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Understanding the Quantitative PSA Determination Range for Whole Blood

For clinical laboratory professionals evaluating point-of-care prostate specific antigen testing, one of the most frequently asked questions concerns the quantitative PSA determination range for whole blood samples. The VivaDiag Prostate Specific Antigen (PSA) Test Kit (FIA), manufactured by VivaChek Biotech (Hangzhou) Co., Ltd., provides a clearly defined answer that is directly relevant to professionals weighing portable immunoassay options for prostate health assessment outside the central laboratory.

Measuring Range Across Sample Types

The VivaDiag PSA Test Kit is a fluorescence immunoassay (FIA) designed for the quantitative determination of prostate specific antigen in human whole blood (obtained by fingerstick or venipuncture), serum, or plasma. According to the kit’s technical specifications, the measuring range differs by sample type:

• Serum/plasma measuring range: 0.1–100 ng/mL
• Whole blood measuring range: 0.37–100 ng/mL

This distinction matters because whole blood testing introduces additional matrix variables compared with processed serum or plasma, and the kit’s validated range reflects that difference while still covering the clinically relevant cut-off (reference range) of 4 ng/mL used in prostate assessment.

Why a Broader Whole Blood Range Matters

In the context of point-of-care testing, the lower boundary of a whole blood assay’s measuring range is particularly important. The VivaDiag PSA Test Kit’s whole blood measuring range of 0.37–100 ng/mL is positioned as broader than competitor whole blood ranges of 2–100 ng/mL, enabling detection at lower PSA concentrations. For clinical workflows where early-stage monitoring or baseline assessment is the goal, a lower detection floor can support more nuanced quantitative tracking rather than a simple above/below threshold readout.

This capability is especially relevant given the scale of the clinical need the test addresses. Prostate cancer is recognized as the second most common cancer in men globally, with approximately 1.47 million new cases and approximately 400,000 deaths worldwide in 2022. Because early prostate cancer often presents with few or no symptoms, accessible screening and assessment tools are necessary, and aging populations continue to increase the overall disease burden and the corresponding demand for earlier detection pathways.

Test Performance: Volume, Time, and Precision

Beyond the measuring range itself, several technical parameters define how the VivaDiag PSA Test Kit performs in practice:

• Sample volume: Only 20 μL is required, enabling fingerstick whole blood testing with minimal patient burden compared with venipuncture-only workflows.
• Test time: Results are delivered in 15 minutes, supporting timely clinical decisions at the point of care rather than waiting on central laboratory turnaround.
• Operation temperature: The kit is validated for use at 18–25°C.
• Precision: Intermediate precision coefficient of variation (CV) is 4.97% at low concentration, 4.05% at medium concentration, and 4.69% at high concentration.
• Mixed solution volume: The added mixed solution volume of 75 μL matches the lowest among compared competitor kits.
• Catalog number: VID24-06-011.

Each kit 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, giving laboratory professionals a complete, self-contained testing set for 25 determinations per package.

The Analyzer Behind the Range: VIM300H

The quantitative range and precision figures above are only meaningful when paired with a reliable analyzer, and this is where the VivaDiag Portable FIA Analyzer VIM300H becomes relevant. The VIM300H is a compact, portable point-of-care immunofluorescence analyzer built on photoelectric detection principles and fluorescence immunochromatography technology, using an ID Card coding system for parameter-specific calibration — the same coding approach referenced in the PSA Test Kit’s own contents.

Key specifications of the VIM300H include:

• Weight: 370 g in a handheld 146 x 77.6 x 55.5 mm form factor
• Battery runtime: Up to 10 hours on a removable and rechargeable lithium battery
• Screen: 3.97-inch color touch screen
• Memory: Stores up to 10,000 results
• Connectivity: USB, Wi-Fi, and optional Bluetooth, with an optional external Bluetooth printer
• Test menu: Supports 39 venous-blood parameters and more than 20 capillary-blood-ready parameters
• Operation temperature: 5–40°C; storage temperature: -10–55°C

This pairing of a quantitative PSA test kit with a dedicated handheld analyzer is designed to replicate laboratory-quality fluorescence immunoassay results outside the central laboratory, addressing the industry pain point of traditional FIA testing being constrained by laboratory-bound instruments, large sample volume requirements, long turnaround times, and high operational costs.

Regulatory Standing for Professional Use

For clinical laboratory professionals and healthcare professionals operating in regulated European markets, regulatory status is a core consideration alongside technical performance. The VivaDiag PSA Test Kit is IVDR-certified for professional use, with CE Marking under Notified Body Identification Number 0344 (DEKRA), and is covered under the EU Quality Management System Certificate per Regulation (EU) 2017/746 on In Vitro Diagnostic Devices, Annex IX Chapter I and III. This certification framework supports market access across the company’s priority European markets, including Germany, France, Italy, Spain, and the UK.

Who This System Is Designed For

The VivaDiag PSA Test Kit, used with the VIM300H or related VivaDiag FIA analyzers, is intended for clinical laboratory professionals as an aid in the management and monitoring of prostate cancer or other prostate disorders. It is applicable to point-of-care testing settings including general practice, primary care, emergency, and outpatient workflows. The system is explicitly intended for in vitro diagnostic use by trained professionals and is not intended for self-testing or near-patient testing by untrained users.

Summary

For professionals specifically researching the quantitative PSA determination range for whole blood, the VivaDiag PSA Test Kit from VivaChek Biotech (Hangzhou) Co., Ltd. offers a validated range of 0.37–100 ng/mL for whole blood samples (and 0.1–100 ng/mL for serum/plasma), delivered through a 15-minute fluorescence immunoassay requiring only 20 μL of sample. Combined with the IVDR-certified regulatory status and the portable VIM300H analyzer platform, this specification set is directly relevant to decentralized prostate health assessment workflows seeking quantitative, laboratory-grade results outside the central laboratory.

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

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