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OBJECTIVE：To explore the feasibility of using colloidal gold immunochromatography for quantitative detection of aflatoxin B1 in traditional Chinese medicine. METHODS：Negative samples were used to investigate matrix interference by different levels of spikes.The rapid inspection performance was evaluated by examining the precision, sensitivity, linearity, repeatability and recovery rate. The sample was determined by rapid test method and verified by HPLC. RESULTS：High-concentration and low-concentration aflatoxin B1 reference materials were added to the negative sample matrix. After the measurement, it was found that there were matrix interferences in the samples such as tangerine peel and cassia seed, and the interference was greater when the concentration was increased. So high dilution factor was used to reduce the interference. The precision RSD of the rapid test method was 4.6% (n=10), the reproducibility RSD was 4.1% (n=6), and the recoveries of different samples were between 72.8% and 112.8%. The overall performance of the method was good. A total of 43 batches of 19 kinds of medicinal materials such as silkworm, cockroach and leeches were detected by two methods. The coincidence rate between the fast test and the HPLC test was 83.7%. Therefore, the results obtained by the two detection methods were considered to be approximate. CONCLUSION：Colloidal gold immunochromatographic rapid test method can be used for the quantitative detection of aflatoxin B1 in some traditional Chinese medicines, and provides technical support for the establishment and improvement of relevant rapid detection standard methods.
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Objective Comparison the coincidence rate in the colloidal gold method and the passive agglu-tination method to detect mycoplasma pneumoniae (MP) infection, discuss the clinical value in rapid diagnosis of MP infection in the two methods. Methods Two-hundred patients with MP infection, including 100 cases in the the children group, and 100 cases in the adult group, were detected in MP-IgM antibody in serum with the colloidal gold method and the passive agglutination method. Results The positive rate of MP-IgM antibody with the passive agglutination method were slightly higher than that of the colloidal gold method in the children group (P > 0.05), While the positive rate of MP-IgM antibody with the passive agglutination method in the adult group were signifi-cantly higher than that of the colloidal gold method (P<0.05). When the antibody titer of MP-IgM antibody were 1:60, ≥1:320 in the children group, the coincidence rate of the positive results with the colloidal gold method and the passive agglutination method were 95.40%, 95.30%;When the antibody titer of MP-IgM antibody were 1:80, 1:160,≥1:320 in the adult group, the coincidence rate of the positive results with the colloidal gold method and the passive agglutination method were 0, 61.90%, 63.80%. Conclusions In the pediatric MP infection, for the high an-tibody titer of MP-IgM antibody, the positive coincidence rate with the colloidal gold method can reach clinical diag-nostic requirements. Clinical physicians according to the age and disease process of patients choose the appropriate method in order to realize the simple, rapid and accurate diagnosis of mycoplasma pneumoniae infection.
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Objective To investigate the clinical effect of enzyme linked immunosorbent assay (ELISA) in detecting hepatitis C antibody. Methods 200 cases of patients with hepatitis C was measured by ELISA, the gold standard method for detection of hepatitis C virus antibody, recording the test results, the data input SPSS software to give the corresponding analysis and conclusions. Results 200 cases of patients with hepatitis C were successfully completed the gold standard method and ELISA method for detection of hepatitis C virus antibody, the analysis showed that positive rate of ELISA method for detection of hepatitis C virus antibody was significantly higher than that of the gold standard method, the positive rate of ELISA was 82.50％, the positive rate of the gold standard method for was 50.00％, results suggested that HCV detection rate of ELISA method is significantly better (P<0.05). Conclusion The method of ELISA can be used for the detection of hepatitis C antibody, which has positive significance in improving the diagnostic accuracy of hepatitis C, and is beneficial to protect the efficacy and quality of life of patients.
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Objective:To study the correlation between chronic urticaria and Helicobacter pylori infection,and to explore the significance of HP detection in the diagnosis and treatment of chronic urticaria. Methods: Totally 420 cases of chronic urticaria,who were treated in outpatient department from April 2014 to July 2015,and 450 cases of healthy physical people were selected randomly as healthy control group in the same period,then the serum HP unease antibody was detected by colloidal gold method,the positive rate of two groups patients with HP was analysed. Meanwhile 162 chronic urticaria patients with positive HP were divided into experimental group with 88 cases and control group with 74 cases. The patients in the control group were treated with conventional treatment,while the experimental group were treated with triple therapy based on the treatment of control group,and the clinical efficacy of different ther-apeutic methods was analysed in the chronic urticaria patients with positive HP. Results: The positive rate of HP in chronic urticaria group was 38. 6%, and the positive rate of HP in healthy control group was 14. 4%, the difference was statistically significant ( P<0. 05). The effective rate of clinical efficacy in the experimental group was significantly higher than the control group(P<0. 05). Con-clusion:There is close correlation between chronic urticaria and HP infection,HP detection has important clinical significance for the diagnosis and treatment of chronic urticaria.
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Objective To use the syphilis helicoid gelatin aggregation experiment (TPPA ) method to compare the results of syphilis serological detection reagents between the ELISA method and the colloidal gold method for evaluating the clinical applica ‐bility of each detection reagent .Methods 6 291 serum samples were selected from the hospitalized patients before surgery or before blood transfusion ,and performed the preliminary screening detection by the ELISA method (reagent A and B) and the colloidal gold method ,the positive or weakly positive specimens in preliminary screening were performed the confirmation test by the TPPA method .Results In 6 291 serum specimens ,the positive cases of the reagent A ,reagent B and colloidal gold method were 66 ,64 and 56 cases respectively ,the positive detection rate of colloidal gold method had no obvious difference between the reagent A and rea ‐gent B (P> 0 .05) .The positive samples were confirmed to be 66 cases by TPPA ,including 61 cases of reagent A and reagent B positive ,and the colloidal gold method had 56 cases .5 cases of reagent A positive and 3 cases of reagent B positive were confirmed to be 3 and 2 cases by TPPA respectively ,the sensitivity of the colloidal gold method had significant difference between the reagent A and reagent B(P< 0 .05) .Conclusion ELISA method has high sensitivity and is easy to realize the automated enzyme‐linked im‐munoassay ,which is suitable for the screening of the patient sample before surgery or before blood transfusion .The colloidal gold method has low sensitivity ,but high specificity ,is simple and convenient which is suitable for large‐scale healthy physical examina‐tion and preliminary screening test before emergency surgery .In order to avoid medical disputes ,the positive samples by the ELISA method and colloidal gold method should be confirmed by the TPPA method .
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Objective To explore colloidal gold method used to detect fecal occult blood tests(FOB)detection capability and establish the laboratory standard operation of detecting FOB limit of blank(LOB),limit of detection (LOD)and quantifica-tion limit (LOQ)according to the CLSI document《Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures;Approved Guideline-Second Edition》(EP17-A2),in order to reduce the false negative rate of the weakly positive samples,and to provide a way of quantitative detection for qualitative detection of colloidal gold method.Methods Detected series of solution of hemoglobin made of dissolved fresh whole blood with the ELISA kit of human free hemoglobin,and es-tablished the standard curve of detection of FOB with colloidal gold method.Detected the blank samples and a series of low concentration samples with the colloidal gold test strip of FOB and measured the color bands by the Nato Checker710.The quantitative results obtained were statistically analysised by SPSS 1 9.0 and calculated blank limit,detection limit and quanti-fication limit.Results The LOB,LOD and LOD were 99.01,340.48 and 354.9 ng/ml according to the methods in CLSI EP1 7-A2 ducument.Conclusion The detection limits established by CLSI EP1 7-A2 document was more scientific in j udge-ment positive or negative to FOB than which used naked eye and can meet the clinical laboratory and clinical doctor require-ment better.Clinical laboratories should be strictly in detection limits of reagents in order to ensure their effectiveness,and should be generaly to other tests based on colloidal gold method.
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Objective To know the application of MPB64 antigen detection of immune colloidal gold method for identification of Mycobacterium.Methods Taking the PCR amplified sequencing method as the 'gold standard',a total of 418 clinical isolated mycobacterium tuberculosis and 2 standard strains were tested by immune colloidal gold method,and was compared with the traditional method of PNB/TCH.Results Compared with sequencing method,the coincidence rate of immune colloidal gold method and PNB/TCH identification test was 95. 93%and 87. 08%respectively.The sensitivity, specificity,positive predictive value (PPV ) and negative predictive value (NPV ) of immune colloidal gold method identification were 88. 41%,99. 64%,99. 19% and 94. 58%respectively.It costs MPB64 immune colloidal gold method 15 minutes to carry out the results,less than 28 days of the traditional method,as well as 3 days of sequencing method. Conclusion Compared with PNB/TCH method,MPB64 immune antigen colloidal gold method has higher specificity and sensitivity,and could be applied in identification of Mycobacterium.
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Objective To evaluate the Diagnostic value of pulmonary tuberculosis to detecting the anti Mycobacterium tuberculosis antibody with serum samples by the mycobacterium tuberculosis protein Chip and the M.tuberculosis Antibody Colloidal Gold Diagnostic Kit.Methods Application of mycobacterium tuberculosis protein Chip and the M.tuberculosis Antibody Colloidal Gold Diagnostic Kit to detecting the anti Mycobacterium tuberculosis antibody with serum samples,These serum samples are from 110 cases of tuberculosis patients,60 cases of lung disease and 60 cases of healthy people.Results Mycobacterium tuberculosis protein chip sensitivity was 73.6％ (81/110),the specificity was 93.3％ (112/120),the diagnostic kit for detection of Mycobacterium tuberculosis antibody colloidal gold assay sensitivity was 64.5％ (71/110)and a specificity of 91.7％ (110/120),both the sensitivity and specificity compared to no significant difference (P ＞ 0.05).Conclusions The Tuberculosis protein chip and the M.tuberculosis Antibody Colloidal Gold Diagnostic Kit to detect serum Mycobacterium tuberculosis antibodies for diagnosis of TB has a high sensitivity and specificity.Both can be used for the auxiliary diagnosis of tuberculosis.