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SYPHILIS

The serological diagnosis of syphilis is performed by demonstrating the presence of significant levels of specific Treponema pallidum (TP) antibodies in the serum sample. The reference method used is the FTA-ABS technique but its execution is laborious and the interpretation of the results is not simple; alternative methods have therefore been introduced to simplify the procedure. The TPHA test is the preferred technique for screening purposes, in as far as it detects specific Ig even at low titers. Unfortunately, the result of the test is determined by subjective interpretation as the test cannot be completely automated. The TPHA test is not sensitive in the primary phase. The kits allows screening with the ELISA method. It reveals the presence of specific antibodies of any class, and can be completely automated. The specific assay of IgM as opposed to IgG is of particular importance in the diagnosis of congenital Syphilis.

Method:

Immunoenzymatic method for the qualitative determination of IgG class antibodies to Treponema Pallidum in human serum. The test is based on the ELISA principle (Enzyme Linked ImmunoSorbent Assay) which uses the reaction between the antibodies present in the tested sample and the immobilized antigen bound to solid phases.The immunoglobulins bind to the antigen through incubation with diluted human serum. The result is expressed as an INDEX (ratio between the OD value of the sample and that of the Cut-off).

SYPHILIS SCREEN RECOMBINANT

coated with recombinant proteins of Treponema pallidum antigens

Kit for the determination of anti-Treponema pallidum (Nichols strain) immunoglobulins in human serum, using recombinant antigens. Immunoenzymatic method.
Code 91100
Quantity 2X96 tests
METHOD Indirect ELISA
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 100%
DIAGNOSTIC SPECIFITY 99.9%
INCUBATION TIME 50 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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IFU

SDS

CoA

TREPONEMA IgG

coated with a pool of recombinant proteins of Treponema pallidum

Kit for the determination of anti-Treponema pallidum (Nichols strain) IgG antibodies in human serum. Recombinant antigen.
Code 91050
Quantity 96 tests
METHOD Indirect ELISA
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 97.4%
DIAGNOSTIC SPECIFITY 100% CI95%: 97.1. – 100
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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IFU

SDS

CoA

TREPONEMA IgM

coated with anti-human IgM monoclonal antibodies

Kit for the determination of anti-Treponema pallidum (Nichols strain) IgM antibodies in human serum. Recombinant antigen. Capture method.
Code 91051
Quantity 96 tests
METHOD CAPTURE ASSAY
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 92%
DIAGNOSTIC SPECIFITY 100% CI95%: 97.1. – 100
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

Download

IFU

SDS

CoA