快乐飞艇官方网址

快乐飞艇平台: Report of Chemtron H.P.Antibody Detection Test(golden colloid)

Abstract:
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.


1.Introduction

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%
Specification=427/(17+427)*100%=96.2%
Accordence rate=(548+427)/(548+17+42+427)*100%=94.3%
Predicting value of postive tests=548/(548+17)*100%=97.0%
Predicting value of negative tests=427/(42+427)*100%=91.0%

5. Conclusion
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.?
Related News
  • Drug Test: Development Ahead Of Test

    Drug Test: Development Ahead Of Test

    March 30, 2018The International Association of Athletics Federations (IAAF) in 1928 had declared doping as illegal drugs. But until 40 years later, that is, the 1968 Mexico Olympic Games, for the first time had dru...view
  • Fertility Test Before Pregnancy

    Fertility Test Before Pregnancy

    March 30, 2018What is a fertility test?A fertility test refers to the systematic and multiple detection of the medical history, occupation, diet, living environment, female ovulation, oviduct function, ovarian func...view
  • The Importance Of Hormone Test

    The Importance Of Hormone Test

    March 30, 2018Hormones is originated from the Greek, that is incretion, meaning "activated." Later scholars defined it as chemical substances which produce by endocrine organ , and then released into the blood circ...view
  • Salmonella Antigen Test Clinical Study

    Salmonella Antigen Test Clinical Study

    March 30, 20181. ProfileSalmonella belongs to enterobacteriaceae, it is a conditional intracellular parasitism gram-negative enteric bacilli, it is (0.6~0.9) × (1~3) um in size, without spore and usually without c...view
  • Market Analysis Of Infectious Diseases Test

    Market Analysis Of Infectious Diseases Test

    March 30, 2018In recent years, with the increasingly serious global microbial resistance and pathogen mutation problem, in vitro diagnostic of infectious diseases has become a major academic research hot spot of ma...view
  • Fecal Occult Blood Test (Colloidal Gold)

    Fecal Occult Blood Test (Colloidal Gold)

    December 28, 2017I.Test Purpose To evaluate the sensitivity, specificity and conformity rate of the FOB test produced by Shanghai Chemtron Biotech Co.,Ltd.view
  • TEL:+86-21-68129666
  • FAX:+86-21-68129222
  • EMAIL:[email protected]
  • ADDRESS:No.518, Qingdai Rd., International Medical Park, Pudong, 201318, Shanghai, P.R.China