22,00

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Format

Casette

REF

GTITP02

Regulatory Status

CE

Sample Type

Plasma, Serum, Whole Blood

Incubation Time

20 min

Description

Syphilis is a sexually transmitted infection (STI) caused by bacteria Treponema pallidum and it is curable. Treponema pallidum is a gram-negative and micro-aerophilic bacteria, which is a member of the Spirochaetaceae family.Mostly, Treponema is transmitted by direct contact with the active lesion. However, it may also be transmitted from mother to fetus during pregnancy or at birth and result in congenital syphilis.

As a result of the serological response in individuals exposed to syphilis infection, both non-specific and specific anti-Treponema pallidum antibodies are produced.

Anti-treponemal IgM starts increasing and reaches a detectable levels after syphilis lesions are observed as a result of a syphilis infection. Anti-treponemal IgG antibodies can be detected starting from the fourth week of infection. Therefore, it is possible to detect the anti-treponemal IgG and IgM antibodies in many patients after symptoms begin to appear.

INTENDED USE

The Anti-Syphilis Test is an immunochromatographic assay for the qualitative detection of treponemal antibod- ies (IgA, IgM, IgG) generated against Treponema pallidum antigens (17 kDa, 15 kDa, 47 kDa) in human whole blood/serum/plasma with high sensitivity and specificity.

PERFORMANCE EVALUATION

• Sensitivity: 99,9%

• Specificity: 99,8%

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