| Helicobacter pylori(H.pylori) was found out first and isolated cultured by Warren andMarshall in1983from a chronic gastritis patient’s gastric mucosa.H.pylori can adhere togastric mucosa and produce several kinds of toxins to impair gastric mucosa,such asurease,vacuolating cytotoxin and cytotoxin associating gene protein. A lot of scientists revealedthat H.pylori infection is strongly as soxiated with gastritis,peptic ulcer disease,gastriccancer,mucosa-associtaed lymphoid tissue lymphoma and coronary heart disease,et al. TheH.pylori infection rates of gatreic ulcer(GU) and duodenal ulcer(DU) patients are84%and95%. Eradicating H.pylori can significantly promote healing ulcer and descend recurrence rate.Can use the biopsy specimens of gastric juice, gastric mucosal breath, feces and urine,serum, and other specimens for the diagnosis of Helicobacter pylori infection, and according tothe selection method in the diagnosis of different diseases, diagnosis and treatment process,economic conditions and equipment conditions, generally can be divided into invasive andnon-invasive. In recent years, many foreign literature for Helicobacter pylori antigen detectionas a noninvasive diagnostic method has been used in clinical, with sensitivity and specificityare good, wider application range, can be used for children, the elderly, pregnant women,chronic renal failure and liver cirrhosis patients and other special populations, with highclinical application value, antigen detection method using monoclonal antibody based which,accuracy is more ideal. But after so many years of development and improvement of immunitychromatography technology, methods for detecting Helicobacter pylori antigen so far have notseen widespread application, the reason for the detection methods of Helicobacter pyloriantigen of production technology is not yet mature, uneven, some good and some badHelicobacter pylori detection reagent quality families make, can only be used for clinicalresearch, not as a clinical diagnosis. According to the State Food and drug supervision andManagement Bureau official website, at present there is no domestic production technology ofHelicobacter pylori antigen and products to obtain the State Food and drug supervision andmanagement approved the production license.Production process is the main purpose of this study is to establish a set of high sensitivity,high specificity, safe and effective Helicobacter pylori antigen detection kit, can detectHelicobacter pylori effective use of Helicobacter pylori antigen detection kit to produce. Thiscan help hospitals Helicobacter pylori antigen detection reagent for clinical unit effectivediagnosis of Helicobacter pylori, also for patients with effective drug to guarantee, the method of detecting Helicobacter pylori antigen in future application has a positive effect.Based on the existing research results at home and abroad, to establish a productionprocess and quality control of a high sensitivity, high specificity, safe and effectiveHelicobacter pylori antigen detection kit. The production process includes antibody and themain raw material selection and use of parameters, the production process to identify criticalcontrol point determination, production, production operation rules to determine the productionequipment, use of parameters. Kit including the quality control analysis of sensitivity, detectionand analysis of specific. This research finally according to the production process and qualitycontrol of the formation of detection reagent, the reagent products were validated by2001cases of large quantities of clinical trials, the quality standard products, confirmed toHelicobacter pylori antigen detection test agent for the production of this research formed theproduction process, quality control method of Helicobacter pylori antigen detection the reagentof formation energy quality detection for Helicobacter pylori antigen detection kit effectively. |
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