Clinical Test Report
Concluded by: Shanghai Chemtron Biotech Co.,Ltd
To evaluate the sensitivity, specificity and conformity rate of the FOB test produced by Shanghai Chemtron Biotech Co.,Ltd.
1.Qilu Hospital Affilliated to Shandong University
Affiliated to Shandong University, an integrity unversity belong to China Ministry of Education. It is the national clinical base for pharmacology.
2.Xinhua Hospital Affilliated to Shanghai No. 2 Medical University
The first integrity educational hospital established after the establishment of P.R.C in Shanghai. Now it is affilliated to Shanghai No.2 Medical University.
3.Changzheng Hospital Affilliated to The Second Military Medical University
An educational hospital affilliated to The Second Military Medical University, the natioanal clinical base for pharmacology.
III.Material and Method
1.1Chemtrue FOB test strip, produced by Shanghai Chemtron Biotech Co.,Ltd, Lot No. 20031001, within the expiry.
1.2FOB test strip, producted by Beijing WHPM, Lot No. 20030906, within the expiry.
1.3Chemical Reagent: Phenilphthalin or Benzidine, provided by each hospital.
2.Specimen and Resource
Totall specimen: 1112 pcs. Provided by each hospital’ digestion section, anorectum section, including peptic ulcer, colonic polyp, colon tumor and none digestive tract disease confirmed by endoscope or other methods.Collect the patients’ feces as specimens.
3.Specimen Collection and Treatment
3.1Collect the feces into clean and dry containers.
3.2Prepare a tube, put on a tube rack, add 0.6ml distilled water into the tube.
3.3Collect enough specimen from different angles of the feces.
3.4Put the specimen into the saline tube, and mix completely.
3.5The feces specimen should be used in 4 hours, if unable to test immediately, it can be stored 2~3 days under 2~8℃.
4.1The operation of Chemtrue FOB test and WHPM FOB test are same, the details are as follow:
4.1.1Remove the test strip from te foil pouch, and return to room temperature(around 25℃).
4.1.2Mix the feces compeltely
4.1.3Take out the FOB strip, dip the strip into the mixed solution. Do not exceed the MAX line. Put the strip on a flat surface and wait the test result.
4.1.4Read the result in 3-5 minutes. Strong positive result can be shown in 3 minutes, pls do not read the result after 5 minutes to ensure the accuracy.
4.1.5Read Results: 2 lines, positive; only C line, negative; no C line, invalid.
4.1.6Quality control: Test the control before testing to ensure the accuracy.
4.2Phenilphthalin method, conducted by hospital standard.
4.3Benzidine method, conducted by hospital standard.
1. Totally 1112 specimens are tested, see table below:
2. Test results:
Compared with WHPM FOB test, Chemtrue FOB test:
Positive Predictive Value: 288/291=98.9%
Negative Predictive Value: 816/821=99.4%
Conformity Rate(Rough Rate): (288+816)/1112=99.3%
3.Chemtron, WHPM FOB test and Chemical Test Result:
The FOB test produced by Shanghai Chemtron Biotech Co.,Ltd, by testing 1112 pcs feces specimens, compared with WHPM FOB test, the sensitivity is 98.3%, specificity 99.6%, positive predictive value is 98.9%, negative predictive value is 99.4%, conformity rate is 99.3%.
Clinical test shows, the false positive rate is high by using chemical method to test fecal occult blood.
Chemtrue FOB test has very good conformity rate in sensitivity and specificity with WHPM FOB test which is already registered in China, it can be used as an aid of diagnosis for digestive tract bleeding.