NRL

What NRL does

NRL (National Serology Reference Laboratory, Australia) is a government-affiliated not-for-profit reference laboratory founded in 1985 as part of Australia's HIV/AIDS strategy, and designated a WHO Collaborating Centre for Diagnostics and Laboratory Support for HIV and AIDS and other Blood-borne Infections in the same year. Headquartered in Fitzroy, Victoria, with a new TGA GMP-licensed high-throughput screening laboratory in Notting Hill, NRL provides quality assurance products and services to medical laboratories, blood banks, IVD manufacturers, research institutions, and laboratories in low- and middle-income countries across more than 70 countries.

The portfolio spans external quality controls (QConnect, including Optitrol products), external quality assessment schemes (EQAS via the OASYS portal), pre-market IVD evaluations, TGA-licensed reference and contract testing (including the 2NAT Program screening ~150,000 plasma samples monthly for hepatitis A virus and human parvovirus B19), ISO 20387-accredited biobanking through SVI Biobank (50,000+ specimens, 1,800+ participants), biospecimen supply (BioSpec), and consulting and training services for LMIC laboratories. Supporting infrastructure includes the EDCNet QC data portal, a mobile QR-code-enabled portal for point-of-care QA, and integration with the One World Accuracy platform for OASYS.

Revenue is generated through a mix of one-time QC product sales, recurring EQAS subscriptions, recurring testing services contracts (notably with Australian Red Cross Lifeblood and CSL Behring for 2NAT), recurring biobank storage fees, professional services for IVD evaluation, and training fees (AUD $80 per session or AUD $350 for a 5-session package). The go-to-market is sales-led, relying on scientific credibility, participation in international conferences (the annual NRL Workshop on Infectious Disease Testing, Asia Pacific Quality Summit, HTLV International Conference), peer-reviewed publications, and direct engagement with laboratory customers and WHO/FIND-mediated distribution into LMIC markets.

Name

NRL

Legal name

National Serology Reference Laboratory (NRL), Australia

Website

https://nrlquality.org.au

Company type

Private

Founded year

1985

Operating status

Operating

Headcount range

11–50 employees

Short description

NRL (National Serology Reference Laboratory) is a WHO-designated Australian not-for-profit reference laboratory providing quality control products, proficiency testing, IVD evaluations, TGA-licensed screening, and biobanking services to laboratories, blood banks, and IVD manufacturers in 70+ countries.

Ownership category

akta.pro rank

Product category

Laboratory Quality Assurance Services

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), Medical and Diagnostic Laboratories (6215), In-Vitro Diagnostic Substance Manufacturing (325413), Testing Laboratories and Services (541380), Testing Laboratories and Services (54138)

SIC

Services-Medical Laboratories (8071), Services-Testing Laboratories (8734), In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Laboratory Quality Systems, Accreditation & Proficiency Testing Programs (HLAJAIAM)

akta.pro secondary industries

Disease-Specific Reference Laboratory Networks (e.g., TB, HIV, Influenza) (HLAJAIAD), Reference & Esoteric Testing Laboratories (HLAFAMAJ), Microbiology & Infectious Disease Testing Laboratories (HLAFAMAD)

Keywords

• Infectious disease testing
• Laboratory quality assurance
• Proficiency testing programs
• Quality control materials
• Biobanking services

Headquarters

HQ city

Fitzroy

HQ country

Australia

HQ region

Oceania

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Quality Control Products (QConnect): Sale of external quality control materials including Optitrol products for serology and NAT testing. Products are manufactured in bulk to keep costs low and distributed internationally to laboratories.
2. EQAS Programs: External proficiency testing scheme subscriptions providing laboratory quality assurance across multiple testing panels including viral respiratory, bacterial, HIV, HCV, and other infectious disease programs.
3. Testing Services: TGA-licensed screening of blood and tissue donors, reference testing, and contract testing for projects. Includes the 2NAT Program screening approximately 150,000 samples monthly.
4. Biobank Services: Storage and repository services for research groups, clinical trials organisations and others requiring contract storage of biological samples.
5. IVD Evaluations: Pre-market in vitro diagnostic/device evaluations for manufacturers seeking independent assessment of their products.
6. Consulting and Training: Customised training and consulting services for quality systems in LMIC countries, including workshops and educational seminars.

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels8 records

Core offering

NRL is a reference laboratory that provides quality assurance products and services for infectious disease testing, including external quality control materials (QConnect), proficiency testing programs (EQAS), pre-market IVD evaluations, TGA-licensed donor and reference testing services, and ISO 20387 accredited biobanking. As a designated WHO Collaborating Centre since 1985, NRL supports laboratories in more than 70 countries to ensure their infectious disease test results are accurate, consistent, and reliable.

Product overview

NRL (National Serology Reference Laboratory, Australia) is a world leader in the science of quality for infectious disease testing, supporting laboratories in more than 70 countries. The company operates as a portfolio of interconnected products and services rather than a single unified platform. The core offerings include: QConnect for external quality controls utilizing the QConnect Concept; EQAS for external proficiency/QA schemes; Evaluations for pre-market IVD assessments; Testing Services including TGA-licensed screening (notably the 2NAT Program for plasma); SVI Biobank (ISO 20387 accredited) and BioSpec for biorepository services; Consulting and Training for LMIC countries; Research and Development commercializing IVD products; and RapidQ/Point of Care Quality Assurance for decentralized testing. Supporting infrastructure includes the EDCNet QC portal and OASYS EQAS portal. Founded in 1985 and designated WHO Collaborating Centre, NRL focuses on infectious diseases including HIV, hepatitis, HTLV, COVID-19, and influenza.

Differentiator

Problem solved

Functional benefit

Brands

• QConnect: World class external quality controls utilizing the QConnect Concept for quality control services
• EQAS
• EDCNet
• RapidQ
• SVI Biobank
• BioSpec
• OASYS

Products and services

• QConnect Quality Control Services World class external quality controls utilizing the QConnect Concept, providing samples, software and associated services to monitor the precision and accuracy of test results. Designed for medical laboratories performing infectious disease testing including serology and NAT testing.
• EQAS External Proficiency Testing External proficiency/QA schemes designed to ensure laboratory quality and effectiveness of testing processes through proficiency testing programs covering multiple panels including viral respiratory, bacterial, HIV, HCV, CMV, and transplant-transmitted infections.
• Evaluations
• Testing Services (including 2NAT Program) TGA-licensed screening of blood and tissue donors, reference testing, and contract testing for projects. The 2NAT Program screens approximately 150,000 plasma samples monthly for hepatitis A virus and human parvovirus B19, supporting plasma supply safety for CSL Behring's plasma-derived therapies.
• SVI Biobank Tissue and blood biorepository providing storage resources and repository services for research groups, clinical trials organizations, and others requiring contract storage. Holds ISO 20387 accreditation and houses over 50,000 specimens from 1,800+ participants across multiple disease areas.
• Consulting and Training Consulting and mentoring services in quality systems for laboratories in low- and middle-income countries (LMIC), including training on quality requirements for pathology laboratories performing infectious disease testing. Individual training sessions priced at AUD $80 or full 5-session package at AUD $350.
• BioSpec Biorepository service providing reliable and high-quality biospecimens, delivering precision and excellence for research needs including plasma, serum, PBMC, and whole blood samples.
• Research and Development Commercializing IVD products for infectious disease testing, including the development of HTLV-1 Proviral Load assay and other diagnostic innovations. Provides custom services to enable new ideas and products to be brought to market.
• RapidQ Point-of-Care Quality Assurance Point-of-Care Quality Assurance solution providing quality and confidence through competency panels and EQA schemes specifically designed for PoCT settings. Features QR code-enabled panels for smartphone-based result submission and real-time analysis.
• Certified HTLV-1 and HTLV-2 Reference Materials World's first Certified Reference Materials for HTLV-1 and HTLV-2, developed in collaboration with the National Measurement Institute with funding from the Australian Centre for Disease Control, providing definitive reference standards for HTLV testing.

Quantifiable outcome

• Screens approximately 150,000 plasma samples monthly
• +5 more outcomes

Named customers8 records

Segments5 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature6 records

Partnerships

17 partnerships are on record, tiered major and core.

• National Measurement InstitutemajorStrategic or Co-development Partner · 1 January 2026Australian national measurement institute collaborating with NRL on development of the world's first Certified Reference Materials for HTLV-1 and HTLV-2, with funding from the Australian Centre for Disease Control.
• Australian Red Cross LifebloodcoreStrategic or Co-development Partner · 1 January 2025Key partner in the 2NAT Program providing plasma samples for nucleic acid testing screening. Australian Red Cross Lifeblood collects blood and plasma donations and works with NRL to ensure the safety of Australia's plasma supply for CSL Behring's plasma-derived therapies.
• CSL BehringcoreStrategic or Co-development Partner · 1 January 2025Global leader in plasma-derived therapies that is the end recipient of plasma screened through NRL's 2NAT Program. The plasma is used to treat rare and serious conditions, and to support transplantation and critical care.
• Roche AustraliacoreTechnology or Integration · 1 January 2025Technology partner providing equipment and collaboration for the newly commissioned Notting Hill screening laboratory. Roche Australia's instrumentation enables the high-throughput 2NAT screening of plasma donations.
• Therapeutic Goods Administration (TGA)coreOthers · 1 January 2025Australian regulatory body that issued the GMP licence for NRL's Notting Hill screening laboratory and oversees TGA-licensed testing services. Provides regulatory oversight and approval for testing programs.
• National Blood AuthoritymajorOthers · 1 January 2025Australian government body responsible for overseeing the blood supply that collaborated with NRL on the 2NAT Program development and implementation.
• Asian Association of Transfusion Medicine (AATM)majorStrategic or Co-development Partner · 1 January 2023AATM promotes blood transfusion development across 24 member countries in WHO WPRO, SEARO, EMRO and EURO regions. Signed MOU with NRL to promote blood safety, quality, EQAS, and research in blood transfusion safety.
• WHO SEAROmajorStrategic or Co-development Partner · 1 January 2023WHO South-East Asia Regional Office initiated EQAS capacity building project with NRL in Sri Lanka, including baseline assessment of EQAS manufacturing resources at the Sri Lankan National Blood Transfusion Service.
• Yayasan KNCV Indonesia (YKI)majorStrategic or Co-development Partner · 1 January 2023Indonesian foundation supporting NRL's provision of theoretical and practical EQAS training to four identified laboratories in Indonesia, with onsite assessments for national EQAS provider capacity.
• FIND (Foundation for Innovative New Diagnostics)coreStrategic or Co-development Partner · 1 January 2021FIND oversees the Diagnostic Pillar of the Access to COVID-19 Tools Accelerator (ACT-A) partnership hosted by WHO. Awarded NRL USD $1.2 million to provide a Quality Assurance Program for COVID-19 Rapid Diagnostic Testing at Point of Care in LMICs.
• WHO ACT-AcoreStrategic or Co-development Partner · 1 January 2021Access to COVID-19 Tools Accelerator partnership recognized that COVID-19 could not be controlled unless everyone, especially LMICs, could access testing. NRL provides PoCT QA for COVID-19 RDTs under this program.
• World Health Organization (WHO)coreStrategic or Co-development Partner · 1 January 1985NRL was designated as a WHO Collaborating Centre for Diagnostics and Laboratory Support for HIV and AIDS and other Blood-borne Infections in 1985. This long-standing partnership involves collaboration on quality assurance programs, development of reference materials, and support for LMIC laboratory capacity building. NRL has worked with WHO on ACT-A COVID-19 projects and PoCT QA barrier identification.
• SVI (St. Vincent's Institute)coreStrategic or Co-development PartnerSVI Biobank operates as part of St. Vincent's Institute, providing tissue and blood biorepository services for research and CROs. NRL and SVI collaborate on biobanking operations with ISO 20387 accreditation.
• Australian Government Department of Foreign Affairs and Trade (DFAT)majorStrategic or Co-development PartnerAustralian government department supporting international health initiatives that aligns with NRL's work in LMIC countries for laboratory quality systems capacity building.
• Fondation MérieuxmajorStrategic or Co-development PartnerInternational nonprofit organization fighting diseases and strengthening capacities of developing countries, working with NRL on laboratory quality improvement initiatives.
• Baker InstitutemajorStrategic or Co-development PartnerLead organiser of HTLV-1 Longitudinal Study in central Australia covering communities spanning NT and WA. NRL provides study planning, sample validation, and testing services for over 1,200 participants.
• Kirby InstitutemajorStrategic or Co-development PartnerResearch collaborator on HTLV-1 Longitudinal Study receiving comprehensive testing database results from NRL for assessment of HTLV infection prevalence and health impacts.

Scale indicators8 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• Bio-Rad Laboratories: Global diagnostics and life science company whose Unity and Liquichek QC product lines directly overlap with NRL's QConnect business. A larger incumbent offering broader QC, IVD and laboratory instrument portfolios rather than specialising in infectious disease QA.
• Roche Diagnostics: Global IVD manufacturer and NRL's technology partner for the 2NAT program at Notting Hill. Overlaps with NRL in infectious disease diagnostics space and offers integrated QC alongside reagent sales as a larger incumbent.
• Abbott Diagnostics: Global IVD manufacturer offering infectious disease assays, point-of-care platforms and QC programmes. Comparable as a broad incumbent serving similar laboratory and blood-bank customers, though not specialising in independent reference laboratory services.

Direct peers

• QCMD (Quality Control for Molecular Diagnostics): UK-based not-for-profit provider of External Quality Assessment (EQA) / proficiency testing programmes for molecular diagnostics, including infectious diseases. Closely comparable to NRL's QConnect and EQAS offerings in target customers and scientific mission.
• One World Accuracy (OWA): Canadian-based provider of EQA / proficiency testing programmes that hosts the OASYS EQAS portal used by NRL customers. Directly comparable in EQAS delivery model, multi-analyte scheme offerings and laboratory customer base.
• Svar Life Science: Nordic-based specialty provider of quality control materials and proficiency testing for infectious disease and autoimmune serology. Comparable niche positioning to NRL in QC materials for clinical laboratories.
• UK NEQAS (United Kingdom National External Quality Assessment Service): UK-based provider of comprehensive EQA schemes across pathology disciplines including virology, serology and molecular diagnostics. Directly comparable to NRL's EQAS business in scheme structure, customer base (clinical laboratories) and proficiency testing methodology.
• INSTAND e.V. German non-profit scientific medical society operating worldwide proficiency testing schemes and reference laboratory services. Comparable to NRL as a reference laboratory network providing EQAS, QA materials and external quality assessment across infectious disease and clinical chemistry.
• LGC Clinical Diagnostics (formerly SeraCare): Commercial provider of quality control materials, reference standards and proficiency testing panels for infectious disease and molecular diagnostics. Closely comparable to NRL's QConnect product line in QC materials, IVD manufacturer support and accreditation-grade controls.
• College of American Pathologists (CAP) — Proficiency Testing: Operates one of the largest laboratory proficiency testing programmes globally, including infectious disease and serology surveys. Comparable to NRL's EQAS offerings in serving hospital and reference laboratories seeking accreditation-ready PT performance.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/nrlscience
• LinkedInlinkedin.com/company/nrl--quality-of-science

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 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 NRL