Accu-Tell® H.pylori Antigen Rapid Test Cassette (Feces)
|Product Name||Specimen||Catalog No.||Quantity per box||Certificate|
|H.pylori Antigen Cassette||Feces||ABT- IDT-B76||40T/20T||CE|
Detection for: Helicobacter pylori (H. pylori) antigens in human feces.
Specimen volume: Refer to the test procedure;
Reading time: 10 minutes;
Relative sensitivity: >99.9% (95%CI*: 96.2%~100.0%);
Relative specificity: 98.1% (95%CI*: 93.2%~99.8%);
Accuracy: 98.9% (95%CI*: 96.1%~99.9%).
H.pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis. Both invasive and non-invasive methods are used to diagnose H.pylori infection in patients with symptoms of gastrointestinal disease.
ACCU-TELL® H.pylori Antigen Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of H. pylori antigens in human feces specimens to aid in the diagnosis of H. pylori infection.
1. To collect fecal specimens:
Collect sufficient quantity of feces (1-2mLor1-2g) in a clean, dry specimen collection container to obtain maximum antigens (if present). Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8°C if not tested within 6 hours. For long term storage, specimens should be kept below -20°C.
2. To process fecal specimens:
For Solid Specimens:
Unscrew the cap of the specimen collection tube，then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites to collect approximately 50mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.
For Liquid Specimens:
Hold the dropper or pipette vertically, aspirate fecal specimens, and then transfer 2 drops (approximately 80μL) into the specimen collection tube containing the extraction buffer.
Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the tube alone for 2minnutes.
3. Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
4. Hold the specimen collection tube upright and open the cap onto the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
5. Read results at 10 minutes after dispensing the specimen. Do not read results after 20 minutes.
Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80μL of supernatant, dispense into the specimen well (S) of a new test cassette and start afresh following the instructions mentioned above.
|ACCU-TELL® H.pylori Antigen Rapid Test Cassette (Feces)||Results||Positive||Negative|
Relative sensitivity: 78/78=>99.9% (95%CI*: 96.2%~100.0%);
Relative specificity: 101/103=98.1% (95%CI*: 93.2%~99.8%);
Accuracy: (78+101)/(78+103) =98.9% (95%CI*: 96.1%~99.9%).
Within-run precision has been determined by using 15 replicates of four specimens: negative, low titer positive, middle titer positive and high titer positive specimens. The specimens were correctly identified >99% of the time.
Between-run precision has been determined by 15 independent assays on the same four specimens: negative, low titer positive, middle titer positive and high titer positive specimens. Three different lots of ACCU-TELL® H.pylori Antigen Rapid Test Cassette (Feces) have been tested using these specimens. The specimens were correctly identified >99% of the time.
Cross reactivity with following organisms has been studied at 1.0E9 organisms/ml. The following organisms were found negative when tested with ACCU-TELL® H.pylori Antigen Rapid Test Cassette (Feces):
Acinetobacter spp Acinetobacter calcoaceticus Branhamella catarrhalis
Candida albicans Chlamydia trachomatis E.coli
Enterococcus faecalis Enterococcus faecium Gardnerella vaginalis
Group A Streptococcus Group B Streptococcus Group C Streptococcus
Hemophilus influenza Klebsiella pneumonia Neisseria gonorrhea
Neisseria meningitides Proteus mirabilis Proteus vulgaris
Pseudomonas aeruginosa Rotavirus Salmonella choleraesius
Staphylococcus aureus Adenovirus
1. ACCU-TELL® H.pylori Antigen Rapid Test Cassette (Feces) is for in vitro diagnostic use only. The test should be used for the detection of H. pylori antigens in feces specimens only. Neither the quantitative value nor the rate of increase in H. pylori antigens concentration can be determined by this qualitative test.
2. ACCU-TELL® H.pylori Antigen Rapid Test Cassette (Feces) will only indicate the presence of H.pylori in the specimen and should not be used as the sole criteria for H. pylori to be etiological agent for peptic or duodenal ulcer.
3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of H. pylori infection.
5. Following certain antibiotic treatments, the concentration of H. pylori antigens may decrease to the concentration below the minimum detection level of the test. Therefore, diagnosis should be made with caution during antibiotic treatment.
Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.