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iStatis Hepatitis B Surface Antigen Test

Detect Hepatitis B in Just 15 Minutes

Professional-grade rapid test for accurate HBsAg detection at the point of care—no lab, instrumentation, or specialized setup required.

Rapid Results

Highly Accurate Results

Room Temperature Storage

01

Highly Accurate Results

Proven ≥99.5% sensitivity and 100% specificity across fingerstick, venous whole blood, serum, and plasma samples.

02

Rapid Detection

Results in just 15 minutes—no delays, no uncertainty.

03

No Equipment Needed

Visual interpretation with clear test and control lines—no reader, power source, or instrumentation required.

04

Room Temperature Storage

Store and transport kits between 2°C and 30°C with no cold chain required.

The iStatis HBsAg Test is a professional-use rapid diagnostic test for detecting Hepatitis B Surface Antigen (HBsAg) at the point of care. It offers ≥99.5% sensitivity and 100% specificity, delivering accurate results in just 15 minutes—with no instrumentation or complex procedures required.

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.

>99.9%

Sensitivity (PPA)

>99.9%

Specificity (NPA)

Step 1: Collect Sample

Use the sterile lancet and capillary pipette provided in the kit to collect a small blood sample. Ensure the pipette fills automatically to the mark—no squeezing required

Step 2: Add Sample & Buffer

Transfer the sample into the sample well on the cartridge. Wait one minute, then add 2 drops of chase buffer using the vial with dispensing cap

Step 3: Read Results

Start a timer and read the result at 15 minutes. A visible control line confirms a valid test; any test line—no matter how faint—indicates a positive result

Product Instructions

Size

1.18 MB

Date

05/13/2024

Size

1.18 MB

Date

05/13/2024

Run Time

15 MINS

Sensitivity

91.43%

Specificity

100%

Specimens Collection

nasal swab

Authorizations/Approvals:

Health Canada

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