VivaDiag Molecular System for Professional IVD Use Guide

VivaDiag Molecular System for Professional IVD Use Guide

Clinical laboratory professionals, general practitioners, and procurement teams who search for a VivaDiag molecular system for professional IVD use are typically asking one practical question: can quantitative diagnostic testing move out of the central laboratory without losing analytical quality? VivaChek Biotech (Hangzhou) Co., Ltd., the manufacturer behind the VivaDiag diagnostic brand, has organized its professional in vitro diagnostic (IVD) portfolio around exactly that requirement — a portable analyzer paired with disposable test kits, certified for professional use under European IVD regulation.

What the VivaDiag Professional IVD Platform Actually Is

VivaChek Biotech is a medical device manufacturer headquartered at Building 2, No. 17 Wuzhou Road, Donghu Street, Linping District, 311199 Hangzhou, Zhejiang, China. Its strategic positioning is specific: a provider of IVDR-certified point-of-care fluorescence immunoassay diagnostics, pairing a portable analyzer with quantitative test kits so that clinical decisions can be supported outside the central laboratory.

The switching term here is fluorescence immunoassay (FIA) — a detection method in which a fluorescent signal generated on an immunochromatographic test device is read photoelectrically and converted into a quantitative concentration. The company’s proprietary work spans a fluorescence immunochromatography technology platform, a photoelectric detection based immunofluorescence detection device, and an ID Card coding system used for test parameter calibration. Together these elements form the technology foundation on which the professional-use system is built.

The Problem the Platform Was Designed to Solve

Traditional FIA testing is constrained by laboratory-bound instruments, large sample volume requirements, long turnaround times, and high operational costs. Those constraints limit timely diagnostics at the point of care, and they are felt most acutely in primary care, emergency, and field settings where a result is only useful if it arrives during the same clinical encounter.

For the company’s lead assay, the burden of disease is well documented: 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, aging populations increase the disease burden, and central laboratory testing involves venipuncture, larger sample volumes, and longer turnaround — each of which creates a barrier to timely point-of-care assessment.

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

The flagship assay of the professional IVD range is the VivaDiag Prostate Specific Antigen (PSA) Test Kit (FIA), catalog number VID24-06-011. It is a fluorescence immunoassay for the quantitative determination of prostate specific antigen in human whole blood (obtained by fingerstick or venipuncture), serum, or plasma.

Key verified performance characteristics include:

• 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
• Precision: intermediate precision CV = 4.97% at low concentration, 4.05% at medium concentration, and 4.69% at high concentration
• Cut-off (reference range): 4 ng/mL
• Operation temperature: 18–25 °C
• Test principle: fluorescence immunoassay / fluorescence immunochromatography
• 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

Two design decisions stand out for professional users. First, the 20 μL sample volume plus fingerstick whole blood capability reduces the barriers associated with venipuncture-only workflows and larger-volume assays. Second, the whole blood measuring range extends to 0.37 ng/mL, which supports detection at lower PSA concentrations. The kit is intended as an aid in the management and monitoring of prostate cancer or other prostate disorders by clinical laboratory professionals.

VivaDiag Portable FIA Analyzer VIM300H

The analyzer that completes the system is the VivaDiag Portable FIA Analyzer VIM300H, introduced together with the PSA Test Kit. It is a compact point-of-care immunofluorescence analyzer combining a 10-hour battery, a touchscreen interface, and support for 39 venous-blood parameters and more than 20 capillary-blood-ready parameters.

Its verified 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)
• Printer: external Bluetooth printer (optional)
• Sample types: whole blood, serum, plasma, urine, hair, and other sample types
• Coding: ID Card
• Operation temperature: 5–40 °C; storage temperature: -10–55 °C
• Unit conversion: yes

The commercial logic of these specifications is straightforward: a 370 g handheld format with a 10-hour runtime supports continuous operation across clinical shifts and mobile workflows in ambulances, field units, and at the bedside, while the 10,000-result memory supports record keeping and data review across multiple testing sessions.

Prior-Generation Models and the Growth Path

The VIM300H did not appear in isolation. The VIM3000 is a prior-generation VivaDiag FIA analyzer with a 7-inch color touch screen, a built-in thermal printer, 1.8 kg of weight, dimensions of 192 x 209 x 169 mm, Ethernet port RJ-45, USB and Wi-Fi connectivity, and a 10,000-result memory — a configuration suited to fixed-location settings with built-in printing and wired network needs. The VIM220H is a further prior-generation model weighing 165 g, measuring 124.5 x 72.5 x 40 mm, with a 1.54-inch LCD, a rechargeable lithium battery, optional Bluetooth printing, and a 999-result memory.

Regulatory Readiness for European Markets

For professional IVD buyers, certification is not a detail — it is the entry condition. VivaChek Biotech holds an EU Quality Management System Certificate under Regulation (EU) 2017/746 on In Vitro Diagnostic Devices, Annex IX Chapter I and III, alongside CE Marking with Notified Body Identification Number 0344 (DEKRA). The PSA Test Kit is IVDR-Certified for Professional Use, and regulatory compliance is supported by EU Notified Body DEKRA. The system is intended for in vitro diagnostic use only, for use by clinical laboratory professionals, and is not intended for self-testing or near-patient testing.

Where the System Fits in Practice

The VIM300H is positioned for primary healthcare — GP clinics and surgeries, community health centers, township and rural clinics, and walk-in care facilities — as well as emergency and pre-hospital care, including ambulances and paramedic units, mobile medical units, emergency department triage, and urgent care centers. Niche deployments include corporate and school health clinics, retail pharmacy testing services, home healthcare and domiciliary visits, research and field operations, and remote offshore and maritime stations.

Deployment Readiness

Launch preparation for the VIM300H is documented: 32 sample units were ready for distribution before Mid-Autumn Festival, approximately 78 finished units were available for distribution by late October, and trial production is scheduled to conclude in December. The analyzer ships with a 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 an optional Bluetooth printer, charging station, and backup battery.

Conclusion

For professional IVD users, the relevant question is not whether a portable analyzer can exist, but whether it can deliver laboratory-quality quantitative results in 15 minutes from 20 μL of sample under IVDR certification. The VivaDiag PSA Test Kit and VIM300H analyzer from VivaChek Biotech (Hangzhou) Co., Ltd. address precisely that combination — portability, quantitative performance, and European regulatory readiness — for clinical teams working outside the central laboratory.

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