Influence of inflammatory arthritis on leukocyte esterase strip results in the diagnosis of periprosthetic joint infection.

BACKGROUND: The leukocyte esterase (LE) strip is considered as a helpful method to detect infection, which might be influenced by other inflammatory diseases. This study aims to explore whether the centrifugation of synovial fluid could influence the positive result of LE strip caused by inflammatory arthritis during the diagnosis of periprosthetic joint infection (PJI). METHODS: From March 2016 to December 2018, 64 patients who were diagnosed as PJI or aseptic arthritis and another 20 patients with inflammatory arthritis were enrolled in our study. After synovial fluid samples were obtained, the LE strip test was performed with and without centrifugation. Then clinicians read the color changes 3 min after the samples were dropped and classify the results based on the instruction of strip. The differences between septic and aseptic arthritis patients and septic and inflammatory arthritis patients were analyzed. RESULTS: Among the included 21 PJI samples, 19 of them showed positive results (++) of LE strip before centrifugation. After centrifugation, two samples changed from two-positive (++) to one-positive (+), which is also considered as positive. Before centrifugation, 29 of the LE strip tests in the aseptic arthritis group (43 samples included) were ++ or +. After centrifugation, 16 of the samples yielded negative results. Among 20 samples with inflammatory arthritis, LE strip of 18 samples were positive (++ or +) before centrifugation, among which only 3 samples remained as positive after centrifugation. CONCLUSION: LE strip test results could be influenced by inflammatory arthritis during the diagnosis of PJI. Centrifugation should be performed for LE strip tests to determine whether the result is a true positive or a false positive influenced by inflammatory arthritis.

Assessment of the accuracy of salivary cotinine readings from NicAlert strips against a liquid chromatography tandem mass spectrometry assay in self-reported non-smokers who passed carbon monoxide but failed NicAlert validation.

BACKGROUND AND AIMS: NicAlert produces semi-quantitative assessments of cotinine levels in saliva or urine for verification of smoking abstinence. This study aimed to assess the accuracy of NicAlert readings against a liquid chromatography tandem mass spectrometry assay in smokers who had passed expired-air carbon monoxide (CO) verification but failed NicAlert verification. DESIGN: Comparison of NicAlert readings against readings from a reference assay using liquid chromatography tandem mass spectrometry. SETTING: Geneva, Switzerland. PARTICIPANTS: Self-reported non-smokers (n = 92) who in previous testing had CO of 0-3 parts per million (indicating no recent smoking) and reported not using any nicotine product, but had NicAlert readings ≥ 1 (indicating smoking). MEASUREMENTS: NicAlert produces readings of 0, 1 and 2+, which are reported by the manufacturer to correspond to saliva cotinine concentrations of 0-10 ng/ml (indicating not smoking), 10-30 ng/ml and 30+ ng/ml, respectively. Liquid chromatography tandem mass spectrometry was used as the reference. FINDINGS: For 82 participants with a NicAlert reading of 1, only two of the liquid chromatography tandem mass spectrometry values were within the purported range of 10-30 ng/ml; 71 were below 4 ng/ml and half the values were below 0.5 ng/ml. Two of the eight participants with NicAlert readings of 2 had laboratory values within the designated range. Neither of the two participants with NicAlert readings of 3 had a cotinine value within the designated range. CONCLUSIONS: In people who had passed carbon monoxide verification, NicAlert readings yielded a very high false-positive rate in detecting levels of cotinine indicative of smoking.

The diagnostic performance of human urinary dipsticks to estimate urine pH, specific gravity (SpG), and protein in horses: are they reliable?

BACKGROUND: Urinalysis is a critical diagnostic test which is performed in routine veterinary medicine practice. In this diagnostic test, semiquantitative measurement of urine biochemical substances is carried out using urinary dipstick. In the current study, we evaluated the diagnostic performance of human urinary dipsticks to estimate pH, specific gravity (SpG), and protein in 80 urine specimens collected from horses. These parameters were measured using two commercial human dipsticks (KP and MN in abbreviation) and quantitative reference methods. The reference methods for pH, SpG, and protein were pH meter, handheld refractometer, and pyrogallol red method, respectively. The correlation between the semiquantitative dipstick analysis and quantitative reference methods was determined using Spearman's rank correlation coefficient. RESULTS: In general, our results revealed that the both human urinary dipsticks are unreliable tests for urinary pH, SpG, and protein content in horses. The analysis indicated that there was a poor correlation between the urine dipsticks and reference method (KP: rS = 0.534 and MN: rs = 0.485, Ps < 0.001) for protein. Additionally, there was a weak correlation between the results of pH measured using the urine dipsticks and reference method (KP: rS = 0.445 and MN: rs = 0.370, Ps < 0.001). Similar findings were obtained for SpG (KP: rS = 0.285, MN: rs = 0.338, Ps < 0.001). The estimation of proteinuria using the human dipsticks in horses lacked specificity, as many false positive protein results were obtained. CONCLUSION: We observed that the human commercial urinary dipsticks used in this study were not reliable to correctly estimate urine protein, SpG, and pH in horses.

Comparison of the detection performance of two different one-step-combined test strips with fluorescent microspheres or colored microspheres as tracers for influenza A and B viruses.

BACKGROUND: Influenza A and B viruses mainly cause respiratory infectious disease. Till now, few tests are able to simultaneously detect both, especially in primary medical establishments. METHODS: This study was designed to compare the performance of two different one-step-combined test strips for the detection of influenza A and B: one strip with fluorescent microspheres for tracers (FMT); and the other strip with colored microspheres for tracers (CMT). To test the strips, cultures of influenza A, B, and other pathogenic viruses were used, in addition to 1085 clinical specimens from symptomatic patients with respiratory infections. Real-time RT-PCR was also considered as a reference method used to detect the different results of FMT and CTM. RESULTS: Detection thresholds for influenza A and B cultures using serial dilutions revealed that the sensitivity of FMT was higher than that of CMT (both P < 0.05). With the culture mixtures of Coxsackie virus (A16), enteric cytopathic human orphan virus (ECHO type30), enterovirus (EV71), rotavirus (LLR strain), and enteric adenovirus (AdV 41), specificity assessment demonstrated that there was no cross reaction during the usage of the two test strips as shown by the results which were negative. In the detection of influenza A in 1085 clinical specimens, the total coincidence rate was 96.7%, the positive coincidence rate was 97.1%, and the negative coincidence rate was 96.7%. In the case of influenza B detection, the total coincidence rate was 99.1%, the positive coincidence rate was 92.6%, and the negative coincidence rate was 98.5%. In addition, with influenza A or B real-time RT-PCR detection method, the results showed that, for influenza A, 26 of the 33 specimens that negative with CMT but positive with FMT, showed positive results, and none of the 3 specimens that positive with CMT but negative with FMT showed a positive result; For influenza B, 12 of the 15 specimens that negative with CMT but positive with FMT, showed positive results, and none of the 5 specimens that positive with CMT but negative with FMT showed a positive result. CONCLUSIONS: FMT performed better than CMT in the combined detection of influenza A and B viruses.

Urinary strips for proteins: easy to do but difficult to read!

Urine is an easily accessible biological fluid. This availability makes it tempting for a direct analysis of urinary parameters by physicians. Urinary proteins, that are interesting markers for several pathologies, are detected by urinary strips, rapidly and at a low cost. However, to ensure an optimal use of urinary strips, one may be familiar to their characteristics and their limits. This paper details the available urinary strips used for the detection of urinary proteins and urinary albumin, as well as their analytical performances in clinical conditions such as pregnancy, chronic renal disease, diabetes or for the screening of general populations.

Diagnostic accuracy of self-administered urine glucose test strips as a diabetes screening tool in a low-resource setting in Cambodia.

OBJECTIVE: Screening for diabetes in low-resource countries is a growing challenge, necessitating tests that are resource and context appropriate. The aim of this study was to determine the diagnostic accuracy of a self-administered urine glucose test strip compared with alternative diabetes screening tools in a low-resource setting of Cambodia. DESIGN: Prospective cross-sectional study. SETTING: Members of the Borey Santepheap Community in Cambodia (Phnom Penh Municipality, District Dangkao, Commune Chom Chao). PARTICIPANTS: All households on randomly selected streets were invited to participate, and adults at least 18 years of age living in the study area were eligible for inclusion. OUTCOMES: The accuracy of self-administered urine glucose test strip positivity, Hemoglobin A1c (HbA1c)>6.5% and capillary fasting blood glucose (cFBG) measurement ≥126 mg/dL were assessed against a composite reference standard of cFBGmeasurement ≥200 mg/dL or venous blood glucose 2 hours after oral glucose tolerance test (OGTT) ≥200 mg/dL. RESULTS: Of the 1289 participants, 234 (18%) had diabetes based on either cFBG measurement (74, 32%) or the OGTT (160, 68%). The urine glucose test strip was 14% sensitive and 99% specific and failed to identify 201 individuals with diabetes while falsely identifying 7 without diabetes. Those missed by the urine glucose test strip had lower venous fasting blood glucose, lower venous blood glucose 2 hours after OGTT and lower HbA1c compared with those correctly diagnosed. CONCLUSIONS: Low cost, easy to use diabetes tools are essential for low-resource communities with minimal infrastructure. While the urine glucose test strip may identify persons with diabetes that might otherwise go undiagnosed in these settings, its poor sensitivity cannot be ignored. The massive burden of diabetes in low-resource settings demands improvements in test technologies.

Análisis de orina: estandarización y control de calidad / Urine analysis: standardization and quality control / Análise de urina: padronização e controle de qualidade

El examen de orina completa data de los tiempos de Hipócrates. En la actualidad se basa en la utilización de tiras reactivas y la visualización al microscopio, careciendo de una estandarización actualizada y control de calidad. En el presente trabajo se realizó un estudio comparativo entre observadores, estandarizando el proceso y elaborando una solución control junto con una colección fotográfica del sedimento para enseñanza, entrenamiento y control interno. Se evaluaron 200 muestras de orinas de pacientes al azar. Los parámetros fisicoquímicos se determinaron en un equipo Urisys 2400 (Roche). El análisis microscópico fue realizado por dos operadores experimentados. Se preparó una solución control positiva de los parámetros usuales de tiras reactivas. Los resultados fueron analizados mediante el test Kappa, p<0,05. La correlación entre observadores, utilizando el procedimiento propuesto, fue siempre mayor que con el proceso de rutina. La solución control fue estable durante los 4 meses que duró la experiencia, dando positivas las determinaciones de glucosa, proteínas, hemoglobina, cetonuria y leucocitos, manteniéndose el valor de pH y de densidad. Se concluye que con la estandarización se logró aumentar el grado de correlación entre observadores, por lo tanto se propone el uso de esta metodología para uniformar criterios; además, la preparación de la sustancia control y de una colección fotográfica permitió controlar el procedimiento de una forma más económica sin dejar de lado la confiabilidad.

Urine analysis is one of the most ancient tests. It dates back from Hyppocrates times. Nowadays it is based on the use of reactive dipsticks and visual examinations in the microscope, with no quality control or adjusted standardization. In the present work, a standardized procedure, a positive control solution for dipsticks and a photographic collection of urine sediment were performed for teaching, training and control of the laboratory staff. Urisys 2400 (ROCHE) was used to analyze 200 samples randomly. The microscopic analysis was made by two experienced operators. A positive control solution of usual parameters of reactive dipsticks was performed. Data analysis was fulfilled by Kappa test p<0.05. The correlation between observers, using the proposed procedure, was always higher than in the routine process. The control solution was stable over the 4-month experience, yielding positive results in glucose, protein, hemoglobin, ketonuria and leukocyte, keeping pH and density values. It can be concluded that with standardization, the degree of correlation between observers was increased, for which reason this methodology is proposed to unify criteria; besides, elaboration of the control substance and a photographic collection makes it possible to control the procedure in a more economic fashion without leaving aside reliability.

O exame de urina completa data dos tempos de Hipócrates. Atualmente é baseado no uso de tiras-teste e a visualização no microscópio, carecendo de uma padronização atualizada e controle de qualidade. No presente trabalho foi realizado um estudo comparativo entre observadores padronizando o processo e elaborando uma solução de controle juntamente com uma coleção de fotografias do sedimento para ensino, treinamento e controle interno. 200 amostras de urinas de pacientes selecionados aleatoriamente foram avaliadas. Os parâmetros físico-químicos foram determinados em um equipamento Urisys 2400 (Roche). A análise microscópica foi realizada por dois operadores experientes. Foi realizada uma solução controle positiva dos parâmetros usuais de tiras-teste. Os resultados foram analisados através do teste Kappa, p<0,05. A correlação entre observadores, utilizando o procedimento proposto, foi sempre maior que com o processo de rotina. A solução controle manteve-se estável durante os 4 meses em que foi levada a cabo a experiência, dando positivas as determinações de glicose, proteínas, hemoglobina, cetonúria e leucócitos, mantendo o valor de pH e de densidade. Conclui-se que com a padronização foi possível aumentar o grau de correlação entre observadores, portanto se propõe o uso desta metodologia para uniformizar critérios; além disso, a elaboração da substância controle e de uma coleção fotográfica permite controlar o procedimento de uma maneira mais econômica, sem deixar de lado a confiabilidade.

Application of the reference method isotope dilution gas chromatography mass spectrometry (ID/GC/MS) to establish metrological traceability for calibration and control of blood glucose test systems.

Self-monitoring of blood glucose (BG) by means of handheld BG systems is a cornerstone in diabetes therapy. The aim of this article is to describe a procedure with proven traceability for calibration and evaluation of BG systems to guarantee reliable BG measurements. Isotope dilution gas chromatography mass spectrometry (ID/GC/MS) is a method that fulfills all requirements to be used in a higher-order reference measurement procedure. However, this method is not applicable for routine measurements because of the time-consuming sample preparation. A hexokinase method with perchloric acid (PCA) sample pretreatment is used in a measurement procedure for such purposes. This method is directly linked to the ID/GC/MS method by calibration with a glucose solution that has an ID/GC/MS-determined target value. BG systems are calibrated with whole blood samples. The glucose levels in such samples are analyzed by this ID/GC/MS-linked hexokinase method to establish traceability to higher-order reference material. For method comparison, the glucose concentrations in 577 whole blood samples were measured using the PCA-hexokinase method and the ID/GC/MS method; this resulted in a mean deviation of 0.1%. The mean deviation between BG levels measured in >500 valid whole blood samples with BG systems and the ID/GC/MS was 1.1%. BG systems allow a reliable glucose measurement if a true reference measurement procedure, with a noninterrupted traceability chain using ID/GC/MS linked hexokinase method for calibration of BG systems, is implemented. Systems should be calibrated by means of a traceable and defined measurement procedure to avoid bias.

The primary care perspective on routine urine dipstick screening to identify patients with albuminuria.

Proponents of routine urine dipstick screening to identify patients at risk for ESRD in the primary care setting have argued that urine dipsticks are inexpensive, low risk, acceptable to patients, and now, more accurate. Proponents believe that urine dipstick screening has the potential to improve outcomes for people with early disease and increase awareness of CKD. Most primary care physicians agree that populations who are at high risk for CKD should be tested and appropriately treated to decrease complications of ESRD. However, proponents of mass screening may not appreciate the challenges, limitations, and potential harms of screening. Urine dipstick testing does not meet all of the criteria for a good screening test. Screening the general population with urine dipsticks will generate many false positives--between 50% and 90% of positive tests--that will require follow-up, increase costs, and cause patient anxiety. Routine screening with urine dipsticks is not cost-effective on the order of $200,000 per quality-adjusted life year. Most importantly, there is little evidence that early identification of microalbuminuria in unselected patients influences outcomes of CKD. Without proof of effectiveness, overdiagnosis, a problem for even well established screening tests, is risked. Finally, no specialty society or preventive services group currently recommends general screening. Instead of screening, primary care physicians and nephrologists should work together to identify patients at high risk for ESRD and optimize management to improve outcomes for patients with CKD.

Effects of dynamic temperature and humidity stresses on point-of-care glucose testing for disaster care.

OBJECTIVE: To characterize the performance of glucose meter test strips using simulated dynamic temperature and humidity disaster conditions. METHODS: Glucose oxidase- and glucose dehydrogenase-based test strips were dynamically stressed for up to 680 hours using an environmental chamber to simulate conditions during Hurricane Katrina. Paired measurements vs control were obtained using 3 aqueous reagent levels for GMS1 and 2 for GMS2. RESULTS: Stress affected the performance of GMS1 at level 1 (P < .01); and GMS2 at both levels (P < .001), lowering GMS1 results but elevating GMS2 results. Glucose median-paired differences were elevated at both levels on GMS2 after 72 hours. Median-paired differences (stress minus control) were as much as -10 mg/dL (range, -65 to 33) at level 3 with GMS1, with errors as large as 21.9%. Glucose median-paired differences were as high as 5 mg/dL (range, -1 to 10) for level 1 on GMS2, with absolute errors up to 24.4%. CONCLUSIONS: The duration of dynamic stress affected the performance of both GMS1 and GMS2 glucose test strips. Therefore, proper monitoring, handling, and storage of point-of-care (POC) reagents are needed to ensure their integrity and quality of actionable results, thereby minimizing treatment errors in emergency and disaster settings.

A Bayesian evaluation of two dip-stick assays for the on-site diagnosis of infection in calves suspected of clinical giardiasis.

The objective of the present study was to evaluate two commercially available dip-stick assays for the diagnosis of Giardia infections in faecal samples from calves suspected of clinical giardiasis. The dip-stick assays provide an on-site and hence quick alternative to laboratory diagnosis. A three-test Bayesian model was used, including the test results of the Coris Giardia strip (Coris Bioconcept, Gembloux, Belgium), the Speed Giardia or BVT dip-stick (Bio Veto Test/Virbac, La Seyne sur Mer, France), and the Meridian immunofluorescence assay (IFA: Meridian Diagnostics Inc., Cincinnati, OH). In total, 421 faecal samples were examined with the three diagnostic assays between October 2008 and November 2009. Overall, the number of positive samples was markedly higher using the IFA compared to both dip-stick assays, resulting in a high sensitivity (se: 88%, with a 95% probability interval (PI) 60-99%) compared to the Coris dip-stick assay (se: 28%; PI: 16-41%) and the BVT dip-stick assay (se: 26%, PI: 16-35). The specificities of all the three assays were very high (IFA sp: 94%, PI: 90-99%; Coris sp: 92%, PI 86-98%; BVT sp: 93%, PI 88-98%). A positive diagnosis by the dip-stick assays was significantly correlated with a higher cyst excretion level, as measured by IFA. The majority (76%) of the positive samples in the present study contained less than 5000cyst per gram of faeces, even though all these animals displayed clinical symptoms of diarrhea potentially due to Giardia. The low level of cyst excretion in these samples might in part explain the poor sensitivity of both dip-stick assays. Although multiple samplings might be an option to increase the sensitivity of the dip-stick assays, the laboratory based IFA seems at current to be the best option for clinical diagnosis of Giardia in calves.

Dipsticks and diagnostic algorithms in urinary tract infection: development and validation, randomised trial, economic analysis, observational cohort and qualitative study.

OBJECTIVES: To estimate clinical and dipstick predictors of infection and develop and test clinical scores; to compare management using clinical and dipstick scores with commonly used alternative strategies; to estimate the cost-effectiveness of each strategy; and to understand the natural history of urinary tract infection (UTI) and women's concerns about its presentation and management. DESIGN: There were six studies: (1) validation development for diagnostic clinical and dipstick scores; (2) validation of the scores developed; (3) observation of the natural history of UTI; (4) randomised controlled trial (RCT) of scores developed in study 1; (5) economic analysis of the RCT; (6) qualitative study of patients in the RCT. SETTING: Primary care. PARTICIPANTS: Women aged 17-70 with suspected UTI. INTERVENTIONS: Patients were randomised to five management approaches: empirical antibiotics; empirical delayed antibiotics; target antibiotics based on a higher symptom score; target antibiotics based on dipstick results; or target antibiotics based on a positive mid-stream specimen of urine (MSU). MAIN OUTCOME MEASURES: Antibiotic use, use of MSUs, rates of reconsultation and duration, and severity of symptoms. RESULTS: (1) 62.5% of women had confirmed UTI. Only nitrite, leucocyte esterase and blood independently predicted diagnosis of UTI. A dipstick rule--based on having nitrite or both leucocytes and blood--was moderately sensitive (77%) and specific (70%) [positive predictive value (PPV) 81%, negative predictive value (NPV) 65%]. A clinical rule--based on having two of urine cloudiness, offensive smell, reported moderately severe dysuria, moderately severe nocturia--was less sensitive (65%) (specificity 69%, PPV 77%, NPV 54%). (2) 66% of women had confirmed UTI. The predictive values of nitrite, leucocyte esterase and blood were confirmed. The dipstick rule was moderately sensitive (75%) but less specific (66%) (PPV 81%, NPV 57%). (3) Symptoms rated as moderately bad or worse lasted 3.25 days on average for infections sensitive to antibiotics; resistant infections lasted 56% longer, infections not treated with antibiotics 62% longer and symptoms associated with urethral syndrome 33% longer. Symptom duration was shorter if the doctor was perceived to be positive about prognosis, and longer with frequent somatic symptoms, previous history of cystitis, urinary frequency and more severe symptoms at baseline. (4) 66% of the MSU group had laboratory-confirmed UTI. Women suffered 3.5 days of moderately bad symptoms if they took antibiotics immediately but 4.8 days if they delayed taking antibiotics for 48 hours. Taking bicarbonate or cranberry juice had no effect. (5) The MSU group was more costly over 1 month but not over 1 year. Cost-effectiveness acceptability curves showed that for a value per day of moderately bad symptoms of over 10 pounds, the dipstick strategy is most likely to be cost-effective. (6) Fear of spread to the kidneys, blood in the urine, and the impact of symptoms on vocational and leisure activities were important triggers for seeking help. When patients are asked to delay taking antibiotics the uncomfortable and worrying journey from 'person to patient' needs to be acknowledged and the rationale behind delaying the antibiotics made clear. CONCLUSIONS: To achieve good symptom control and reduce antibiotic use clinicians should either offer a 48-hour delayed antibiotic prescription to be used at the patient's discretion or target antibiotic treatment by dipsticks (positive nitrite or positive leucocytes and blood) with the offer of a delayed prescription if dipstick results are negative.

Diagnostic accuracy of urine dipsticks for detecting albuminuria in indigenous and non-indigenous children in a community setting.

Albuminuria predicts cardiovascular and end-stage kidney disease in indigenous populations. Early detection in indigenous children may identify those who could benefit from early treatment. Community-based detection of albuminuria needs to be performed using a reliable, inexpensive, and widely available test, such as a proteinuria dipstick. Dipstick accuracy for detecting albuminuria in a community setting has not been evaluated. We assessed the accuracy of Multistix 10 SG dipsticks to detect baseline albuminuria and predict for persistent albuminuria at a 2-year follow-up in a population-based cohort of Australian Aboriginal and non-Aboriginal elementary-school-aged children. Variability in the accuracy of dipsticks in subgroups of higher risk children was analyzed using the relative diagnostic odds ratio (RDOR). Using Multistix 10 SG dipsticks, index-test-positive cases were defined as >/=0.30 g/L (1+) proteinuria and index-test-negative cases as <0.30 g/L (negative or trace) proteinuria. Referent-test-positive cases were defined as spot albumin:creatinine (ACR) >/=3.4 mg/mmol, and referent-test-negative cases as ACR <3.4 mg/mmol. There were 2,266 children (55.1% Aboriginal, 51.0% boys, mean age 8.9 years) enrolled. At the 2-year follow-up, 1,432 (63.0%) children were retested (54.0% Aboriginal, 50.5% boys, mean age 10.5 years). Prevalence of baseline albuminuria was 7.3%, and persistent albuminuria was 1.5%. Dipsticks had a sensitivity of 62% and specificity of 97% at baseline. In predicting persistent albuminuria, sensitivity was 75% and specificity 93%. Accuracy did not vary with ethnicity, gender, or body mass index. Accuracy was less in younger children (4.0-7.9 years), and in those with hematuria. The performance characteristics of Multistix dipsticks make them suitable for albuminuria detection in Aboriginal and other higher-risk groups of children. More than two thirds of children detected at a single test will have transient rather than persistent albuminuria. Multistix dipsticks are particularly useful for detecting children who will have persistent albuminuria.

Evaluation of the ARKRAY AUTION Eleven reflectometer in detecting microalbuminuria with AUTION Screen test strips and proteinuria with AUTION Sticks 10PA strips.

OBJECTIVE: Albumin/creatinine and protein/creatinine ratios were measured with the ARKRAY AUTION Eleven reflectometer using AUTION Screen and AUTION Sticks 10PA strips, respectively, against quantitative Siemens Advia reference procedures from 368 patient urines, as an evaluation of their applicability for use in points-of-care and small laboratories. MATERIAL AND METHODS: Direct reflectance measurements were utilized to estimate imprecision, as well as to suggest reclassification of ordinal scale categories into normoalbuminuria, microalbuminuria and macroalbuminuria groups (3.4 g/mol and 34 g/mol cut-off limits, corresponding to 30 mg/g and 300 mg/g creatinine in conventional units). RESULTS: Analytically, ordinal scale albumin/creatinine ratios agreed in 86% of cases with those obtained from Advia measurements, resulting in a kappa coefficient of 0.79. Protein/creatinine ratios of the AUTION Sticks 10PA strip were classified into three groups at limits of 11.3 g/mol and 56.6 g/mol (100 mg/g and 500 mg/g in conventional units), with an agreement of 77% and a kappa coefficient of 0.65 against Advia procedures. To optimize clinical outcomes, cut-off reflectances of ordinal scale categories of AUTION Eleven were adjusted. The clinical specificity of detecting an increased albumin/creatinine ratio was then increased from 81% to 95%, with clinical sensitivity kept at 88% at the 3.4 g/mol limit of the reference procedure. Clinical specificity of the albuminuria field alone (at a clinical sensitivity of 88%) was only 73%. Adjustments to cut-off reflectances of the reported categories for protein/creatinine ratios increased clinical specificity from 54% to 94%, while losing clinical sensitivity from 97% to 89% only, with an improved concordance of 83% and a kappa coefficient of 0.75 against Advia measurements. The combination to creatinine measurements improved clinical specificity compared to 50% by the protein field alone. In economic terms, it is estimated that population screening for microalbuminuria using the AUTION Eleven reflectometer is cheaper than by quantitative albumin/creatinine measurements alone, based on the incidence of end-stage renal disease of 90 patients/million/year at the Northern Ostrobothnia Hospital District.

Diagnostic accuracy of a reagent strip for assessing urinary albumin excretion in the general population.

BACKGROUND: Albuminuria is a sensitive marker of renal derangement and has been included in a number of studies investigating chronic kidney diseases (CKDs). This study is aimed to evaluate the diagnostic performances of a strip for measuring the albumin/creatinine ratio (ACR) in the general population and to compare it with those found in a diabetic population. METHODS: Urine samples were obtained from 201 consecutive subjects enrolled in an epidemiological study and from 259 type 2 diabetic patients. Urine was tested for albumin and creatinine using the strip (Clinitek Microalbumin) and laboratory methods. A hundred samples were stored under various conditions to assess analyte stability. RESULTS: In the general population, the strip test reached a 90% sensitivity and 91% specificity, considering the laboratory method as the 'gold standard', sparing >80% of subjects the laboratory tests at the expense of a 1% false negative rate and an 8% false positive rate. Regarding sensitivity and specificity, the ACR test performs very similarly in the general population and in the diabetics. The stability study showed that storage at -20 degrees C induced a significant decrease in the albumin concentration with both methods, such that 5% of the samples were re-classified in the lower ACR class. Storage at -80 degrees C for up to 12 months did not affect the measurement with both methods. CONCLUSION: Clinitek Microalbumin strips can be used for screening purposes in the general population since they correctly classify a significant percentage of subjects, particularly those with a normal albuminuria. Storage at -80 degrees C does not affect strip results. Screening with the strip and confirming positive results with a wet chemistry method are an efficient strategy for detecting albuminuria in the general population.

Field evaluation of simple rapid tests in the diagnosis of syphilis.

The aim of this study was to detect the sensitivity and specificity of rapid syphilis diagnostic tests (immunochromatographic strip [ICS] test and rapid test device [RTD]) performed by low-skilled paramedics in field clinics and by highly-skilled technologists in laboratories and compare them with the gold standard (rapid plasma reagin [RPR] and Treponema pallidum haemagglutination [TPHA]) tests for diagnosis of syphilis. A cross-sectional study was conducted among female sex workers (FSWs) in Dhaka, Bangladesh, from August 2004 to July 2005. Blood specimens were tested for syphilis using (i) ICS, (ii) RTD, (iii) RPR tests performed by low-skilled paramedics; and (i) ICS, (ii) RTD, (iii) RPR and (iv) TPHA tests by highly-skilled technologists. The sensitivity and specificity of the ICS and RTD test performed by low- and highly-skilled personnel were compared with the gold standard. A total of 684 FSWs were enrolled and the prevalence of syphilis among FSWs was 20.8% as determined by the gold standard. There was no significant difference in the performance of ICS test done by paramedics in the field when compared with the gold standard performed by highly-skilled technologists in the laboratory (sensitivity, 94.45%; specificity, 92.6%). The ICS test could fulfil the need for a non-invasive, rapid screening test for syphilis.

Early results of bladder-cancer screening in a high-risk population of heavy smokers.

OBJECTIVE: To report first results of an early bladder-cancer detection programme, and to evaluate the detection rate and the diagnostic value of the tests used. SUBJECTS AND METHODS: Urine samples of 183 screened subjects with a history of smoking of > or =40 pack-years were collected for analysis with a urinary dipstick test for haematuria, the nuclear matrix protein-22 test (BladderChek, Matritech, Inc., Newton, MA, USA), voided urine cytology and a molecular cytology test (UroVysion, Abbott Molecular Inc., Des Plaines, IL, USA). Participants with at least one positive test result had a further evaluation including cystoscopy and radiological imaging. The subjects' risk factors, test results and histological findings were analysed. RESULTS: In all, 75 subjects had at least one positive test result and were evaluated further; abnormal histological findings were detected in 18 (24% of those who had cystoscopy, 9.8% of the original 183), 15 of those in the urinary bladder, with pTaG1 (one), carcinoma in situ (two), dysplastic lesions (11) and one an inverted papilloma. In the upper urinary tract, two urothelial tumours (pTaG1 and pTxN2G3) and one renal cell carcinoma (pT1G2) were detected by computed tomography. In summary, six of 183 subjects (3.3%) had a histologically confirmed malignant tumour and another 12 (6.6%) were identified with a possible pre-cancerous lesion of the urinary tract. The urinary dipstick, BladderChek, cytology and UroVysion detected (i.e. were true-positive in) nine (50%), one (6%), seven (39%) and 11 (61%) of the 18 tumours found, while they failed to detect nine (50%), 17 (94%), 11 (61%) and seven (39%) of these lesions, respectively. Omitting the urine dipstick test, the BladderChek, cytology or UroVysion from the test setting could have spared 40, five, two or one subjects(s) from unnecessary invasive interventions; however, three, none, two or six lesions, would have been missed. More positive screening tests per subject was associated with a higher probability of a (pre)-malignant lesion. CONCLUSION: Screening a high-risk group with a history of smoking of > or =40 pack-years showed a significant proportion (3.3%) with malignancy. These first results are encouraging and warrant continuation of the screening programme. In this series the most efficient screening tool was the combination of UroVysion, cytology and urinary dipstick testing. Of special scientific interest will be the follow-up of those patients with a possible pre-cancerous lesion.

Diagnosis of spontaneous bacterial peritonitis in cirrhotic patients in northeastern Brazil by use of rapid urine-screening test / Diagnóstico de peritonite bacteriana espontânea em pacientes cirróticos com o uso fita reagente para urinanálise no nordeste do Brasil

CONTEXT AND OBJECTIVE: Spontaneous bacterial peritonitis (SBP) is a frequent and severe complication of cirrhotic patients with ascites. It has been proposed that the reagent strip for leukocyte esterase designed for the testing of urine (Combur test® UX) could be a useful tool for diagnosing SPB. The aim of this study was to assess the sensitivity and specificity of urine test strips for diagnosing SBP in cirrhotic patients with ascites. DESIGN AND SETTING: Prospective study, at a university hospital in northeastern Brazil. METHODS: Forty-two unselected consecutive cirrhotic patients (32 males; mean age: 51.7 ± years) were included, and a total of 100 paracenteses were performed. All ascitic fluid samples were analyzed using the reagent strip and cytology, neutrophils, lymphocyte count, appropriate biochemical tests and culturing. The strips were considered positive if the color became purple on a colorimetric scale. RESULTS: Nine patients were diagnosed with SBP using cytology (> 250 neutrophils/mm³), and the strips were positive for all these nine patients with SBP. In one sample, the strip was positive but the neutrophil count was less than 250 cells/mm³. For 86 samples, both the strips and cytology were negative. At the threshold of 250 neutrophils/mm³ in ascitic fluid, the sensitivity, specificity, positive predictive value and negative predictive value for the strips were respectively 100 percent, 98.9 percent, 92.3 percent and 100 percent. CONCLUSION: The Combur test® UX urine screening test is a very sensitive and specific method for diagnosing SBP in cirrhotic patients with ascites.

CONTEXTO E OBJETIVO: Peritonite bacteriana espontânea (PBE) é uma freqüente e grave complicação em pacientes cirróticos com ascite. Vem sendo proposto o uso de fitas reagente para esterase leucocitária, utilizadas para diagnóstico de infecção urinária, como instrumento para diagnosticar PBE. O objetivo deste estudo é avaliar a sensibilidade e a especificidade da fita reagente Combur Test® UX no diagnóstico de PBE em pacientes cirróticos com ascite. TIPO DE ESTUDO E LOCAL: Estudo prospectivo, realizado no Hospital Universitário Walter Cantídio, Fortaleza, Ceará, Brasil. MÉTODOS: Quarenta e dois pacientes consecutivos, não selecionados (32 homens, com média de idade de 51,7 ± anos) foram incluídos e um total de 100 paracenteses foram realizadas. O líquido ascítico foi avaliado pela fita reagente (Combur Test® UX), citologia, contagem de neutrófilos, linfócitos, testes bioquímicos e cultura. As fitas reagentes foram consideradas positivas se havia mudança na cor para roxo na escala colorimétrica fornecida pelo fabricante. RESULTADOS: Foram diagnosticados nove pacientes com PBE pela citologia (> 250 neutrófilos/mm³), estando a fita Combur Test® UX positiva em todos os nove pacientes. Em uma amostra o teste da fita foi positivo, embora a contagem de neutrófilos fosse < 250 células/mm³. Nas outras 86 amostras ambos os testes foram negativos. Tendo-se como ponto de corte 250 PMN/mm³ no líquido ascítico, a sensibilidade, a especificidade, o valor preditivo positivo e o valor preditivo negativo foram respectivamente 100 por cento, 98,9 por cento, 92,3 por cento e 100 por cento. CONCLUSÕES: Combur Test® UX (fita reagente para urinanálise) é um método sensível e específico para o diagnóstico de PBE em pacientes cirróticos com ascite.

Comparative evaluation of a new bedside faecal occult blood test in a prospective multicentre study.

BACKGROUND: Faecal occult blood testing is an established method of colorectal neoplasia screening. Guaiac-based tests are limited by poor patient compliance, low sensitivity, specificity and positive predictive value. Newer immunochemical-based tests, accurate but tedious, require a well-established laboratory set up. There is need for simpler immunochemical tests that can be performed at the out-patient clinic. AIM: To compare the performance characteristics of a new bedside immunological test strip device with a sensitive Guaiac-based and established immunochemical test for detection of faecal occult blood in patients undergoing colonoscopy. METHODS: A total of 389 consecutive patients from four centres who were referred for colonoscopy also provided the stool samples for detection of occult blood without dietary restrictions. Stool tests performed were (i) Guaiac-based, (ii) immunochemical enzyme-linked immunosorbent assay and (iii) bedside immunochemical strip test. RESULTS: At the optimal threshold level, the sensitivity and specificity of the beside immunochemical strip test for detection of significant colorectal neoplasia (adenomas >1.0 cm and carcinomas) were 60% and 95%, respectively. CONCLUSIONS: This bedside immunochemical strip test proved to be a simple, convenient, non-cumbersome and accurate tool with similar performance characteristics for detection of any bleeding lesion including colorectal neoplasia when compared with an established immunochemical faecal occult blood test.