/ iStatis syphilis Antibody TEST

Fast, Reliable Syphilis Screening—At the Point-of-Care

The iStatis Syphilis Antibody Test is a rapid point-of-care test designed to detect Treponema pallidum antibodies in whole blood, serum, or plasma. Delivering results in minutes, it supports timely clinical decisions in a range of care settings, without the need for lab equipment or a complex setup.
Contact UsHow It Works
The iStatis Syphilis Antibody Test provides healthcare providers with rapid, reliable results at the point of care. It supports early detection, helps reduce the risk of transmission, and enables timely clinical decisions in various point-of-care settings.
/ key features

Smart Features That Work for You

/ 01 rapid results
Get clear results in just 15 minutes. No delays, no guesswork. Fast turnaround supports quicker decisions, more efficient workflows, and a better experience for both patients and providers. It’s testing that keeps pace with real-world care.
/ 02 All-in-One Design
Everything you need comes in one kit. No extra tools, setup, or equipment required. Just open the pouch and begin. Fewer steps mean fewer errors and a smoother testing experience.
/ 03 Built-in Controls
Integrated controls offer instant visual confirmation that the test is working properly. This built-in safeguard adds confidence and helps ensure reliable results, with no extra tools or steps required.
/ 04 SHELF-STABLE AND PORTABLE
No refrigeration or special handling required. iStatis tests store at room temperature, making them easy to transport, manage, and use in clinics, mobile units, or outreach settings.
/ 05 Clear Visual Results
Results are easy to read with clear visual lines that appear directly on the test cartridge. No additional tools or interpretation steps are required, supporting clear, reliable decision-making and confidence in every result.
/ 06 Easy 3-Step Process
Designed with usability in mind, the test follows three simple steps, each with clear instructions at every stage. Its intuitive format helps professionals perform testing efficiently and confidently.

Everything You Need in One Kit

Each kit includes: Test cartridge + Sterile single-use lancet + Capillary pipette (50 µL) + Buffer vial + Dispensing cap + Vial holder. Just open and go.
Designed for Real-World Use
The iStatis Syphilis Test is built for ease and reliability in busy healthcare settings. With easy-to-interpret visual results, each kit includes all necessary components: test cartridge, sterile lancet, capillary pipette, buffer vial, dispensing cap, and vial holder. The compact and portable format supports accurate results in a range of clinical and outreach environments.
Perfect for Point-of-Care Settings
Whether in community clinics, emergency care, or mobile health units, the iStatis Syphilis Test is designed to fit seamlessly into point-of-care workflows. With results in just 15 minutes and no need for refrigeration or extra tools, this test helps healthcare providers deliver care where it’s needed most.
IFU
Instructions For Use
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/ How to use

Fast. Simple. 

‍Results in 3 Steps.

Everything you need to start testing, with no extra equipment or setup required. Built for real-world use, right out of the box.
See in action
Clean the fingertip with the alcohol pad and use the lancet to collect a drop of blood. Fill the pipette to the line and add the sample to the cartridge. Wait 1 minute, then add 2 drops of buffer. Keep the cartridge flat and read the result at 15 minutes. Results should not be read after 30 minutes.
/ FAQs

Your Questions, Answered

Answers to common questions about the iStatis Syphilis Antibody Test
What is the iStatis Antibody Test used for?

The iStatis Syphilis Antibody Test is a rapid, single-use lateral flow immunoassay used to detect antibodies to Treponema pallidum (the bacterium that causes syphilis) in human whole blood (venous and fingerstick), serum, or plasma. It delivers results in 15 minutes and is intended for use by healthcare professionals in clinical, laboratory, or point-of-care settings. This test is not intended for home use.

Who can be tested with this product?

The iStatis Syphilis Antibody Test is intended for use in individuals aged 18 years or older who require syphilis screening or diagnostic evaluation. It may be used for patients with signs or symptoms of infection or those at increased risk. The performance of this test has not been established in individuals under 18 years of age. Testing must be conducted by trained healthcare professionals in clinical or point-of-care settings

How does the test work?

The iStatis Syphilis Antibody Test detects antibodies to Treponema pallidum in a blood sample. When the sample is applied, it interacts with reagents on the test strip. A positive result shows a blue line at the test position “T” along with a control line “C”. A negative result shows only the control line. If no control line appears, the test is invalid. The result should be read at 15 minutes and not after 30 minutes.

What sample types can be used?

The iStatis Syphilis Antibody Test can be performed using fingerstick whole blood, venous whole blood collected in EDTA tubes, serum, or plasma. A sample volume of 50 µL is required. Serum or plasma samples should be properly separated and stored according to standard procedures before testing

How do I collect a sample using a fingerstick?

First, clean the fingertip with the alcohol swab included in the kit. Use the sterile lancet to prick the finger, then collect the blood using the provided capillary pipette up to the fill line. Dispense the blood into the sample well on the test cartridge, wait one minute, then add 2 drops of buffer. Keep the cartridge flat and start the timer. Read the result at 15 minutes. Do not interpret results after 30 minutes.

How will I know if my test was successful?

The control line must appear at the “C” position on the test cartridge. This confirms that the sample and buffer have flowed correctly and that the test is working properly. If no control line appears, the result is invalid, and the test must be repeated using a new test kit.

What do the test results mean?

A positive result shows blue lines at both the control (C) and test (T) areas, indicating the presence of antibodies to Treponema pallidum in the sample. A negative result shows a blue line at the control area only. An invalid result means no control line is visible, regardless of whether a test line appears. If the result is invalid, repeat the test using a new kit.

What should I do if I test positive?

A positive result means antibodies to Treponema pallidum have been detected in the sample. This indicates a current or past syphilis infection. All positive results should be followed up with confirmatory testing and appropriate clinical evaluation by a healthcare professional. Testing and diagnosis should always be interpreted alongside patient history, risk factors, and other relevant clinical information.

How accurate is the iStatis Syphilis Antibody Test?

In clinical studies, the iStatis Syphilis Antibody Test demonstrated high accuracy across all sample types. For fingerstick whole blood, the test showed 96.4% Positive Percent Agreement (PPA) and 100% Negative Percent Agreement (NPA). For venous whole blood, serum, and plasma, the PPA was 98.8% and the NPA was 100%. These results support the test’s strong performance in point-of-care settings.

Can anything interfere with the test results?

No interference was observed from common infectious diseases such as HIV, HCV, or influenza, nor from autoimmune conditions, pregnancy, or commonly used medications. However, very high levels of certain substances or improper sample handling may affect results. Always follow the Instructions for Use to ensure reliable performance

Is the solution in the buffer vial harmful?

Yes. The chase buffer contains 0.08% sodium azide, which can be harmful if swallowed. Avoid contact with skin and eyes, and keep the buffer out of reach of children. After use, dispose of the vial and any waste according to local hazardous materials regulations.

Can I get syphilis from the test?

No. The iStatis Syphilis Antibody Test does not contain live bacteria and cannot transmit syphilis or any other infection. All components are sterile and single-use, designed for safe handling by healthcare professionals.