Syphilis (Treponema pallidum) Ab Test

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CAT # PRODUCT DESCRIPTION SPECIMEN CUT-OFF SENSITIVITY SPECIFICITY ACCURACY FORMAT KIT SIZE RS303C NGH Ag （GON） Neisseria Gonorrheae (NGH) Antigen Test Swab N/A 94.40% 96.90% 95.90% Cassette 20T Gonorrhea is a sexually transmitted disease caused by the bacterium Neisseria gonorrhoeae. Gonorrhea is one of the most common infectious bacterial diseases and is most frequently transmitted during sexual intercourse, including vaginal, oral and anal sex. The causative o...

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Product Parameters

CAT #	PRODUCT	DESCRIPTION	SPECIMEN	CUT-OFF	SENSITIVITY	SPECIFICITY	ACCURACY	FORMAT	KIT SIZE
RS201S	SYP (TP) Ab	Syphilis ( Treponema pallidum) Ab Test	Serum/Plasma	N/A	99.70%	98.86%	99.80%	Strip	*50T/100T
RS201C	SYP (TP) Ab	Syphilis ( Treponema pallidum) Ab Test	Serum/Plasma	N/A	99.40%	98.54%	99.32%	Cassette	25T
RS202S	SYP (TP) Ab	Syphilis ( Treponema pallidum) Ab Test	WB/S/P	N/A	99.70%	98.86%	99.80%	Strip	50T
RS202C	SYP (TP) Ab	Syphilis ( Treponema pallidum) Ab Test	WB/S/P	N/A	100.00%	99.58%	99.71%	Cassette	25T

Summary

Syphilis, believed to have infected 12 million people worldwide in 1999, with greater than 90percent of cases in the developing world, is a sexually transmitted infection caused by the spirochete bacterium Treponema pallidum (Tp) subspecies pallidum. The primary route of transmission is through sexual contact; however, it may also be transmitted from mother to fetus during pregnancy or at birth, resulting in congenital syphilis.

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 EUGENE® SYP (Tp) Ab Rapid Test permits the measurement of antibodies (IgM, IgG and IgA) to recombinant antigens of Tp in serum or plasma rapidly and reliably without instrumentation.

Principle

The EUGENE® Syphilis (Tp) Ab Rapid Test 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 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 region. If the specimen contains IgG, IgM, or IgA antibodies to Tp, a pink test line will appear, indicating a positive result. If the specimen does not contain IgG, IgM, or IgA antibodies to Tp, the test line will not appear, indicating a negative result. The test contains an internal control line 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 strip.