The Growing Need For Point-Of-Care Diagnostics Beyond The Central Lab
Clinical diagnostics has long depended on central laboratory infrastructure to deliver quantitative immunoassay results. While accurate, traditional fluorescence immunoassay (FIA) testing is constrained by laboratory-bound instruments, large sample volume requirements, long turnaround times, and high operational costs. These constraints limit access to timely diagnostics at the point of care, particularly in primary care clinics, emergency departments, and field settings where rapid clinical decisions are required.
This gap is especially relevant for conditions such as prostate health assessment. 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, which means accessible screening and assessment tools are essential. Aging populations further increase the disease burden and drive demand for early detection. Central laboratory testing, which typically involves venipuncture, larger sample volumes, and longer turnaround, creates barriers to timely point-of-care assessment—underscoring why a decentralized, professional-use diagnostic system matters.
Introducing The VivaDiag FIA Platform For Professional IVD Use
VivaChek Biotech (Hangzhou) Co., Ltd., headquartered in Hangzhou, Zhejiang, China, has developed the VivaDiag fluorescence immunoassay (FIA) platform as an IVDR-certified point-of-care diagnostic system for professional use. The platform pairs a portable analyzer with quantitative test kits, supporting clinical decision-making outside the central laboratory across inflammatory, cardiac, diabetes, tumor marker, hormone, and other parameters.
VivaDiag Prostate Specific Antigen (PSA) Test Kit (FIA)
The VivaDiag Prostate Specific Antigen (PSA) Test Kit (FIA) is a fluorescence immunoassay for the quantitative determination of prostate specific antigen in human whole blood (obtained by fingerstick or venipuncture), serum, or plasma, delivering results in 15 minutes. Its defining attributes include:
- Low sample volume: Only 20 μL of sample is required, enabling fingerstick whole blood testing with minimal patient burden.
- Broad measuring range: 0.1–100 ng/mL for serum/plasma and 0.37–100 ng/mL for whole blood—broader than competitor whole blood ranges of 2–100 ng/mL, enabling detection at lower PSA concentrations.
- Lower added mixed solution volume: 75 μL, matching the lowest among compared competitors.
- Cut-off (reference range): 4 ng/mL.
- Precision: Intermediate precision CV of 4.97% at low concentration, 4.05% at medium concentration, and 4.69% at high concentration.
- Operation temperature: 18–25°C.
- Catalog number: VID24-06-011.
Each kit (catalog number VID24-06-011) contains 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, making it a complete reagent package for professional use with the VivaDiag FIA analyzer system. The kit is intended for use by 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.
VivaDiag Portable FIA Analyzer VIM300H
Supporting the test kit is the VivaDiag Portable FIA Analyzer VIM300H, a compact, portable point-of-care immunofluorescence analyzer built on photoelectric detection principles. Key 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, up to 10 hours of continuous operation.
- Memory: 10,000 results.
- Connectivity: USB, Wi-Fi, Bluetooth (optional), with an external Bluetooth printer available as an option.
- Sample types: Whole blood, serum, plasma, urine, hair, and other sample types.
- 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 uses ID Card coding for test parameter calibration, matching each VivaDiag FIA test kit to the correct measurement protocol. A complete deployment package includes the analyzer, quality control ID card and test device, power adapter, Type C and USB 2-in-1 cable, protective cover, user's manual, and quick reference guide, with optional Bluetooth printer, charging station, and backup battery available.
Regulatory Readiness: IVDR Certification And CE Marking
For professional IVD use in European markets, regulatory compliance is a prerequisite. The VivaDiag system 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, meaning it is intended for use by clinical laboratory professionals and is not intended for self-testing or near-patient testing. This regulatory foundation supports market access across priority European markets, including Germany, France, Italy, Spain, and the UK.
A System Built On A Consistent Technology Platform
The VivaDiag system is built on fluorescence immunochromatography technology and a photoelectric detection based immunofluorescence detection device, forming a consistent technology platform across the product family. This includes earlier analyzer models such as the VIM3000—a 1.8 kg analyzer with a 7-inch color touch screen, built-in thermal printer, 10,000-result memory, and Ethernet port RJ-45 connectivity for wired laboratory information system integration—and the VIM220H, a 165 g portable analyzer with a 1.54-inch LCD display and rechargeable lithium battery, designed for lightweight portability. The VIM300H represents the newer generation in this lineage, combining the compactness valued in the VIM220H with expanded connectivity and an enlarged test menu.
Industry Adaptation Across Care Settings
Because the VIM300H and its companion test kits do not depend on a controlled laboratory environment, the system is adaptable across a range of care settings: primary healthcare locations such as GP clinics, community health centers, and township or rural clinics; emergency and pre-hospital care environments 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 visits, research and field operations, and remote offshore or maritime stations.
Looking Ahead
VivaChek's rollout plan for the VIM300H includes 32 sample units made available for distribution before the Mid-Autumn Festival, approximately 78 finished units available for distribution by late October, and trial production scheduled to conclude in December. As this rollout progresses, the VivaDiag FIA platform—anchored by IVDR certification, a 20 μL low-sample-volume PSA assay, and a 370 g, 10-hour-battery analyzer—positions itself as a professional-use diagnostic system designed to extend quantitative immunoassay testing beyond the central laboratory.
https://www.vivachek.com/
VivaChek Biotech (Hangzhou) Co., Ltd.
About Author
