/ iStatis Hepatitis B Surface Antigen TEST

Screen for Hepatitis—Fast. Reliable. Where It Counts Most.

The iStatis HBsAg Test delivers reliable, on-site results for Hepatitis B Surface Antigen detection in 15 minutes or less - no lab, no wait, and no additional equipment required.
Contact UsHow It Works
By keeping testing fast and simple, the iStatis HBsAg Test helps more people get screened and connected to care – right at the point of care.
/ 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 to Use
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 is self-contained and ready to use, requiring no additional equipment. Includes: test cartridge, sterile lancet, buffer vial with dispensing cap, alcohol pad, and vial holder. Streamlined for fast, confident testing.
Designed for Real-World Use
From clinics and pharmacies to outreach programs and mobile units, the iStatis HBsAg Test is built to perform in real-world conditions. The all-in-one kit eliminates the need for additional equipment or cold storage, making it an ideal solution for point-of-care testing in both clinical and outreach settings.
Reliable Results. Anywhere
With all essential components included in each kit, the iStatis HBsAg Test delivers consistent results across a range of point-of-care settings. Results are easy to interpret. Any visible test line is considered positive. If no control line appears, the test is invalid. No ambiguity. Just clear outcomes that support faster connections to care.
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 Hepatitis B Surface Antigen Test
What is the iStatis HBsAg Test used for?

The iStatis HBsAg Test is a rapid, single-use lateral flow immunoassay designed to detect Hepatitis B Surface Antigen in human EDTA-whole blood, fingerstick blood, serum, or plasma. It provides results within 15 minutes and is intended for use by healthcare professionals in clinics, laboratories, and point-of-care settings. It is not intended for home use

Who can be tested with this product?

This test is authorized for use on adults aged 18 years or older. The performance of the device has not been established in individuals under 18

How does the test work?

The test uses antibodies to detect the presence of Hepatitis B Surface Antigen (HBsAg) in a blood sample. When a sample is applied, it reacts with antibodies on the 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. The test should be read at 15 minutes and no later than 30 minutes

What sample types can be used?

The iStatis HBsAg Test can be performed using fingerstick whole blood, venous whole blood collected in EDTA tubes, serum, or plasma. A 50 µL sample volume is required. Plasma or serum should be separated and stored appropriately 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 use the provided capillary pipette to collect blood up to the fill line. Dispense the blood into the cartridge sample well, add 2 drops of chase buffer, and start the timer

How will I know if my test was successful?

A control line must appear at the “C” position of the cartridge. This indicates that the sample and buffer have flowed correctly. If no control line appears, the test is invalid and 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 HBsAg 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 the test line. Repeat the test if the result is invalid

What should I do if I test positive?

If your test result is positive, a venous blood sample must be collected in an appropriate tube and sent to a laboratory for confirmatory testing. Follow all applicable pre- and post-test counseling procedures

How accurate is the iStatis HBsAg Test?

In clinical studies, the iStatis HBsAg Test demonstrated excellent accuracy across all sample types. For fingerstick capillary blood, the test showed 100% Positive Percent Agreement (PPA) and 100% Negative Percent Agreement (NPA). For venous whole blood, serum, and plasma, the PPA was 99.5% and the NPA was 100%

Can anything interfere with the test results?

No interference was observed from common infectious diseases (like HIV, HCV, influenza) or from conditions like autoimmune diseases, pregnancy, or use of common medications. However, very high levels of interfering substances or improper handling may impact results

Is the solution in the buffer vial harmful?

Yes. The chase buffer contains 0.08% sodium azide, which is harmful if swallowed. Avoid contact with skin or eyes, and keep out of reach of children. Dispose of the used vial according to local hazardous waste regulations