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Understanding the Quantitative PSA Determination Range for Whole Blood

For clinical laboratory professionals evaluating point-of-care prostate specific antigen (PSA) testing, the measuring range achievable in whole blood samples is one of the most critical performance indicators. VivaChek Biotech (Hangzhou) Co., Ltd., operating under its diagnostic product brand VivaDiag, has developed the VivaDiag Prostate Specific Antigen (PSA) Test Kit (FIA), a fluorescence immunoassay designed specifically to deliver quantitative PSA results across multiple sample types, including whole blood obtained by fingerstick or venipuncture, as well as serum and plasma.

According to the product specifications, the VivaDiag PSA Test Kit measures PSA concentration within a range of 0.37–100 ng/mL in whole blood, while the range for serum and plasma samples extends slightly lower, from 0.1–100 ng/mL. This distinction matters because whole blood testing—particularly fingerstick whole blood—introduces different matrix characteristics compared with processed serum or plasma, and the assay has been calibrated to maintain quantitative accuracy across this broader biological sample type.

Why the Whole Blood Testing Range Matters

Prostate cancer is the second most common cancer among men globally, with approximately 1.47 million new cases and about 400,000 deaths worldwide in 2022. Early-stage prostate cancer often presents with few or no symptoms, which places significant importance on accessible, reliable screening and monitoring tools. Traditional central laboratory testing typically requires venipuncture, larger sample volumes, and longer turnaround times—factors that can create barriers to timely point-of-care assessment, especially in aging populations where disease burden and screening demand continue to grow.

The VivaDiag PSA Test Kit addresses these constraints through its whole blood measuring range of 0.37–100 ng/mL, which is broader than competitor whole blood ranges of 2–100 ng/mL, enabling detection at lower PSA concentrations. This expanded lower boundary allows clinical professionals to capture PSA values that might otherwise fall below the detection threshold of narrower whole blood assays, supporting more nuanced monitoring and management decisions at the point of care.

Technical Specifications and Performance

The kit is engineered around a fluorescence immunoassay (FIA) platform, also described as fluorescence immunochromatography, which underpins its quantitative detection capability. Key technical parameters include:

• Sample volume: Only 20 μL is required, enabling fingerstick whole blood testing with minimal patient burden.
• Test time: Results are delivered in 15 minutes, supporting timely clinical decision-making.
• Cut-off (reference range): 4 ng/mL.
• Operation temperature: 18–25°C.
• Catalog number: VID24-06-011.
• Precision: Intermediate precision coefficient of variation (CV) is 4.97% at low concentration, 4.05% at medium concentration, and 4.69% at high concentration.

Another notable differentiator is the added mixed solution volume of 75 μL, which matches the lowest volume among compared competitor assays, further streamlining the testing workflow. Each kit includes 25 test devices, 25 buffer tubes, 25 safety lancets, 25 alcohol prep pads, 25 pipettes calibrated for 20 μL, 25 pipettes calibrated for 75 μL, and 1 ID Card used for analyzer calibration. The ID Card coding system allows the paired analyzer to automatically recognize and calibrate for the specific test parameter being run, reducing manual configuration steps for laboratory staff.

Supporting Analyzer Platform: VIM300H

The VivaDiag Prostate Specific Antigen (PSA) Test Kit (FIA) is designed for use with VivaDiag FIA analyzers, most notably the VivaDiag Portable FIA Analyzer VIM300H, introduced alongside the PSA kit in 2026. This portable device weighs just 370 g, measures 146 x 77.6 x 55.5 mm, and features a 3.97-inch color touch screen for streamlined operation. Its removable and rechargeable lithium battery supports up to 10 hours of continuous operation, making it suitable for mobile and shift-based clinical workflows.

The analyzer supports a test menu covering 39 venous-blood parameters and more than 20 capillary-blood-ready parameters, with a memory capacity of 10,000 results. Connectivity options include USB, Wi-Fi, and optional Bluetooth, allowing flexible integration into various point-of-care environments. The analyzer is also compatible with earlier VivaDiag models, such as the VIM3000 (1.8 kg, 7-inch touch screen with built-in thermal printer) and the VIM220H (165 g, 1.54-inch LCD display), reflecting a continued evolution of the platform’s portability and functionality over time.

Regulatory Compliance and Market Readiness

The VivaDiag PSA Test Kit is IVDR-certified for professional use, meeting the requirements of Regulation (EU) 2017/746 on In Vitro Diagnostic Devices, Annex IX Chapter I and III. It carries CE Marking with Notified Body Identification Number 0344, issued by DEKRA, the EU Notified Body supporting VivaChek’s regulatory compliance. These certifications confirm that the assay meets European standards for professional diagnostic use, which is particularly relevant given the company’s stated business coverage across priority European markets including Germany, France, Italy, Spain, and the United Kingdom, in addition to broader global market activity.

As part of its 2026 launch preparation, VivaChek reported that 32 sample units of the VIM300H were ready for distribution before the Mid-Autumn Festival, with approximately 78 finished units available by late October, and trial production scheduled to conclude in December—timelines that indicate a structured rollout of the analyzer alongside the PSA test kit.

Clinical Application and Deployment Scenarios

The combination of a 15-minute quantitative result, a 20 μL sample requirement, and a whole blood measuring range of 0.37–100 ng/mL positions the VivaDiag PSA Test Kit as a practical tool for clinical laboratory professionals working across general practice, primary care, emergency, and outpatient settings. Rather than relying solely on venipuncture and central laboratory processing, healthcare professionals can use fingerstick whole blood samples to obtain quantitative PSA results directly at the point of care, aiding in the management and monitoring of prostate cancer or other prostate disorders.

For organizations seeking a diagnostic solution that pairs a validated whole blood measuring range with portable hardware, the VivaDiag system—manufactured by VivaChek Biotech (Hangzhou) Co., Ltd.—offers a technically documented, IVDR-certified pathway for quantitative PSA assessment outside the traditional central laboratory environment.

https://www.vivachek.com
VivaChek Biotech (Hangzhou) Co., Ltd.

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