ISO Certified Syphilis IVD Test Strip with 99.71% Sensitivity and 15-20 Minute

Product Specification

ISO Certified Instant Syphilis IVD Testing Strip Easy-to-Use Strips & Accurate Results

The ISO Certified Instant Syphilis IVD Testing Strip is a rapid, easy-to-use diagnostic tool designed for the detection of syphilis infection at home or in clinical settings. This product provides fast, accurate, and reliable results, ensuring peace of mind for individuals seeking to monitor their reproductive health or those at higher risk of blood-borne and intimate contact-related diseases.

Our product represents a breakthrough in rapid diagnostic technology, offering healthcare professionals and public health programs a reliable tool for quick syphilis screening. This immunochromatographic test delivers accurate visual results within 15-20 minutes, making it an ideal solution for settings requiring immediate testing decisions. With its simple dip-and-read procedure and minimal training requirements, this testing strip has become the go-to choice for syphilis screening across diverse healthcare environments.

Features:

ISO Certified Quality: Manufactured under strict quality control standards, this testing strip meets international standards for in vitro diagnostic (IVD) devices.

Rapid Results: Provides results within 15-20 minutes, allowing for quick decision-making regarding potential medical intervention.

Easy-to-Use: The test requires minimal steps, making it ideal for at-home testing. No special training or medical expertise is needed.

Accurate Detection: The test is highly sensitive and specific, detecting antibodies that indicate the presence of syphilis infection with over 98% accuracy.

Compact & Portable: Conveniently packaged for individual use, this testing strip can be used in the comfort of your own home, making it suitable for both personal and professional use.

Components & Technical Specifications

Test Strip Composition:

Nitrocellulose membrane with immobilized recombinant Treponema pallidum antigens.Colloidal gold-conjugated antigen pad, sample absorption pad with capillary flow design.Plastic cassette housing with a clear result window.

Kit Components:

• Individually packaged test devices
• Disposable capillary tubes
• Buffer solution in dropper bottles
• Manufacturer's instructions for use

Intended Use & Applications

This testing strip is designed for the qualitative detection of antibodies to Treponema pallidum in:

• Human whole blood (fingerstick), Venous blood, Serum, Plasma samples, Primary Application Settings.
• Public health clinics and screening centers
• Antenatal care and pregnancy screening programs
• Emergency departments and urgent care facilities
• Primary healthcare centers in resource-limited settings
• STD clinics and community health initiatives

Target User Groups:

• Pregnant women requiring routine syphilis screening
• Individuals with multiple partners
• HIV-positive patients needing co-infection monitoring
• Pre-operative patients requiring infectious disease screening
• High-risk populations in syphilis endemic areas.

​How It Works:

The test strip uses a simple process to detect the presence of syphilis antibodies in a sample (usually blood or serum). When the sample is applied to the test strip, it interacts with the antibodies present on the strip. If syphilis-specific antibodies are present, a color line will appear, indicating a positive result. If no antibodies are detected, no color change will occur, indicating a negative result.