Overview of the VivaChek Blood Glucose and β-Ketone Dual System
VivaChek, the brand under Weice Biotech, has developed a one-meter, one-strip dual testing system that measures both blood glucose and β-ketone from a single capillary blood sample. The product—named the VivaChek Blood Glucose and β-Ketone Dual System—is positioned as a point-of-care solution for individuals managing diabetes, metabolic health, or ketosis risk. Rather than requiring two separate devices and two separate strip types, the system consolidates both measurements into one meter and one test strip, aiming to simplify the daily routine of self-monitoring.
Addressing Common Pain Points in Metabolic Monitoring
Traditional blood glucose and ketone monitoring often requires separate test strips, separate meters, manual coding, larger blood samples, and limited data connectivity. These factors can increase the number of supplies a user must carry, add extra steps to each test, and introduce opportunities for error. Manual coding in particular may introduce result inaccuracies if a user selects the wrong code for a strip batch. Larger sample volumes can also make routine fingerstick testing less comfortable, especially for frequent testers.
VivaChek’s strategic response is to provide a dual testing system that performs both glucose and β-ketone analysis from one strip, paired with Auto Coding that automatically reads each test strip’s coding information. This removes the manual coding step entirely and reduces the risk of setup error. The system also uses a smaller sample size of about 1.6 microliters, a testing time of about 12 seconds, and offers an optional Bluetooth Low Energy version 5.1 connection for users who want to track results digitally.
Technical Capabilities and Analytical Performance
Core Technology Platform
The dual system relies on an electrochemical biosensor platform. Glucose is measured using glucose dehydrogenase, while β-ketone is measured using β-hydroxybutyrate dehydrogenase. This enzyme-based approach supports the meter’s ability to generate two distinct results from one applied sample.
Measurement Ranges and Sample Requirements
The system reports a glucose measurement range of 20–600 mg/dL and a β-ketone measurement range of 0.1–8.0 mmol/L, covering values from low to high glucose and from normal to severe ketosis levels. Results are calibrated to be plasma-equivalent, which supports clinical interpretation. Sample application uses a wicking action, end-fill method, and the primary test site is the fingertip, using fresh capillary whole blood. Notably, the meter supports a hematocrit range of 20–65%, which is wider than many standard systems and is intended to reduce the effect of hematocrit variation on test accuracy across a broader range of users.
Analytical performance data included in the source material shows that meter results clustered along the fitted regression line with strong linearity (R² greater than 0.96, slope approximately 1, and no obvious bias). Glucose results specifically showed R² = 0.97 with a slope approximately 1 compared to a comparator method, while β-ketone results demonstrated R² = 0.996, slope approximately 1, and an intercept approximately 0. These figures indicate close agreement between the dual system’s readings and reference comparator values.
Battery, Connectivity, and Data Management
The meter uses a rechargeable 250 mAh, 3.7 Volt DC nominal lithium polymer battery with a 5V input charge voltage, charged through a USB Type-C port. It automatically shuts off 120 seconds after the last action to conserve battery life. The device includes a backlight and beep function for usability, along with a hypo warning to alert users to low glucose readings. The system does not include test averaging, a strip ejector, a ketone warning, meal markers, or test alarms.
For data management, the meter stores 300 records with date and time, supporting a history of self-monitoring results. When the optional Bluetooth Low Energy version 5.1 is enabled, results can be transferred to the VivaChek GlucoKet App, extending the meter’s usefulness beyond the device display itself.
Key Features and Differentiated Value
Several features work together to define the product’s value proposition of simplifying metabolic monitoring:
- Dual measurement: One test strip simultaneously measures blood glucose and β-ketone, removing the need for separate strips or meters.
- Auto Coding: Automatically identifies and reads the coding information of each test strip, lowering the risk of coding error.
- Small sample size: About 1.6 microliters per test, supporting a more comfortable fingerstick experience.
- Fast testing time: About 12 seconds per result, supporting timely metabolic decisions.
- Wide hematocrit range: 20–65%, reducing bias across a broader range of users.
- Optional connectivity: Bluetooth Low Energy version 5.1 for data transfer to the VivaChek GlucoKet App.
- Operating conditions: Functions across an operating temperature of 45.5°F–113°F (7.5°C–45°C) and operating humidity of 10–90% R.H. non-condensing, with test strips stored at 36°F–86°F (2°C–30°C).
- Shelf life: Test strips carry a 24-month unopened shelf life and a 6-month opened shelf life.
Together, these specifications reflect VivaChek’s stated goal to deliver glucose and ketone results from one fingerstick, with fewer supplies, fewer steps, and faster feedback.
Clinical Interpretation Guidance
The source material accompanying the VivaChek Blood Glucose and β-Ketone Dual System includes interpretation ranges referenced from external clinical sources. For fasting glucose, values below 100 mg/dL are considered normal, 100–125 mg/dL indicates prediabetes, values at or above 126 mg/dL are considered high, and values below 70 mg/dL are considered low. For β-ketone, values below 0.6 mmol/L are considered normal, 0.6–1.5 mmol/L indicates mild elevation, 1.5–3.0 mmol/L indicates moderate ketosis, and values above 3.0 mmol/L indicate severe ketosis. These interpretation ranges are attributed to the American Diabetes Association’s Standards of Care in Diabetes—2023 and the International Society for Pediatric and Adolescent Diabetes’ Clinical Practice Consensus Guidelines on Diabetic Ketoacidosis and Hyperglycemic Hyperosmolar State.
Business Scope and Deployment
VivaChek positions the dual system within the broader category of point-of-care blood glucose and β-ketone monitoring, with its customer base defined as individuals who need to track both measurements, whether for diabetes management, metabolic health, or ketosis risk. The delivery model is structured around a hardware meter paired with disposable test strips, with an optional Bluetooth Low Energy companion app connection for users who prefer digital tracking of their results over time.
Summary
The VivaChek Blood Glucose and β-Ketone Dual System, developed by Weice Biotech, consolidates glucose and β-ketone testing into a single meter and single test strip format. Through Auto Coding, a small sample requirement of about 1.6 microliters, a roughly 12-second test time, a wide 20–65% hematocrit range, and optional Bluetooth Low Energy connectivity to the VivaChek GlucoKet App, the system is built around the stated goal of reducing supplies, steps, and complexity in day-to-day metabolic self-monitoring for capillary blood testing.
https://www.vivachek.com
Vivachek Biotech (Hangzhou) Co., Ltd.
