients to whom test strips are dispensed. OBJECTIVE: To assess whether variations between community pharmacies in dispensing of blood glucose test strips can be explained by differences in patient characteristics and the region in which the pharmacy is located. SETTING: PHARMO-Record Linkage System containing drug dispensing histories from 40 community pharmacies of about 450,000 patients in the Netherlands. METHOD: We performed a retrospective cohort study. Data on prescription of all drugs and medical aids between 1991 and 2001 were extracted for all new users of antidiabetic drugs. Patients were excluded if the dispensing history did not allow classification of the type of diabetes or if the dispensing pharmacy could not be determined. The data were analysed using a Cox proportional hazard model. MAIN OUTCOME MEASURE: Time to first test strips dispensed. RESULTS: We identified 8,233 starters of antidiabetic drugs. During a median follow-up of 2.1 years, 20% of the patients were dispensed test strips at least once. Community pharmacy was significantly associated with the dispensing of test strips after adjustment for patient characteristics. This association was less apparent when stratified for the geographical location of the pharmacy. CONCLUSION: Community pharmacy is an independent determinant of the start of use of test strips. Differences in dispensing of test strips between pharmacies are dependent on geographical region. This suggests that implementing practice guidelines for diabetes care in community pharmacy requires different approaches in different regions.

Adult↗

The use of the Micral-Test strip to identify the presence of microalbuminuria in people with insulin dependent diabetes mellitus (IDDM) participating in the EUCLID study.

In IDDM, microalbuminuria (urinary albumin excretion rate (AER) of 20-200 micrograms/min) is a predictor of persistent proteinuria and diabetic nephropathy. Early intervention may prevent or reduce the rate of progression of renal complications. The Micral-Test strip can be used to establish a semi-quantitative estimate of AER. We assessed the field performance of the Micral-Test strip in detecting microalbuminuria in the EUCLID study, an European wide, 18 centre study of 530 IDDM participants, aged 20 to 59 years. People with macroalbuminuria were excluded. On entry, all participants had albumin concentrations from two overnight urine collections measured by a central laboratory, and the corresponding Micral-Test performed on the two collections locally. a cut off of > or = mg/l albumin from the first Micral-Test, to detect a centrally measured albumin concentration > or = 20 mg/l, yielded 29 (5.8%) false negative results and 58 (11.6%) false positive results (sensitivity 70%, specificity 87%). The mean AER, from two collections, was compared with the corresponding 'pooled' Micral-Test results (mean of the two readings). Receiver Operating Characteristic (ROC) curves were used to assess if there was a suitable 'pooled' Micral-Test result for screening microalbuminuria. A 'pooled' Micral-Test result (> or = 15 mg/l) was used to detect mean AER > or = 20 micrograms/min (sensitivity 78%, specificity 77%). This 'pooled cut-off' had already been used for screening on to the study and led to an over-estimate (154 vs. 77) of the true number of microalbuminuric participants on the study. In conclusion, our findings suggest that the Micral-Test strip is not an effective screening tool for microalbuminuria, using the 'pooled' result from two measurements did not improve the sensitivity of the test.

Adult↗

Effect of gingival fluid collection on subgingival plaque sampling.

The purpose of this study was to determine whether gingival crevicular fluid (GCF) sampling by paper strip removes sufficient bacteria to affect subsequent subgingival plaque sampling using a curette. In 25 subjects, one healthy, gingivitis and periodontitis site was sampled for GCF using a strip followed by subgingival plaque sampling with a curette. Bacterial assays indicated that GCF strips removed significant numbers of bacteria when placed intracrevicularly for 5 s. A greater proportion of total bacteria was removed with strip sampling at healthy rather than gingivitis or periodontitis sites. Qualitative assessment of presence or absence of spirochaetes and dark-pigmented species indicated potential for significant interference of curette sampling by the strip at gingivitis and healthy sites. We concluded that paper strip GCF sampling may significantly affect curette sampling at the same sites. The magnitude of this impact depended on the clinical classification of specific sites and the assay performed.

Bacteria↗

One-step immunostrip test for the simultaneous detection of free and total prostate specific antigen in serum.

The development of a one-step lateral flow immunoassay on a strip format for the rapid and reliable simultaneous detection of serum levels of free and total prostate specific antigen (f-PSA and t-PSA) and estimation of f-PSA to t-PSA ratio (f/t-PSA) is reported. The f/t-PSA ratio has shown to be more specific for the correct diagnosis of prostate cancer than t-PSA alone, especially in the so-called diagnostic grey zone of 4-10 microg/l t-PSA. The performance of the system described relied on non-competitive immunoassay protocols. Herein, f-PSA and t-PSA were sandwiched between anti-f-PSA and anti-t-PSA monoclonal antibodies immobilised on the strip and a colloidal gold anti-PSA antibody tracer. In the presence of PSA in the sample, the tracer accumulated on the strip results in the appearance of specific pink colour lines. The colour intensity of these lines was found to be directly proportional to the PSA concentration and a semi-quantitative estimation could be carried out visually. Quantitative analysis was also possible by densitometry. Using PSA standards prepared in female serum, the strip could be calibrated up to a concentration of 60 microg/l for both PSA species, with an assay time of less than 20 min. The estimated detection limit was 1 microg/l in all cases. The immunostrip showed good storage stability for at least 2 months and the reproducibility was always between 12% and 17%. Fifty-one male serum samples were analysed with the strip and results compared with values obtained by two different commercial immunoassays taken as reference methods. The study yielded acceptable correlation and agreement. An estimation of the sensitivity and specificity demonstrated the strip validity as a potential front-line device for the early detection of prostate cancer and differentiation of benign prostatic anomalies. Small plastic cartridges incorporating the immunostrip and a small blister containing washing solution that helps remove unbound species from the strip were envisaged in order to avoid false positive readings and decrease background signals, thereby leading to better sensitivity and detection limits.

Antibodies, Monoclonal↗

Comparison of blue dye visualization and glucose oxidase test strip methods for detecting pulmonary aspiration of enteral feedings in intubated adults.

STUDY OBJECTIVE: To compare the relative utility of blue dye visualization with a glucose oxidase test strip method for detecting aspiration of enteral feedings. DESIGN: Tracheally intubated adults were prospectively monitored for aspiration of enteral feedings. SETTING: Intensive care units of two community hospitals in Michigan. INTERVENTIONS: None. PATIENTS: The experimental group consisted of 15 patients receiving enteral feedings. The control group included 14 patients not enterally fed. MEASUREMENTS AND RESULTS: Blue food coloring was added to feeding formulas to obtain a visible blue color. At 8-h intervals, tracheal secretions were examined for blue discoloration, followed by measurement of glucose concentration using a calibrated glucose meter. Clinically significant aspiration was defined to require the following: (1) a bloodless positive glucose reading (> or = 20 mg/dl); (2) one or more signs of systemic inflammation; and (3) one or more signs of respiratory deterioration. Eight (53 percent) of 15 patients in the experimental group experienced at least one episode of presumptive aspiration as defined by either a bloodless positive glucose reading or visible blue discoloration of tracheal secretions. Clinically significant aspiration occurred in 5 (33 percent) of 15 patients in whom bloodless glucose readings were positive in 13 (19 percent) of 67 samples; among patients not developing this complication, glucose was found in only 3 (5 percent) of 60 samples; (p = 0.005). Inspecting tracheal secretions for blue dye usually failed to detect aspiration episodes identifiable by the glucose oxidase test strip method (relative sensitivity, 13 percent). Blue dye visualization performed no better among patients developing clinically significant aspiration (relative sensitivity, 15 percent). Patients who developed clinically significant aspiration received more of their enteral feedings in the supine position than patients without this complication (98 percent vs 21 percent; p < 0.001). CONCLUSIONS: Inspecting tracheal secretions for blue discoloration failed to detect most episodes of enteral feeding aspiration. Glucose oxidase test strip methods should replace blue dye visualization for detecting aspiration of enteral feedings in intubated adults.

Adult↗

Self-monitoring of blood glucose: an evaluation of the BM test glycemie 20-800 system.

Concentrations of whole blood glucose were measured using two different glucose oxidase impregnated test-strips. The recordings obtained by one observer with Dextrostix were compared with those recorded by an independent observer using BM Test Glycemie 20-800 strips. Dextrostix need a reflectance meter (Ames-Eyetone or Hypocount) for accurate quantitation whereas the BM Test Glycemie 20-800 strips can be read by eye alone. These two semi-quantitative methods for self-monitoring of blood glucose gave similar results over the range 2.2 to 22.0 mmol glucose per litre. The BM Test Glycemie 20-800 strips however are technically easier to use than the Dextrostix in that there is less error if the operator fails to comply exactly with instructions regarding exposure time to the drop of blood. They furthermore eliminate the need for a reflectance meter.

Blood Glucose↗

[Evaluation of screening methods (catalase, sediment, reactive strip and Gram stain) in urinary tract infection in a Colombian university hospital].

BACKGROUND: To evaluate the catalase test as a screening method in urinary tract infection (UTI) versus sediment, reactive strip and Gram. METHODS: Two hundred forty-five's stain urine samples were prospectively analyzed in the Hospital Universitario San Ignacio de Bogotá (Colombia). The culture was used as a reference test for the evaluation of the screening parameters in UTI patients. RESULTS: Of the 245 urine samples 45 were discarded. The remaining 200 urine samples were cultured being 100 positive and 100 negative. The former were analyzed by screening methods. The sensitivity and specificity of the catalase test was 97% and 94%, respectively with a positive predictive value of 94% and negative of 97%. The most frequently isolated microorganism was E. coli (84%), followed by Proteus sp. (6%). CONCLUSIONS: The use of the catalase test in urinary tract infection is a safe, economic and rapid method providing advantages due to its high sensitivity and specificity values, its good correlation with the different parameters evaluated in this study (sediment, strip, Gram's stain), and offers optimum diagnosis in urinary tract infection in developing countries such as Colombia.

Adolescent↗

Comparison of four methods for determining nitrate utilization by cryptococci.

This study evaluated the following methods for determining nitrate utilization: Wickerham broth, a special nitrate broth, Delft plate, and nitrate strip. With 236 isolates of cryptococci as test organisms, the special nitrate broth method gave 99% correct results and the Wickerham broth method gave 98%. The nitrate strip and Delft plate methods gave correct results in 94 and 86% of tests, respectively. The special nitrate broth method is judged superior because it provides accurate results within 48 h, compared to 14 days with the Wickerham broth method.

Cryptococcus↗

[First two years of an external quality assurance program for urinalysis].

OBJECTIVE: To analyze the first two years of a strip uroanalysis quality assurance scheme operating in Mexico. METHODS: The participants received 8 shipments of four controls each as dried tablets to be dissolved and analyzed with urine strips. The number of participants increased from < 50 in the 1st shipment to > 200 in the 8th. They assayed 6-10 analytes depending on the strip used and sent in 763 reports. For each report we calculated a score per analyte (n = 4), per shipment (n = 24 to 40) and a global score in the 8 shipments (n = 707 to 763 reports). The scores ranged from zero (excellent accuracy) to a maximum of 400 and were calculated by comparison with the modal value of about 600 American and Canadian laboratories which assayed the same controls using exclusively Bayer strips and instrumental readings. RESULTS: The best score was for nitrites (global score of 3 in 741 reports) and the worst for specific gravity (58 in 744 reports); the other analytes had scores from 11 to 19 (Table 1). The scores of four types of methods (Table 2) showed the best results with Bayer strips and instrumental readings (score of 13 in 469 reports) and the worst with strips of other suppliers (scores of 28 for visual and 31 for instrumental readings) and intermediate with visual readings of Bayer strips (score of 21). CONCLUSIONS: 1. Our results led us to the decision to exclude from the program participants who do not use Bayer strips as our program may disorient them instead of helping to improve their assays. 2. We confirmed that instrumental readings perform better than visual readings. 3. The causes of suboptimal performance in specific gravity need to be explored.

Humans↗

Non-microscopic method for malaria diagnosis using OptiMAL IT, a second-generation dipstick for malaria pLDH antigen detection.

Rapid diagnostic tests for malaria are now a commonly used procedure for malaria diagnosis. New or improved devices need to be evaluated against a recognised gold-standard procedure and subjected to conditions of temperature and humidity that may affect their performance. The OptiMAL 48 RDT has now been available commercially for several years and a second-generation OptiMAL IT test is now coming onto the market. In this study the problems associated with the routine use of OptiMAL 48 is investigated and its performance compared with a second-generation individual test, OptiMAL IT. Sensitivity and specificity for detection of all malaria species for both tests were comparable but loss of sensitivity of the test strips due to humidity or temperature found with the routine use of OptiMAL 48 was not seen with the individual OptiMAL IT. False-positive results for Plasmodium falciparum, seen in two negative blood samples, were attributed to the presence of high levels of heterophile antibodies.

Animals↗

Rapid analytical detection of microcystins using gold colloidal immunochromatographic strip.

Routine monitoring of microcystin in natural waters is difficult because the concentration of the toxin is low and the detection method is usually complicated. We developed a rapid analytical detection method of microcystins gold colloidal immunochromatogeraphic strip. The sensitivity of the strip is about 1 ng/mL for microcystin LR; it is able to distinguish visually among different concentrations of microcystin solutions. The developed gold colloidal strip can detect microcystins within 15 min and does not require either a complicated extraction system, or trained or qualified experts.

Antibodies, Monoclonal↗

Rapid microalbuminuria screening in type 2 diabetes mellitus: simplified approach with Micral test strips and specific gravity.

BACKGROUND: Microalbuminuria is known to be a harbinger of serious complications in type 2 diabetes mellitus. Since medical intervention at the onset of microalbuminuria can be critical in reducing these adverse outcomes, it is widely agreed that type 2 diabetic patients should be screened for microalbuminuria. The purpose of the present study is to evaluate Micral test strips in conjunction with a urine specific gravity determination as a rapid and accurate method for detecting microalbuminuria in type 2 diabetic patients. METHODS: In this prospective study, a total of 444 urine samples of type 2 diabetic patients were obtained from the ABCD study cohort for analysis. Urinary albumin concentrations were determined using Micral test strips and compared to results measuring albumin by the immunoturbidimetry method of timed collections. Urine specific gravity was measured by a standard urine dipstick. RESULTS: The performance characteristics of the Micral test strips for detecting microalbuminuria (30-300 mg albumin/24 h) were adequate but not optimal: sensitivity 88%, specificity 80%, positive predictive value 69%, negative predictive value 92%. A concomitant specific gravity determination was useful in indexing the magnitude of false negative and false positive readings by the Micral test strips. CONCLUSIONS: While the use of Micral test strips provides a rapid approach to detecting microalbuminuria in type 2 diabetic patients, this method has limitations. The simultaneous measurement of specific gravity is helpful in addressing some of the shortcomings of this screening test.

Albuminuria↗

Detection of pigment precursors in white clinical strains of Serratia marcescens.

Filter paper strips containing a pigment precursor extracted from Serratia marcescens strain 933 were used to determine whether white, clinical S. marcescens strains could form pigment syntrophically. In all, 114 strains (113 of clinical origin) were tested, and 99% were found to develop colors ranging from violets to pinks.

Enterobacteriaceae Infections↗

Biotyping of Haemophilus using API 10S--an epidemiological tool?

One hundred and ninety-nine strains of Haemophilus isolates were biotyped by Kilian's method(1) and a modified API 10S strip and the results compared. One hundred percent correlation was found between the two systems. The ONPG test proved of value in differentiating between Haemophilus influenzae and Haemophilus parainfluenzae when there was growth factor disc failure.

Adolescent↗