Salmonella Antigen Rapid Test Cassette Stool Package Insert

Product Description:

Salmonella Rapid Test is an in vitro qualitative Immunochromatographic assay for the rapid detection of S. Typhi antigens in human stool specimen. The test are intended to help in the diagnosis of S. Typhi infection and to monitor the effectiveness of therapeutic treatment.

Typhoid fever is a life threatening illness caused by the bacterium Salmonella typhi, and was observed by Eberth (1880) in the mesenteric nodes and spleen of fatal cases of typhoid fever. The infection is acquired typically by ingestion. On reaching the gut, the bacilli attach themselves to the epithelial cells of the intestinal villi and penetrate to the lamina and submucosa. They are then phagocytosed there by polymorphs and macrophages. The ability to resist intracellular killing and to multiply within these cells is a measure of their virulence. They enter the me senteric lymph nodes, where they multiply and, via the thoracic duct, enter the blood stream.

INTRODUCTION:

This Colloidal Gold Rapid Test is ideal for use in clinical, hospital, laboratory and home settings. It is a quick and easy test that can be used to detect the presence of Dengue IgG/IgM Cassette, making it an essential tool for healthcare professionals.

The high sensitivity of this test means that it is able to detect even small amounts of Dengue IgG/IgM Cassette, making it a reliable choice for accurate results. The test method used is colloidal gold, which is a highly effective method for detecting the presence of specific antigens in a sample.

In addition to its use in healthcare settings, the Biovantion 0079 Colloidal Gold Rapid Test can also be used for self-testing at home. This makes it a convenient and accessible option for individuals who wish to monitor their own health.

It is important to note that while this product is designed for the detection of Dengue IgG/IgM Cassette, it can also be used for the detection of other conditions such as HIV and AIDS. This makes it a versatile tool that can be used in a range of scenarios and situations.

SUMMARY AND PRINCIPLE OF THE TEST:

The test uses new homogenous immunochromatographic system with gold particules. It is a ready to use test which only needs a faecal sample dilution with the supplied ready to use dilution buffer. Specificity is ensured by using a monoclonal antibody conjugated with gold particules and directed against specific salmonella LPS core antigen. The immunochromatographic test is coated with a monoclonal immunoreagent specific for salmonella LPS antigens. Liquid sample and gold conjugate both migrate by capillarity and reach the first specific anti-salemonella monoclonal reagent. If salmonella is present in the sample, it is blocked and immunoreaction appears as a red-pink line. As sample still migrates, it reaches the second non specific anti-mouse IgG which gives rise to a second red-pink line. This rear line indicates that the chromatography has been developped without hindrance. It appears also with negative samples.

PRECAUTION FOR USERS:

1. For in-vitro diagnostic use only.

2. Handle all specimens as if they contain infectious agents. When the assay procedure is completed, dispose of specimens carefully after autoclaving for at least one hour. Alternatively, treat with a 0.5 or 1% solution of sodium hypochlorite for one hour before disposal.

3. Wear protective clothing (laboratory coats and disposable gloves) whenassaying samples.

4. Do not eat, drink or smoke in areas where specimens and kit reagents are handled.

5. Avoid contact between hands and eyes or nose during specimen collection and testing.

SPECIMEN COLLECTION:

Stool samples must be taken as soon as the symptoms appear. The samples can be stored in the refrigerator for 1 to 2 days. For longer storage they must be kept frozen at -20ºC. In this case, the sample should be totally thawed, and brought to room temperature and homogenised before testing.

Support and Services:

The Colloidal Gold Rapid Test is a diagnostic tool designed for qualitative detection of SARS-CoV-2 antigen in human nasopharyngeal swab and throat swab samples. The product is intended for use by healthcare professionals and trained operators.

The product technical support and services include:

• Instructions for Use (IFU) and product training
• Technical consultation and troubleshooting
• Assistance with product performance and interpretation of results
• Product updates and notifications
• Quality control and product certifications

STORAGE OF TEST KIT:

The Salmonella Rapid Test can be stored at any temperature between 4-30°C. Do not freeze. The stability of the kit under these storage conditions is 36 months. Use up the reagents as soon as possible after the kit is unpacked

PACKING AND SHIPPING:

Product Packaging:

• 25 test cassettes
• 25 droppers
• 1 buffer solution bottle
• 1 instruction manual

Shipping:

• Ships within 1-2 business days
• Standard shipping rate applies
• Tracking number provided once shipped