Syphilis Health Check™

Syphilis Health Check is a reliable, user-friendly rapid test for the detection of Treponema pallidum (syphilis) antibodies.

As the first and only CLIA-waived rapid syphilis test in the United States, it delivers results in 10 minutes with onboard controls to ensure accuracy.

Designed for convenience and precision, it provides reliable results quickly, enabling prompt diagnosis and timely intervention. Healthcare professionals can confidently screen for syphilis, contributing to effective disease management and prevention.

To learn how Syphilis Health Check can enhance your screening process, explore the key benefits below.

Product Details

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Visit our resources and training to learn more and get certified with Syphilis Health Check™

Resources

Benefits of Syphilis Health Check

Accuracy

Aligns with the CDC’s syphilis testing algorithms (traditional and reverse)

Can detect syphilis at all stages of infection, from early primary infection to latency

Sensitivity 98.0%, Specificity 97.2%, detects both IgM and IgG antibodies to Treponemal antigens

Can be used with pregnant patients for screening of congenital syphilis at every trimester

Results from various sites were studied to confirm accuracy using RPR as a comparison

Compliance and Certification

CLIA-waived: Fingerstick sample testing

FDA-approved: For all blood sample types (fingerstick, venous whole blood, serum, and plasma)

Ease of Use

Compatible with human whole blood (both fingerstick and venous), serum, and plasma samples

Can be easily read in all settings without a reader

Uses a premixed buffer rather than having to use multiple solutions

Multiple tests can be run concurrently

Compact design makes for flexible use, including in-clinic or other CLIA Waived facilities, mobile testing units, outdoor locations, and outreach events

Can be used for people as young as 13 years old

Simple Storage

Shelf life of 30 months from date of manufacturing

Flexible storage range (4°C to 30°C)

Small storage footprint

How to run the test by fingerstick

For complete instructions, refer to the Package Insert here.

Step 1: Collect a sample

CLIA-waived for fingerstick, moderately complex for whole blood, serum and plasma.

Step 2: Run the test

Add the sample & buffer to the test, wait 10 minutes then read results.

Watch fingerstick procedure video and view training materials here

Key Technical Documents

Package Insert for Syphilis Health Check Tests (English)

Package Insert for Syphilis Health Check Tests (Spanish)

Quick Reference Guide for Fingerstick Wholeblood (English)

Quick Reference Guide for Fingerstick Wholeblood (Spanish)

Quick Reference Guide for Lab Assay Procedure Venous Whole Blood, Serum, or Plasma

Syphilis Health Check™ Product Update – Aug 2023

Additional product documentation

Related Items

Syphilis Health Check External Controls

Syphilis Health Check On-Demand Training