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Understanding the Quantitative PSA Determination Range for Whole Blood

For clinical laboratory professionals evaluating point-of-care prostate health assessment, one of the most important technical specifications to understand is the measuring range of a given assay—particularly how that range performs across different sample types. The VivaDiag Prostate Specific Antigen (PSA) Test Kit (FIA), manufactured by VivaChek Biotech (Hangzhou) Co., Ltd., 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. This review examines the kit’s whole blood measuring range in detail, alongside the broader technical and clinical context that makes this specification clinically meaningful.

Why the Whole Blood Range Matters

Prostate cancer is reported as the second most common cancer in men globally, with approximately 1.47 million new cases and approximately 400,000 deaths worldwide in 2022. Early-stage prostate cancer often presents with few or no symptoms, which places considerable importance on accessible screening and assessment tools that clinicians can deploy without waiting on central laboratory turnaround. Traditional central laboratory testing typically requires venipuncture, larger sample volumes, and longer processing times—creating barriers to timely point-of-care assessment, especially in primary care, emergency, and field settings where aging populations and rising disease burden are driving increased demand for early detection.

Against this backdrop, the ability to run a quantitative PSA assay directly on fingerstick whole blood, rather than requiring serum or plasma extraction, is a meaningful operational advantage. It is within this context that the specific numerical range of the VivaDiag PSA Test Kit becomes clinically significant.

The Specific Measuring Range

According to VivaChek’s technical specifications, the VivaDiag PSA Test Kit (FIA) delivers the following quantitative determination ranges:

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

This whole blood range of 0.37–100 ng/mL is described in the source material as broader than whole blood ranges of 2–100 ng/mL offered elsewhere in the market, enabling detection at lower PSA concentrations directly from a fingerstick whole blood sample. In practical terms, this means the assay is capable of identifying lower-end PSA values in whole blood that a narrower-range assay might not reliably quantify, which is relevant for clinicians monitoring borderline or early-stage changes in PSA concentration rather than only flagging already-elevated results.

Supporting Technical Specifications

The whole blood range does not exist in isolation—it is supported by a set of complementary technical parameters that collectively define how the assay performs in a point-of-care setting:

• Test time: 15 minutes, enabling healthcare professionals to make informed decisions directly at the point of care rather than waiting for central laboratory processing.
• Sample volume: 20 μL, which supports fingerstick whole blood testing with minimal patient burden compared to venipuncture-only workflows requiring larger volumes.
• Cut-off (reference range): 4 ng/mL, providing a defined clinical reference point within the broader quantitative range.
• Operation temperature: 18–25°C.
• Precision: Intermediate precision coefficient of variation (CV) of 4.97% at low concentration, 4.05% at medium concentration, and 4.69% at high concentration—figures that describe the assay’s reproducibility across the measuring range.
• Added mixed solution volume: 75 μL, described as matching the lowest volume among compared assays, which simplifies the handling workflow.
• Catalog number: VID24-06-011.
• Test principle: Fluorescence immunoassay / fluorescence immunochromatography.

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—a packaging configuration designed to support repeated use in professional clinical settings.

Analyzer Compatibility and System Context

The PSA Test Kit’s whole blood range is realized through compatibility with VivaChek’s VivaDiag FIA analyzer platform. The current flagship analyzer, the VivaDiag Portable FIA Analyzer VIM300H, is a 370 g handheld device with a 146 x 77.6 x 55.5 mm footprint, a 3.97-inch color touch screen, and a removable, rechargeable lithium battery offering up to 10 hours of continuous operation. The VIM300H supports a test menu of 39 venous-blood parameters and more than 20 capillary-blood-ready parameters, with connectivity via USB, Wi-Fi, and optional Bluetooth, plus a 10,000-result memory capacity for record keeping across testing sessions.

The analyzer uses ID Card coding for parameter-specific calibration, a system that allows the device to correctly interpret results from different VivaDiag FIA test kits, including the PSA kit. This coding approach is one of VivaChek’s proprietary R&D elements, alongside its fluorescence immunochromatography technology platform and photoelectric detection based immunofluorescence detection device.

Regulatory Standing

The VivaDiag PSA Test Kit is IVDR-certified for professional use and carries CE Marking under Notified Body Identification Number 0344 (DEKRA), in accordance with the EU Quality Management System Certificate under Regulation (EU) 2017/746 on In Vitro Diagnostic Devices, Annex IX Chapter I and III. This regulatory status supports market access across VivaChek’s priority European markets, including Germany, France, Italy, Spain, and the UK.

Industry Adaptation

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. It is applicable across point-of-care testing settings including general practice, primary care, emergency, and outpatient workflows. It is worth noting that the broader VivaDiag FIA system—test kits paired with analyzers such as the VIM300H—is intended for in vitro diagnostic use only by clinical laboratory professionals, and is not intended for self-testing or near-patient testing by untrained users.

Summary

For professionals evaluating quantitative PSA determination specifically in whole blood, the VivaDiag PSA Test Kit (FIA) from VivaChek Biotech (Hangzhou) Co., Ltd. offers a documented range of 0.37–100 ng/mL, paired with a 20 μL fingerstick-compatible sample volume, a 15-minute result turnaround, and IVDR-certified regulatory standing. These figures, drawn directly from VivaChek’s published technical specifications, provide a clear basis for assessing whether this assay’s whole blood performance characteristics align with a given clinical point-of-care testing workflow.

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

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