Clinical evaluation is made on H.P Antibody Detection Test (golden colloid) manufactured by Chemtron Biotech Inc. and 1034 cases are analysed . Compared with 14 C-UBT,the sensitivity is 92.9%,specification is 96.2% and accordance rate is 94.3%.The accordance rate between the two detection methods is very high.The test is non-invasive,rapid ,simple and of high sensitivity and specification. It can be use as an aid in the diagnosis of H.P infection.
Helicobater pylori are gram negative bacteria that infect gastric mucosa. Infection with Helicobacter pylori may lead to chronic gastritis and predispose to gastric and duodenal ulcers. Infection with H.pylori is very common and has been estimated to occur in 40-50% of the population in developed countries and 80-90% of the population in developing countries. Now H.P. has been listed on the first catalogue of cancer-resulting factors. The early detection of H.P infection is useful for the early treatment and prevent the further damage to the human body.
Several techniques, both invasive and non-invasive have been utilized to diagnose H.pylori infection. The urea breath test is based on the detection of labeled carbon dioxide in expired air as a result or urease production by H.pylori. Serological tests are based on the detection of a specific anti-H.pylori antibody, mostly by IgG antibodies in a patient’s blood.
Different invasive techniques are used for the diagnosis of H.pylori infection. One of which is the endoscopic biopsy of antrum or corpus of stomach to detect H.pylori by specialized stains such as Giemsa, culture and rapid urease test. These methods need special laboratory equipment and trained technicians. Also, the culture method takes a long time to produce a result. Serological approaches detect the host’s immune response to the infection, but do not permit a doctor to distinguish a current active infection from a past infection. In addition, the antibody titer does not change during the treatment. The 14 C-UBT and 13 C-UBT and N15 emission test is with a relatively high cost ,a restriction by specialized reagents and particular detection equipment but a accurate results. It’s regarded as the golden standard of the Helicobater pylori detection.
The Chemtrue H.pylori Antibody Rapid Test is a chromatographic immunoassay for the qualitative determination of anti-H.pylori. IgG antibodies in human serum, plasma and whole blood .It can be used extensively in the initial screening or as an aid in the diagnosis of H.P infection and the examination in the prognosis.
2.Purpose for evaluation
To evaluate the clinical performance of Chemtron H.P antibody test such as sensitivity ,specification and accuracy and etc.
3.The design of Clinical trial
3.1 The samples of clinical trial
3.2 There are 1034 cases in this trial ,consisted of 706 male cases and 328 female cases, aging from 15-82 .
3.3 Materials of trial
3.3.1Chemtron HPAb test (golden colloidal) ,batach No.20060402,20060703
3.3.214 C-UBT test: manufactured by China nuclear –dewei biotech ltd. National Medicine Licence No.S20000021,batch No.20060501,20080301
3.3 Method of evaluation:
3.3.1 Every sample is tested by Chemtron H.P.test and 14 C-UBT respectively and make a comparison.
3.3.2 Test procedure: Operate according to the product instruction.
4.Results of clinical trial
Results of tests on 1034 cases compared with 14 C-UBT
14 C-UBT positive 590,negative 444;Chemtron H.P. antibody test (golden colloidal) positive 565,negative 469;Positive in common 548,negative in common 427.
Compared with 14 C-UBT,Chemtron H.P. antibody Test(golden colloid ):
Sensitivity=548/(548+42) * 100%=92.9%
Predicting value of postive tests=548/(548+17)*100%=97.0%
Predicting value of negative tests=427/(42+427)*100%=91.0%
Results of clinical tests shows:Compared with 14 C-UBT test,the sensitivity of Chemtron H.P.Antibody test is 92.9%,specification is 96.2% and accordance rate is 94.3%.It has a high rate of accordance and a good clinical performance.The test procedure is rapid and simple and can be used as an aid in the detection of H.P. infection.