Overview of the Quantitative POCT System
For clinical teams evaluating point-of-care testing (POCT) technology that can deliver quantitative immunoassay results outside the central laboratory, VivaChek Biotech (Hangzhou) Co., Ltd. offers a system built around the VivaDiag Portable FIA Analyzer VIM300H paired with the VivaDiag Prostate Specific Antigen (PSA) Test Kit (FIA). The system is designed to address a well-documented industry pain point: traditional fluorescence immunoassay (FIA) testing has historically been constrained by laboratory-bound instruments, large sample volume requirements, long turnaround times, and high operational costs, limiting access to timely diagnostics at the point of care. This review walks through the quantitative measurement specifications, technical architecture, and deployment scope of the VivaChek system based on the manufacturer's published technical data.
Analyzer Hardware Specifications
The VIM300H is the current-generation analyzer in VivaChek's FIA platform. Its specifications include:
- Size: 146 x 77.6 x 55.5 mm
- Weight: 370 g
- Screen: 3.97-inch color touch screen (LCD touch screen)
- Battery: Removable and rechargeable lithium battery, supporting up to 10 hours of continuous operation
- Memory: Stores 10,000 results
- Connectivity: USB, Wi-Fi, and optional Bluetooth
- Operation temperature: 5–40°C
- Storage temperature: -10–55°C
- Coding system: ID Card coding for test-kit-specific calibration
- Unit conversion: Supported
- Sample types supported: Whole blood, serum, plasma, urine, hair, and other sample types
The 370 g handheld form factor combined with a 10-hour battery runtime positions the VIM300H for continuous use across shifts and mobile workflows without frequent recharging. The analyzer's test menu covers 39 venous-blood parameters and more than 20 capillary-blood-ready parameters, giving laboratory professionals a single platform that spans inflammatory, cardiac, diabetes, tumor marker, hormone, and other parameter categories through the fluorescence immunoassay (FIA) technology platform.
Quantitative Measurement Specifications: The PSA Test Kit
The flagship quantitative test kit compatible with the VIM300H is the VivaDiag Prostate Specific Antigen (PSA) Test Kit (FIA), intended for the quantitative determination of prostate specific antigen in human whole blood (obtained by fingerstick or venipuncture), serum, or plasma. Its measurement specifications include:
- Measuring range: 0.1–100 ng/mL for serum/plasma; 0.37–100 ng/mL for whole blood
- Test time: 15 minutes
- Sample volume: 20 μL
- Cut-off (reference range): 4 ng/mL
- Operation temperature: 18–25°C
- Catalog number: VID24-06-011
- Test principle: Fluorescence immunoassay / fluorescence immunochromatography
- Precision: Intermediate precision CV = 4.97% at low concentration, 4.05% at medium concentration, 4.69% at high concentration
- Kit contents: 25 test devices, 25 buffer tubes, 25 safety lancets, 25 alcohol prep pads, 25 x 20 μL pipettes, 25 x 75 μL pipettes, and 1 ID Card
Two specification points are worth highlighting for professionals comparing quantitative POCT systems. First, the 20 μL sample volume enables fingerstick whole blood testing, reducing the sample burden compared with venipuncture-only workflows. Second, the whole blood measuring range of 0.37–100 ng/mL is described as broader than competitor whole blood ranges of 2–100 ng/mL, enabling detection at lower PSA concentrations. The kit also uses a lower added mixed solution volume (75 μL), matching the lowest volume among the assays compared in VivaChek's own technical materials.
Clinical Rationale Behind the Specifications
These specifications are not arbitrary — they respond to a specific clinical context. Prostate cancer is the second most common cancer in men globally, with approximately 1.47 million new cases and approximately 400,000 deaths worldwide in 2022. Early prostate cancer often presents with few or no symptoms, which creates demand for accessible screening and assessment tools. Aging populations further increase the disease burden and drive demand for early detection. Central laboratory testing, by contrast, involves venipuncture, larger sample volumes, and longer turnaround — creating barriers to timely point-of-care assessment. The VivaChek PSA Test Kit's 15-minute quantitative result and 20 μL sample volume are designed to address these specific barriers directly, enabling healthcare professionals to make informed decisions at the point of care rather than waiting for central laboratory processing.
Regulatory Compliance Supporting the Specifications
The quantitative measurement specifications above are backed by formal regulatory certification rather than internal claims alone. The system holds:
- EU Quality Management System Certificate under Regulation (EU) 2017/746 on In Vitro Diagnostic Devices, Annex IX Chapter I and III
- CE Marking with Notified Body Identification Number 0344 (DEKRA)
- IVDR-certified status for professional use
This regulatory framework supports market access in Europe, with priority markets identified as Germany, France, Italy, Spain, and the UK. The intended use is explicitly for clinical laboratory professionals as an aid in the management and monitoring of prostate cancer or other prostate disorders, within settings such as general practice, primary care, emergency, and outpatient workflows. The system is not intended for self-testing or near-patient testing by non-professionals.
Platform Compatibility and Deployment Scope
The VIM300H is built to operate as a system alongside VivaDiag FIA Test Kits for quantitative or qualitative measurement of multiple parameters, using a photoelectric detection based immunofluorescence detection device and ID Card coding for parameter-specific calibration. This modularity allows the same analyzer hardware to support an expanding test menu without requiring separate instruments for each parameter category. Industry adaptation scenarios documented for the VIM300H include primary healthcare settings (GP clinics and surgeries, community health centers, township and rural clinics, walk-in care facilities), emergency and pre-hospital care (ambulances and paramedic units, mobile medical units, emergency department triage, urgent care centers), and niche markets such as corporate and school health clinics, retail pharmacy testing services, home healthcare and domiciliary visits, research and field operations, and remote offshore and maritime stations.
Comparing Current and Prior Analyzer Generations
VivaChek's product history shows an evolution in form factor and connectivity across three analyzer generations. The VIM220H, a prior model, weighs 165 g with a 1.54-inch LCD display, a rechargeable lithium battery, no Wi-Fi, and a 999-result memory — emphasizing ultra-light portability. The VIM3000, another prior model, weighs 1.8 kg with a 7-inch color touch screen, a built-in thermal printer, Ethernet port RJ-45 connectivity, and 10,000-result memory — suited to fixed-location settings requiring built-in printing and wired laboratory information system integration. The current VIM300H sits between these in weight (370 g) while adding Wi-Fi, optional Bluetooth, and a broader parameter menu, reflecting specification choices aimed at balancing portability with connectivity and data capacity.
Conclusion
For organizations assessing quantitative measurement POCT system specifications, the VivaChek VIM300H and PSA Test Kit combination offers documented, certified technical parameters spanning sample volume, measuring range, precision, turnaround time, and hardware connectivity — all positioned around the goal of extending laboratory-quality quantitative immunoassay testing into primary care, emergency, and field settings across its priority European markets.
https://www.vivachek.com
VivaChek Biotech (Hangzhou) Co., Ltd.