Diagnostic Kit for Antigen to Helicobacter Pylori(Fluorescence Immunochromatographic Assay)
For in vitro diagnostic use only
Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

INTENDED USE
Diagnostic Kit for Antigen to Helicobacter Pylori (Fluorescence Immunochromatographic Assay) is suitable for the quantitative detection of human faeces HP antigen by fluorescence immunochromatographic assay, which has important accessory diagnostic value for gastric infections. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY
Gastric helicobacter pylori infection is closely related with chronic gastritis, gastric ulcer, gastric adenocarcinoma, gastric mucosa associated lymphoma, H.p ylori infection rate of about 90% in gastritis, gastric ulcer, duodenal ulcer and gastric cancer patients. The world health organization has identified h. pylori as the first type of cancer-causing factor and is clearly a risk factor for gastric cancer.H.pylori detection is of great value in the diagnosis of h. pylori infection.The test based on fluorescence immunochromatographic assay analysis technics, which can give a result within 15 minutes.

PRINCIPLE OF THE PROCEDURE

The strip has anti-HP coating antibody on test region, which is fastened to membrane chromatography in advance. Lable pad is coated by fluorescence labeled anti-HP antibody in advance. When testing positive sample, the HP in sample can be mixed with fluorescence labeled anti-HP antibody, and form immune mixture. As the mixture is allowed to migrate along the test strip, the HP conjugate complex is captured by anti-HP coating antibody on the membrane and forms complex. The fluorescence intensity is positively correlated with the HP content. The HP in sample can be detected by fluorescence immunoassay analyzer.

REAGENTS AND MATERIALS SUPPLIED

25T package components：
Test card individually foil pouched with a desiccant 25T
Sample diluents 25T
Package insert 1

MATERIALS REQUIRED BUT NOT PROVIDED
Sample collection container,timer

SAMPLE COLLECTION AND STORAGE
1.Use a disposable clean container to collect fresh faeces sample, and tested immediately. If can not be tested immediately, please stored at 2-8°C for 3 days or below -15°C for 6 months.
2.Take out the sampling stick, inserted into the faeces sample,repeat the action 3 times, take the different parts of the faeces sample each time, then put the sampling stick back, screw tight and shake well, Or using the sampling stick picked about 50mg faeces sample, and put in a faeces sample tube containing sample dilution, and screw tightly.
3.Use disposable pipette sampling take the faeces sample from the diarrhea patient, then add 3 drops (about 100µL) to the fecal sampling tube and shake well.

Notes:
1.Avoid freeze-thaw cycles.
2.Thaw samples to room temperature before use.

ASSAY PROCEDURE
Please read the instrument operation manual and package insert before testing.
1.Lay aside all reagents and samples to room temperature.
2.Open the Portable Immune Analyzer(WIZ-A101), enter the account password login according to the operation method of the instrument, and enter the detection interface.
3.Scan the dentification code to confirm the test item.
4.Take out the test card from the foil bag.
5.Insert the test card into the card slot, scan the QR code, and determine the test item.
6.Remove the cap from the sample tube and discard the first two drops diluted sample, add 3 drops (about 100uL) no bubble diluted sample verticaly and slowly into sample well of the card with provided dispette.
7.Click the “standard test” button, after 15 minutes, the instrument will automatically detect the test card, it can read the results from the display screen of the instrument, and record/print the test results.
8.Refer to the instruction of Portable Immune Analyzer(WIZ-A101).

EXPECTED VALUES
HP-Ag<10
It is recommended that each laboratory establish its own normal range representing its patient population.

TEST RESULTS AND INTERPRETATION
1.The HP-Ag in sample is more than 10, and should rule out the change of the physiological state. The results are indeed abnormal and should be diagnosed with clinical symptoms.
2.The results of this method are only applicable to the reference ranges established in this method, and there is no direct comparability with other methods.
3.Other factors can also cause errors in detection results, including technical reasons, operational errors and other sample factors.

STORAGE AND STABILITY
1.The kit is 18 months shelf-life from the date of manufacture. Store the unused kits at 2-30°C. DO NOT FREEZE. Do not use beyond the expiration date.
2.Do not open the sealed pouch until you are ready to perform a test, and the single-use test is suggested to be used under the required environment (temperature 2-35℃, humidity 40-90%) within 60 mins as quickly as possible.
3.Sample diluent is used immediately after being opened.

WARNINGS AND PRECAUTIONS
.The kit should be sealed and protected against moisture.
.All positive specimens shall be validated by other methodologies.
.All specimens shall be treated as potential pollutant.
.DO NOT use expired reagent.
.DO NOT interchange reagents among kits with different lot No..
.DO NOT reuse test cards and any disposable accessories.
.Misoperation, excessive or little sample can lead to result deviations.

LIMITATION
.As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen. Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA. Such specimens may cause false positive or false negative results.
.This test result is only for clinical reference, should not serve as the only basis for clinical diagnosis and treatment, the patients clinical management should be comprehensive consideration combined with its symptoms, medical history, other laboratory examination, treatment response, epidemiology and other information.
.This reagent is only used for fecal tests. It may not obtain accurate result when used for other samples such as saliva and urine and etc.

PERFORMANCE CHARACTERISTICS

REFERENCES

1.Shao,J.L.&F.Wu.Recent advances in the detection methods of Helicobacter pylori[J].Journal of Gastroenterology and Hepatology,2012,21(8):691-694
2.Hansen JH,et al.HAMA Interference with Murine Monoclonal Antibody-Based Immunoassays[J].J of Clin Immunoassay,1993,16:294-299.
3.Levinson SS.The Nature of Heterophilic Antibodies and the Role in Immunoassay Interference[J].J of Clin Immunoassay,1992,15:108-114.

Key to symbols used:

	In Vitro Diagnostic Medical Device
	Manufacturer
	Store at 2-30℃
	Expiration Date
	Do Not Reuse
	CAUTION
	Consult Instructions For Use

Xiamen Wiz Biotech CO.,LTD
Address:3-4 Floor,NO.16 Building,Bio-medical Workshop,2030 Wengjiao West Road,Haicang District,361026,Xiamen,China
Tel:+86-592-6808278
Fax:+86-592-6808279