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Evaluation of an automated urine chemistry reagent-strip analyzer.

We evaluated the Miles Inc., Clinitek Atlas Automated Urine Chemistry Analyzer for 11 tests: bilirubin, color, glucose, ketones, leukocyte esterase, nitrite, occult blood, pH, protein, specific gravity, and urobilinogen. The instrument uses a roll of reagent strips affixed to a clear plastic support; urine specimens are automatically pipetted onto these strips. The instrument measures the pads' color using reflectance colorimetry. Specific gravity is measured using a fiberoptic refractive index method. Four hospitals participated in the evaluation, and tests were performed only on fresh urine samples. We found the instrument easy to use; it has walk-away capability with up to 40-specimen loading capacity plus spaces for STATs, calibrators and controls. We found good comparability with chemical tests and other nonreagent strip procedures, as well as good agreement with the Miles Inc. Clinitek 200+ urine chemistry analyzer and visual reading of the Miles Inc. Multistix Reagent Strips. The Clinitek Atlas is rugged and reliable, and is suitable for a high-volume urinalysis laboratory.

Automation↗

[Assay of digoxin on dry-reagent strips].

An automated immunoassay for Digoxin in serum using dry-reagent strips (Stratus Dade) was evaluated, and compared with two others immunoassays (TDX Abbott and ACA Du Pont). Precision, sensitivity and specificity were satisfying, as well as correlation study, but discrepancies observed for some sera proved that these techniques still pose serious problems of specificity or of standardisation.

Digoxin↗

Diagnosis of schistosomiasis by reagent strip test for detection of circulating cathodic antigen.

A newly developed reagent strip assay for the diagnosis of schistosomiasis based on parasite antigen detection in urine of infected individuals was evaluated. The test uses the principle of lateral flow through a nitrocellulose strip of the sample mixed with a colloidal carbon conjugate of a monoclonal antibody specific for Schistosoma circulating cathodic antigen (CCA). The strip assay to diagnose a group of highly infected schoolchildren in Mwanza, Tanzania, demonstrated a high sensitivity and association with the intensity of infection as measured both by egg counts, and by circulating anodic antigen and CCA levels determined by enzyme-linked immunosorbent assay. A specificity of ca. 90% was shown in a group of schistosome-negative schoolchildren from Tarime, Tanzania, an area where schistosomiasis is not endemic. The test is easy to perform and requires no technical equipment or special training. The stability of the strips and the conjugate in the dry format lasts for at least 3 months at ambient temperature in sealed packages, making it suitable for transport and use in areas where schistosomiasis is endemic. This assay can easily be developed to an end-user format.

Adolescent↗

Ascorbic acid interference in reagent-strip reactions for assay of urinary glucose and hemoglobin.

Vitamin C (ascorbic acid), commonly taken as a dietary supplement and excreted in the urine, can interfere with peroxidase redox indicator systems such as those used in reagent-strip tests for urinary glucose and hemoglobin. We investigated whether the concentrations of ascorbic acid in urine after modest supplementary doses of vitamin C are high enough to interfere with such dipstick tests. After adding glucose or hemoglobin to urine collected from persons not taking vitamin C and from persons taking 350 to 1000 mg of vitamin C daily, we tested four reagent strips for interference and found that these commonly taken doses did frequently interfere with all test systems examined.

Ascorbic Acid↗

Reagent strip testing of antenatal urine specimens for infection.

OBJECTIVE: To compare reagent strip testing (RST) with microscopy and culture in identifying significant bacteriuria, and secondly, to consider potential cost savings if RST screening proved to be reliable. DESIGN: Prospective descriptive study. SETTING: Antenatal Clinic, Bristol Maternity Hospital. SUBJECTS: Eight hundred and ninety-eight women having urine testing in pregnancy for microscopy and culture either routinely or because of a clinical infection. INTERVENTIONS: The midstream specimens of urine had RST examination using Ames Multistix 8SG prior to being sent to the laboratory. MAIN OUTCOME MEASURE: Significant culture (> 10(5) colonies/ml) of a single organism in culture. RESULTS: The highest predictive value for a negative result of the urine culture (99.7%) was obtained when using four RSTs in combination. The RST for nitrite had a high predictive value for a positive urine culture (90%). The samples which gave a false negative result with RST screening were mainly infected with low grade urinary pathogens or genital tract contaminants. CONCLUSION: RST screening for bacteriuria provides a reliable and cheap alternative to culture of all urine specimens.

Bacteriuria↗

Dry-reagent strips for measuring phenytoin in serum.

A new reagent strip has been developed for measuring phenytoin in serum or plasma. It utilizes the chemistry of the Apoenzyme Reactivation Immunoassay System (ARIS) and is designed for use with the Seralyzer reflectance photometer. The 90-s test relies on comparison of strip reactivities with a two-point calibration line, which can be validly stored in the instrument for two weeks. Within-run CVs for controls at five concentrations ranged from 2.7 to 5.6%, between-run CVs from 2.3 to 6.3%. Phenytoin values obtained for clinical serum samples correlated well (r greater than 0.99) with those obtained by liquid chromatography or substrate-labeled fluorescent immunoassay. The speed and convenience of this assay for monitoring phenytoin in serum make it well suited for decentralized test sites such as emergency rooms, urgent-care centers, and physician's offices.

Chromatography, High Pressure Liquid↗

Comparison of agar gel (CLOtest) or reagent strip (PyloriTek) rapid urease tests for detection of Helicobacter pylori infection.

OBJECTIVE: Rapid urease tests (RUTs) are used commonly as a convenient method to detect Helicobacter pylori infection. New rapid tests have been commercially available with promotional literature suggesting enhanced utility. We compared CLOtest to a new reagent strip RUT, PyloriTek. METHODS: Gastric antral mucosal biopsy specimens were obtained from 102 patients for comparison between CLOtest and PyloriTek (204 specimens). Biopsy specimens obtained from a nearby area were stained using the Genta stain for determination of H. pylori status. The RUT to be used first was selected randomly. RESULTS: Sixty-five of the 102 patients had peptic ulcer disease, two had gastric cancer, and 35 had dyspepsia; 61 patients had active H. pylori infection. There were one false-negative and three false-positive CLOtest results, compared with one false-negative and 13 false-positive PyloriTek results (p < 0.02 for incorrect categorization with PyloriTek). Sensitivity and specificity were 98 and 92% compared with 98 and 68% for CLOtest and PyloriTek, respectively. An erroneous categorization of H. pylori status occurred in 3.9% (95% confidence interval [CI]: 1-9.7%) with CLOtest compared with 13.7% (95% CI: 7.7 -22%) with PyloriTek. When the PyloriTek was scored at 1 h (0-1 h) after obtaining the specimen, the accuracy improved; erroneous categorization of H. pylori status occurred in only 2.9% (95% CI: 0.6-8.3%). CONCLUSION: Used according to manufacturer instructions, the new reagent strip RUT PyloriTek has too many false-positive results for use in a clinical situation. In contrast, when the test was interpreted within 1 h, accuracy was comparable to that of CLOtest.

Adult↗

Urine reagent strips: an MDA evaluation.

Despite being cheap to buy, the annual UK urine reagent strip bill is more than 4 Pounds million. Nurses need to be aware that each company's test strip works differently. They also need to learn about the external factors that can interfere with tests.

Bias↗

Saliva alcohol reagent strips in altered response protocols.

The prehospital care provider has been limited in his or her initial assessment of patients due to having available only a limited number of simple diagnostic tests. There has not been an accurate field test available to rule out significant ethanol intoxication. We designed a prospective trial for the prehospital setting to test the utility of a rapid, semi-quantitative, saliva alcohol reagent strip for patients with an altered level of consciousness. We found that these strips were useful in ruling out significant ethanol intoxication as a cause of an altered level of consciousness with a sensitivity of 85.7% and a specificity of 94.4%, but were not useful in accurately predicting the blood alcohol level. We conclude that these reagent strips are useful in the prehospital setting to provide information about patients with an altered level of consciousness.

Alcoholic Intoxication↗

A new reagent strip (Visidex) for determination of glucose in whole blood.

A new solid-phase reagent strip for determination of glucose in whole blood, Visidex, has been developed specifically for visual use in conjunction with a calibrated color scale. Two reagent pads are used, each formulated for a different portion of the range of clinical values, to maximize the visual resolution available to the user. Colorimetric examination of reacted reagent pads indicated that the label color blocks match closely the appearance of the reagent pads; that the reagent pads exhibit good precision; and that the colors of the reagent pads are independent of operator technique, sample volume (20-50 microL), and effects of potential interferents studied (although high concentrations of fluoride slightly inhibited color development). Glucose measurements obtained visually with the Visidex system correlated well with values obtained with a YSI Glucose Analyzer (for two separate studies, slope = 0.96 and 1.04, r = 0.99 and 0.96, and n = 172 and 543, respectively).

Autoanalysis↗

Evaluation of a rapid reagent strip test for blood glucose determination in diarrheic calves.

Sixty-three blood samples from 10 diarrheic calves were tested for glucose concentration by two methods. Plasma glucose concentration was measured by the conventional glucose-6-phosphate dehydrogenase method in the clinical laboratory, and the results compared to those obtained using a rapid reagent strip test for blood glucose concentration measurement. The rapid reagent strip test result could not be used to make an accurate prediction of the actual plasma glucose concentration as determined by the conventional method, due to the wide variability in actual plasma glucose concentrations corresponding to each rapid test result.

Journal Article↗

Screening of Tanzanian women of childbearing age for urinary schistosomiasis: validity of urine reagent strip readings and self-reported symptoms.

The screening of women of childbearing age for haematuria, leukocyturia and proteinuria to detect urinary schistosomiasis can be confounded by several factors such as menstruation, pregnancy and genitourinary infections. We therefore undertook a study in an area endemic for Schistosoma haematobium in the United Republic of Tanzania to carry out the following: assess the sensitivity, specificity and predictive values--in women of childbearing age--of indirect indicators of urinary schistosomiasis, as measured by urine reagent strip readings; assess the predictive values of self-reported symptoms; and finally to estimate the morbidity attributable to S. haematobium. A total of 303 women (128 and 175, respectively, living in high- and low-risk sites) participated in the study. Haematuria was more frequent among women excreting S. haematobium eggs than among those who did not (65% versus 32%). The predictive potential of all indirect disease markers was poor in the highly endemic site, while in the sites with low endemicity the negative predictive values were high. Among infected women, 54% of haematuria could be attributed to S. haematobium, but for patients with more than 10 eggs/10 ml the attributable fraction rose to 70%. Symptoms of "bloody urine" and "pain while urinating" were recalled significantly more often by women living in the highly endemic site. On a population level, one-third of the self-reported cases with bloody urine could be attributed to urinary schistosomiasis. Screening of women of childbearing age for urinary schistosomiasis using urine reagent strips can be biased in two directions. The prevalence of S. haematobium will be overestimated if other causes of haematuria, such as reproductive tract infections, are highly endemic. On the other hand, women with light or very light infections will be missed and will not be treated. This is of concern because genital schistosomiasis, a possible risk factor for the transmission of HIV, occurs among women even with light infections.

Adolescent↗

Evaluation of reagent strips for detection of Schistosoma haematobium infection in the lower Awash valley, Ethiopia.

The use of reagent strips as indirect morbidity indicators in Schistosoma haematobium infection has been assessed in comparison with urine filtration technique in the lower Awash valley of Ethiopia in 1991. The prevalence of infection by reagent sticks and urine filtration was 16.0% and 3.6%, respectively. Reagent stick haematuria was highly related with urine filtration at the 2+ limit rather than the 1+ limit. A strong association was also obtained between prevalence rate and intensity of infection of all children at both haematuria limits. The prevalence of haematuria was not sex-related but there was age-associated infection and the prevalence was highest in the 10-13 year age group. The possible use of reagent stick haematuria in the monitoring of S. haematobium infection in Ethiopia is discussed.

Aged↗

Microstix-A reagent strip for urine culture.

Microstix is a simple and convenient reagent strip for obtaining a semi-quantitative bacterial count on urine specimens. This method correctly predicted over 10(5) gram-negative organisms per ml in 84 percent of samples and over 10(5) gram-positive organisms per ml in 72 percent. Urine specimens containing 10(4) per ml or more of any organism should be recultured using fully quantitative methods. If this criterion had been used 89 percent of urine samples with over 10(5) organisms per ml would have been detected with Microstix and only 33 of the 393 remaining samples would need to have been repeated. The false positive rate was low. This method would be ideal for use in doctors' offices to culture the urine of patients presenting with urinary tract symptoms. It would also be very suitable for use in hospital clinics and for the screening of asymptomatic populations who are high risk of having urinary tract infections.

Bacteriological Techniques↗

Are blood glucose reagent strips reliable in renal failure?

In vitro studies have suggested that a low packed cell volume may cause reagent strips to overestimate blood glucose concentration. The reliability of such strips has therefore been investigated in diabetic patients with end-stage renal failure, all of whom had low haematocrits (24 +2- 4 (4/- SD) %). Three brands of strips were evaluated and their results were compared with laboratory whole blood glucose concentrations determined on the same samples. All over-read compared with the laboratory (BM Glycemie 1-44 strips 118 +/- 1%, Glucostix 132 +/- 2%, ExacTech strips 163 +/- 4%) and the percentage overread was negatively correlated with the haematocrit for each strip (all p less than 0.001).

Blood Glucose↗

Evaluation of a new urease reagent strip for detection of Helicobacter pylori in gastric biopsy specimens.

OBJECTIVES: Determine sensitivity and specificity of a new urease reagent strip (URS) test for detection of Helicobacter pylori in gastric biopsy specimens. METHODS: Six paired biopsy specimens were obtained from the greater curvature of the distal antrum, the lesser curvature near the incisura, and the corpus along the greater curvature during 66 procedures on 59 patients with endoscopic findings of gastric antral mucosal erythema or erosions, or gastric or duodenal ulcers. One biopsy from each site was tested with the URS. The second was evaluated with histology. A final antral biopsy was evaluated with a urea/gel test. RESULTS: Twenty-eight of the 66 cases were histologically positive, with H. pylori observed in at least one of the three biopsy sites. The URS test correctly identified all 28. Of 193 individual biopsy specimens, 78 were positive for H. pylori. The URS correctly identified 77. Sensitivity was 0.99, specificity 0.95, positive predictive value 0.93, negative predictive value 0.99, and kappa 0.92. Average time to positive was 20 min. Twenty-seven antral biopsies were histologically positive for H. pylori. The URS test correctly identified all 27, whereas the urea/gel test correctly identified 21. For antral sites, URS sensitivity was 1.00 and specificity 0.95 versus urea/gel test sensitivity of 0.75 and specificity of 1.00. CONCLUSIONS: In this sample, the URS test is as accurate as histology in diagnosing H. pylori infections, and it provides results in less time and at a lower cost than histology.

Bacteriological Techniques↗

Urinalysis by use of multi-test reagent strips: two dipsticks compared.

We compared Ames' "N-Multistix" with Boehringer's "Combur-8" ("Chemstrip-8") multi-test urine reagent strips by analysis of contrived urine specimens, testing accuracy, precision, specificity, and limits of detection of both products. Relative cost and ease of use were also examined. Each brand of urinary dipstick had specific advantages but it is unlikely that patient care would be adversely affected by preferential use of either product.

Acetoacetates↗

Reagent strips in the evaluation of cerebrospinal fluid glucose levels.

The value of Visidex IIR, Haemo-Glukotest 20-800RR, MultistixR and DextrostixR reagent strips--the latter alone or in combination with a glucometer--in the determination of cerebrospinal fluid (CSF) glucose levels has been evaluated and compared with the results of a standard glucose oxidase method (Beckman). Fifty-four CSF specimens were evaluated and the closest correlation (r = 0.8002) obtained by the use of DextrostixR in combination with a glucometer. All four methods detected two cases with very low CSF glucose values (less than 1.5 mmol/l) but confusing results were obtained in three cases having slightly reduced CSF glucose values (2.0-2.2 mmol/l).

Child↗