Detection Of Poison Colloidal Gold Rapid Test For SYP Antibody Cassette Strip

Product Description:

The Syphilis (Tp) Ab Rapid Test (Whole blood/Serum/Plasma) is a lateral flow immunochromatographic assay for the qualitative detection of antibodies including IgG, IgM, and IgA to Treponema pallidum (Tp) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Tp. The test is recommended for professional use only. All results must be interpreted together with other clinical information or other diagnosis methods available to the physician.

Syphilis is believed to have infected 12 million people worldwide in 1999, with greater than 90 percent of cases in the developing world. It is a sexually transmitted infection caused by the spirochete bacterium Treponema pallidum (Tp) subspecies pallidum, which is a spiral-shaped, Gram-negative, highly mobile bacterium. Serological detection of anti-Tp antibody has been long recognized in the diagnosis of syphilis since the natural course of the infection was characterized by periods without clinical manifestations. Both IgM and IgG antibodies were detected in sera from patients with primary and secondary syphilis. The IgM antibody may be detectable towards the second week of infection, while IgG antibody appears later, at about 4 weeks. These antibodies could last for several years or even decades in the serum of a patient with untreated latent syphilis. The Syphilis (Tp) Ab(Whole blood/Serum/Plasma)Rapid Test permits the measurement of antibodies (IgM, IgG and IgA) to recombinant antigens of Tp in human whole blood, serum or plasma in a manner of user friendly, highly sensitive and specific without additional instrumentation.

Features:

• Product Name: SYP (Tp) Ab Rapid Test

   

• Application: Clinical/ Hospital/ Laboratory/ Home
• Reading Time: 5-15 Minutes
• Type: Colloidal Gold
• Shelf Life: 24 Months

Technical Parameters:

This Colloidal Gold Rapid Test is suitable for clinical, hospital, and laboratory use. It has a high sensitivity and can detect IgM antibodies to Adenovirus in WB/S/P samples in just 5-15 minutes. The test comes in a convenient cassette or strip format and has a long shelf life of 24 months. It is not intended for home use and is not an aids test.

Test Principle:

The Syphilis (Tp) Ab Rapid Test (Whole blood/Serum/Plasma)is a qualitative, membrane based immunoassay for the qualitative detection of antibodies including IgG, IgM, and IgA to Treponema pallidum (Tp) in human whole blood, serum or plasma.

The membrane of the test strip contained in the cassette is pre-coated with recombinant Tp antigens. During testing, the specimen is added into the sample pad and antibodies to Tp if present will react with Tp antigens coated particles in the membrane strip. The mixture then migrates upwards by capillary action on the membrane and reacts with recombinant Tp antigens on the membrane in the test line (T) region. If the specimen contains IgG, IgM, or IgA antibodies to Tp, a pink test line (T) will appear, indicating a positive result. If the specimen does not contain IgG, IgM, or IgA antibodies to Tp, the test line (T) will not appear, indicating a negative result. The test contains an internal control line (C) which should always exhibit a pink line regardless of the color in the test region. Otherwise, the test result is invalid and the specimen must be retested with a new device.

Reagents and Materials Provided:

25 X Test devices. Test cassettes are individually sealed in a foil pouch with a dropper and a package of desiccant.

1 X Assay buffer

1 X Instruction for use

Materials Required But Not Provided:

Clock or Timer

Clean containers for the collection of specimen

Lancets (for fingerstick whole blood only)

Centrifuge (for plasma only)

Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)