A preliminary investigation study of islet function assessment / 中国糖尿病杂志

Objective To investigate doctors'knowledge and differences in islet function assessment methods in China.Methods This is a cross-sectional study that conducted by online questionnaire survey.Demographic data,examination items,blood collection point of OGTT,detection method,kit type and follow-up frequency were collected and compared among doctors in different regions,different levels of hospitals,different specialties and different titles.Results 79.2%and 85.1%of physicians believed that the levels of insulin and C-peptide should be measured at the same time to assess islet function in patients with newly diagnosed and follow-up diabetes mellitus patients.Endocrinologists preferred to access insulin and C-peptide at the same time(P<0.05).56.0%of physicians chose bread meal test for T1DM patients and 54.7%for T2DM patients.Compared with non-specialists,endocrinologists preferred to commit bread meal test to T1DM patients(61.4%vs 41.0%,P<0.05).In addition,for the islet function assessment of new-onset diabetes patients,7.6%of physicians chose the six-point method(0,30,60,90,120,180 min),27.3%selected the five-point method I(0,30,60,120,180 min),8.5%selected the five-point method II(0,30,60,90,120 min),9.8%selected the four-point method I(0,30,60,120 min),10.3%selected the four-point method II(0,60,120,180 min),13.8%chose the three-point method(0,60,120 min)and 13.4%chose the two-point method(0,120 min).At the time of follow-up assessment,the above selection rates were 5.3%,20.4%,6.4%,6.6%,9.4%,15.8%and 24.1%,respectively.In terms of the frequency of assessment,39.2%of doctors assessed islet function once a year and 24.7%once every six months.Specialists preferred to assess islet function once a year,and physicians with senior titles chose to assess islet function more variably.Conclusion At present,there are still great differences in assessment methods of islet function in China.It is of great significance for the clinical diagnosis and treatment of diabetes to understand the differences in the selection of islet function assessment methods among doctors in different regions,specialties and job titles.

Development and evaluation of light-initiated chemiluminescent assay for quantitation of milk-specific IgG 4 antibody in human serum / 临床检验杂志

Objective@#To develop and evaluate a beads-based light-initiated chemiluminescent assay (LICA) for quantitation of cow milk component (Bos d 5) specific IgG 4 antibody in human serum. @*Methods@#The sIgG 4 -LICA was performed by incubated serum samples with biotinylated allergens, emission beads coated with mouse anti-human IgG 4 antibody and streptavidin-coated sensitizer beads. The reaction conditions of sIgG 4 -LICA were optimized and the analytical performance was evaluated. @*Results@#The precision of intra-assay, within-day and inter-assay (coefficient of variation) were 1.78% to 3.13%, 6.65% to 8.41% and 7.94% to 12.30%, respectively. The functional sensitivity of this assay was 4.71 ng/mL. For the linear range, the sIgG 4 -LICA had a good linear relationship within the range between 28.13 and 1 800 ng/mL, and the linear regression equation was Y=0.98X-1.31(r 2 =0.997). Maximum dilution limit was 1∶64. The disturbing rates measured by adding hemoglobin, triacylglycerol, total bilirubin, acid resistance and biotin to human sera with different concentrations of Bos d 5 sIgG 4 were from -6.38% to 8.60%. @*Conclusions@#The sIgG 4 -LICA introduced in this study was demonstrated to have effective performance for quantitation of allergen-specific IgG 4 and can meet the need of clinical requirement.

Establishment and performance evaluation of light-initiated chemiluminescent assay for quantitation of prolactin in human serum / 临床检验杂志

Objective@#To establish an analytical method for serum prolactin (PRL) based on the photoinduced chemiluminescence technology, and evaluate its performance. @*Methods@#A pair of PRL monoclonal antibodies were labeled with luminescent nanospheres and biotin respectively, and the double antibody sandwich detection system was formed with the serum prolactin and streptavidin-labeled photosensitive microspheres (universal photosensitive solution) under homogeneous conditions. The performance index and correlation of the detection system were evaluated. @*Results@#The precision of intra-assay and within-day (coefficient of variation) of the developed assay were 4.60% and 5.25%, respectively. The functional sensitivity was 2.48 μIU/mL, and its reportable results were ranged from 2.48 to 4 240 μIU/mL. The recovery rates of different PRL calibrators (42.2, 424, 4 240 μIU/mL) added to human sera were ranged from 96.25% to 102.93%. There was no interference from bilirubin＜20 mg/dL, hemoglobin＜200 mg/dL, triglyceride＜3 000 mg/dL and biotin＜20 ng/mL. Also, the light-initiated chemiluminescent assay for PRL (PRL-LICA) correlated well with Beckman Unicel Dxi 800 Access 2. @*Conclusions@#LICA showed effective performance for detecting PRL in human serum, and it could meet the basic requirements of clinical diagnosis.

Development and application of competitive light-initiated chemiluminescent assay for quantitation of total IgE in human serum / 临床检验杂志

Objective To develop a competitive immunoassay for quantitative determination of total immunoglobin E (tIgE) in human serum based on light-initiated chemiluminescent assay (LICA).Methods The LICA-tIgE assay was performed by incubating serum samples or calibrator with anti-human IgE antibody-coated chemiluminescet beads,biotinylated human IgE and streptavidin-coated sensitizer beads.The working conditions of this assay were optimized,analytical performance was detected and the correlation of tIgE results between LICA and Beckman Coulter IMMAGE 800 was evaluated.Results The precision of intra-assay and inter-assay (coefficient of variation) ranged from 5.50％ to 7.73％ and 6.45％ to 9.90％,respectively.The functional sensitivity of this assay was 12.65 IU/mL.The recovery rates measured by adding IgE calibrators to human sera with different IgE concentrations were ranged from 104.15％ to 109.37％.The disturbing rates measured by adding total bilirubin,hemoglobin and triacylglycerol to human sera with different IgE concentrations were ranged from-4.49％ to 8.46％.Also,the tIgE results of 111 patients measured by LICA correlated well with those by Beckman Coulter IMMAGE 800 (r2 =0.959).Conclusion LICA developed in this study for detecting tIgE of human serum showed effective perfomance and could meet the basic requirements of clinical diagnostic reagents.

Patch Test and Specific IgE Level with Food Antigens in Atopic Dermatitis Patients / 대한피부과학회지

BACKGROUND: Food allergies have been demonstrated to play an important role in the pathogenesis of atopic dermatitis(AD), affecting around 10 to 40% of patients with AD. While immediate-type clinical reactions to food can easily be identified, the evaluation of a food allergy in the absence of immediate clinical reactions still presents diagnostic difficulties. OBJECTIVE: The purpose of this study was to evaluate the diagnostic value of the atopy patch test with regard to late-phase reactions and to evaluate the relationship between patch test and specific serum IgE level. METHODS: We performed the patch test and chemiluminescent assay(CLA) for food antigens(cow's milk, soybean milk and hen's egg) in 45 patients with AD who were suspicious of food-related symptoms and 15 normal controls. RESULTS: 1. Positive reaction of CLA in 45 patients with AD were 7/18(38.9%) for the cow's milk, 5/14(35.7%) for the soybean milk and 4/13(30.7%) for the hen's egg. 2. Positive reaction of the patch test in patients with AD were 5/18(27.8%) for the cow's milk, 6/14(42.9%) for soybean milk and 4/13(30.7%) for hen's egg, but only one(6.7%) for cow's milk in 15 normal controls. 3. A highly significant correlation to food antigens existed between patch test and CLA, but one patient showed a positive reaction in the patch test for soybean milk despite the negative reaction in CLA. 4. There was no significant statistical correlation between the severity of AD and the positive reaction rate of the patch test. 5. There were no significant statistical differences between the age of AD patients and the positive reaction rate of the patch test. CONCLUSION: The atopy patch test seems to be a valuable tool in the diagnostic work-up of food allergies in patients with AD-especially with regard to late-phase clinical reactions.

A Comparison Study of Prick Test and Chemiluminescent Assay / 대한피부과학회지

BACKGROUND: Prick test is most frequently used in clinical procedures because its simplicity and safety of application and better correlation with clinical history as well as specificity and high reproducibility. The chemiluminescent assay(CLA) is a new in vitro non-radioactive modification of radioallergosorbent test(RAST). The CLA permits quick, simultaneous detection of total and specific IgE in human serum. The CLA has shown good sensitivity, specificity, and a good correlation with the RAST and skin prick test. OBJECTIVE: The purpose of this study was to find causative allergens and to evaluate the clinical significance of CLA comparing the results of the CLA with those of the prick test in dermatologic outpatients. METHODS: We performed the prick test with 51 allergens(Bencard Ltd. Brentford, England) in 448 patients, and CLA with 35 allergens(Boehringer mannheim Korea. green cross inc.) in 280 patients with dermatologic diseases. RESULTS: 1. The positive reaction rate was highest in third decade and decreased over the age of 40 in prick and CLA. 2. The positive reaction rate of prick test(52.8%) was higher than that of CLA(25.0%). 3. The positive reaction rate to single allergens and compound allergens was 14.2% and 38.6% in the prick test and 2.5% and 22.5% in the CLA respectively. 4. In the prick test, the positive allergens, in descending order, were House dust 114(25.4%), D. farinae 88(19.6%), D. pteronyssinus 79(17.6%), Mixed inhalants 61(13.6%), and Threshing 47(10.5%). In the CLA Thistle 35(12.5%), Dandelion 31(11.1%), D. farinae 30(10.7%), D. pteronyssinus 29(10.4%), and Cat fur 12(4.3%). 5. The results of the CLA to common 2 allergens showed a concordance rate of 84.6%, sensitivity of 58.9%, and specificity of 86.1% compared with those of prick test. CONCLUSION: CLA may be a useful alternative method and shows a good correlation with the prick test. Combination of the two method results in a high diagnostic accuracy for the cause of allergic diseases.

Comparison of MAST Chemiluminescent Assay(MAST-CLA) with Skin Prick, Test in Patients with Atopic Dermatitis / 대한피부과학회지

BACKGROUND: Allergic reactions are known to be associated with symptomatic aggravation of atopic dermatitis. Skin prick tests were used as a routine in vivo screening test for the evaluation of allergic patients. Many tests to detect specific IgE antibody including RAST, FAST and MAST chemilu-minescent assay (MAST-C~LA) were also used. Previous studies revealed that the results of skin prick tests and MAST-CLA were well correlated in patients with asthma, allergic rhinitis and urticaria. OBJECTIVES: The purpose of this study was to evaluate the effectiveness of MAST-CLA compared with skin prick tests in patients with atopic dermatitis. METHODS: We performed the chemiluminescent assay with 35 allergens and skin prick tests with 23 allergens common with allergens used in MAST-CLA in 34 patients with atopic dermatitis. The positive reaction rate of allergens in each test and sensitivity, specificity, efficiency, positive predictive value and negative predictive value of MAST-CLA to the skin prick test were evaluated and MAST net volts of serum total IgE was compared with PRIST.

Patch test and Specific IgE Concentration with House Dust Mite Antigens in Atopic Dermatitis Patients / 대한피부과학회지

BACKGROUND: Recently several papers have been published dealing with positive patch reactions to house dust mite antigens in atopic dermatitis patients. The possibility that house dust mite antigens, brought in direct contact with the skin such as through the air, may contribute in the pathogenesis of the dermatitis, is an interesting aspect of the relationship between atopic dermatitis and allergic reactions. OBJECTIVE: The purpose of this study is to evaluate type-IV and type-I hypersensitivity to house dust mite antigens in atopic dermatitis patients. METHODS: We performed the patch test and chemiluminescent assay(CLA) for house dust mite antigens in 42 patients with atopic dermatitis and 10 normal controls. RESULTS: 1. Positive reactions of the patch test in patients with atopic dermatitis were 11(26.2% ) for the Df antigen and 10(23.8%) for the Dp antigen. 2. Positive reactions of CLA in 42 patients with atopic dermatitis were 12(28.5%) for both Df and Dp antigen, but only one(10%) for both Df and Dp antigen in 10 normal controls. 3. A highly significant correlation to house dust mite antigens existed between the patch test and CLA, but some patients showed a positive reaction in the patch test despite the level of IgE which was in class 1 or 0. 4. There was no significant statistical correlation between the severity of atopic dermatitis and the positive reaction rate of both the patch test and CLA CONCLUSION: These results suggested that in atopic dermatitis patients with positive patch test reactions to house dust mite antigens, delayed type hypersensitivity reactions to these antigens might play an important role in the development of atopic dermatitis skin lesion .

A Study of Patients with Chronic Urticaria Using the Chemiluminescent Assay and Prick Test / 대한피부과학회지

BACKGROUND: The chemiluminescent assay(CLA) is a new in vitro non-radioactive modification of the radioallergosorbent test(RAST). The CLA permits quick, siultaneous detection of total and specific IgE in human serum up to 35 different allergens, as well as their semiquantitative concentrations into classes from 0(negative) to 4(very high). The CLA has shown sensitivity, specificity, and a good correlation with the RAST and also with skin pick testing. OBJECTIVE: The purpose of this study was to find the causatix llergens and to evaluate the clinical significance of CLA comparing the results of tbe CLA wi! h hose of the prick test in patients with chronic urticaria. METHODS: We performed the CLA with 35 allergens(MAST immunosunosystems, Inc., California, America) and the prick test with 51 allergens(Bencard Ltd., Bricantord, England) in 70 patients with chronic urticaria. The CLA detects the allergen-IgE reactic say the use of an enzyme-labeled anti-IgE and a coupled photoreagent mixture. lhe amount of the luminescent energy is measured by exposing a polarcid film and then semiquantitation is a sessed by using a densitometer. RESULTS: Except for those over the age of 60, all age-groups ealed a similar positive reaction to the CLA and prick test, but the positive reaction rate o the prick test(91.4%) was higher than that of the CLA(38.6%). The positive reaction rate oringle allergen and compound allergens was 10.0% and 28.6% in the CLA, but 10.0% and 81.4% in the prick test, respectively. In the CLA, the rate of positive reaction was 17(24.3%) in Dermatophagoides(D.) farinae, 15(21.4% ) in D. pteronyssinus, 5(7.1% ) in house dust, an 13(4.3%) in shrimp in that order. In the prick test, the rate of positive reaction was 39(55.7%) in house dust, 35(50.0%) in D. farinae, 29(41.4%) in D. pteronyssinus, and 21(30.0%) in haydrst(30.0%) in that order. The results of the CLA to 3 comrnon allergens showed a concordance rare of 67.6%, sensitivity of 34.3%, and specificity of 97.3% compared with those of the prick case. The levels of total IgE and eosinophils were elevated in 59(n=70, 843%) and in 5(n=56, 84.3%), respectively. CONCLUSION: The results of this study suggest that the CLA may be used as an alternative method for the diagnosis of chronic urticaria because it is and coiomic, safe, simple procedure with very high specificity and trelative low sensitivity, and is sirnilt. neously capable of testing to multiple allergens.