/ iSTATIS COVID-19 Ag test

Rapid, Reliable Results 
for Informed Clinical Decisions

The iStatis COVID-19 Antigen Test is a single-use, visually read, lateral-flow in vitro qualitative immunoassay intended for the detection of nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens.
Contact UsHow It Works
No waiting. No lab. Just fast, clear answers when you need them most. With easy-to-read visual indicators and results delivered in under 15 minutes, iStatis puts reliable diagnostics directly into your hands—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 means quicker decisions, smoother workflows, and a better experience for both patients and providers. It’s testing that keeps pace with real-life care.
/ 02 All-in-One Design
Everything you need is integrated into a single, compact test device. No additional tools, accessories, or preparation required—just open the pouch and begin. This streamlined approach reduces errors and ensures a smooth experience from start to finish.
/ 03 Built-in Controls
Integrated quality controls give you instant visual confirmation that the test is functioning correctly. This built-in safety net adds confidence and ensures the reliability of every result, without requiring separate validation tools.
/ 04 SHELF-STABLE AND PORTABLE
No need for refrigeration or special handling. iStatis tests can be stored at standard room temperatures, simplifying inventory management and eliminating cold chain logistics—perfect for any environment.
/ 05 Clear Visual Results
Results are easy to interpret with clear visual indicators—no confusing lines or extra interpretation tools required. This reduces the chance of misreading results and improves confidence in every outcome.
/ 06 Easy to Use
Designed with usability in mind, the test features straightforward steps and clear instructions to support a smooth user experience. Its intuitive format minimizes training time and helps streamline workflows, making it easier for professionals to perform testing efficiently and confidently.

Everything You Need in One Kit

Each kit includes: Test cartridge + Sterile nasal swab + Buffer vial + dispensing cap + Vial holder. Just open and go.
Designed for Real-World Use
Built for busy healthcare environments—whether you're testing symptomatic patients within 7 days of symptom onset or screening asymptomatic individuals through serial testing (2 tests over 2–3 days). Results are simple to read: any visible test line means positive. No control line? That’s an invalid test—no guesswork, just clarity.
Perfect for Point-of-Care Settings
Whether you're in a clinic, pharmacy, mobile unit, or workplace, the iStatis COVID-19 Antigen Test fits seamlessly into your workflow. Designed for fast, reliable use with both symptomatic and asymptomatic individuals, including support for serial testing—so you can test with confidence, wherever you are.
IFU
Instructions For Use
Download
/ How to use

Fast. Simple. 

‍Done in 3 Steps.

Performing the test is quick and simple. Follow these three steps for accurate results—no special equipment or lab setup required.
See in action
Gently insert the swab into each nostril, rotating for 15 seconds per side. Place the swab in the buffer vial, mix thoroughly by swirling and squeezing, then secure the cap. Add 3 drops to the test cartridge, start your timer, and read the result at 15 minutes.
/ FAQs

Your Questions, Answered

Answers to common questions about the iStatis COVID-19 Antigen Test
What is the iStatis COVID-19 Antigen Test?

It is a single-use, lateral-flow immunoassay designed to detect nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens. Results are visually interpreted and available within 15 minutes

Who can use this test?

The test is intended for use by trained healthcare professionals or operators in near-patient or point-of-care (POC) settings

How soon should the result be read?

Test results should be read at 15 minutes and no later than 30 minutes after adding the sample to the cartridge

What does a positive result look like?

A control line and any visible test line (even faint) indicate a positive result.

What does a negative result look like?

A visible control line and no test line indicate a negative result.

What if no control line appears?

The result is invalid. Retest with a new cartridge

Can this test be used for asymptomatic individuals?

Yes, but only as part of serial testing (twice over 2–3 days with 24–48 hours between tests). Confirmatory molecular testing may be needed, especially in cases of high exposure risk

What should I do if I spill the buffer?

Discard the vial and use a new kit.

How should the test be stored?

Store at 2°C to 30°C (35.6°F to 86°F). Ensure the kit is at room temperature before use

Can the kit be reused?

No, all components are single-use only.

Can a negative result rule out COVID-19 infection?

No. Negative results do not exclude infection. If symptoms persist or exposure is suspected, confirm with a molecular test