Diagnostic tests for human Schistosoma mansoni and Schistosoma haematobium infection: a systematic review and meta-analysis.

BACKGROUND: Accurate diagnosis is pivotal for implementing strategies for surveillance, control, and elimination of schistosomiasis. Despite their low sensitivity in low-endemicity areas, microscopy-based urine filtration and the Kato-Katz technique are considered as reference diagnostic tests for Schistosoma haematobium and Schistosoma mansoni infections, respectively. We aimed to collate all available evidence on the accuracy of other proposed diagnostic techniques. METHODS: In this systematic review and meta-analysis, we searched PubMed, Embase, the Cochrane Library, and LILACS for studies published from database inception to Dec 31, 2022, investigating the sensitivity and specificity of diagnostic tests for S haematobium and S mansoni infections against Kato-Katz thick smears or urine microscopy (reference tests) involving adults (aged ≥18 years), school-aged children (aged 7 to 18 years), or preschool-aged children (aged 1 month to 7 years). We extracted raw data on true positives, true negatives, false positives, and false negatives for the diagnostic tests and data on the number of participants, study authors, publication year, journal, study design, participants' age and sex, prevalence of Schistosoma infection, and treatment status. To account for imperfect reference tests, we used a hierarchical Bayesian latent class meta-analysis to model test accuracy. FINDINGS: Overall, we included 121 studies, assessing 28 different diagnostic techniques. Most studies (103 [85%] of 121) were done in Africa, 14 (12%) in South America, one (1%) in Asia, and one (1%) in an unknown country. Compared with the reference test, Kato-Katz thick smears, circulating cathodic antigen urine cassette assay version 1 (CCA1, 36 test comparisons) had excellent sensitivity (95% [95% credible interval 88-99]) and reasonable specificity (74% [63-83]) for S mansoni. ELISA-based tests had a performance comparable to circulating cathodic antigen, but there were few available test comparisons. For S haematobium, proteinuria (42 test comparisons, sensitivity 73% [62-82]; specificity 94% [89-98]) and haematuria (75 test comparisons, sensitivity 85% [80-90]; specificity 96% [92-99]) reagent strips showed high specificity, with haematuria reagent strips having better sensitivity. Despite limited data, nucleic acid amplification tests (NAATs; eg, PCR or loop-mediated isothermal amplification [LAMP]) showed promising results with sensitivity estimates above 90%. We found an unclear risk of bias of about 70% in the use of the reference or index tests and of 50% in patient selection. All analyses showed substantial heterogeneity (I2>80%). INTERPRETATION: Although NAATs and immunological diagnostics show promise, the limited information available precludes drawing definitive conclusions. Additional research on diagnostic accuracy and cost-effectiveness is needed before the replacement of conventional tests can be considered. FUNDING: WHO and Luxembourg Institute of Health.

Construction of test strips for lung cancer detection based on aptamers.

Lung cancer is the most common malignancy worldwide. Early diagnosis helps to reduce mortality and improve survival. Aptamers are widely used in cancer screening because of their high specificity, good stability and low cost. In this study, using the specific aptamer of lung cancer serum, the sandwich method colloidal gold test strip was prepared by isothermal amplification technique and the principle of nucleic acid hybridisation for the early diagnosis of lung cancer. The results showed that the test strip was positive in 8 patients with lung cancer, which was consistent with the actual cases. The test strip can accurately identify lung cancer patients. The concentration range of nucleic acid detection is 1 × 10-4 - 7 × 10-4 mol/L, and the detection limit is 0.67 mM. The test strip detection method has low cost and simple operation, and provides a reference for the development of home portable tumor early detection.

Point-of-care image-based quantitative urinalysis with commercial reagent strips: Design and clinical evaluation.

Urinalysis is a useful test as an indicator of health or disease and as such, is a part of routine health screening. Urinalysis can be undertaken in many ways, one of which is reagent strips used in the general evaluation of health and to aid in the diagnosis and monitoring of kidney disease. To be effective, the test must be performed properly, and the results interpreted correctly. However, different light conditions and colour perception can vary between users leading to ambiguous readings. This has led to camera devices being used to capture and generate the estimated biomarker concentrations, but image colour can be affected by variations in illumination and inbuilt image processing. Therefore, a new portable device with embedded image processing techniques is presented in this study to provide quantitative measurements that are invariant to changes in illumination. The device includes a novel calibration process and uses the ratio of RGB values to compensate for variations in illumination across an image and improve the accuracy of quantitative measurements. Results show that the proposed calibration method gives consistent homogeneous illumination across the whole image. Comparisons against other existing methods and clinical results show good performance with a correlation to the clinical values. The proposed device can be used for point-of-care testing to provide reliable results consistent with clinical values.

Development of Colloidal Gold Test Strips for the Detection of Oxamyl Residues in Tobacco.

In this study, monoclonal antibodies against oxamyl were prepared, and colloidal gold immunochromatography was used to design a rapid test strip product for the detection of oxamyl in tobacco with high specificity, accuracy and stability without cross-reactivity to commonly used tobacco fungicides based on the optimization of conditions such as pH value of diluent, diluent dosage, concentration of antibody marker, type of confining solution and complex solution. 5 The results of five samples of post-harvest ready-to-bake tobacco and first-harvest tobacco were consistent with the gas chromatographic method, which proved the reliability of the test strips. The limits of detection for the post-harvest and first-harvest tobacco samples were 0.1 mg/kg, and the test strips developed in this study are suitable for mass testing in tobacco laboratories with good application prospects because of their short detection time, simple pre-treatment and detection methods.

Development of Colloidal Gold Test Strips for the Detection of Triadimenol Residues in Tobacco.

The rapid and accurate determination of triadimenol residues is of great significance. In this study, based on the advantages of high efficiency, rapidity, reliability, simplicity and low cost of immunology, a test strip product for the rapid detection of triadimenol residues in tobacco was designed based on the optimization of conditions such as pH and dosage of diluent, concentration of antibody stock solution, type of confining solution and complex solution, with high specificity, accuracy and The results of 20 samples of fresh and first roasted tobacco were all consistent with the method of gas chromatography, which proved the reliability of the test strips. The detection limit for fresh and roasted tobacco was 5 mg/kg, and the test strips developed in this study are suitable for mass testing of tobacco samples in tobacco-related laboratories because of their short detection time, simple pre-treatment and detection methods, and good application prospects.

Application of analytical performance specifications for urine test strip methods: Importance of reflectance signals.

INTRODUCTION: Urinalysis is essential for diagnosing kidney-related medical conditions. Urine test strip analysis serves as an initial and efficient screening method for reflex testing with accurate quantitative methods. MATERIALS AND METHODS: Freshly voided urines (n = 206) were analysed using two urine test strip brands on UC-MAX (Menarini) and cobas u 601 (Roche Diagnostics) instruments. Ordinal scale categories and reflectance signals (if available) were both used for the comparison with reference quantitative methods for glucose, proteins and albumin (cobas 503). Samples were considered positive when glucose > 15 or ≥ 54 mg/dL, proteins ≥ 200 mg/L and albumin ≥ 10 mg/L. Optimized reflectance thresholds were calculated by ROC curve analysis. Analytical performance specifications (APS) for trueness of test strip were gathered from the EFLM guideline (FPD, FNG, FNC). RESULTS: Reflectance signals were significantly lower in urine samples considered positive by the reference method (p < 0.0001). Reflectance signals were also correlated with quantitative measurements, showing strong correlation (0.754 to 0.969). Only the use of optimized reflectance thresholds on cobas u 601 achieved at least the minimum EFLM APS (FPD < 20%, FNG < 50% and FNC < 10%). CONCLUSION: The use of reflectance signals from urine test strips enhanced accuracy for glucose, proteins, and albumin measurement and may contribute to improve diagnosis of diverse kidney-related conditions.

Establishment, verification, and application of concentration intervals corresponding to dipstick grades for urinary protein.

BACKGROUND: To address the situation that the accuracy of concentration intervals (CI) corresponding to dipstick grades is not given by the manufacturers or literature, we developed a method that determined reasonable dipstick grades with concentration intervals (GCIs) based on the percent agreement (PA) and discussed the GCI application to comparability among currently dipstick tests. METHODS: By comparing the results of 2 dipstick tests (iChem and KU-500) with the quantitative test (AU5800), the GCIs were verified and established based on the PAs, which were calculated and used as an indicator of GCI's accuracy. The overlap (percent) between the 2 GCIs with the same grade (2 dipstick devices), was calculated and used to evaluate the agreement between their test results. RESULTS: After verification and adjustment, the GCI and PA combinations for iChem Velocity were as follows: - (<0.1 g/l, 85 %), ± (0.1-0.3 g/l, 66 %), 1+ (0.3-1 g/l, 78 %), 2+ (1-3 g/l, 74 %), 3+ (3-6 g/l, 77 %), and 4+ (≥6 g/l, 84 %). The determined GCI and PA combinations for KU-500 were: - (<0.1.2 g/l, 75 %), ± (0.12-0.5 g/l, 63 %), 1+ (0.5-1.2 g/l, 69 %), 2+ (1.2-3.2 g/l, 76 %), and 3+ (≥3.2 g/l, 82 %). The GCI overlaps between the 2 dipstick devices were - (83 %), ± (45 %), 1+ (56 %), 2+ (82 %), and 3+ or ≥3+ (94 %). The overall overlap was 72 %. Since the overlaps ± (45 %) and 1+ (56 %) were within the overlap reject limit for any grade (70 %), and the overall overlap (72 %) was within the overall overlap reject limit (80 %), the test results of the 2 devices were not comparable. CONCLUSIONS: GCIs can be verified and established correctly based on PAs, and industry standards for dipstick tests can be established based on GCIs and PAs. Comparability between dipstick devices, historical data, and literature data can be roughly determined based on the overlap.

Assessment of inter-observer agreement among experienced and inexperienced observers and an automated device for dipstick urinalysis in dogs and cats.

Standard visual urine dipstick analysis (UDA) is performed routinely in veterinary medicine; results can be influenced by both the operator and the method. We evaluated the agreement of results for canine and feline urine samples analyzed using a 10-patch dipstick (Multistix10SG; Siemens), both visually under double-anonymized conditions by students and a laboratory technician, and with an automated device (AD; Clinitek Status, Siemens). The mean concordance for semiquantitative urinalysis results between students and the technician and between students and the AD was fair (κ0.21-0.40) in dogs and cats; concordance was moderate between the technician and the AD (κ0.41-0.60) in dogs and good (κ0.61-0.80) in cats. For pH, the mean concordance between students and the technician and between the technician and the AD was good (ρ0.80-0.92) in dogs and cats; concordance was good between students and the AD (ρ0.80-0.92) in dogs and moderate (ρ0.59-0.79) in cats. Repeatability was higher (p < 0.001) for the technician and the AD than for a student. We found good agreement between UDA performed by an experienced operator and an AD in dogs and cats but found low reproducibility and low repeatability for urinalysis performed by an inexperienced operator.

Diagnosis of Spontaneous Bacterial Peritonitis with Dipstick Test.

INTRODUCTION: Spontaneous bacterial peritonitis (SBP) is a common and serious complication in cirrhosis patients with an incidence and mortality of about 30% and 25% respectively in hospitalised patients. Currently the diagnostic criteria is presence of >250 neutrophils per microlitre in ascitic fluid, but these facilities are not available at all timings and often the results are delayed. A rapid and bedside test is needed for diagnosis of SBP which aids in timely treatment.Dipsticks based on detection of leukocyte esterase in fluid are available everywhere and widely used for detecting urinary tract infection. In this study we aimed to find out the diagnostic utility of these dipsticks in SBP for immediate diagnosis. MATERIALS: An observational cross sectional study was conducted among 75 patients with cirrhosis suspected of having SBP clinically. Relevant investigations, diagnostic paracentesis and dipstick test of ascitic fluid was done. The patients were divided into two groups with and without SBP.The ascitic fluid neutrophil count and dipstick results were compared in both groups. RESULT: 26 patients (34.6%) had SBP out of total 75 patients. AKI and hepatic encephalopathy were significantly higher in SBP patients (53% and 50% respectively in SBP patients; 28% and 18% in patients without SBP). Sensitivity and specificity of dipstick test with cutoff of more than 1+ was 96% and 75% respectively; with cutoff of more than 2 was 80% and 91% respectively. CONCLUSION: The dipstick can be used as a bedside maneuver for immediate diagnosis of SBP. Having a good negative predictive value, it can also be used to exclude SBP, thus avoiding unnecessary antibiotics administration. References Koulaouzidis A. Diagnosis of spontaneous bacterial peritonitis: an update on leucocyte esterase reagent strips. World J Gastroenterol 2011;17(9):1091-1094. Oey RC, Kuiper JJ, Van Buuren HR, et al. Reagent strips are efficient to rule out spontaneous bacterial peritonitis in cirrhotics. Neth J Med 2016;74(6):257-261.

Evaluation of pre-processing methods for tear fluid proteomics using proximity extension assays.

Tear fluid forms a potential source for biomarker identification, and can be minimal invasively collected via Schirmer strips. The lack of knowledge on the processing of Schirmer strips however complicates the analysis and between-study comparisons. We studied two different pre-processing methods, specifically the use of punches of the strip versus elution of the strip in a buffer. Tear fluid filled Schirmer strips were collected from 5 healthy participants, and divided into two halves over the length of the strip. In either part, punches or eluates were obtained from 4 different locations, from the first part touching the eye (head) to the end, to assess the protein distribution along the strips. The levels of 92 inflammatory proteins were measured in the punches/eluates using proximity extension assays. The punch method yielded higher protein detectability compared to the elution method (76% vs 66%; p ≤ 0.001). Protein expression level was found to be slightly higher in the head of the strip, however, 3 out of 5 punches from the head failed quality control. Protein expression levels over the remaining parts of the strips were similar. Our study showed beneficial use of punches of any part of the strip except the head in future biomarker research.

A functional nanoflower based lateral flow immunoassay for the rapid and robust detection of pathogens.

In the face of complex public health emergencies and various social medical needs in new situations, it is urgent to establish rapid detection technology for the early detection of pathogens to control their spread and minimize the resultant health and societal impact. Point-of-care testing (POCT) that allows rapid, on-site, and affordable detection and monitoring of health conditions at home or away from clinical labs has received increasing attention in modern medicine. In this work, we have synthesized multifunctional magainin I-human chorionic gonadotropin (hCG)-Cu3(PO4)2 nanoflowers and demonstrated a new strategy for the fast diagnosis of pathogenic microorganisms by combining functional nanoflowers with a lateral flow immunoassay device. The prepared multifunctional nanoflowers immobilized many signal molecules, which solves the poor sensitivity of traditional lateral flow strips and realizes the highly sensitive detection of pathogenic microorganisms ("accurate detection"). Besides, this method can complete the rapid transformation of commercial-off-the-shelf lateral flow strips and realize the fast diagnosis of target analytes in case of an outbreak ("fast detection"). Therefore, the established rapid and highly sensitive lateral flow immunoassay for the detection of pathogenic microorganisms will effectively improve the early diagnosis efficiency of infectious diseases caused by pathogenic microorganisms and shorten the diagnosis time of diseases.

Nitrite-negative results in urinary tract infection by Enterobacterales: does the nitrite dipstick test have low sensitivity?

Urinary tract infection (UTI) is one of the most common bacterial infections among humans. Urine culture is the gold standard diagnostic method for UTI; however, the dipstick test for nitrite is a widely used method signalling the presence of urinary nitrate-reducing bacteria. Unlike the gold standard, the dipstick test is easy to perform, while it is also less time-consuming and less expensive, and produces a result in a few minutes. This study investigates the sensitivity of the dipstick test for nitrite compared with the Griess test in urine samples from UTI caused by Enterobacterales species. We used the Griess test, which is the gold standard in nitrite measurement, to determine the sensitivity of the nitrite dipstick test. Semiquantitative urine culture was performed using standard procedures, and Enterobacterales identification was performed by manual conventional biochemical tests. In the first sample selection, 3 % (8/267) of urine samples suspected of UTI, analysed from March to April 2016, were nitrite-negative by dipstick test but positive for Enterobacterales in the urine culture. In the second sample selection, 5 % (2/44) of urine samples from October to December 2022 were also nitrite-negative but showed urine Enterobacterales isolation. All nitrite-negative dipstick results were consistent with the Griess test. Escherichia coli was the most prevalent bacterium, followed by Klebsiella pneumoniae, independent of sample selection. The dipstick test is a safe alternative for investigating nitrite in urine samples. We believe that the cause of nitrite-negative results is a lack of dietary nitrate, dilution of urine and exogenous interference (e.g. ascorbic acid). These findings support the idea that standard urine culture is necessary to rule out UTI.

Effects of Simulated Adverse Environmental Conditions Related to Actual Conditions at Health Promoting Hospitals on the Performance of Blood Glucose Testing by Glucose Meters.

BACKGROUND: Annual peaks in temperature and humidity exceed manufacturers' specifications for blood glucose test strip storage in Thailand. Health Promoting Hospitals (HPH) do not always provide the same level of health services that hospitals do since they often only turn on air-conditioning units during working hours. METHODS: The blood glucose testing performance of 4 glucose meters were investigated for short and long terms stress at 5 simulated conditions. Temperature and relative humidity (RH) at 5 HPHs in different regions of Thailand were monitored for 9 weeks during April to July 2019. The use of air conditioning in storage rooms for storing test strips was surveyed at 131 HPHs using questionnaires. RESULTS: Median-paired differences of glucose measurements with stressed test strips in 5 simulated conditions significantly differed (P < 0.05) both in the short term (3 days) and in the long term (30 days) with 4 glucose meters when compared to unstressed test strips. The average temperature of all HPHs exceeded 30°C (86°F). The average RH was 84%. There was only one HPH that occasionally turned on its air conditioners. Most HPHs kept both opened and unopened vials of test strips in rooms without air conditioners. Further, 21.4-32.0% of HPHs kept test strips at room with air conditioners. CONCLUSIONS: This study provides evidence for poor performance of blood glucose testing by glucose meters that are affected by adverse environmental conditions. The environmental for test strips storage at HPHs should be considered to prevent analytical errors of glucose measurement.

Pruebas con sondas lineales para detectar la tuberculosis farmacorresistente. Manual sobre interpretación y notificación de resultados dirigido al personal médico y de laboratorio / Linear probe tests to detect drug-resistant tuberculosis. Handbook on Interpretation and notification of results addressed to medical and laboratory personnel

En el presente manual se describen las mutaciones detectadas mediante tiras reactivas en pruebas con sondas lineales (LPA) tanto de primera como de segunda línea, y se brinda información sobre su asociación con la farmacorresistencia fenotípica, con base en el catálogo de la OMS de mutaciones del complejo M. tuberculosis y su relación con la resistencia a los fármacos y las concentraciones inhibitorias mínimas (CIM) de los fármacos de primera y segunda línea informadas por la OMS. Asimismo, se describe la interpretación de las pruebas, las pruebas diagnósticas complementarias y las consecuencias clínicas de la presencia de mutaciones específicas y de la resistencia inferida. En la guía también se presentan estudios de casos con ejemplos de resultados de LPA y se describe la forma como se deben informar los resultados al personal médico, con modelos recomendados de informes adaptables

Urogenital schistosomiasis among pre-school and school aged children in four districts of north western Tanzania after 15 years of mass drug administration: Geographical prevalence, risk factors and performance of haematuria reagent strips.

BACKGROUND: Urogenital schistosomiasis remains as a public health problem in Tanzania and for the past 15 years, mass drug administration (MDA) targeting primary school children has remained as the mainstay for its control. However, after multiple rounds of MDA in highly risk groups, there are no data on the current status of Schistosoma haematobium in known endemic areas. Furthermore, the performance of commonly used diagnostic test, the urine reagent strips is not known after the decline in prevalence and intensities of infection following repeated rounds of treatment. Thus, after 15 of national MDA, there is a need to review the strategy and infection diagnostic tools available to inform the next stage of schistosomiasis control in the country. METHODS/FINDINGS: A analytical cross-sectional study was conducted between October and November, 2019 among pre-school (3-5years old) and school aged children (6-17 years old) living in four (4) districts with low (<10%) and moderate (10%-<50%) endemicity for schistosomiasis as per WHO classification at the start of the national control programme in 2005/06, with mean prevalence of 20.7%. A total of 20,389 children from 88 randomly selected primary schools participated in the study. A questionnaire was used to record demographic information. A single urine sample was obtained from each participant and visually examined for macrohaematuria, tested with a dipstick for micro-haematuria, to determine blood in urine; a marker of schistosome related morbidity and a proxy of infection. Infection intensity was determined by parasitological examination of the urine sample for S. haematobium eggs. Overall, mean infection prevalence was 7.4% (95%CI: 7.0-7.7, 1514/20,389) and geometric mean infection intensity was 15.8eggs/10mls. Both infection prevalence (5.9% versus 9%, P<0.001) and intensity (t = -6.9256, P<0.001) were significantly higher in males compared to females respectively. Light and heavy infections were detected in 82.3% and 17.7% of the positive children respectively. The prevalence of macrohaematuria was 0.3% and that of microhaematuria was 9.3% (95%CI:8.9-9.7). The sensitivity and specificity of the urine reagent strip were 78% (95%CI: 76.1-79.9) and 99.8% (95%CI: 99.7-99.9). Having light (P<0.001) and heavy infection intensities (P<0.001) and living in the study districts increased the odd of having microhaematuria. Predictors of S. haematobium infection were being male (P<0.003), microhaematuria (P<0.001), and living in the three study districts (P<0.001) compared to living at Nzega district. CONCLUSION: The findings provide an updated geographical prevalence which gives an insight on the planning and implementation of MDA. Comparing with the earlier mapping survey at the start of the national wide mass drug administration, the prevalence of S. haematobium infection have significantly declined. This partly could be attributed to repeated rounds of mass drug administration. The urine reagent strips remain as a useful adjunct diagnostic test for rapid monitoring of urogenital schistosomiasis in areas with low and high prevalence. Based on prevalence levels and with some schools having no detectable infections, review of the current blanket mass drug administration is recommended.

Smartphone-Based Point-of-Care Urinalysis Assessment.

A dipstick urinalysis test is performed by immersing a reagent strip in the urine specimen and then comparing the resulting reagent pad colors with a reference key. The color assessment of the reagent strip can be performed manually or by using a urine analyzer. However, the manual procedure is prone to subjective inaccuracies in varying ambient illumination and urine analyzer equipment is expensive. This paper presents a smartphone-based machine-learning approach to accurately determine the reagent pad colors for automated assessment. We start with a unique calibration chart and use multivariate linear regression to map the captured color values to their true equivalents. This accounts for the camera-induced distortions and ambient illumination factors. Subsequently, the color comparison is performed using the least Euclidean distance to match the calibrated color of each reagent pad with the reference key. The results from an experimental study, using five different smartphone cameras and three common illumination settings, indicate a high degree of accuracy in color assessment for synthetic dipsticks. The proposed smartphone-based method is an easy-to-perform, time-efficient, and cost-effective solution for an automated urinalysis and could be used as an alternative to manual reading or benchtop urine analyzers. Clinical Relevance- The methods, technology, and data reported in this research can serve as an accurate, reliable, and cost-effective means for automated urinalysis in comparison to the existing methods. Furthermore, the ubiquity of smartphones opens new avenues for automated diagnostics in clinical, at-home, and point-of-care settings.

Leukocyte Esterase and Nitrite Urine Reagent Strip Utility Under Altered Assay Conditions in Dogs.

The study evaluated leukocyte esterase (LE) and nitrite reagent pad usefulness in canine urine using multiple time endpoints and decision thresholds. Whole and sedimented urine samples from 116 client-owned dogs were analyzed with reagent strips from four manufacturers. Results for LE and nitrite were recorded every 30 s up to 150 s using "trace" and "+" positive thresholds and compared to microscopic urine sediment analysis and culture results. Sedimented urine assessed at 150 s with a "trace" positive threshold for LE had significantly or trending higher sensitivity (brand dependent) for pyuria detection compared with manufacturer recommendations. Using these parameters, LE sensitivity and negative likelihood ratio were 66.67-89.47%, and 0.13-0.37, respectively. Following manufacturer recommendations, LE specificity and positive likelihood ratio were 96.91-100% and 17.02-30.63, respectively. Nitrite performance for pyuria and bacteriuria detection was poor for all conditions. LE reagent pads are a useful screening test for pyuria detection using sedimented urine and a "trace" positive threshold at 150 s, whereas LE use with traditional manufacturer recommendations is a good confirmatory test for pyuria detection. Nitrite reagent pads are not useful for pyuria or bacteriuria detection.

[Diagnostic value of a novel test paper detection of ECP in nasal secretion for allergic rhinitis].

Objective:To explore the diagnostic value of a novel test paper, which detect eosinophil cationic protein（ECP） of nasal secretion in allergic rhinitis（AR）. Methods:Nasal secretion and serum samples from 107 patients with allergic rhinitis（AR group） and 40 healthy volunteers（control group） were selected. The nasal symptoms were also evaluated in AR group. The degree of ECP coloration was evaluated by nasal secretion eosinophil cationic protein-myeloperoxid（ECP-MPO） test paper, and the concentration of ECP in nasal secretion and the concentration of cytokines in serum were detected at the same time. The difference and correlation among these indexes were analyzed. The best cutoff value and test efficiency of ECP chromogenic grade and concentration of nasal secretion were calculated by receiver operating characteristic curve（ROC）. Results:The concentration of ECP in nasal secretion of AR patients was significantly higher than that of healthy controls（P<0.05）. The color grade of nasal secretion detected by the test paper was positively correlated with the concentration of ECP in nasal secretion（P<0.05）, and there was significant difference among different grades（P<0.05）. There was a satisfying symmetry between the ECP color grade of nasal secretion and the serum specific IgE（sIgE） level as well as a high diagnostic consistency between them（P<0.05）. The area under the curve（AUC） of ECP concentration ROC in nasal secretion was 0.807 2, corresponding to 64% sensitivity and 85% specificity when the cutoff value was set at 0.980 5; when the cutoff value was set at 1, the AUC of nasal secretion ECP color grading was 0.941 9, corresponding to 92% sensitivity and 94% specificity. No clear correlation between the concentration of ECP in nasal secretion and serum cytokines was found（P>0.05）. Conclusion:The results of this novel test paper is in good agreement with those of serological allergens. It could serve as a preliminary test to evaluate the severity of allergy with satisfactory sensitivity and specificity, and is especially suitable in clinical practice for primary hospital.