新一代罗康全整合型血糖仪的准确度分析

目的评价新一代自我血糖检测仪——罗康全整合型血糖仪(ACCU-CHEKIntegra,Roche Diagnostics GmbH,Germany)在糖调节受损(impaired glucose regulation,IGR)和初发2型糖尿病患者自我血糖检测中的准确度。方法采用横断面研究的方法,对109例初发2型糖尿病或IGR患者进行口服葡萄糖耐量试验(oral glucose tolerance test,OGTT)的同时,在±2 min内用罗康全整合型血糖仪测定指尖毛细血管血糖,而后比较毛细血管血糖(capillary blood glucose,CBG)和静脉血浆血糖(venous plasma glucose,VPG)数值差异,以VPG为参考值,评价该血糖仪的准确度。用绝对差值的中位数(median AD)、绝对差值的相对数的中位数(median RAD)评价其准确度;用Clarke误差表格分析指尖血CBG和VPG的一致性;用线性回归方法分析CBG值与VPG值的相关性;用敏感度、特异度评估血糖仪对高血糖检测的准确度和特异度。结果共收集到292对CBG-VPG值。93.49%的CBG值符合ISO家用血糖仪检测标准,median AD为7.2 mg/dL,median RAD为4.76%;误差表格分析显示100%位于A区和B区;CBG值与VPG值在整体水平上具有较好的相关性(r=0.984,P=0.000),检测高血糖的敏感度和特异度分别为94.6%和95.7%。结论罗康全整合型血糖仪具有良好的准确度,能较准确地反映血糖的真实水平。     

POCT血糖仪与全自动生化分析仪检测血葡萄糖结果对比分析

目的 探讨POCT快速血糖仪与自动生化分析仪检测血糖结果的相关性及差异性,为临床提供参考.方法 用5个浓度的质控品和患者标本在POCT血糖仪上进行检测,连续测试5 d,计算变异系数(CV).用POCT快速血糖仪和全自动生化分析仪对54例患者的末梢血和静脉血浆进行血糖检测,测得的数据用SPSS统计学软件进行分析,评价POCT血糖仪与全自动生化仪与测定结果的相关性.结果 5个浓度的质控品和患者标本在POCT血糖仪上所测结果的CV在2.6%～4.2%,低于厂家的声明,也符合国家对血糖检测系统的测量重复性要求(CV不超过7.5%).雅培Optium Xceed血糖仪与全自动生化仪所测结果的相关系数(r)=0.974,相关性较好.结论 雅培Optium Xceed血糖仪在精密度和准确度等方面均符合临床要求,其检测结果接近血浆葡萄糖检测结果.但是POCT血糖仪仅可用于患者空腹血糖的监测或血糖过筛实验,不能代替实验室血糖的检测结果作为确诊实验.     

糖化血红蛋白诊断糖尿病标准的初步探讨

目的初步评估使用糖化血红蛋白(HbA1c)诊断糖尿病(DM)的最佳切点,探讨美国糖尿病协会(ADA)推荐的HbA1c≥6.5%作为糖尿病诊断标准是否适用于中国人群。方法 2010年6月至2011年10月在南京明基医院门诊进行75 g口服葡萄糖耐量试验的未被诊断为糖尿病的患者393例,同时测定其HbA1c。以世界卫生组织(WHO)的标准诊断DM,用受试者工作特征曲线(ROC)分析HbA1c诊断DM的能力。结果以非DM组为对照组,用HbA1c来诊断DM时,ROC曲线下面积(AUCROC)为0.926,最佳切点为6.3%,敏感度为91.1%,特异度为88.0%。当切点为6.5%时,敏感度下降为81.8%,特异度为93.7%。结论 HbA1c诊断DM的最佳切点为6.3%,ADA推荐HbA1c≥6.5%的诊断标准也许更适合欧美人群,中国人群的诊断标准仍有待大范围调查后确定。     

Point‐of‐care Glucose and Hemoglobin A1c in Emergency Department Patients without Known Diabetes: Implications for Opportunistic Screening

Objectives: The objectives were to evaluate the correlation between random glucose and hemoglobin A1c (HbA1c) in emergency department (ED) patients without known diabetes and to determine the ability of diabetes screening in the ED to predict outpatient diabetes. Methods: This was a cross‐sectional study at an urban academic ED. The authors enrolled consecutive adult patients without known diabetes during eight 24‐hour periods. Point‐of‐care (POC) random capillary glucose and HbA1c levels were tested, as well as laboratory HbA1c in a subset of patients. Participants with HbA1c ≥ 6.1% were scheduled for oral glucose tolerance test (OGTT). Results: The 265 enrolled patients were 47% female and 80% white, with a median age of 42 years. Median glucose and HbA1c levels were 93 mg/dL (interquartile range [IQR] = 82–108) and 5.8% (IQR = 5.5–6.2), respectively. The correlation between POC and laboratory HbA1c was r = 0.96, with mean difference 0.33% (95% confidence interval [CI] = 0.27% to 0.39%). Glucose threshold ≥ 120 mg/dL had 89% specificity and 26% sensitivity for predicting the 76 (29%) patients with abnormal HbA1c; ≥ 140 mg/dL had 98% specificity and 14% sensitivity. The correlation between random glucose and HbA1c was moderate (r = 0.60) and was affected by age, gender, prandial status, corticosteroid use, and current injury. Only 38% of participants with abnormal HbA1c returned for OGTTs; 38% had diabetes, 34% had impaired fasting glucose/impaired glucose tolerance, and 28% had normal glucose tolerance. Conclusions: ED patients have a high prevalence of undiagnosed diabetes. Although screening with POC random glucose and HbA1c is promising, improvement in follow‐up with confirmatory testing and initiation of treatment is needed before opportunistic ED screening can be recommended.     

Diagnostic strategies to detect glucose intolerance in a multiethnic population

OBJECTIVE: Identifying individuals who have elevated glucose concentrations is important for clinicians so that preventive strategies can be invoked, and it is useful for researchers who study associations between elevated glucose and adverse health outcomes. These methods should be applicable worldwide across different ethnic groups. Therefore, the objective of our analysis was to determine whether using the fasting glucose and HbA(1c) together could improve the classification of individuals with impaired glucose tolerance and diabetes in a multiethnic cohort randomly assembled in Canada. RESEARCH DESIGN AND METHODS: We determined the optimum diagnostic criteria to identify people with abnormal glucose tolerance using fasting plasma glucose, 2-h post-glucose load plasma glucose, and HbA(1c) in 936 Canadians of South Asian, Chinese, and European descent. RESULTS: The sensitivity of the American Diabetes Association (ADA) criteria to diagnose diabetes compared with the World Health Organization definitions was poor at 48.3% (95% confidence interval [CI] 35.7-61.0). Using a receiver operator characteristic curve, the optimum combined cut-point using fasting glucose and HbA(1c) to diagnose diabetes was a fasting glucose > or =5.7 mmol/l and an HbA(1c) > or =5.9%. These cut-points were associated with a sensitivity and specificity of 71.7% (60.3-83.1) and 95.0% (93.5-96.4), respectively, a positive likelihood ratio (LR) of 14.3 (9.6-19.0), and a negative LR of 0.3 (0.2-0.4). Significant ethnic variation in the sensitivity and specificity of this approach was observed: 47.4% (24.9-69.8) and 97.6% (95.9-99.4) among Europeans, 78.6% (57.1-100) and 95.9% (93.6-98.2) among Chinese, and 85.2% (71.8-98.6) and 91.3% (88.1-94.6) among South Asians, respectively. Participants with impaired glucose tolerance could not be identified reliably using the fasting glucose or HbA(1c) alone or in combination. CONCLUSIONS: The sensitivity of the ADA criteria to diagnose diabetes is low, and there is substantial variation between ethnic groups. Fasting glucose and HbA(1c) may be used together to improve the identification of individuals who have diabetes, allowing clinicians to streamline the use of the oral glucose tolerance test.     

Comparison of HbA1 and fructosamine in diagnosis of glucose-tolerance abnormalities

Total glycosylated hemoglobin (HbA1) and fructosamine were evaluated as screening tools for detection of glucose-tolerance abnormalities in 144 asymptomatic subjects undergoing a 75-g oral glucose tolerance test. Subjects were classified according to World Health Organization criteria as having normal (n = 78), impaired (n = 40), or diabetic (n = 26) glucose tolerance. We found good specificity for HbA1 and fructosamine (100 and 97%, respectively) but low sensitivity (15 and 19%, respectively). At the intersection of the curves of sensitivity and specificity drawn from various thresholds of normality, both sensitivity and specificity were 75% for HbA1 and 55% for fructosamine. Thus, neither HbA1 nor fructosamine seems to be suitable for the diagnosis of mild abnormalities in glucose tolerance.     

尿胰蛋白酶原-2在筛查急性胰腺炎临床应用中的评价

目的评价尿胰蛋白酶原-2试纸条在筛查急性胰腺炎中的临床价值.方法收集50例急腹症患者的血清和尿液,按最终诊断分为急性胰腺炎组(22例)和非急性胰腺炎组(28例),分别检测尿胰蛋白酶原-2,血淀粉酶和尿淀粉酶,并将结果进行比较.结果尿胰蛋白酶原-2诊断急性胰腺炎的敏感性、特异性分别为96%、86%;血淀粉酶为73%、82%;尿淀粉酶为82%、86%.结论尿胰蛋白酶原-2的敏感性和阴性预期值均高于血、尿淀粉酶,可以作为急性胰腺炎诊断的筛选指标.     

液基薄层细胞学技术在尿路上皮癌患者术后随访中的应用

目的:探讨尿液膜式液基薄层细胞学技术(TCT)在尿路上皮癌患者术后随访中应用的临床价值.方法:对74例尿路上皮癌患者进行术后随访,定期行尿液TCT和手工涂片法找尿中肿瘤细胞和监测肿瘤复发,并对结果进行分析.结果:在本组74例患者之中,25例高级别尿路上皮癌患者,随访近1年,复发13例,其中尿液TCT找到肿瘤细胞11例,灵敏度84.6％,且有6例患者尿液TCT检查要早于膀胱镜检查发现肿瘤复发;手工涂片法尿中找到肿瘤细胞7例,灵敏度为53.8％.41例低级别尿路上皮癌患者中,随访近1年,复发6例,其中尿液TCT检查找到肿瘤细胞4例,灵敏度66.7％;手工涂片法尿中找到肿瘤细胞2例,灵敏度为33.3％.结论:尿液TCT检查较手工涂片法更为灵敏,可以应用于尿路上皮癌患者术后随访,且对肿瘤复发能起到早发现、早诊断的作用.     

Quantitative evaluation of urinalysis test strips

BACKGROUND: Urine test strip results are generally reported in categories (i.e., ordinal scaled), but automated strip readers are now available that can report quantitative data. We investigated the possible use of these meters to complement flow cytometry of urine and compared reflectance readings with quantitative determinations of urinary glucose and microalbumin. METHODS: We compared URISYS 2400 (Roche) quantitative reflectance data with data from the UF-100 (Sysmex) and biochemical data for 436 nonpathologic and pathologic urine samples. RESULTS: Reproducibility of the reflectance signal was good for high- and low-concentration urine pools for protein (0.8% and 0.9% and 1.5% and 2.2% within and between runs, respectively), leukocyte esterase (1.1% and 1.0%; 5.1% and 1.2%), hemoglobin (1.7% and 1.1%; 8.9% and 1.1%) and glucose (2.1% and 0.5%; 6.5% and 2.3%). Fair agreement was obtained between UF-100 and test strip reflectance data for erythrocytes and hemoglobin (r = -0.680) and leukocytes and leukocyte esterase (r = -0.688). Higher correlations were observed for biochemical and test strip data comparing protein and albumin (r = -0.825) and glucose data (r = -0.851). The lower limits of detection for erythrocytes and leukocytes were 8 x 10(6)/L and 19 x 10(6)/L, respectively. The protein test (n = 220) detected 86% (95% confidence interval, 78-92%) of samples with <30 mg/L albumin with a specificity of 84% (95% confidence interval, 76-91%). CONCLUSIONS: In urine test strip analysis, quantitative hemoglobin and leukocyte esterase reflectance data are complementary with flow cytometric results and glucose and albumin results.     

2型糖尿病患者血糖与尿糖相关性分析

目的 分析2型糖尿病患者尿糖与血糖的相关性。方法 同步测定37例2型糖尿病患者空腹血糖和尿糖，并设对照组。结果 37例2型糖尿病患者中32例血糖与尿糖呈正相关，5例血糖和尿糖无相关性；对照组尿糖均呈阴性。结论 在实施治疗以前，判断患者肾糖阈值是否异常，对尿糖能否作为糖尿病日常监控指标非常重要。     

荧光原位杂交技术在尿路上皮细胞癌诊断中的应用

目的应用荧光原位杂交技术（fluorescenceinsituhybridization,FISH）检测分析3、7、17号染色体及9p21位点异常与尿路上皮细胞癌发生、发展的关系,评估其用于尿路上皮细胞癌诊断的可行性和临床应用前景。方法选取2011年7月至2013年8月在青海红十字医院泌尿外科经膀胱镜活检确诊为尿路上皮细胞癌的患者116例作为实验组,另外选取正常体检者92例作为对照组,分别行尿脱落细胞学检查和FISH检测,比较两种方法诊断的特异性和灵敏性,统计分析3、7和17号染色体及9p21位点的畸变率与尿路上皮肿瘤分级的相关性。结果①尿路上皮细胞癌患者中,FISH和细胞学诊断尿路上皮细胞癌的灵敏度分别为81．0％和37．9％;对照组中,FISH和细胞学诊断尿路上皮细胞癌的特异度分别为90．2％和93．4％。②各染色体及区带呈较高的畸变发生率,3、7、17号染色体畸变阳性率分别为94．3％、95．6％和88．5％;9号染色体p21位点畸变阳性率为63．2％。③FISH的灵敏性随着肿瘤分级分期的升高而增高。结论FISH技术能明显改进尿路上皮细胞癌的诊断,对于尿路上皮细胞癌的诊断及复发监测具有重要意义。     

Determination of urinary myo-inositol concentration by an improved enzymatic cycling method using myo-inositol dehydrogenase from Flavobacterium sp

BACKGROUND: To determine myo-inositol more accurately, we improved the enzymatic cycling method. METHODS: We screened myo-inositol dehydrogenase (MIDH; EC.1.1.1.18) from Flavobacterium sp., which was highly specific to myo-inositol. We measured urinary myo-inositol/creatinine ratio 2 h after 75-g oral glucose tolerance test (2 h MI) of 71 volunteers, and investigated the relationship between diabetes and urinary myo-inositol concentration. RESULTS: The calibration curve was linear (r = 1.00) up to 2000 micromol/l, and the detection limit was 10 micromol/l. Within-run and between-run CVs were 0.5-1.1% and 0.4-1.3%, respectively. The 2 h MI of impaired fasting glycemia (IFG; 65.1 +/- 46.6 mg/g Cr, P < 0.005), impaired glucose tolerance (IGT; 85.0 +/- 73.7 mg/g Cr, P < 0.001) and diabetes (163.4 +/- 73.7 mg/g Cr, P < 0.0001) increased significantly compared with that of normal glucose tolerance (NGT; 24.0 +/- 14.4 mg/g Cr). From receiver operating characteristic analyses on 2 h MI, with 50 mg/g Cr as a tentative cutoff value to detect diabetes, the sensitivity and specificity were 100% and 77%, respectively. With 40 mg/g Cr as a tentative cutoff value to detect NGT, the sensitivity and specificity were 74% and 85%, respectively. CONCLUSIONS: The myo-inositol measurement method demonstrated high specificity and yielded accurate results. The results of clinical trials suggested that 2 h MI could not only determine diabetes but also distinguish IFG and IGT from NGT.     

Diagnostic value of various urine tests in the Jordanian population with urinary tract infection.

We compared the performance of leukocyte esterase and nitrite reductase dipstick tests with microscopic examination and uroculture in cases with clinically suspected urinary tract infection (UTI). We studied urine specimens from 504 Jordanian patients which were obtained by the mid-stream clean catch method and analyzed for bacteria. All samples were subjected to culture. Results of urine dipstick tests and pyuria (white blood cells (WBC)/high power field) were compared with urine culture for each sample. Significant bacteriuria was found in 117 cases (23.2%) with positivity of 59% and 68.5% for the presence of nitrite reductase and leukocyte esterase, respectively. Echerichia coli was the most common organism isolated. The dipstick leukocyte esterase and nitrite testing had a sensitivity of 68.5% and 59% for detecting bacteriuria in UTI cases and specificity of 73.5% and 78%, respectively. The positive predictive value of the tests was 44% and 60%, and the negative predictive value 88.5% and 86.2%, respectively. Microscopic WBC showed 86.5% specificity but low sensitivity. Urine dipstick results and pyuria significantly correlated with the results of urine culture but demonstrated more false-positive results, which ranged from 13.4-26.6%. The probability of growing a urinary pathogen correlated with urinary WBC counts and allowed prediction of the presence or absence of bacteriuria by counting urinary leukocytes. A combination of pyuria and urine dipstick testing appears to be a very useful marker for the diagnosis of UTI. Urine culture can be omitted if both tests are negative.     

尿特定蛋白和β2-MG在糖尿病肾病中的水平变化及意义

目的探讨尿微量白蛋白(MA)、尿转铁蛋白(TRU)、尿免疫球蛋白(IgU)、尿α1-微球蛋白(α1-MG)和β2-微球蛋白(β2-MG)在糖尿病肾病(DN)早期诊断中的价值。方法将研究对象分为糖尿病肾病组和健康对照组,利用免疫散射速率比浊法测定尿特定蛋白含量,利用比浊法测定血、尿β2-微球蛋白含量,并进行分析。结果与健康对照组比较,糖尿病肾病患者尿微量白蛋白(MA)、尿转铁蛋白(TRU)、尿免疫球蛋白(IgU)、尿α1-微球蛋白(α1-MG)和β2-微球蛋白(β2-MG)含量和阳性率均显著增高,有显著性差异(P0.05);糖尿病肾病患者在早期检测中,尿微量蛋白的敏感度和特异度优于尿素和肌酐。结论联合检测尿特定蛋白和尿β2-微球蛋白可作为糖尿病肾病患者肾损害早期诊断的重要指标。     

Evaluation of a dipstick test for glucose in urine.

As an example of qualitative tests, a dipstick analysis for glucose in urine has been tested for the influence of modifying factors on the test result. Two different types of dipsticks were examined, "Clinistix" and "S-Gluko-test." Used according to manufacturer's instructions, the latter is more sensitive and selective. By multivariance analysis the following variables were examined: urine samples, inter- and intra-analyst, exposure to light, and dipstick batch. The first three contributed significantly to the total variation in results, inter-specimen variation being the most important. With knowledge of the frequency of testing urines with a given glucose concentration and the probability of the result at that concentration, an expression of the probability of the glucose content of a urine sample can be obtained. Even with the tests of the type examined having a sensitivity and specificity exceeding 95%, 14 of 100 patients suspected of having diabetes mellitus on the basis of a dipstick examination will be found to have a urinary glucose concentration of less than 2 mmol/liter. These figures were found when the prevalence of urines with a glucose concentration exceeding 2 mmol/liter was 17.5%.     

Fasting plasma glucose versus glucose challenge test: screening for gestational diabetes and cost effectiveness

OBJECTIVE: To compare the performance in screening for gestational carbohydrate intolerance of the 1-h 50-g glucose challenge test (GCT), fasting plasma glucose (FPG) and fasting capillary glucose (FCG). DESIGN AND METHODS: FPG and FCG were measured at the same time as the GCT in 188 women. Gestational carbohydrate intolerance was diagnosed according to the Canadian Diabetes Association criteria. We constructed receiver operator characteristic (ROC) curves and compared the sensitivity and specificity of the FPG, FCG and GCT. RESULTS: Gestational diabetes was diagnosed in 11.2% women and gestational impaired glucose tolerance in 8.4%. The areas under the ROC curves for the FPG, the GCT and the FCG were not statistically different (P = 0.26). The GCT yielded a better specificity than the FPG and the FCG for a comparable level of sensitivity. CONCLUSIONS: The GCT is better than the FPG in our population and is cost effective.     

Impaired fasting glucose or impaired glucose tolerance. What best predicts future diabetes in Mauritius?

OBJECTIVE: To determine if impaired fasting glucose (IFG; fasting plasma glucose level 6.1-6.9 mmol/l) can predict future type 2 diabetes as accurately as does impaired glucose tolerance (IGT; 2-h plasma glucose level 7.8-11.0 mmol/l). RESEARCH DESIGN AND METHODS: A longitudinal population-based study was performed with surveys in 1987 and 1992 on the island of Mauritius, assessing diabetes status by the oral glucose tolerance test. A total of 3,717 subjects took part in both surveys. Of these subjects, 3,229 were not diabetic in 1987 and formed the basis of this study. RESULTS: At baseline, there were 607 subjects with IGT and 266 subjects with IFG. There were 297 subjects who developed diabetes by 1992. For predicting progression to type 2 diabetes, the sensitivity, specificity, and positive predictive values were 26, 94, and 29% for IFG and 50, 84, and 24% for IGT, respectively. Only 26% of subjects that progressed to type 2 diabetes were predicted by their IFG values, but a further 35% could be identified by also considering IGT. The sensitivities were 24% for IFG and 37% for IGT in men and 26% for IFG and 66% for IGT in women, respectively. CONCLUSIONS: These data demonstrate the higher sensitivity of IGT over IFG for predicting progression to type 2 diabetes. Screening by the criteria for IFG alone would identify fewer people who subsequently progress to type 2 diabetes than would the oral glucose tolerance test.     

多种尿液检测方法对尿路感染诊断价值的meta分析

目的 采用Meta方法对比多种尿液分析检测方法在尿路感染诊断中的价值,检查方法包括细菌培养、尿沉渣镜检、尿液分析仪、尿液常规干化学法对细菌、白细胞、红细胞等。方法 检索论文数据库PubMed、EMbase、Cochrane library、Springerlink、CNKI、万方数据库,检索时限为数据库建库至2014年12月,由两名系统评价员按照纳入排除标准对文献质量进行独立筛选,采用RevMan5.3、Meta-DiSc对纳入研究的文献进行分析,计算合并敏感度(Sen)、特异度(Spe)、阳性似然比(LR⁺)、阴性似然比(LR^-)、诊断比值比(DOR)、绘制SROC曲线。结果 ①按照纳入、排除标准最终纳入14篇文献,共9 518例患者(12 560例次);②尿液白细胞检测以尿沉渣镜检为金标准,尿常规干化学法检测AUC为0.9656、综合Sen为0.845(0.805,0.879)、综合Spe为0.944(0.929,0.957);尿液分析仪检测AUC为0.8983,综合Sen为0.631(0.591,0.669),综合Spe为0.929(0.911,0.944);③尿液红细胞检测以尿沉渣镜检为金标准,尿液常规干化学法检测AUC为0.9306、综合Sen为0.590(0.572,0.608),综合Spe为0.948(0.938,0.956);尿液分析仪检测AUC为0.7319,综合Sen为0.473(0.433,0.513),综合Spe为0.971(0.958,0.980);④尿液细菌检测以细菌培养为金标准,尿液分析仪AUC为0.9048,综合Sen为0.842(0.811,0.870),综合Spe为0.881(0.865,0.896)。结论 在尿路感染白细胞、红细胞的检查中,尿液常规干化学法在AUC、Sen、Spe方面均优于尿液分析仪,在尿液白细胞、红细胞的检测中具有优势;尿液分析仪在尿液细菌检查诊断价值较高,同时较细菌培养周期短,可推荐用于尿液细菌的筛选,但Sen、Spe均在0.9以下,如需确诊还需要结合细菌培养。     

Validation of capillary glucose measurements to detect glucose intolerance or type 2 diabetes mellitus in the general population

BACKGROUND: The use of an oral glucose tolerance test (OGTT) has been recommended to diagnose type 2 diabetes, but an OGTT with venous blood sampling may not be feasible in the screening phase preceding large epidemiological studies. We have conducted a population-based screening in 2715 men and women and evaluated the diagnostic validity of capillary plasma glucose concentration measurements versus venous plasma glucose concentration measurements in a subset of 350 subjects. METHODS: During a single OGTT, glucose concentrations were measured in venous plasma as well as in capillary plasma. RESULTS: Based on the 1999 WHO criteria for venous glucose concentrations, the study population (n=350) yielded 97 subjects with type 2 diabetes mellitus, 77 subjects with impaired glucose tolerance and 176 subjects with normal glucose tolerance. Sensitivity and specificity to diagnose type 2 diabetes mellitus by capillary plasma were 84% and 98%, respectively. Consistent classification by either venous or capillary plasma glucose measurements was 78% (kappa=0.65, p<0.001). CONCLUSION: Capillary glucose measurements are suitable for use in epidemiological studies to diagnose and detect type 2 diabetes and normal glucose tolerance. Use of capillary measurements can result in cost-effective inclusion schemes in epidemiological studies.     

The clinical applications and accuracy of 2 rapid near-patient tests in detecting Helicobacter pylori infection

Noninvasive methods for assessing Helicobacter pylori infection status are now an integral part of managing patients with upper gastrointestinal complaints. The aim of this study is to evaluate the feasibility and diagnostic accuracy of 2 rapid tests: a urine-based H. pylori antibody detection method (Rapirun) and a stool-based H. pylori antigen detection method (immunocard STAT! HpSA). The combined use of the mentioned 2 tests was also evaluated, which has not been described in previous similar studies. Urine and stool specimens were collected from patients who were arranged for gastroendoscopic examination. The urine and stool specimens were tested with Rapirun and immunocard STAT! HpSA separately. The estimated reaction time was about 15 to 20 min for the former and 5 to 10 min for the latter. H. pylori infection was confirmed with 4 tests: culture, histology, rapid urease test, and the (13)C-urea breath test. Obtained results from both kits were compared with confirmed results. One hundred twenty patients were eligible for analysis. Of them, 62 tested positive for H. pylori infection and 58 were negative by the confirmation criteria. The urine Rapirun test relative to the confirmed results showed sensitivity, specificity, and accuracy as 87.1% (confidence interval [CI] = 81.1-93.1%), 89.7% (CI = 84.2-95.1%), and 88.3%, respectively. The stool immunocard STAT! HpSA test relative to the confirmed results showed sensitivity, specificity, and accuracy as 96.8% (CI = 93.6-99.9%), 82.8% (CI = 76.0-89.5%), and 90%, respectively. The combined-use method of both tests revealed sensitivity, specificity, and accuracy as 98.4% (CI = 96.1-100%), 81.0% (CI = 74.0-88.1%), and 90%, respectively. These 2 urine and stool tests have a satisfactory accuracy around 90% in detecting H. pylori infection. In consideration of the advantages of cheapness, timesaving, and ease of use, both can be used as rapid near-patient tests in general practice. The combined use of both tests was also promising in detecting H. pylori infection.