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Detection of fluoroquinolones in urinary specimens from patients undergoing anti-tuberculous therapy.

A paper strip impregnated with ferric chloride has been developed for visual detection of fluoroquinolones in urine based on a change of colour due to the chelation of the transition metal ion to the beta-oxo acid array in the 4-oxo-1,4-dihydropyridine-3-carboxylic acid moiety of the fluoroquinolone molecule. In urine specimens, the detection limit of the strip was 100 mg/l for pefloxacin, 200 mg/l for ciprofloxacin, fleroxacin, levofloxacin, norfloxacin, ofloxacin and sparfloxacin, and 300 mg/l for trovafloxacin. In 193 urine specimens taken from 138 patients on ofloxacin therapy and 55 controls preliminary evaluation of the strip showed that all the 55 specimens from control patients were negative, while 112 out of the 138 ofloxacin-treated patients were positive. Quantitative analysis by high-performance liquid chromatography of the 26 strip-test-negative specimens taken from patients with ofloxacin treatment indicated that these urinary specimens contained less than 200 mg/l of the antimicrobial, mostly because of poor renal function and in some occasions, non-compliance. This strip method would provide a convenient way of monitoring drug compliance in patients who receive fluoroquinolone therapy for tuberculosis.

Anti-Infective Agents↗

Safely reducing manual urine microscopy analyses by combining urine flow cytometer and strip results.

We aimed to reduce the number of manual urine microscopy examinations safely by cross-interpretation of the Sysmex UF-100 (TOA Medical Electronics, Kobe, Japan) and urine strip results such that microscopy would be performed if there was discordance between the UF-100 and urine strip results. We also evaluated the usefulness of the optional UF-100 expert software. We performed 2 studies: study 1 to establish review rules for eventual microscopic examination; study 2, a validation study. Our review rates were 40% and 48% and those of UF-100 software were 16% and 32% for the 2 studies. Our false-positive and false-negative results, among the samples not flagged for microscopic review, were acceptably low. We did not find a good correlation between the microscopic classification of RBC morphologic features and the classification given by the UF-100. Since incorporation of the automated urine strip reader and the UF-100 in routine use, our manual microscopy has been reduced to less than 40%.

Adolescent↗

[Demonstration of bacteriuria in elderly hospitalized patients. Comparison between leukocyte and nitrite strips and culture].

The purpose of this study was to assess the accuracy of test strips for urinary nitrite and leucocytes for detection of bacteriuria in elderly patients. The material consisted of 213 urine samples from 85 women and 26 men (median age 79 years, range 60-93 years) within the first two days in hospital. The results of the test strip reactions were read in the department and in the laboratory. The strip test results and symptoms of UTI were compared with culture results. 27% of the samples showed significant bacteriuria on culture (> or = 10(5) colonies/ml urine). 21% of the 102 patients who had submitted two urine samples within the first two days had significant bacteriuria in both samples. Less than half of these patients had symptoms of UTI. The false negative rate of test strips (defined as the number of proven laboratory UTIs not demonstrated by the test strips, expressed as a percentage of the total number of proven UTIs) was 29% in the department and in the laboratory it was 13%. 15% of the test strips at the laboratory failed to detect significant E. coli infections which were predominant. In conclusion, we found that it is advisable to perform urine culture if symptoms of urinary tract infections are present.

Aged↗

A randomized comparative crossover evaluation of glucose monitoring technologies.

Twenty-four diabetic patients receiving insulin were randomized to 3 groups. Group I began self blood glucose monitoring by meter and switched to visually read strips at 3 months. Group II began self blood glucose monitoring by visually read strips and switched to meter readings at 3 months. Group III monitored urine glucoses for the 6 months of the trial. Professional interaction time was the same for all patients and each patient was placed on the same insulin delivery scheme (3 shots NPH and/or regular). Mean C-peptide levels 6 min following intravenous glucagon was comparable in all 3 groups. Patients monitoring blood glucose showed a significant decrease in glycosylated hemoglobin values (p less than 0.01) from patients monitoring urine at 6 months of the trial. Patients subjectively felt meters were more accurate than visual strips but both groups I and II showed lower glycosylated hemoglobin levels (p less than 0.02 at 6 months) and sequence analysis revealed no sequence effect. The trial confirms that blood glucose monitoring technologies have advantages over urine monitoring in helping patients achieve improved glucose levels. Patients perform equally well in terms of blood glucose "control" whether visually read strips or meters are used for initial teaching or maintenance if patients are instructed appropriately in each methodology. These findings have economic implications for large scale treatment programs.

Adolescent↗

Cystic fibrosis detection by means of a test-strip.

The effectiveness of meconium screening for albumin as an indication of cystic fibrosis is examined. BM-Test Meconium was applied to 69,000 investigations. In 60 positive tests, cystic fibrosis was confirmed later. No increased albumin content was observed in four cases of cystic fibrosis.

Albumins↗

False positive and false negative reactions encountered in the use of sulfite test strips for the detection of sulfite-treated foods.

The reliability of a qualitative test for sulfites in foods (Sulfitest sulfite test strips) was evaluated by comparison of the results obtained from the analysis of 90 food and beverage samples to results obtained by the quantitative, modified Monier-Williams method (the preferred procedure for sulfite analysis in foods of the Food and Drug Administration). The results obtained with the sulfite test strips compared favorably to the results of the Monier-Williams procedure when the sulfite test strips were used on sulfite-treated lettuce and raw or cooked potatoes. However, the strips yielded many false negative and false positive results with other types of foods. False positive results (strips indicated a substantial amount of sulfite when sulfite was not detectable by the Monier-Williams method) were obtained with fin fish, red meats, and poultry. False negative results (strips indicated the absence of sulfites when sulfite was detected at levels greater than 10 ppm total sulfur dioxide by the Monier-Williams method) were obtained with dried fruits and wines under certain conditions of testing. The false negative responses with the test strips may result in the hazardous consumption of foods with high levels of sulfites, such as dried fruit or wine, by a sulfite-sensitive individual. The false positive responses would not be hazardous but could lead sensitive individuals to avoid foods that could be safely consumed. Although the strips may be useful for the detection of sulfites in certain foods, such as lettuce and potatoes, their use by sulfite-sensitive individuals cannot be recommended because of the confusion and potential hazards posed by the false negative and false positive responses.

False Negative Reactions↗

Oxygen effects on glucose meter measurements with glucose dehydrogenase- and oxidase-based test strips for point-of-care testing.

OBJECTIVES: To determine the effects of different oxygen tensions (Po2) on glucose measurements with glucose dehydrogenase (GD)-based and glucose oxidase (GO)-based test strips, to quantitate changes in glucose measurements observed with different Po2 levels, and to discuss the potential risks of oxygen-derived glucose errors in critical care. DESIGN: Venous blood from healthy volunteers was tonometered to create different oxygen tensions simulating patient arterial Po2 levels. Venous blood from diabetic patients was exposed to air to alter oxygen tensions simulating changes in Po2 during sample handling. Whole-blood glucose measurements obtained from these samples with six glucose meters were compared with reference analyzer plasma glucose measurements. Glucose differences were plotted vs. different Po2 levels to identify error trends. Error tolerances were as follows: a) within +/-15 mg/dL of the reference measurement for glucose levels 100 mg/dL. SETTING AND SUBJECTS: Five healthy volunteers in the bench study and 11 diabetic patients in the clinical study. RESULTS: In the bench study, increases in Po2 levels decreased glucose measured with GO-based amperometric test strips, mainly at Po2 levels >100 torr. At nearly constant glucose concentrations, glucose meter systems showed large variations at low (39 torr) vs. high (396 torr) Po2 levels. Glucose measured with GD-based amperometric and GO-based photometric test strips generally were within error tolerances. In the clinical study, 31.6% (Precision PCx), 20.2% (Precision QID), and 23.0% (Glucometer Elite) of glucose measurements with GO-based amperometric test strips, 14.3% (SureStep) of glucose measurements with GO-based photometric test strips, and 4.6% (Accu-Chek Advantage H) and 5.9% (Accu-Chek Comfort Curve) of glucose measurements with GD-based amperometric test strips were out of the error tolerances. CONCLUSIONS: Different oxygen tensions do not significantly affect glucose measured with the GD-based amperometric test strips, and have minimal effect on GO-based photometric test strips. Increases in oxygen tension lowered glucose measured with GO-based amperometric test strips. We recommend that the effects of different oxygen tensions in blood samples on glucose measurements be minimized by using oxygen-independent test strips for point-of-care glucose testing in critically ill and other patients with high or unpredictable blood Po2 levels.

Blood Gas Analysis↗

Evaluation of a rapid test for the detection of antibodies to human immunodeficiency virus type 1 and 2.

Hema-Strip HIV-1/2 is a one-step rapid test for the detection of anti-HIV-1/2 antibodies in whole blood. The test requires no expensive equipment and the results are available within 10-15 min. Using 72 known HIV-1 positive samples and 780 high-risk prisoners, the sensitivity and specificity of Hema-Strip HIV-1/2 was found to be comparable to microparticle enzyme immunoassay (MEIA). The data also indicated that Hema-Strip HIV-1/2 is an effective alternate testing system to conventional ELISA where the use of ELISA is not suitable and the result of the HIV testing is needed urgently.

Evaluation Studies as Topic↗

Quantification of MUC5AC protein in human tears.

PURPOSE: MUC5AC has been identified as a major secretory mucin of conjunctival goblet cells and precorneal tear film. However, no method has been reported to quantify MUC5AC protein in human tears. The objective of this study was to establish a method to measure the amount of MUC5AC in human tears and to correlate the amount of MUC5AC with age, gender, and dry eye diseases. METHODS: A goat antibody was raised to synthetic peptides corresponding to nonglycosylated epitopes of human MUC5AC mucin. This antibody and a horseradish peroxidase-coupled second antibody were used to develop a quantitative immunoassay to measure the MUC5AC concentration of tear samples collected on Schirmer strips. Porcine stomach mucin was used as a standard for the assay. The chemiluminescent MUC5AC signal was digitized and quantified. Tear samples from 19 healthy volunteers and 31 clinically diagnosed dry eye patients were analyzed. RESULTS: MUC5AC concentration in human tears ranged from undetectable to more than 200 microg/mL porcine stomach mucin equivalent. In the healthy population, low, moderate, and high concentrations were found in the tear samples from younger and older persons and from both men and women. The mean MUC5AC content in tears was lower in the dry eye patients than in the age- and gender-matched healthy individuals. CONCLUSIONS: A method was established to quantify MUC5AC in human tear samples obtained on Schirmer strips. There was no correlation between the amount of MUC5AC and age or gender in the healthy population. Dry eye disease patients, however, typically showed reduced concentrations of soluble MUC5AC in the tear film.

Adult↗

Sampling methods for tear stix tests.

Four different methods for transferring conjunctival fluid to stix test pads were studied. One hundred and twenty eyes from 120 cataract-extracted patients (35 in the operated eye 0-5 days post-operatively and 85 in the contralateral eye) were included in the study. Transfer of fluid by a glass rod from the lateral part of the inferior fornix was demonstrated to be the most suitable method, showing the highest sensitivity to leucocyte-esterase (83%, N = 120, p < 0.05) and with a specificity equal to that of the other methods tested (cotton, spongostan, Schirmer paper strip). The glass rod method is suitable for detecting blood, nitrite, albumin, pH, and glucose, and is a both quick and unintrusive procedure. All four transferring methods may, however, cause an increased desquamation of epithelial cells and an increased amount of mucus.

Adult↗

K39 strip test--easy, reliable and cost-effective field diagnosis for visceral leishmaniasis in India.

OBJECTIVE: A firm diagnosis of visceral leishmaniasis (VL) requires demonstration of the parasite in splenic or bone marrow aspirate. The aim of this prospective study was to assess the usefulness of K39 strip test as a noninvasive method of diagnosing visceral leishmaniasis under field conditions by testing serum antibody to the leishmanial antigen K39. MATERIAL AND METHODS: One drop of serum/blood was applied to the sample application pad on the test strip, which was diluted with 2 drops of chase buffer solution. The development of two visible red lines indicates the presence of IgG anti-K39. In the first phase of the study (2001), a total of 200 patients (Active VL-70, ex-VL-30, healthy endemic control-20 and patients with other tropical diseases-80) were tested with the K39 strip test at the School of Tropical Medicine, Kolkata. In the second phase of the study (2002), the test was applied in a remote tribal area of West Bengal where an epidemic of VL had occurred. Thirty-two patients were identified in 207 villagers of the affected area; all of them were tested with the K39 strip test. RESULTS: In the first phase, all VL and ex-VL cases gave positive results (100%). Ten percent of the healthy endemic controls were positive. The test results were negative in all other prevalent tropical diseases (100%). The estimated sensitivity of the test was 100% and the specificity was 98.18%. In the second phase of the study, all 32 patients of the epidemic were shown to be positive. All patients were treated with sodium stibogluconate injections and they recovered uneventfully. CONCLUSIONS: K39 strip test is ideal for rapid reliable field diagnosis of visceral leishmaniasis. The test has high sensitivity and specificity but it remains positive long after treatment (up to 3 years).

Agglutination Tests↗

[Evaluation of a strip test (Micral test) for the semi-quantitative assessment of microalbuminuria in clinical practice].

Microalbuminuria (AER 20-200 micrograms/min) is the earliest clinical sign of incipient diabetic nephropathy. Current methods for measuring urinary albumin are not suitable for use in an office setting. A test strip (Micral-Test, Boehringer Mannheim [D]) based on immunochemical principles has recently been developed which allows semiquantitative detection of urinary albumin concentrations. In this study Micral-Test results were compared with conventional immunoturbidimetric laboratory measurement. 65 single-void urine samples of diabetic patients were analyzed (38 type 1, 27 type 2). Urinary albumin values as obtained from Micral-Test and laboratory measurement showed a significant correlation (r = 0.85, p less than 0.001). An interclass correlation was performed for normal urinary albumin values (less than 20 micrograms/ml) and for microalbuminuric values (20-200 micrograms/ml) and resulted in correlation coefficients of 0.56 and 0.81 respectively. Interindividual variation was checked by three observers reading the same 13 urine samples. The values obtained from the three observers correlated significantly (r greater than 0.95, p less than 0.001). The test strip must be evaluated after precisely 5 minutes in order to avoid false pathological results. In conclusion, the Micral-Test is a good screening method for easy and quick detection of microalbuminuria in an office setting.

Adult↗

Rapid and simple quantitative measurement of alpha-fetoprotein by combining immunochromatographic strip test and artificial neural network image analysis system.

BACKGROUND: Quantitative immunochromatographic strip (ICS) assay can facilitate clinical diagnosis by providing more information than traditional qualitative or semiquantitative strip assay. METHODS: We constructed a human serum alpha-fetoprotein (AFP) measurement system by combining semiquantitative ICS tests and artificial neural network (ANN) image analysis system [immunochromatographic strip analyzed by artificial neural network image analysis system (IAIS)]. After ICS tests completed, the AFP concentration can be obtained from analysis of IAIS software. The equipment required are commercial semiquantitative AFP dipstick, optical scanner, centrifuge (option), personal computer, and software of IAIS. RESULTS: The serum AFP concentrations measured by IAIS were strongly correlated (r = 0.9971) with that by RIA. Using Bland-Altman analysis, the IAIS achieved clinical acceptable limits of agreement in comparison with RIA. The within-run precision of IAIS, expressed as coefficients of variation (CV), at 81.7 ng/ml was 1.50% and, at 244.4 ng/ml, was 1.09%. The measurement of serum AFP by IAIS can be completed in 20 min. CONCLUSIONS: The newly constructed quantitative immunochromatographic strip assay (IAIS) is a simple, rapid, and reliable method for serum AFP measurement. With the simple equipment required, the IAIS can be performed outside the laboratory and is ideal for outpatient or point-of-care AFP testing.

Biomarkers, Tumor↗

Measurement of net acid excretion by use of paper strips.

OBJECTIVE: Net endogenous acid production, reflected in the steady state as net acid excretion (NAE), is implicated in bone loss because it is positively associated with urinary calcium loss. Protein is one of the main sources of dietary acid load, whereas fruit and vegetables provide alkaline potassium salts that counteract the dietary acid load. This study investigated whether a pH paper strip measurement of overnight (i.e., first void) urine would reflect 24-h NAE, measured as excretion rates of titratable acid minus bicarbonate plus ammonium. METHODS: Twenty-three subjects collected 24-h urine in two parts: day (approximately 7 am to 11 pm) and overnight (approximately 11 pm to 7 am). At first void, subjects recorded pH using paper strips. Subjects recorded intake and 20 subjects provided fasting urine collected from 7 to 9 am. RESULTS: The pH paper strip measurements of first void urine was significantly correlated with 24-h titratable acid minus bicarbonate (r = -0.466, P < 0.025) but not with 24-h NAE. We examined the association of dietary protein, potassium, protein:potassium ratio, and sodium with NAE, with fasting morning urinary calcium excretion, an indirect measurement of bone loss, and with urinary cross-links, a direct measurement of bone resorption. Of these, only sodium intake (measured as 24-h urine excretion) and urine potassium:sodium ratio showed a significant relation (with fasting calcium excretion). CONCLUSIONS: We did not find that the first void urine pH by paper strip measurement provided an index of daily net endogenous acid production as reflected in 24-h NAE. In our sample of young adults, daily sodium intake positively correlated with bone resorption, as reflected in fasting urine calcium, whereas daily NAE did not.

Adult↗

[Urinary infection in geriatric short stay: value of urinary strips].

The blinded study of CBUE (cytobacteriological urine examination) test strips was carried out in 100 patients (65 women, 35 men), mean age 85.52 +/- 6.28 years, admitted for a short stay in a geriatrics department. Urinary infection was present in 19% of the cases. Typical clinical signs (pollakiuria, dysuria, hematuria, burning upon voiding) were rare, less than 10%. General signs, such as deterioration of general status (65% of the cases) and loss of autonomy (53% of the cases), on the other hand, were predominant and their relatively unspecific nature required a reliable screening test for urinary infection. Good results of sensitivity (89.5%), specificity (98.7%), and the leukocytes/nitrites values, confirmed the validity of the urine test strip in hospitalized elderly patients. In addition, the negative predictive value of the combination leukocytes and nitrites (90.8%) would have prevented 71 samples from being sent to the laboratory for CBUE, resulting in an obvious financial savings.

Aged↗

Pre-clinical assessment of the performance of the Glucostix and Glucometer II blood glucose monitoring system.

The Glucostix/Glucometer II blood glucose system has been evaluated in a hospital laboratory, with the purpose of assessing the suitability for use by nurses and diabetic patients. In the hands of laboratory personnel, the strips and meter gave precise results which correlated well with the laboratory plasma glucose assay, taking into account the difference between plasma and whole blood. The system was simple to use and rapid (50 seconds), and should prove useful and acceptable in the hands of non-laboratory personnel.

Blood Glucose↗

Usefulness of sweat testing for the detection of MDMA after a single-dose administration.

Nine healthy male subjects and recreational users of 3,4-methylenedioxymethamphetamine (MDMA) participated in a study aimed to assess the usefulness of sweat testing for the detection of MDMA after a single 100-mg dose. Sweat was collected for up to 24 h with the PharmChek sweat patches from which drugs were eluted and then analyzed by immunoassay and gas chromatography-mass spectrometry using deuterated internal standards. The usefulness of a rapid onsite test, the Drugwipe immunochemical strip test, was also assessed. In the sweat patches, MDMA was detected as early as 1.5 h after consumption and peaked at 24 h. Intersubject variability was large; peak MDMA concentrations for the same dose varied in magnitude 30-fold. MDMA concentrations ranged between 3.2 and 1326.1 ng/patch. Only traces of the minor metabolite 3,4-methylenedioxyamphetamine were detected. In all subjects, the onsite test with the Drugwipe was positive at 1.5 h (peak time of MDMA plasma concentration). However, few false-negative results (18%) appeared in the first 6 h after administration. Both sweat patch testing and the onsite sweat strip test may find useful application for noninvasive monitoring of MDMA abuse in sweat.

3,4-Methylenedioxyamphetamine↗