Helicobacter Pylori Antigen (HP-Ag) Rapid Test Kit (Colloidal Gold) ISO,CE cetificated 25test per box

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 ]

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%.

[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