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Evaluation of a new screening system for enteric pathogens.

The two-hour Rapid SST strip (DMS Laboratories, Inc.) was compared with our standard screening system (triple sugar iron agar, lysine iron agar, and urea) for enteric pathogens. We tested 50 stock cultures of enteric pathogens and 213 stool cultures received in the Barnes Hospital Clinical Microbiology Laboratory over a two-month period. All enteric pathogens from the stock cultures and clinical specimens were identified correctly with the Rapid SST system. More false-positive reactions were observed with the Rapid SST system (34%) than with the conventional system (23%). However, the costs associated with using both systems were equivalent and the test results were available one day faster with the Rapid SST system. Thus, the Rapid SST is a rapid, accurate, and cost-effective method for screening stool specimens for enteric pathogens.

Bacteriological Techniques↗

[Evaluation of novel test strip to measure albumin and creatinine in urine].

The purpose of this study was to evaluate the clinical usefulness of novel test strip that simultaneously measure urinary albumin and creatinine. Testing was performed on 95 random urine samples from diabetics. Each sample was assayed with following methods: test strip by instrument (AX4280) reading and by visual interpretation, quantitative method for albumin, creatinine, and alpha1-microglobulin and cellulose acetate membrane electrophoresis. The results of test strip had good correlation with quantitative results. In the case of instrument reading, the sensitivity, specificity and consistency were 91.2%, 78.9% and 86.3% for albumin and 94.5%, 87.5% and 91.6% for albumin index (albumin/creatinine ratio; A/C ratio), respectively. The percent same level agreement for creatinine was 63.2%. After correction using creatinine value on test strip, 18.4% of samples defined as negative by albumin quantitative value were turned to be positive, 12.3% of samples defined as positive were turned to be negative. The same level of creatinine correction effect as the quantitative method was obtained at the test strip. When alpha1-microglobulin/creatinine (alpha1 m/g x Cr) ratio was compared with albumin index, percent positive of alpha1 m/g x Cr ratio was 35.0% for samples with albumin index less than 30 mg/g x Cr, 59.5% for those with albumin index between 30 and 300 mg/g x Cr. In addition, on cellulose acetate membrane electrophoresis, both retinol binding protein (RBP) and beta2-microglobulin (beta2 m) were detected in 12.5% of patients in normal condition or pre-nephropathy. Among patients at early-nephropathy, the detection rate of RBP and beta2 m were 20.0% and 15.0% respectively. These results indicate that the renal tubule is also damaged at the early stages of nephropathy.

Adult↗

Comparison of three test methods used for the diagnosis of candidiasis.

A total of 266 specimens was taken from oral mucosa or dentures of 88 patients with suspected Candida-infected oral mucosa. One-third of the debris from each sample was cultured on Microstix-Candida (C), strips, one-third was cultured on Oricult-N-plates, and the rest was collected on glass plates and stained by the periodic acid-Schiff (PAS) method. The PAS-stained samples were analyzed under the light microscope for the presence of Candida hyphae. The other samples (Oricult-N or Microstix-C) were studied visually, according to the manufacturer's recommendation. PAS-stained specimens showed significantly less often positive results than those of the two culture methods. These data suggest that oral candidiasis may be incorrectly diagnosed if based upon results obtained with the culture methods. It is also possible that the PAS-staining method yielded false negative findings. This possibility should always be considered, especially if other findings and symptoms disagree with the test results obtained.

Candida↗

[Blood glucose self-monitoring with the Glucosignal test strip in routine practice--experiences of a district diabetes center].

32 patients (19 females, 13 males; 28 type I diabetics and 4 type II diabetics) with a diabetes mellitus we taught the blood glucose self-control under working conditions by means of the test strip Glucosignal. 9 diabetics were excluded from the investigation. The main reasons for this were: inability to acquire the withdrawal technique, abuse of alcohol, unreliability and attitude of opposition to the own disease. During the duration of observation of on an average 13.8 months (11 to 25 months) in the remaining 23 patients an improvement of metabolism could be obtained with the same need of insulin. In three quarters of the cases correction of the metabolism were made by the patients by insulin variation and only for the smallest part by physical conditioning. Intensive theoretical and practical training and good motivation of the patients decide on success or failure of the optimization of metabolism. The various possibilities of an influence on ambulatory day-night-profiles under working conditions are discussed.

Adult↗

[Evaluation of the acceptability of 2 methods for self monitoring of blood sugar by a group of insulin-dependent diabetic patients].

In order to evaluate the advantages and disadvantages of two methods of blood glucose self-monitoring (either direct semi-quantitative reading on Haemoglukotest 20-800 or quantitative reading of Dextrostix strips using a reflectance-meter, Glucometer) 20 insulin-dependent diabetics selected according to the quality of the management of their own diabetes were asked to try both methods for 3 months and then fill a questionnaire assessing their acceptance. Analysis of the responses shows that home blood glucose monitoring is well accepted even after one year by patients aware of the necessity of a good glycemic control. It is specially useful for the adaptation of insulin doses and less so for identification of hypoglycemic attacks. Haemoglukotest 20-800 is appreciated for its easy utilization specially during professional life and outside leisure. However, the reflectance-meter Glucometer is preferred by most patients because they feel it is more reliable and safe.

Adolescent↗

Spectral analysis of biochemical reactions used for identification of bacteria.

To define parameters for optimizing automated discrimination of bacterial biochemical reactions certain theoretical considerations of spectrophotometric analysis were explored. One-hundred and one recent clinical isolates of gram-negative bacilli (21 species) were inoculated into AP1 20 E strips and read manually after 24 hours. With spectrophotometric scanning, the AP1 reactions could be classified into three analytical categories: pH change, production of new products, and darkening of the medium. Whereas single wavelength analysis gave 2.9% disagreement from the visual, multiple wavelength analyses were uniformly more accurate. The best results for pH change reactions were obtained by calculating a ratio of two wavelengths. New color reactions were best interpreted by demonstration of the new peak, whereas darkening reactions required quantitation of the area under the entire curve. With these methods, a 99.3% overall agreement of individual reactions and a 97% agreement of identification were achieved. Multiple-point analysis of spectra coupled with computerized interpretation of the data should help resolve the problem of equivocal reactions in bacterial identification schemes optimized for spectral analysis.

Bacteriological Techniques↗

Novel diagnostic method of testing for Helicobacter pylori infection using the rapid leukocyte strip test, Leukostix.

BACKGROUND AND AIM: A characteristic of gastric mucosa infected with Helicobacter pylori is infiltration of inflammatory cells, mainly consisting of neutrophils. The present study aimed to detect neutrophils in homogenates of biopsied gastric mucosa semiquantitatively using the rapid leukocyte strip test, Leukostix. The authors then investigated the association of these results with H. pylori status. METHODS: The authors studied 342 patients undergoing endoscopy. Of these, 160 were treated for eradication of H. pylori infection and were reassessed after treatment. For the definitive diagnosis of H. pylori infection, quantitative culture, the rapid urease test and immunohistostaining were performed. Additionally, serum antibody against H. pylori was determined at the initial examination, and the 13C-urea breath test was performed after treatment. With the use of Leukostix, homogenates of biopsied gastric mucosa were spotted onto strips and judged 2 min later. RESULTS: There was a significant correlation between the positive reaction of Leukostix and the number of neutrophils in gastric tissues determined by microscopic observation. The sensitivity and specificity of Leukostix at the initial examination were 97.9% and 76.9%, respectively, while those after eradication treatment were 100% and 97.2%, respectively. There was a significant positive correlation between the degree of reaction of Leukostix and the amount of H. pylori determined by quantitative culture. CONCLUSIONS: The Leukostix test, using biopsied samples of gastric mucosa, was excellent for quantitative determination of neutrophils and useful for diagnosis of H. pylori infection and early assessment of treatment efficacy. Positive gradations of Leukostix results corresponded closely with the amount of H. pylori in gastric tissues.

Adult↗

Evaluation of a test for abnormal rectal mucus for early detection of colon cancer.

This report describes the evaluation of a chemical test for T-antigen in rectal mucus as a screening test for colon cancer. The test, called the Mucus Strip Test, detects the disaccharide residue sialic acid-free beta-D-Gal(1-->3)-D-GalNAc or T-antigen, which accumulates in mucus from malignant cells and colonic mucosa adjacent to cancer but not in normal mucosa. Participants were an unselected case series of 660 persons undergoing colonoscopy, excluding those with ulcerative colitis, polyposis, Crohn's disease, or nonspecific inflammatory bowel disease. In the first study (n = 608) rectal mucus was collected after preparation of the bowel for colonoscopy; in the second study (n = 52) a modified protocol was used to collect mucus approximately 2 weeks before colonoscopy and again following preparation for the procedure. Mucus Strip Test results were compared to the diagnosis received after colonoscopy, which was classified as cancer, adenomatous polyp(s), and others (normal). Analyses were also stratified by previous history of large intestinal disease, classified as previous cancer; previous diagnosis of adenomatous polyp(s); or others. In the first study, T-antigen was detected in approximately 30% of mucus samples, and test results were independent of both diagnosis at colonoscopy and previous medical history. In the second study, T-antigen was detected in 85% of samples collected before and 96% of samples collected after preparation for colonoscopy, but test results were again independent of diagnosis and medical history.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

A dip-and-read test strip for the determination of mercury(II) ion in aqueous samples based on urease activity inhibition.

A sensitive dip-and-read test strip for the determination of mercury in aqueous samples based on the inhibition of urease reaction by the ion has been developed. The strip has a circular sensing zone that containing two layers: the top layer is a cellulose acetate membrane where urease is immobilized on it; the bottom layer is a pH indicator wafer that is impregnated with urea. The principle of the measurement is based on the disappearance of a yellow spot on the pH indicator wafer. The elapsing time until the disappearance of the spot which depends on the concentration of mercury(II) ion is measured with a stopwatch. Under the experimental conditions, as low as 0.2 ng/ml mercury can be observed with the detection range from 0.2 to 200 ng/ml in water. Organomercury compounds give essentially the same response as inorganic mercury. Heavy-metal ions such as Ag(I), Cu(II), Cd(II), Ni(II), Zn(II), and Pb(II) as well as other sample matrixes basically do not interfere with the mercury measurement.

Biosensing Techniques↗

[Approximation to the epidemiology of salt intake and arterial pressure. Study on a community of Toledo].

The relationship between salt intake and Blood Pressure (BP) is studied in a random sample of adults from 25 to 64 years of age in a urban community in Toledo, by means of a semiquantitative determination with a reactive (Saltex strip). Of the 3,824 people included in the census (1984), 384 were selected, regarding whom, in addition to the Cl- NaCl in the night fraction of urine being studied, the average BP of two samples, the body mass index (BMI), chronic communicable diseases, the use of tobacco, alcohol and drugs, as well as other social variables of the population were studied. Data was collected regarding the salt intake of 238 individuals and the BP of 236 individuals. A prevalence of high blood pressure (BP greater than 140 and/or 90 mmHg) in 14% was observed, and 81% of the sample studied ingested over 11 g of salt daily. The results were analyzed in strata, by age and BMI to avoid factors resulting in confusion, no relationship between salt intake, BP and rest of the variables studied being found in our community.

Adult↗

Evaluation of the creatinine assay on the Reflotron analyser under centralized and non-centralized conditions.

The creatinine assay, performed on Reflotron "dry chemistry" analysers in six offices of general practitioners, was evaluated as part of a project on the quality of laboratory determinations in decentralized situations. The method itself was evaluated before this investigation was started. Differences were noticed between Reflotron machines, batches of strips, and various types of sample, viz. heparin-treated blood or plasma gave higher results than serum of EDTA-treated samples. All Reflotron results were lower in comparison with wet chemistry methods. The "dry chemistry" technique was not influenced by the presence of glucose or bilirubin (below 170 mumol/l); haemoglobin interfered. By simultaneous sampling, all creatinine determinations performed on whole EDTA blood in the general practitioners offices were repeated on serum in centralized laboratories using "wet chemistry" techniques. In this comparison 3% of all creatinine determinations in general practitioners offices were outside the 95% confidence interval. We conclude that the creatinine determination on the Reflotron may be used in general practitioners office testing as long as the general practitioner is aware of its limitations and can rely on a "reference" laboratory for training, quality control and repetition of unexpected results.

Bilirubin↗

[Evaluation of Clinitek in the screening and optimisation of the diagnosis of urinary tract infection].

A study was conducted to compare the interest of using Clinitek and leucocytes esterase, blood, nitrites strip Multistix-8 SG (Ames-Bayer Diagnostics) with conventional method (dilution of urine in agar plate) and with automated system (Autobac) as a screening procedure to detect significant bacteriuria. The results are expressed in terms of sensitivity, specificity, predictive value of a negative and positive test. A total of 1303 urine samples were tested of which 730 (56%) were founded negative with Clinitek or conventional urine analysis (Se = 83.6%; VPN = 89.6%). Criteria for urinary tract infection were present for 193 samples (14.8%), the predictive value of a negative test for leucocytes, blood or nitrites (99.6%) justifies the use of Clinitek for economical screening of urine. Overall agreement is higher with the results or Clinitek (in few seconds) than with the Autobac (in 4-5 hours) when compared to the conventional method. The authors propose Clinitek as an effective method for screening and optimised urine analysis for urinary tract infection.

Bacteriological Techniques↗

Salivary mutans streptococci and caries prevalence in 8-year-old Swedish schoolchildren.

The aim of this study was to obtain cross-sectional information about the quantitative distribution of salivary mutants streptococci assessed with a clinically applicable microbiological method and the relation to dental caries in young schoolchildren. A total of 355 8-year-old children were examined for the presence and number of mutants streptococci in saliva by a specially prepared strip, the "Strip-mutans" method, cultivated in a selective broth. The strips were first visually examined and grouped by aid of a templet provided by the manufacturer and thereafter transferred to a laboratory for enumeration of colony forming units (CFU) with aid of a stereomicroscope. Caries scores were obtained from the dental records. Mutans streptococci were identified in 70% of all children. 46% were free from the bacterium or harboured low levels (0-10 CFU) while high levels (greater than or equal to 500 CFU) were found only in 6% of the material. Strong positive correlations (p less than 0.001) were found between different levels of mutans streptococci infection and the caries experience in both the primary (dmfs) and the permanent (DMFS) dentition. A statistically significant correlation between the direct examination and the microscopic enumeration was disclosed (r = 0.84). The bacterial culturing technique used in this study proved to be practical and reliable and thus useful in clinical routines of pediatric dentistry.

Child↗

Comparative analysis of four methods for rapid glucose determination in neonates.

As an important aspect of newborn care, the rapid assessment of glucose homeostasis is often accomplished by a glucose oxidase-peroxidase chromagen test strip method, either alone or with a reflectance colorimeter. The precision of these techniques has been established, but few studies have determined accuracy in an intensive care setting. We performed the following study. During the time of routine heelstick blood sampling, the nurses collected 90 complete study sets for glucose analysis from 43 neonates. Dextrostix, Ames Meter, Chemstrip bG, and Stat Tek Meter determinations were performed according to manufacturers' instructions. Concurrent determination of blood glucose level by a glucose analyzer (Beckman) served as a standard for comparison. There was no significant difference in estimation of true blood glucose concentration among the rapid methods tested. The marked variability of results suggests only modest accuracy in estimating whole blood glucose concentration when employed in the routine neonatal clinical setting. These data indicate that the results from rapid blood glucose estimation techniques require confirmation by conventional laboratory methods prior to therapeutic intervention.

Blood Glucose↗

Comparison of pleural fluid pH values obtained using blood gas machine, pH meter, and pH indicator strip.

STUDY PURPOSE: The purpose of this study was to compare the pleural fluid pH values obtained with a blood gas machine (pHbg), with a pH meter (pHmet), and with a pH indicator strip (pHstrip), to determine if the pleural fluid pH measured by a pH meter or a pH indicator strip was sufficiently accurate for clinical decisions. METHODS: The pleural fluid pH was determined, within 20 min after being collected anaerobically, by a blood gas machine (CIBA-Corning model 288), pH meter (Corning pH meter 610A), and pH indicator strip (Baxter Diagnostic) following routine laboratory procedures in 50 pleural fluids. Pleural fluid pH was determined in seven additional samples with the blood gas machine and a pH meter at 25 and 37 degrees C respectively, initially, and after 30 min. RESULTS: The mean pHbg (7.42+/-0.01) was significantly less than the mean pHmet (7.58+/-0.02) or the mean pHstrip (8.23+/-0.06). There were significant differences between the pHbg and the pHmet (p < 0.001), and between the pHbg and the pHstrip (p < 0.001). Analysis of the additional seven samples demonstrated that when the blood gas machine was set at 25 degrees C, the pHbg (pHbg = 7.54+/-0.02) and the pHmet (7.53+/-0.01) were almost identical. CONCLUSION: When the pleural fluid pH is going to be used for decision making, only the pH values provided by the blood gas machine are sufficiently accurate.

Blood Gas Analysis↗

Sweat testing of MDMA with the Drugwipe analytical device: a controlled study with two volunteers.

Rapid on-site tests for the analysis of drugs of abuse in unconventional specimens (e.g., sweat) have recently been developed. Two healthy volunteers familiar with the effects of methylenedioxymethamphetamine (MDMA) were given 100 mg of the drug as a single oral dose. MDMA and its main metabolite 4-hydroxy-3-methoxymethamphetamine (HMMA) were determined in plasma and urine by gas chromatography-mass spectrometry (GC-MS). MDMA was also investigated in sweat with the Drugwipe (an immunochemical strip test). Subjects' armpits were swabbed for 10 s at 0 time (predose) and at 2, 6, 8, 12, and 24 h after MDMA administration. MDMA consumption could be detected using Drugwipe at 2 h and for as long as 12 h after drug administration. However, in one of the volunteers, a faint color change appeared at 0 time, when plasma and urine tested negative for MDMA and did not disappear even 48 h later. Plasma concentrations of MDMA and HMMA measured by GC-MS peaked at 2-4 h, and values greater than 20 ng/mL for MDMA and of 40 ng/mL for HMMA were still detected at 24 h. Urine tested positive by GC-MS for MDMA and HMMA in the 48-h collection period. These findings preliminarily support sweat testing with Drugwipe for monitoring MDMA use.

Humans↗

Diagnosing human asymptomatic visceral leishmaniasis in an urban area of the State of Minas Gerais, using serological and molecular biology techniques.

A population-based cross-sectional study was set up in Sabará country, Southeastern Brazil, to identify asymptomatic human visceral leishmaniasis in an urban area of low disease prevalence. Blood was collected on filter paper (n=1,604 inhabitants) and examined by indirect immunofluorescent test, enzyme-linked immunosorbent assay and immunochromatographic strip test. The prevalence rates of infection ranged from 2.4 to 5.6% depending on the test used. One year later, venous blood was collected in a subset of 226 participants (102 seropositive and 124 seronegative). The tests performed were IFAT, ELISA, rk39-ELISA, polymerase chain reaction and hybridization with Leishmania donovani complex probe. No clinical signs or symptoms of leishmaniasis were observed. Using hybridization as a reference test, the sensitivity and specificity of serology were respectively: 24.8 and 71% (ELISA); 26.3 and 76.3% (rk-39); 30.1 and 63.4% (IFAT). Due to disagreements, different criteria were tested to define the infection and hybridization should be considered in epidemiological studies.

Adolescent↗

A field test for the detection of antibodies to human immunodeficiency virus types 1 and 2 in serum or plasma.

In response to the need for simple and rapid tests for infectious diseases, we have devised a test for antibodies to human immunodeficiency virus type 1 (HIV-1) and HIV-2 which resembles many contemporary strip-style pregnancy tests in format and ease of use. The test was evaluated with 2,928 serum specimens (1,541 reactive and 1,387 nonreactive) collected and tested at a Mexico City hospital clinic and was compared with a laboratory assay (Abbott) performed simultaneously. The sensitivity and specificity of the test using these serum specimens were 99.68 and 99.71%, respectively (before the code of the blinded study was broken). This compares with 100% sensitivity and 97.55% specificity with the laboratory assay (specificity upon reassay after the code was broken, 99.21%). In a survey of HIV-2 specimens, reactive (positive) specimens were detected in 51 of 51 cases. The test was examined with 21 commercially available (HIV-1) seroconversion panels. The performance of the test was comparable to that of a group of Food and Drug Administration-approved (antibody-based) HIV tests.

Double-Blind Method↗