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iStatis Syphilis Antibody Test

Rapid Syphilis Screening at the Point of Care

Developed for clinical, outreach, and remote settings, the test provides fast, reliable results in just 15 minutes, empowering healthcare professionals to make timely decisions and improve patient outcomes.

Fast

High Accuracy

Easy to Use

01

Room Temperature Storage

o cold storage required – ideal for resource-limited settings

02

Reliable Accuracy

High sensitivity and specificity validated in multiple global settings

03

Easy to Use

Simple steps with clear instructions – no equipment needed

04

High Quality

Trust iStatis by bioLytical, a certified Canadian test manufacturer, to keep you safe.

The iStatis Syphilis Antibody Test is designed for professional use in screening for Treponema pallidum antibodies in clinics, outreach programs, primary care, and public health settings.

To further ensure accuracy, bioLytical employs a rigorous testing and validation process.

Before a product is released to the market, it undergoes extensive testing to ensure that it meets the company's high standards.

98.8%

Sensitivity (PPA)

100%

Specificity (NPA)

Step 1: Collect Sample

Clean your fingertip with the alcohol swab, then use the lancet to prick the side of your finger. Let a drop of blood form. Gently touch the pipette to the blood—don’t squeeze it. The pipette will fill automatically to the line. Once it’s full, you’re ready to test.

Step 2: Testing of Sample

lace the test device on a flat surface. Squeeze the blood from the pipette into the small round well marked “S.” Then, add 2 drops of buffer into the same well. Keep the test flat and still – don’t move it until 15 minutes have passed.

Step 3: Read Results

Set a timer for 15 minutes. When time’s up, check the window. One line at “C” means negative. Two lines (at “C” and “T”) mean positive. No line at “C”? That’s invalid—you’ll need to retest. Don’t read the result after 30 minutes.

Product Instructions

Size

723 KB

Date

07/21/2025

Size

496 KB

497 KB

Date

07/21/2025

07/21/2025

Run Time

15 MINS

Sensitivity

98.8%

Specificity

100%

Specimens Collection

Fingerstick

Authorizations/Approvals:

Health Canada

iStatis Syphilis Antibody Test - Training Video (EN) - SINGLES

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