The syphilis test is a rapid qualitative immunochromatographic test intended for professional in vitro diagnostics. It detects IgG and IgM antibodies against Treponema pallidum, the bacterium that causes syphilis. The test is performed using a sample of whole blood, serum, or plasma.

Treponema pallidum, also known as the pale spirochete, is the bacterium responsible for syphilis. The infection can progress through several stages, including latent and asymptomatic forms. The detection of antibodies against Treponema pallidum can aid in the initial diagnosis of the infection.

The test provides a result as early as 10 minutes after the sample is applied. The result is presented qualitatively—in the form of test lines. The result should not be interpreted after 20 minutes.

This product is intended for professional use. This is a medical device. Use it in accordance with the instructions for use or the label.

Features

• Sample type: whole blood, serum, or plasma
• Quick and easy to perform
• Specificity: 98.5%, sensitivity: 98.6%, accuracy: 98.5%
• High-quality product
• Fast results in just 10 minutes!
• Single-use packaging
• Product intended for professional use

Package Contents

• 1 test strip or cassette with a dropper in a foil pouch
• 1 buffer
• 1 user manual

Application

• Rapid diagnosis of syphilis: The test enables the qualitative detection of IgG and IgM antibodies against Treponema pallidum, the bacterium that causes syphilis.
• Support for the diagnosis of sexually transmitted diseases: The test result can be helpful as preliminary information to support the diagnosis of Treponema pallidum infection.
• Testing of Various Sample Materials: The test can be performed using whole blood, serum, or plasma.
• Support for Medical Decision-Making: The test result may assist healthcare professionals in making further diagnostic or therapeutic decisions.
• Diagnosis of patients with suspected Treponema pallidum infection: The test may be used as an initial screening test in patients with suspected syphilis.
• Professional use: This product is intended for professional in vitro diagnostics and should be used in accordance with the instructions for use.

Product identification and responsible entities

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