When erythrocyte sedimentation rate testing took 60 minutes, laboratories needed faster results without compromising accuracy — Alifax has spent over 35 years revolutionising diagnostic workflows with 20-second ESR technology.

Alifax S.r.l. is an Italian company founded in Padua in 1988 by Dr Paolo Galiano, driven by a vision of innovation in laboratory diagnostics. The company has grown into one of the leading international players in haematology, microbiology and molecular biology diagnostics. Alifax’s patented TEST1 technology, introduced in the 1990s, completely revolutionised erythrocyte sedimentation rate (ESR) analysis by delivering reliable results in just 20 seconds using quantitative capillary photometry. This technology is now installed in over 15,000 locations worldwide.

The company combines expertise, scientific know-how and technology development to deliver diagnostic systems designed to improve laboratory efficiency, support clinical decision-making and address the evolving needs of modern healthcare. Alifax holds ISO 13485 certification, is compliant with MDSAP (Medical Device Single Audit Program) covering five markets (Australia, Brazil, Canada, Japan, and the USA), and maintains a photovoltaic system generating 226 kWp across 1,053 m².

Product Portfolio: Haematology, Microbiology, and Molecular Diagnostics

Alifax’s product portfolio spans three core diagnostic areas, each addressing specific laboratory workflow challenges:

Haematology — ESR Line (TEST1 2.0) : Alifax’s flagship ESR analysis system. TEST1 2.0 is the latest evolution of the company’s patented technology, which revolutionised erythrocyte sedimentation rate testing by delivering reliable results in just 20 seconds through quantitative capillary photometry. The system is designed to improve laboratory efficiency by eliminating the 60-minute waiting time of traditional Westergren methods while providing clinically validated results.

The TEST1 platform is installed in over 15,000 locations worldwide and has been validated through numerous international publications, including the first international publication on TEST1 technology (Plebani, Am J Clin Pathol, 1998) and subsequent studies on TEST1 ESR results in patients with different diseases (Cha, Am J Clin Pathol, 2009). The product line includes the TEST1 2.0 analyser, ESR quality controls (Alfred60, launched 2005), and the Roller 20 (launched 2004).

Microbiology — Bacteriology Line : Alifax’s microbiology solutions address bacterial detection and identification in clinical laboratories. The portfolio includes the MDRO system and the I-dOne platform. I-dOne is a rapid, single-step solution for routine Legionella identification using ATR FTIR technology. As described on the company’s website: “ATR FTIR & I-DONE: A Rapid, Single-Step Solution for Routine Legionella Identification.” The bacteriology line supports clinical microbiology laboratories in identifying pathogens and antimicrobial resistance patterns, addressing the daily pressure faced by microbiologists, laboratory managers, and technical staff.

Molecular Diagnostics — Molecular Mouse : Alifax’s molecular diagnostics platform, introduced in 2022, supports genetic and molecular testing applications in clinical laboratories. The Molecular Mouse system expands Alifax’s molecular biology capabilities, complementing the company’s existing haematology and microbiology offerings. Alifax’s commitment to molecular diagnostics reflects its strategic expansion into this growing segment of the in-vitro diagnostics market.

PenOK Sample Collection Devices (2010) : Sample collection devices designed for laboratory specimen handling. Uro-quick (launched 1992) was an early product in the company’s portfolio, followed by PenOK in 2010. Sidecar was launched in 2013.

TEST1 Technology: 20-Second ESR Revolutionising Laboratory Workflow

TEST1 is Alifax’s foundational technology and remains a cornerstone of its product portfolio. Prior to TEST1, ESR testing required 60 minutes of waiting time using the traditional Westergren method, which involved manual blood collection, pipetting, and visual reading after one hour. TEST1’s quantitative capillary photometry technology reduced this waiting time to just 20 seconds, enabling laboratories to report ESR results within the same patient visit and significantly improving workflow efficiency.

The technology has been validated through more than 15,000 installations worldwide and numerous international publications. As described on the company’s website: “Back in the 90s, it completely revolutionised the way in which the erythrocyte sedimentation rate was analysed, by retrieving reliable results in just 20 seconds, thanks to quantitative capillary photometry.”

Patented technology has resulted in considerable expansion even on foreign markets by means of the industry’s largest multinational companies. European partnership with Beckman Coulter (2004) expanded TEST1 distribution across European markets.

R&D and In-House Design: Integrated Product Development

Alifax promotes research and development through a constant investment programme, handling all new instrumentation and methodology-related design and industrialisation activities in-house. The company coordinates internal resources and collaborates with universities, hospitals, independent institutes, and major international players. As described on the company’s website: “Our multidisciplinary teams of engineers, researchers, chemists, biologists and biotechnologists work closely together to develop instruments, reagents and software aligned with the evolving needs of modern laboratories.”

Alifax directly manages the entire design and production process of its diagnostic solutions, from concept to manufacturing. The integrated approach ensures quality, continuous innovation, and technologies designed for real laboratory workflows. R&D operations are conducted across multiple sites, including the new R&D and production site in Nimis, Udine (opened 2012), and the Alifax R&D in Area Science Park, Trieste (opened 2017).

Global Presence: Subsidiaries and Distribution Network

Alifax has established a significant international presence through direct subsidiaries and distribution partnerships. The company has opened subsidiaries in Moscow (2015), Shanghai (2015), Barcelona (2015), Brazil (2018), and Germany (2020). These direct presences enable local support, regulatory compliance, and market-specific service for customers in key regions. The company’s products are distributed through a network of international partners, including the European partnership with Beckman Coulter (2004). Alifax is MDSAP compliant, enabling single-audit compliance with regulatory requirements of five markets: Australia, Brazil, Canada, Japan, and the USA.

Regulatory Compliance and Quality Certifications

Alifax holds ISO 13485 certification, the internationally recognised standard for quality management systems for medical devices, covering the design, production, and servicing of in-vitro diagnostic devices. The company is also MDSAP compliant, meeting the requirements for Quality Management Systems of organisations specialised in the design and production of medical devices for multiple markets. As described on the company’s website: “Just a single audit is required to become compliant with the standards and regulatory requirements of 5 different markets: Australia, Brazil, Canada, Japan and the USA.”

Sustainability: Solar Energy and CO2 Reduction

Alifax has invested in renewable energy infrastructure at its Polverara, Padua facility. The photovoltaic system at the Polverara site generates 226 kWp across 1,053 m² surface area with 808 panels, saving 119,300 kg of CO2 per year. A second system at the Nimis, Udine facility generates 77 kWp across 562 m² with 274 panels. These installations demonstrate Alifax’s commitment to reducing its environmental footprint while maintaining production capacity for diagnostic devices.

History: 1988 to Present — From Padua to International Leadership

Alifax’s history reflects continuous growth and strategic expansion:

1988 : Foundation in Padua, Italy, by Dr Paolo Galiano. Intuition, entrepreneurship, and innovation drove the founding, leveraging decades-long experience in laboratory diagnostics.

1992 : Uro-quick market launch.

1997 : TEST1 market launch, revolutionising ESR analysis.

1998 : Sire Analytical Systems acquisition. First international publication on TEST1 technology (Plebani, Am J Clin Pathol).

2003 : First ESR international congress in Busan, South Korea.

2004 : European partnership with Beckman Coulter.

2005 : Alfred60 and ESR quality Controls market launch.

2006 : Opening of new facilities in Polverara, Padua.

2007 : First publication about ESR Latex controls (Piva, Clin Biochem).

2009 : First publication about Human Biological Liquid culture (Fontana, Med Sci Monit). Publication on TEST1 ESR results in patients with different diseases (Cha, Am J Clin Pathol).

2010 : PenOK sample collection devices market launch.

2012 : US market introduction. Opening of new R&D and production site in Nimis, Udine.

2013 : Sidecar market launch.

2015 : Opening of 3 subsidiaries in Moscow, Shanghai, Barcelona.

2017 : Inauguration of new building in Polverara. Opening of new Alifax R&D in Area Science Park, Trieste.

2018 : Opening subsidiary Alifax Brazil. 30th anniversary celebration.

2019 : New Logo.

2020 : Opening of new subsidiary in Germany.

2021 : I-dOne market launch.

2022 : Molecular Mouse market launch. New TEST1 2.0 market launch.

Exhibiting at MEDICA 2026

Alifax S.r.l. will exhibit at MEDICA 2026, the world’s leading medical trade fair — a strategic platform for reaching laboratory professionals, hospital procurement, and diagnostic distributors. Learn more about the MEDICA Düsseldorf Trade Fair Overview or visit the official MEDICA website.

Frequently Discussed Topics Regarding Alifax S.r.l.

• What is Alifax’s core business?
  Alifax develops diagnostic solutions in haematology (ESR testing), microbiology (Legionella identification, MDRO detection), and molecular diagnostics, with a focus on improving laboratory efficiency and supporting clinical decision-making.
• What is TEST1 technology?
  Alifax’s patented ESR analysis technology that delivers reliable erythrocyte sedimentation rate results in just 20 seconds using quantitative capillary photometry — compared to 60 minutes for traditional Westergren methods.
• How many TEST1 installations are there worldwide?
  More than 15,000 installations worldwide, supported by numerous international publications validating the technology.
• What is I-dOne?
  Alifax’s rapid, single-step solution for routine Legionella identification using ATR FTIR technology.
• What certifications does Alifax hold?
  ISO 13485 certified (quality management for medical devices) and MDSAP compliant for Australia, Brazil, Canada, Japan, and the USA.
• When was Alifax founded?
  Founded in 1988 in Padua, Italy, by Dr Paolo Galiano, with over 35 years of experience in diagnostic innovation.
• How can a laboratory buyer connect with Alifax?
  Professional inquiries should be directed through Alifax’s official B2B channels on its website https://www.alifax.com/ or by connecting with the team at MEDICA 2026.