TestLine Clinical Diagnostics s.r.o.

What TestLine Clinical Diagnostics s.r.o. does

TestLine Clinical Diagnostics s.r.o. is a Czech Republic-based in-vitro diagnostics (IVD) manufacturer headquartered in Brno, operating as part of the BioVendor Group. The company develops and produces immunoassay kits for human and veterinary clinical diagnostics, with a core focus on ELISA and chemiluminescence immunoassay (CLIA) platforms, supplemented by proprietary Microblot-Array and BLOT-LINE technologies for multiplex detection. Its catalog spans infectious disease serology (including Toxoplasma, CMV, rubella, EBV, and Lyme disease), autoimmune panels, tumor markers, and reproductive endocrinology, alongside microbiological diagnostic products.

The company's technical platform centers on validated manual and automated workflows. Its CLIA kits are designed for use on the KleeYa analyzer and integrate with DYNEX Agility automation through proprietary "SmartKits" calibrator-card technology. The Microblot-Array system enables simultaneous detection of multiple analytes in a single strip, and the firm holds IVDR certification under Notified Body 2265 across its key product lines. BioVendor Group reports more than 30 years of immunoassay experience within the TestLine business, with internal manufacturing of recombinant antigens and proprietary evaluation software (Index of Positivity) supporting kit performance.

TestLine operates a B2B distributor-led commercial model, selling through authorized distributors across Europe, Asia, the Middle East, Africa, and the Americas to clinical laboratories, hospital networks, and veterinary diagnostic providers. The company does not publish revenue or headcount. In 2025 the BioVendor Group entered a partnership with private equity firm ARCHIMED, with TestLine positioned as part of the broader BioVendor diagnostics platform under that ownership transition. Named end-user references include AGEL laboratories in the Czech Republic and Slovakia.

Name

TestLine Clinical Diagnostics s.r.o.

Legal name

TestLine Clinical Diagnostics s.r.o.

Website

https://testlinecd.com

Company type

Private

Founded year

1993

Operating status

Operating

Short description

TestLine Clinical Diagnostics is a Czech IVD manufacturer (part of BioVendor Group) producing ELISA, CLIA, and Microblot-Array immunoassay kits for clinical and veterinary laboratories, sold globally through authorized distributors.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics (IVD)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Veterinary Microbiology & Infectious Disease Testing (Culture/PCR/Serology) (HLAMADAC), Laboratory & Point-of-Care Diagnostic Devices (Analyzers, Test Kits, Microscopy) (HLAMAFAI), Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL)

Keywords

• In vitro diagnostics
• Clinical immunoassays
• ELISA test kits
• Autoimmune diagnostics
• Veterinary diagnostics

Headquarters

HQ city

Brno

HQ country

Czechia

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Supply Chain, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. IVD Diagnostic Kits Sales: Sale of laboratory diagnostic kits for human and veterinary use including ELISA, CLIA, Microblot-Array, BLOT-LINE products and microbiological media. Products sold through distributors and direct enterprise accounts with registration requirement for customers.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

TestLine Clinical Diagnostics develops, manufactures, and distributes in vitro diagnostic (IVD) kits and reagents for human and veterinary clinical laboratories. The portfolio spans ELISA kits (including SmartEIA for DYNEX Agility automation), Microblot-Array multiplex autoimmune panels, BLOT-LINE immunoblots, CLIA reagents and control sets run on the KleeYa analyzer, veterinary ELISA kits, and microbiological diagnostic media. Products are sold through authorized global distributors and direct enterprise accounts to hospitals, clinical labs, and veterinary labs.

Product overview

TestLine Clinical Diagnostics s.r.o. is a Czech biotechnology company specializing in the development, production, and distribution of laboratory diagnostics for human and veterinary use. The company operates as part of BioVendor Group and offers a comprehensive portfolio organized around multiple diagnostic technology platforms: ELISA (including SmartEIA for automation), IMMUNOBLOT (BLOT-LINE), and Microblot-Array for immunodiagnostics; CLIA chemiluminescence assays running on the KleeYa analyzer platform; dedicated Veterinary ELISA kits for livestock and companion animal health; and Microbiological diagnostics including UREASAtest products. The portfolio covers infectious serology, autoimmune diseases, immunology, diabetes and metabolism disorders, renal diseases, oncology, and sepsis diagnostics. Automation support is provided through DYNEX instrument integration (DS2, DSX, Agility, Gemini) with dedicated SmartKits and evaluation software.

Differentiator

Problem solved

Functional benefit

Products and services

• ELISA Kits Enzyme-Linked Immunosorbent Assay kits for detection of specific antibodies and antigens in infectious diseases, autoimmunity, and veterinary diagnostics. Backed by 30 years of immunoassay experience and used as the company's foundational product line for clinical and veterinary laboratories.
• SmartEIA Kits Ready-to-use ELISA kits designed for fully automated processing on the DYNEX Agility instrument, with preprinted barcodes containing assay information, expiry, and volume, and an integrated cap holder for high-throughput laboratory automation.
• IMMUNOBLOT (BLOT-LINE) Kits Immunoblot assay kits using nitrocellulose membrane strips for detection of specific antibodies, used as confirmatory tests to ELISA for autoimmune disease diagnostics including ANA and ANCA testing in clinical laboratories.
• Microblot-Array (MBA) Advanced immunodiagnostic platform using antigen microdots in triplets on nitrocellulose membrane within a microtiter well format, enabling simultaneous detection of multiple antibodies for autoimmune disease panels including ANA, liver profile (13 antigens), and autoimmune gastroenteritis.
• KleeYa Analyzer Fully automated chemiluminescence immunoassay (CLIA) analyzer platform for high-throughput clinical diagnostics, supporting CLIA assays for diabetes, autoimmune, infectious diseases, renal diseases, oncology, and sepsis diagnostics.
• CLIA Reagents and Control Sets Chemiluminescence immunoassay reagents for the KleeYa analyzer covering C-peptide, Insulin, GAD65, IA-2, Chromogranin A, Uromodulin, Toxoplasma, Borrelia CSF, HEV, and antiphospholipid markers (Beta 2 Glycoprotein, Cardiolipin), plus control sets for quality assurance.
• Veterinary ELISA Kits ELISA diagnostic kits for animal health diagnostics covering fish diseases (VHSV, SVCV, IPNV), cattle diseases (BVD-MD, BHV-1, EBLV, PTB), swine diseases (Aujeszky's Disease), and dog diseases (Borrelia), manufactured under GMP and OIE standardization.
• Microbiological Diagnostics Diagnostic media and rapid tests for microbiology applications including UREASAtest for Helicobacter pylori detection, HIPPUstrip, TRIBUstrip, and LEPTOSPIRA culture media for clinical microbiology laboratories.
• ELISA Instruments (DYNEX and STRATEC Automation) Automated ELISA processing instruments including DYNEX DS2 (2 microplate), DYNEX DSX (4 microplate), DYNEX Agility (12 microplate), and DYNEX Gemini (2-3 microplate, manufactured by STRATEC SE) for laboratory automation of TestLine ELISA kits.

Quantifiable outcome

• Unique automated diabetes panel combining functional and autoimmune markers for Type 1, LADA, and Type 2 diabetes differentiation
• +1 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

Feature5 records

Partnerships

Three partnerships are on record, tiered core and flagship.

• DYNEX TechnologiescoreTechnology or IntegrationPartnership for ELISA automation with DYNEX DS2, DSX, and Agility instruments. SmartKits designed specifically for DYNEX Agility system integration.
• STRATEC SEcoreTechnology or IntegrationPartnership for Gemini ELISA processing instrument manufactured by STRATEC SE, Germany.
• BioVendor Group (Parent)flagshipOthersTestLine is a member brand of BioVendor Group - international group of biotechnology companies focusing on development, production and distribution of IVD products and laboratory automation technologies. Group includes BioVendor-LM, BioVendor-RD, TestLine, ViennaLab, DiaSource, and BioVendor MDx.

Scale indicators4 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• EUROIMMUN (PerkinElmer): EUROIMMUN is a global leader in autoimmune diagnostics, offering BIOCHIP immunofluorescence, ELISA, and Western blot products for autoimmune and infectious disease serology. Directly comparable to TestLine's autoimmune ELISA, BLOT-LINE, and Microblot-Array portfolio serving specialty laboratories.
• Orgentec Diagnostika: Orgentec develops and markets ELISA and blot-based diagnostic test kits for autoimmune diseases and infectious serology. Comparable to TestLine in menu composition (autoimmune and infectious disease ELISAs) and target customer base of clinical and specialty laboratories.
• AESKU.DIAGNOSTICS: AESKU is a Germany-based specialty IVD manufacturer producing ELISA, immunofluorescence, and microarray-based autoimmune and infectious disease diagnostics. Directly comparable to TestLine in autoimmune-focused ELISA and microarray multiplex technology targeting clinical laboratories.
• Mikrogen Diagnostik: Mikrogen is a German specialty IVD manufacturer producing recombinant immunoblot (microarray) and ELISA products for infectious disease and autoimmune diagnostics. Directly comparable to TestLine in multiplex immunoblot technology and infectious/autoimmune menu coverage.
• NovaTec Immunodiagnostica: NovaTec is a Germany-based IVD company producing ELISA kits for infectious disease serology (Aspergillus, Brucella, Candida, Legionella, etc.). Already a cooperation partner of TestLine and directly comparable as a specialty infectious-disease ELISA manufacturer serving the same distributor-led European market.
• Serion Diagnostics: Serion Diagnostics is a German IVD company specializing in ELISA and CLIA assays for infectious disease serology and immunity testing. Comparable to TestLine's ELISA and CLIA reagent portfolio serving routine clinical laboratories.
• DiaSource Immunoassays (BioVendor Group sister brand): DiaSource is a sister brand of TestLine within BioVendor Group, also manufacturing IVD immunoassays (RIA, ELISA) for endocrinology and infectious disease diagnostics. It is directly comparable as it operates in the same parent group, the same IVD reagent space, and competes for overlapping R&D resources and distributor attention.

Others

• DYNEX Technologies: DYNEX Technologies manufactures the ELISA processing instruments (DS2, DSX, Agility) that TestLine's SmartKits and reagents are designed to run on. It is an enabling technology partner rather than a competitor; comparable as a key dependency for TestLine's automation strategy.

Broad incumbents

• Binding Site Group (Thermo Fisher Scientific): Binding Site, part of Thermo Fisher, offers specialty immunodiagnostics including automated assays for immune status, neurology, and autoimmune disorders. Comparable as a larger specialty IVD incumbent with overlapping autoimmune and specialty testing menu items.
• IDS Immunodiagnostic Systems (Sysmex): IDS (part of Sysmex) provides automated immunoassay systems and specialty assays for vitamin D, PTH, bone metabolism, and infectious diseases. Comparable to TestLine's CLIA reagent strategy and KleeYa analyzer, though focused on a different specialty menu.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UC6EL-eRbbVRvvrfg3GK8_BA
• LinkedInlinkedin.com/company/testline-clinical-diagnostics-ltd

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about TestLine Clinical Diagnostics s.r.o.