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[Reproducibility of urine strip reactions in medical patients].

Before a method of investigation is introduced in the daily clinical routine, its reproducibility and correctness must be proved. In the present investigation, the reproducibility of urine stix reactions for glucose, haemoglobin and protein were assessed. The urine stix tests were carried out on freshly voided urine from 30 patients selected at random by three junior nurses with seniorities of one, five and nine years. Complete inter- and intraobserver agreement was found for glukose and haemoglobin whereas the reproducibility for protein was unsatisfactory.

Evaluation Studies as Topic↗

Comparison of spot tests with AdultaCheck 6 and Intect 7 urine test strips for detecting the presence of adulterants in urine specimens.

BACKGROUND: Several adulterants are used to mask tests for abused drugs in urine. Adulterants such as "Klear" and "Whizzies" contain potassium nitrite while "Urine Luck" contains pyridinium chlorochromate (PCC). The presence of these adulterants cannot be detected by routine specimen integrity check (pH, specific gravity, creatinine and temperature). We previously reported the development of rapid spot tests to detect the presence of these adulterants. AdultaCheck 6 and Intect 7 urine test strips are commercially available for detecting the presence of these adulterants along with specific gravity, creatinine and pH in urine. METHODS: The performance of these two test strips for detecting adulterants was compared with the results obtained by spot tests. RESULTS: Both AdultaCheck 6 and Intect 7 effectively detected the presence of nitrite and pyridinium chlorochromate in urine. Moreover, both test strips successfully detected the presence of glutaraldehyde, for which no spot test is currently available. High amount of glucose and ascorbic acid did not cause any false positive result with AdultaCheck 6 or Intect 7. CONCLUSIONS: Both AdultaCheck 6 and Intect 7 can be used for checking the integrity of a urine specimen submitted for drugs of abuse testing.

Ascorbic Acid↗

Chromatography paper strip method for collection, transportation, and storage of rotavirus RNA in stool samples.

We developed a novel method that uses sodium dodecyl sulfate-EDTA-treated chromatography paper strips to collect unconcentrated fresh stool samples. After the paper strips were stored for 4 months at room temperature, rotavirus RNA could be successfully amplified by using reverse transcriptase PCR. The use of filter paper strips as a specimen support allows (self-)collection of stool samples by untrained persons. Diarrheal stool samples from remote areas can be stored and transported to a central diagnostic laboratory without the need for freezers or special shipping conditions. This convenient and inexpensive rotavirus sample collection system can be of use in epidemiological surveillance studies and vaccine trials.

Chromatography, Paper↗

A simple test for detecting pyuria.

Pyuria indicates inflammation within the urinary tract. A test strip, Cytur-Test, was used to detect a significant number of white cells in 100 consecutive urine samples and compared with the quantitative white cell concentration. The test was simple, rapid, easy to read, the false positive rate was low and the false negative rate was acceptable. In screening patients for urinary tract disease the Cytur-Test would be particularly useful if combined with tests for protein, blood and glucose.

False Negative Reactions↗

Few-minutes tests for the identification of group A streptococci and enterococci with chromogenic substrates.

The usefulness of paper strip tests for rapid identification of Streptococcus pyogenes and enterococci cultured on blood agar plates was investigated. The paper strips used contain dried chromogenic substrates for pyrrolidonyl peptidase (PYRase) and beta-glucosidase (beta-Gluc). Material from only a few colonies needed to be applied to the test strips. The reactions could be read after two min (PYRase) and 5-7 min (beta-Gluc), respectively. Results from testing 503 streptococcal strains were evaluated. The reactions proved very useful for rapid differentiation of S. pyogenes and enterococci from human sources. Nearly all strains of these streptococcal species showed positive reactions in the PYRase test whereas only the enterococci (E. faecalis and E. faecium) were positive for both enzymes.

Chromogenic Compounds↗

Use of the E test for methicillin sensitivity testing.

Performance of the E test for methicillin sensitivity testing was investigated using 21 methicillin-resistant and 28 methicillin-sensitive staphylococci. Thirty of the strains had previously given equivocal results with a strip diffusion method. The E test performed well with Mueller-Hinton agar plates incubated at 30 degrees C for 24 h but only after supplementation with 5% NaCl. Testing on agar without salt was necessary for the recognition of methicillin resistance in one strain. We recommend a breakpoint of 4 mg/L and heavy inocula. The E test can be controlled by testing a control strain on the same plate.

Culture Media↗

Evaluation of a new semiquantitative test strip for urine glucose determination.

Diabur-Test 5000 is a new semiquantitative test strip for the determination of urine glucose concentrations up to 5%. The results are comparable to those obtained with the Clinitest method, although Diabur-Test 5000 has the advantage of being sensitive also for low glucose concentrations. Diabur-Test 5000 is easier to use than the Clinitest method. It is well accepted by patients for self control, and might also be used for routine clinical work.

Diabetes Mellitus↗

Clinical significance of microalbuminuria and evaluation of the Micral-Test.

Microalbuminuria is defined as excretion of albumin between 20 and 200 micrograms/min. Persistent microalbuminuria indicates a high probability of damage to the glomerular filtration capacity of the kidney and is of great diagnostic relevance: (a) in diabetes, for early diagnosis of diabetic nephropathy; (b) in patients with hypertension, as an indicator of end-organ damage associated with a lowered life expectancy; (c) in pregnancy, as a possible predictor of developing preeclampsia. For screening, a concentration of 20-200 mg/L of albumin in the first morning urine has been proven to be a suitable indicator. The Micral-Test is a test strip now available that makes a semiquantitative assessment of the albumin concentration in the urine at various levels (0, 10, 20, 50, 100 mg/L). Many studies have shown that the sensitivity and specificity of the test strip is 90% or higher in urine containing elevated albumin concentrations. Furthermore, it was shown that there is no influence on the measurement from interfering factors such as glucose concentration, pH value, ketonuria, storage of the sample, or bacterial contamination in the urine. The Micral-Test offers a simple, exact, and with respect to interference effects, a robust testing method for the semiquantitative assessment of albumin concentration in the urine.

Albuminuria↗

Identification of Fusarium graminearum in cereal samples by DNA Detection Test Strips.

AIMS: Development of a fast, sensitive and easy to handle method for the detection of Fusarium graminearum contamination in cereal samples by PCR. METHODS AND RESULTS: DNA Detection Test Strips were used for PCR-product detection and the method was compared to agarose gel electrophoresis. A minimum of 0.26 ng of purified target DNA was detectable with the Test Strip Detection limit in less contaminated samples was slightly lower when gel electrophoresis was used for amplicon detection. In highly contaminated samples, detection limits of both methods were similar. CONCLUSIONS: Detection of PCR products was performed in 20 min without the need of special technical equipment or hazardous fluorescent DNA dyes. SIGNIFICANCE AND IMPACT OF THE STUDY: The new method described is useful for the screening of cereals in industrial quality control.

DNA, Fungal↗

[Efficacy of a rapid test to diagnose Plasmodium vivax in symptomatic patients of Chiapas, Mexico].

OBJECTIVE: To evaluate, under laboratory conditions, the sensitivity and specificity of a rapid diagnostic test (OptiMAL), based on immunoreactive strips, to detect Plasmodium vivax infection in febrile patients in Southern Chiapas, Mexico. MATERIAL AND METHODS: The presence of parasites in blood samples of 893 patients was investigated by Giemsa-stained thick blood smear microscopic examination (gold standard). A blood drop from the same sample was smeared on immunoreactive strips to investigate the presence of the parasite pLDH. Discordant results were resolved by PCR amplification of the parasite's 18S SSU rRNA, to discard infection. RESULTS: OptiMAL had an overall sensitivity of 93.3% and its specificity was 99.5%. Its positive and negative predictive values were 96.5% and 98.9%, respectively. Signal intensity in OptiMAL strips correlated well with the parasitemia density in the blood samples (r = 0.601, p = 0.0001). CONCLUSION: This rapid test had acceptable sensitivity and specificity to detect P. vivax under laboratory conditions and could be useful for malaria diagnosis in field operations in Mexico.

Adolescent↗

Point-of-care glucose testing: effects of critical care variables, influence of reference instruments, and a modular glucose meter design.

OBJECTIVE: To assess the clinical performance of glucose meter systems when used with critically ill patients. DESIGN: Two glucose meter systems (SureStepPro and Precision G) and a modular adaptation (Immediate Response Mobile Analysis-SureStepPro) were assessed clinically using arterial samples from critically ill patients. A biosensor-based analyzer (YSI 2700) and a hospital chemistry analyzer (Synchron CX-7) were the primary and secondary reference instruments, respectively. PATIENTS AND SETTING: Two hundred forty-seven critical care patients at the University of California, Davis, Medical Center participated in this study. OUTCOME MEASURES: Error tolerances of +/-15 mg/dL for glucose levels </=100 mg/dL and +/-15% for glucose levels >100 mg/dL were used to evaluate glucose meter performance; 95% of glucose meter measurements should fall within these tolerances. RESULTS: Compared to the primary reference method, 98% to 100% of SureStepPro and 91% to 95% of Precision G measurements fell within the error tolerances. Paired differences of glucose measurements versus critical care variables (Po(2), pH, Pco(2), and hematocrit) were analyzed to determine the effects of these variables on meter measurements. Po(2) and Pco(2) decreased Precision G and SureStepPro measurements, respectively, but not enough to be clinically significant based on the error tolerance criteria. Hematocrit levels affected glucose measurements on both meter systems. Modular adaptation did not affect test strip performance. CONCLUSIONS: Glucose meter measurements correlated best with primary reference instrument measurements. Overall, both glucose meter systems showed acceptable performance for point-of-care testing. However, the effects of some critical care variables, especially low and high hematocrit values, could cause overestimated or underestimated glucose measurements.

Blood Glucose↗

Self-screening for significant bacteriuria. Evaluation of dip-strip combination nitrite/culture test.

A self-administered dip-strip device was used to screen for urinary tract infection in female subjects. Fifty-two cases of significant persistent bacteriuria were detected among 2,250 subjects by simultaneous use of pourplate quantitative cultures. The dip-strip culture test had good reliability in detecting Gram-negative organisms. Repeated nitrite tests, performed on first-morning specimens and read by the patient, also had good reliability in detecting Gram-negative bacteria. No false-positive test occurred. The device is effective in screening out contaminants, thus decreasing the need for repeated testing.

Adolescent↗

An internally referenced test strip immunoassay for morphine.

We describe an internally referenced immunochemical test-strip for use in the rapid detection of morphine. The method is based on the "enzyme-channelling" immunoassay technique, and a glucose oxidase-horseradish peroxidase enzyme pair is used to immunospecifically generate an insoluble, colored reaction product on the test-strip surface. Test strips are composed of two active surfaces, each of which contain co-immobilized glucose oxidase and antibody. The indicator pad contains antibody directed against the drug, and the color that develops on its surface is inhibited by the presence of drug in the sample. The reference pad contains anti-peroxidase and is used to set the assay detection limit and normalize for variations in temperature, timing, and sample interference. The 10-min assay protocol involves incubating the strip in sample, then incubating it in a developer solution containing glucose, a peroxidase chromogenic substrate, and a peroxidase conjugate of the analyte. The ratio of the color formed on the indicator pad to that formed on the reference pad is used to score the test as positive or negative for drug at a predetermined concentration.

Antibodies↗

Evaluation of the Makromed dipstick assay versus PCR for diagnosis of Plasmodium falciparum malaria in returned travelers.

Microscopy has been the traditional reference standard for malaria diagnosis. However, difficulty in maintaining the required technical skills, particularly in areas where malaria is not endemic, has prompted the development of rapid nonmicroscopic diagnostic assays based on the detection of malaria parasite antigen in whole blood. In this study, we evaluated the performance of one such device, the Makromed dipstick test, blindly compared to PCR and microscopy for the diagnosis of Plasmodium falciparum malaria in 200 febrile returned travelers. The Makromed assay detects the presence of P. falciparum-specific histidine-rich protein II with an antigen capture immunochromatographic strip format. Compared to PCR as the reference standard, the dipstick assay had a sensitivity of 97.0% and a specificity of 96.0%. The positive and negative predictive values were 81.2% and 99.5%, respectively. Rapid malaria diagnostic devices may provide a useful diagnostic adjunct in a clinical setting.

Adolescent↗

Periprandial blood glucose and insulin values during the third trimester of normal pregnancies.

In order to determine the normal periprandial blood glucose values during gravidity, we studied 17 normal pregnant women, near term of gestation, in their homes using test strips and reflectometers . Results show an initial fasting level not higher than 80 mg/dl and not lower than 45 mg/dl. In all cases but one blood glucose levels were lower than 120 mg/dl, irrespective of when the measurements were taken. Insulin determinations permitted us to recognize low and high responders, although no differences could be found between them.

Adult↗

In vitro determination of unbound and total iron-binding capacity in serum by radioiron using a new ion exchange strip.

A simplified method for the in vitro determination of TIBC and UIBC in serum using 59Fe was subjected to quality control in the laboratory and clinically studied in duplicate determinations of 185 sera of an unselected patient population. The data obtained were investigated by statistical means (regression, correlation, variance analysis). The precision of the method was evaluated step by step. The results indicate that the radiochemical determination of TIBC values is equivalent to the "indirect" one (UIBC + SI) as far as accuracy is concerned. Advantages of the radiochemical method are discussed.

Humans↗

An evaluation of a leukocyte esterase/nitrite test strip and a bioluminescence assay for detection of bacteriuria.

A leukocyte esterase/nitrite (Chemstrip LNTM) and a bioluminescence assay (LumacTM) were evaluated for detection of bacteriuria in 1,000 urine specimens. Both devices provided high predictive negative values (95.4-97.8%); however, false-negative values at levels of bacteriuria greater than or equal to 10(4) CFU/ml were 22.6% and 12.3%, respectively, for the leukocyte esterase/nitrate and the bioluminescence assay tests. The corresponding false-negative values at levels of bacteriuria of greater than or equal to 10(5) CFU/ml were 16.5% and 3.9%, respectively.

Bacteriuria↗

Accuracy and precision of analyses for total cholesterol as measured with the Reflotron cholesterol method.

We compared plasma cholesterol measurements made with the Boehringer Mannheim Reflotron reflectance photometric analyzer in 1298 capillary blood samples with measurements made in venous blood samples collected at the same time and analyzed in four standardized Lipid Research Clinics laboratories. The Reflotron measurements averaged 0.8% to 7.8% lower than the laboratory values. Correlations (r) between the two sets of measurements ranged from 0.92 to 0.96. In some samples, however, the Reflotron values differed from the laboratory values by greater than or equal to 12%; the cholesterol concentrations in these samples tended to be higher than in those for which better agreement was observed. The smaller negative biases were observed when test strips were used that were calibrated with reference to the Centers for Disease Control Reference Method for cholesterol. The agreement between sequential Reflotron values averaged less than or equal to 4.3%. There was an average difference of less than or equal to 1.0% between Reflotron measurements made in each of two sequential capillary blood samples taken from a single finger puncture.

Cholesterol↗