Helicobacter Pylori Antigen (HP-Ag) Rapid Test Kit (Colloidal Gold)

【Product Name】

Generic Name:  Helicobacter Pylori Antigen (HP-Ag) Rapid Test Kit (Colloidal Gold)

 [Packing Specification] 25 tests/package

[Intended Use]  Helicobacter Pylori Antigen (HP-Ag) Rapid Test Kit (Colloidal Gold) is used for the rapid qualitative detection of HP-Ag in the stool to assist in the diagnosis of HP infection in patients with gastric symptoms. Some studies have shown that HP infection is a cause for chronic gastritis, peptic ulcerative gastric adenocarcinoma and low-grade gastric lymphoma, so the clinical detection of HP injection is of great significance.

[Test principle] Double antibody sandwich immunochromatography is adopted to qualitatively detect HP in the stool. HP monoclonal antibody is coated on nitrocellulose (NC) membrane, and the other antibody is bound to the surface of colloidal gold particles. The specimen is added to the sample hole through the filter membrane coated with colloidal gold antibody. When HP-Ag is found in the patient’s specimen, it binds to the gold-labeled HP monoclonal antibody.  In the test line (T) area, the HP-Ab complex begins to contact with the Ab coated in the T area, forming a sandwich complex of Ab-HP-gold-labeled Ab with a purplish red band. The Ab labeled by colloidal gold diffuses to the quality control line (C) area and is captured by the secondary antibody to form a red band in C area.

[Main Components ]

Ingredients	Quantity/Specification	Main components:
Test card	25  tests/box	For each test card, the sample pad is coated with HP monoclonal Ab labeled by colloidal gold, and the NC membrane part is coated with another HP monoclonal Ab and  test strips  for goat-anti-mouse Ab
Stool collection tube (containing diluent in tube)	25  tests/package	0.02M of PBS buffer solution
specimen collection container	25  tests/package	/
Manual	1 copy	/

Components required for testing but not provided:

1.        timer

2.        hygrothermograph

Notes: Components in reagents at different batches cannot be used interchangeably to avoid errors.

[Storage and Validity] Store at 2℃-30℃ in a cool, dry place away from light, and the validity period is 18 months.

[Applicable Instrument] NA

【Sample Requirements】

◆    Specimen collection

1.  Collected stool specimens must be collected in a clean, dry, preservative-free, decontamination-free hydrosolvent container; All specimens should be treated as infectious agents.

2. Collect enough stool specimens (1-2 ml or 1-2 g) to get a representative sample.

3.  Do not keep stool specimens at room temperature for a long time. If the specimens are free of bacterial contamination, please use them within 48 hours when stored at 2 to 8 °C; if not within the time limit, the samples must be stored at -20 °C;

4.  Do not use specimens that have been placed for a long time to avoid non-specific reactions caused by specimen contamination and bacteria growth;

◆      Specimen gathering

Unscrew the cover of the stool collection tube, insert the sampling rod attached to the cover into the stool specimen, rotate it 360 degrees clockwise, and then put it into the collection tube and shake it well with the specimen diluent.

【Test Method】

1．    Only after the restoration to room temperature, the kit and collected test sample of low-temperature storage can be used.

2．    Tear off the outer package, take out the test card, and lay it flat on the operating table

3．    Insert the sampling rob into the stool specimen, rotate it 360 degrees clockwise, and then put it into the collection tube, shake it well with the specimen diluent  and then tighten the lid.

4．    Break off the tip on the cover of the stool collection tube that is with specimens, put the stool collection tube upside down vertically and drop two drops (about 80 ul) of the specimens into the specimen hole on the test card to start timing.

5．    Read the final results in 15-20 minutes. But not 20 minutes later.

Attention:  The test should be completed at room temperature of 15-30°C and humidity below 85%.

【Limitations of Test Method】

1．    The kit is only for in vitro diagnosis, and only to qualitatively detect HP in stool specimens, but cannot determine HP content in the specimen.

2．    If there are too few Ag to be tested in the specimens, it will cause false negatives.

3．    But too much can cause false positive or invalid result.

4．    The kit is only for primary screening, and the results cannot be used as the evidence for diagnosis. To ensure the accuracy of the test results, further diagnosis can be made by gastroscopy combined with Warthin-starry silver stain and rapid urease test, etc..

【Product Performance Indicators】

1．    Liquid migration time: Use the same batch of kit to test the internal quality control products, start timing when the liquid is dripped into the well, and the time required for the liquid to completely pass through the observation window should be less than 5 minutes.

2．    Sensitivity: The sensitivity quality control products provided by the manufacturer shall be used as samples for testing, and the results shall meet the requirements.

3．    Specificity: Test with the specific quality control product provided by the manufacturer, and the test results should be consistently negative;

4．    Intra-batch repeatability: 10 test cards are randomly selected from the same batch of kits, and the repeated quality control products provided by the manufacturer are used as samples for parallel testing, and the test results should be consistently positive.

5．    Inter-batch repeatability:  10 test cards are randomly selected from three consecutive batches of kits (at least 3 cards per batch), and the repeated quality control products provided by the manufacturer are used as samples for parallel testing, and the test results should be consistently positive.

6．    Stability: The kit is stored under the required storage conditions for three months beyond the validity period, the specified tests are carried out, and the results should meet the requirements.

【Precautions】

1．    This kit is used only for in vitro diagnosis, and can not be reused.

2．    The kits should be treated as the one containing infectious materials, and the waste after use should be disposed of in accordance with relevant regulations.

3．    Helicobacter Pylori Antigen (HP-Ag) Rapid Test Kit (Colloidal Gold) is for testing stool specimens.

4．    During the interpretation time, regardless of the color of the band, as long as two lines can be observed in C area and T area, it can be judged as positive.

5．    Please ensure that an appropriate amount of specimens is used for testing, too much or too little will lead to deviation.

6．    Read test results at 15-20 minutes, and it is invalid after 20 minutes.

【References】

1．    Fan Wenwei, Du Jianfeng, Liu Shengqi. Clinical application of fecal Helicobacter pylori antigen determination. Chinese Journal of Modern Clinical Medicine, Vol. 3, No. 23, 2005

2．    Yan Wei, Cao Jianbiao. Progress in the test technology of gastric Helicobacter pylori. World Chinese Journal of Digestion, May 28, 2009; 17(15)

3．    Hu Fulian, Zhou Dianyuan. The basis and clinic of Helicobacter pylori infection (third edition). Beijing: China Science and Technology Press, 2009

[Basic Information]

Manufacturer: Shenzhen Lvshiyuan Biotechnology Co., Ltd

101,201,301, D Building, No.2 Industrial Avenue, Buxin Village, Buxin Community, Dapeng Subdistrict Office, Dapeng New District, Shenzhen, 518120 China

E-Mail: info@lsybt.com

EU Authorized Representative: Sungo Cert GmbH

Harffstr.47,40591 Dusseldorf, Germany   

Tel:+49-211-97634133

E-mail:sungo.group@yahoo.com