Understanding the Need for Point-of-Care PSA Testing

Prostate cancer is the second most common cancer in men globally, with about 1.47 million new cases and about 400,000 deaths worldwide in 2022. Early prostate cancer often presents with few or no symptoms, requiring accessible screening and assessment tools, and aging populations increase the disease burden and drive demand for early detection. Traditional fluorescence immunoassay (FIA) testing is 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. Central laboratory testing involves venipuncture, larger sample volumes, and longer turnaround, creating barriers to timely point-of-care assessment. These industry pain points define the context in which VivaChek Biotech (Hangzhou) Co., Ltd. has developed its point-of-care fluorescence immunoassay (POCT FIA) system.

VivaChek Biotech's POCT FIA Platform: An Overview

VivaChek Biotech (Hangzhou) Co., Ltd., operating under the VivaDiag diagnostic product brand and the VivaChek corporate brand, is a medical device manufacturer specializing in in vitro diagnostics. The company is positioned as a provider of IVDR-certified point-of-care fluorescence immunoassay diagnostics, pairing a portable analyzer with quantitative test kits to support clinical decision-making outside the central laboratory. The company's business coverage includes European priority markets—Germany, France, Italy, Spain, and the UK—alongside the global market, and its headquarters is located in Linping District, Hangzhou, Zhejiang, China.

The core value proposition of the VivaChek POCT FIA system is to deliver laboratory-quality quantitative immunoassay results outside the central laboratory, expanding access to prostate health assessment and other diagnostic testing across primary care, emergency, and field settings.

The VivaDiag Prostate Specific Antigen (PSA) Test Kit (FIA)

At the center of this platform is the VivaDiag Prostate Specific Antigen (PSA) Test Kit (FIA), a fluorescence immunoassay for the quantitative determination of prostate specific antigen (PSA) in human whole blood (obtained by fingerstick or venipuncture), serum, or plasma, delivering results in 15 minutes.

Key Technical Specifications

• 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, and 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

Differentiated Value

The kit's 20 μL sample volume requirement enables fingerstick whole blood testing with minimal patient burden, reducing barriers to testing compared with venipuncture-only workflows and larger-volume competitor assays. Its 15-minute quantitative result supports timely clinical decisions at the point of care, avoiding delays associated with central laboratory processing. The whole blood measuring range of 0.37–100 ng/mL is broader than competitor whole blood ranges of 2–100 ng/mL, enabling detection at lower PSA concentrations. Additionally, the kit's added mixed solution volume of 75 μL matches the lowest among compared competitors. The kit is IVDR-certified for professional use, supporting market access in European markets under Notified Body 0344 (DEKRA).

The kit is intended for clinical laboratory professionals as an aid in the management and monitoring of prostate cancer or other prostate disorders, and is applicable to point-of-care testing settings including general practice, primary care, emergency, and outpatient workflows.

The VivaDiag Portable FIA Analyzer VIM300H

The PSA Test Kit operates in conjunction with the VivaDiag Portable FIA Analyzer VIM300H, a compact, portable point-of-care immunofluorescence analyzer built on photoelectric detection based immunofluorescence detection technology.

Key Features

• Size: 146 x 77.6 x 55.5 mm
• Weight: 370 g
• Screen: 3.97-inch color touch screen
• Sample types supported: Whole blood, serum, plasma, urine, hair, and other sample types
• Coding: ID Card system for parameter-specific calibration
• Battery: Removable and rechargeable lithium battery, up to 10 hours of continuous operation
• Connectivity: USB, Wi-Fi, and Bluetooth (optional)
• Memory: 10,000 results
• Operation temperature: 5–40°C
• Storage temperature: -10–55°C
• Test menu: 39 venous-blood parameters and more than 20 capillary-blood-ready parameters

The analyzer's 10-hour battery runtime enables continuous operation across clinical shifts and mobile workflows without frequent recharging, while its 370 g handheld form factor supports use in ambulance, field, and bedside settings. The intuitive touchscreen operation streamlines the testing workflow, and the 10,000-result memory supports record keeping and data review across multiple testing sessions.

Industry Adaptation

The VIM300H is designed for use across primary healthcare settings such as GP clinics, community health centers, and rural clinics; emergency and pre-hospital care settings including ambulances, mobile medical units, and emergency department triage; and niche markets such as corporate and school health clinics, retail pharmacy testing services, home healthcare, research and field operations, and remote offshore stations.

Regulatory Compliance and Quality Assurance

VivaChek Biotech's POCT FIA system, including the PSA Test Kit, holds an EU Quality Management System Certificate under Regulation (EU) 2017/746 on In Vitro Diagnostic Devices, Annex IX Chapter I and III, and carries CE Marking with Notified Body Identification Number 0344, issued by DEKRA. The PSA Test Kit is IVDR-certified for professional use, reflecting compliance with applicable European in vitro diagnostic requirements for professional-use products intended for clinical laboratory professionals.

Evolution of the VivaDiag Analyzer Line

The VIM300H represents the current generation within a broader lineage of VivaDiag FIA analyzers. Prior models include the VIM220H, a 165 g analyzer with a 1.54-inch LCD display and a rechargeable lithium battery, offering an ultra-light design suited for mobile testing workflows with a memory capacity of 999 results. The VIM3000, a 1.8 kg analyzer with a 7-inch color touch screen and built-in thermal printer, was designed for laboratory and fixed-location settings requiring built-in printing and Ethernet-based wired network connectivity. Each analyzer in the lineup works with VivaDiag FIA Test Kits as a system for quantitative or qualitative measurement of multiple parameters.

Market Reach and Industry Positioning

VivaChek Biotech (Hangzhou) Co., Ltd. directs its POCT FIA offerings toward clinical laboratory professionals and healthcare professionals across clinical diagnostics, point-of-care testing, and in vitro diagnostics industries. The company's service scale spans European priority markets—Germany, France, Italy, Spain, and the UK—supported by regulatory compliance overseen by EU Notified Body DEKRA. Launch readiness for the VIM300H includes 32 sample units available before the Mid-Autumn Festival, approximately 78 finished units by late October, and trial production scheduled to conclude in December.

Conclusion

The VivaChek POCT FIA test system—anchored by the VivaDiag Prostate Specific Antigen (PSA) Test Kit and the VivaDiag Portable FIA Analyzer VIM300H—addresses documented gaps in point-of-care prostate health assessment. Through a combination of a 20 μL sample volume, 15-minute test time, IVDR certification, and a portable analyzer ecosystem supporting a broad test menu, VivaChek Biotech (Hangzhou) Co., Ltd. offers a professional-use in vitro diagnostic system designed for clinical laboratory professionals operating across primary care, emergency, and field-based settings within its targeted European markets.

https://www.vivachek.com/poct.html#1
VivaChek Biotech (Hangzhou) Co., Ltd.