Cystatin C clinical serum samples, commutability

The European Commission DG JRC Reference Materials Unit seeks human serum samples with elevated cystatin C for a commutability study supporting ERM-DA471k/IFCC. The procurement is a planned negotiated procedure (EC-JRC/GEE/2026/MVP/2625-EXA) for supplies divided into three lots comprising a total of 21–36 individual donations with varying cystatin C levels and samples frozen only once. Expressions of interest must be submitted electronically via the EU Funding & Tenders Portal using an EU Login account between 4 May 2026 and 19 May 2026 00:59 Brussels time. Contract duration is up to 14 months and suppliers must comply with EU Regulation 2017/746 and applicable ethical, biosafety and traceability requirements.

What it funds

Summary

Purchase of human serum with elevated cystatin C levels to support the commutability study of reference material ERM-DA471k/IFCC. Material is developed with IFCC and must comply with in vitro diagnostics regulation (EU Regulation 2017/746). Samples are provided in three lots, each composed of multiple individual donations and frozen only once.

Who can apply:Suppliers of human blood/serum products (blood banks, clinical suppliers or qualified bioresource providers) able to deliver 3 lots of 21–36 individual donations with documented donor traceability, appropriate ethical approvals and one-time freezing handling.

Estimated value and procedure:Planned negotiated procedure for low/middle value contract (exact estimated value not stated). Contract nature: supplies; CPV: 33141510 Blood products; maximum contract duration up to 14 months. ¹

1. 1Supplies required: 3 lots of human serum with varying elevated cystatin C concentrations, total 21–36 donations per lot.
2. 2Quality requirements: single freeze only, appropriate ethical and traceability documentation, compliance with IVD Regulation (EU) 2017/746.
3. 3Authority: European Commission, DG JRC Joint Research Centre (Reference Materials Unit).
4. 4Submission: expression of interest via EU Login (electronic); start 04/05/2026, deadline 19/05/2026 00:59 Europe/Brussels.

Expressions of interest must be submitted electronically through the EU Funding & Tenders Portal using an EU Login account. This publication is an advance notice of intent to launch a negotiated low/middle value procurement.

Footnotes

1. 1Further procurement details and final contract notice will be published on the EU Funding & Tenders Portal; suppliers should monitor the tender reference EC-JRC/GEE/2026/MVP/2625-EXA for the official documents.

Basic description and purpose

The Joint Research Centre Reference Materials Unit intends to contract the supply of human serum samples with elevated cystatin C values to be used in the commutability study of the higher order reference material ERM-DA471k/IFCC. The material is developed together with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and in compliance with the in-vitro diagnostics Regulation (EU) 2017/746. The procurement is published as a planned negotiated procedure for a middle/low value contract and is for supplies classified under CPV 33141510 Blood products. More information is available on the EU Funding & Tenders Portal Tender details ¹.

Lead contracting authority:European Commission, DG JRC - Joint Research Centre.

Procedure type and nature of contract:Planned negotiated procedure for middle/low value contract. Nature of the contract: supplies.

What is requested (technical scope)

Supply of human serum with elevated cystatin C concentrations. The serum is required to be divided into three Lots. Each Lot should comprise in total between 21 and 36 donations from individual donors. Donations must contain different levels of elevated cystatin C to cover the target measurement range required for commutability testing. Samples must have been frozen only once prior to supply. The material will form part of the higher order reference material ERM-DA471k/IFCC used for commutability studies and method standardisation in clinical chemistry under the IFCC collaboration and in-vitro diagnostic regulation framework.

Key dates and milestones

1. 1Start date for expression of interest: 04/05/2026 Europe/Brussels
2. 2Deadline for expression of interest: 19/05/2026 00:59 Europe/Brussels
3. 3Indicative date of launch of the negotiated procedure: 19/05/2026 Europe/Brussels
4. 4Maximum contract duration: 14 months (if awarded)

Submission method for expression of interest:Electronic submission via the EU Funding & Tenders Portal. An EU Login account is required for electronic submission. From 30 June 2026 two-factor authentication will be required on EU Login accounts.

Eligibility and applicants

The public notice does not list a detailed eligibility table. Based on the procurement subject matter (blood products / human serum) and the contracting authority (DG JRC), suitable applicants are organisations capable of collecting, processing, anonymising and supplying human serum donations in compliance with ethical, biosafety and legal requirements. Typical eligible applicant types: blood banks, hospital transfusion services, clinical laboratories, certified biological materials suppliers, specialised private suppliers of human biological materials, and research organisations with capacity to supply clinical human serum. Suppliers are expected to comply with applicable donor consent, anonymisation and traceability rules, good manufacturing/practice for reference materials where relevant, and any EU legal requirements for human biological materials.

Eligible applicant types (detailed):Recommended and anticipated eligible applicant types include: blood banks, hospital transfusion centres, accredited clinical laboratories, certified suppliers of human biological material, biobanks, research institutes with clinical sampling capability, private companies manufacturing or sourcing human serum, and third-party contractors able to fulfil legal and ethical donor and biosafety requirements.

Geographic and legal scope

The published tender notice does not explicitly restrict participation to a specific country list in the summary text. The contracting authority is the European Commission (DG JRC) and the publication is on the EU Funding & Tenders Portal, therefore normal EC procurement participation rules apply. Prospective suppliers should assume the requirement to meet EU legal, ethical and regulatory standards for handling and supplying human biological material and must register and submit electronically via EU Login. Interested parties should consult the full procurement documents when published for any explicit geographic or nationality restrictions.

Financial and contractual information

The publication is an ex ante notice announcing the intent to launch a planned negotiated procedure for a low or middle value contract. The notice on the portal does not state an estimated total contract value in the displayed summary. The nature of the transaction is procurement for supplies and will result in a contract with payment for provided materials. Contract maximum duration is 14 months.

Funding type:Procurement contract for supplies (purchase). This is not a grant; the instrument is a public supply contract.

Estimated funding amount:Not specified in the published summary. The procurement is described as middle/low value, but no numeric estimate is provided in the available text. Bidders should consult the formal procurement documentation when published for precise contract value.

Application procedure and stages

This publication is an invitation to express interest and not the actual call for tenders. The procedure is planned as a negotiated procedure for a low or middle value contract. The expressed procurement flow based on the summary is: 1) Expression of interest period (electronic via EU Login) 2) Indicative launch of the negotiated procedure 3) Negotiation and submission of tenders as defined in the forthcoming procurement documents 4) Award and contract signature. This implies at least two main stages for interested entities (expression of interest, then participation in the negotiated procedure).

1. 1Stage 1: Electronic expression of interest via EU Login during the published window
2. 2Stage 2: Participation in the negotiated procurement when launched (request for tender documentation, submission of bids, negotiation as required)
3. 3Stage 3: Award, contract signature and supply (contract duration up to 14 months)

Success rates and co-funding

The notice does not provide statistical success rates. For single-supplier supply contracts success depends on the competitive field and conformity with tender specifications. Co-funding is not relevant for a procurement contract: the successful supplier will receive payment under contract terms; there is no requirement for applicant co-funding.

Technical and compliance requirements (what bidders should prepare)

Procurement documentation when published will contain the detailed technical specification and compliance requirements. Based on the summary text, bidders should prepare documentation and evidence covering at least the following points:

1. 1Proven capacity to collect the specified number of individual donations and to assemble three Lots totalling 21–36 donations each as required, with donor documentation and ethical consent where applicable.
2. 2Laboratory data demonstrating measured cystatin C concentrations across the required elevated concentration range and documentation of assay methods used for donor screening.
3. 3Cold-chain and sample handling procedures that ensure samples are frozen only once prior to delivery, including storage and transport protocols and temperature logs.
4. 4Quality management evidence: accreditations, GMP, ISO standards (e.g., ISO 15189 for medical laboratories) or equivalent standards applicable to biological material supply.
5. 5Data protection, anonymisation and donor consent compliance statements in line with applicable legislation.
6. 6Biosafety and bioethics compliance, including donor screening for transmissible agents and documentation of testing performed.
7. 7Traceability, labelling and packaging specifications compatible with international transport and EU import rules where applicable.
8. 8Insurance, liability and indemnity documentation as required for handling and supply of human biological materials.
9. 9Company legal and financial standing documents to meet procurement selection criteria.

Application templates and submission format

The published summary does not include downloadable tender documents or templates. Expression of interest submissions must be made electronically via the EU Funding & Tenders Portal using an EU Login account. When the negotiated procurement is launched the contracting authority will publish the formal tender documentation and any submission templates on the portal. Bidders should prepare to upload standard procurement forms, technical offer, administrative documentation and commercial proposal in the format required by the portal. There is no bespoke template available in the summary; bidders must consult the future tender documents for exact templates and forms.

Administrative and practical notes

This publication is an ex ante notice and explicitly states it is not a call for tenders but a publication announcing the contracting authority’s intention to launch a future negotiated low or middle value procedure. Prospective bidders must register and use an EU Login account to express interest and to participate in the forthcoming procedure. From 30 June 2026 two-factor authentication will be mandatory for EU Login access. Questions to the contracting authority will be handled through the portal Q&A once the procedure is open.

Mentioned countries and geographic references

No specific supplier countries are mentioned in the summary. The contracting authority is an EU institution (DG JRC) and publication occurs on the EU Funding & Tenders Portal, therefore the procurement follows EU contracting practice. Prospective suppliers should assume relevance to EU-based suppliers or entities able to meet EU legal/regulatory requirements for human biological material supply.

Final summary

This planned negotiated procurement is an ex ante notice from the Joint Research Centre seeking suppliers able to provide human serum donations with elevated cystatin C concentrations for use in the commutability study of ERM-DA471k/IFCC. The supplier must assemble three Lots comprised of between 21 and 36 individual donations each, with varying elevated cystatin C levels and samples frozen only once. The procedure is a planned negotiated middle/low value procurement to be launched after the expression of interest period. Interested parties must express interest electronically via the EU Funding & Tenders Portal using EU Login, and should prepare quality, ethical, biosafety and cold-chain documentation and evidence of clinical/analytical measurement capability. Detailed technical specifications, templates, eligibility rules, award criteria and contract value will be published in the formal tender documentation at the time of the negotiated procedure launch. For initial information see the tender page on the EU Funding & Tenders Portal and the JRC webpages Tender details ¹.

Footnotes

1. 1Official tender notice and publication on the EU Funding & Tenders Portal: ec.europa.eu

Opportunity Overview

The Reference Materials Unit of the Joint Research Centre (JRC) is seeking to procure human serum samples with elevated cystatin C values for a commutability study of the ERM-DA471k/IFCC reference material. This procurement is part of the development of higher-order reference materials conducted in collaboration with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), in compliance with EU Regulation 2017/746 on in-vitro diagnostics.

Procurement Details

Procedure Identifier:EC-JRC/GEE/2026/MVP/2625-EXA

Contracting Authority:European Commission, Directorate-General for the Joint Research Centre (DG JRC)

Procedure Type:Planned negotiated procedure for middle or low value contract. This is an ex ante publicity notice announcing the contracting authority's intention to launch a future negotiated procedure, not an active call for tenders at this time ¹.

Nature of Contract:Supplies

CPV Classification:33141510 - Blood products

Technical Specifications

The procurement is structured in three separate lots containing a combined total of 21 to 36 donations from individual donors. Each donation must contain different levels of elevated cystatin C and must be frozen only once. The serum samples will serve as higher-order reference materials to support the commutability assessment of the ERM-DA471k/IFCC standard, which is essential for ensuring the accuracy and comparability of cystatin C measurements across different laboratory assays and methods.

Cystatin C is an endogenous biomarker used to estimate glomerular filtration rate (GFR) and assess kidney function. The development of standardized reference materials with certified cystatin C values is critical for improving the accuracy and consistency of GFR estimation across clinical laboratories, particularly following the adoption of the IFCC reference standard which resulted in significant changes to measured cystatin C values ².

Contract Duration and Timeline

Maximum Contract Duration:14 months

Expression of Interest Timeline:Start date: 4 May 2026. Deadline: 19 May 2026 at 00:59 Brussels time.

Indicative Launch of Negotiated Procedure:19 May 2026

Who Can Apply

This is a negotiated procedure, meaning the contracting authority will select specific suppliers to negotiate with rather than conducting an open competitive tender. Potential suppliers should be organizations capable of providing human serum samples that meet the technical specifications outlined, including the ability to source donations with elevated cystatin C levels and ensure proper handling and storage protocols.

Eligible suppliers may include clinical laboratories, blood banks, diagnostic companies, biobanks, and other organizations with established capabilities in human serum collection, processing, and quality control. Suppliers must be able to comply with EU regulations on blood products and in-vitro diagnostics, as well as ethical and safety requirements for human biological materials.

Submission Requirements

Method of Expression of Interest:Electronic submission only

Required Account:Prospective suppliers must have an EU Login account in the European Commission's authentication system to submit expressions of interest and participate in the procurement process. As of 30 June 2026, two-factor authentication will be required for all EU Login accounts ³.

Submission Address:Expressions of interest must be submitted through the EU Funding and Tenders Portal electronic submission system. Submissions sent through other channels will not be accepted.

Estimated Contract Value

The estimated total value of the contract has not been disclosed in the published procurement notice. As this is classified as a middle or low value contract under EU procurement rules, the value is likely below the thresholds that would trigger full open tender procedures, but the specific budget allocation is not publicly available at this stage.

Framework Agreement Status

This procurement is not structured as a framework agreement. It is a direct supply contract for the provision of specified serum samples.

Key Information for Prospective Suppliers

• This is a planned procurement notice, not an active call for tenders. Interested suppliers should express interest by the deadline to be considered for the subsequent negotiated procedure.
• The procurement is for a specific, defined product: human serum with elevated cystatin C values divided into three lots with varying concentration levels.
• Suppliers must demonstrate capability to source and process human biological materials in compliance with EU regulations, particularly EU Regulation 2017/746 on in-vitro diagnostics.
• The samples must be single-frozen only, indicating strict requirements on handling and storage protocols.
• This is a collaborative project with the International Federation of Clinical Chemistry and Laboratory Medicine, suggesting alignment with international standards and quality requirements.
• Questions and answers regarding the procurement can be submitted through the portal, though currently no public Q&A has been published.
• The Reference Materials Unit of the JRC is the contracting authority, indicating this is a specialized procurement for scientific reference materials rather than routine supplies.

Regulatory Context

This procurement is conducted under EU Regulation 2017/746 on in-vitro diagnostic medical devices. The development of certified reference materials for cystatin C is essential for ensuring the accuracy and reliability of kidney function testing across the European Union. The IFCC standardization of cystatin C measurements has been critical for improving the comparability of results across different laboratory methods and assays, as previous research demonstrated substantial method-specific biases in cystatin C measurement procedures ⁴.

How to Proceed

1. 1Create or verify your EU Login account at the European Commission's EU Login system if you do not already have one.
2. 2Access the EU Funding and Tenders Portal at EU Funding and Tenders Portal.
3. 3Locate the procurement opportunity using the procedure identifier EC-JRC/GEE/2026/MVP/2625-EXA.
4. 4Review the full procurement notice and any available documentation to understand the technical specifications and requirements.
5. 5Prepare your expression of interest, ensuring it demonstrates your organization's capability to supply the required serum samples and comply with all regulatory and quality requirements.
6. 6Submit your expression of interest electronically through the portal before the deadline of 19 May 2026 at 00:59 Brussels time.
7. 7Monitor the portal for updates regarding the launch of the formal negotiated procedure, expected on or after 19 May 2026.
8. 8If selected, participate in the negotiated procedure to finalize contract terms and conditions.

Additional Resources

For more information about this procurement, prospective suppliers can consult the EU Funding and Tenders Portal, access the ex ante publicity documentation for planned negotiated procedures, or contact the JRC through the portal's helpdesk. The portal also provides guidance on how to participate in EU procurement procedures and access to the F&T eProcurement wiki for additional procedural information.

Footnotes

1. 1This notice is published under the ex ante publicity rules for planned negotiated low and middle value contracts of the European Commission. It announces the contracting authority's intention to conduct a negotiated procedure in the future. Interested suppliers should submit expressions of interest by the specified deadline to be considered for participation in the subsequent formal procurement process.
2. 2The adoption of the IFCC reference standard (ERM-DA471/IFCC) for cystatin C resulted in measured values that were approximately 17 to 24 percent higher than values obtained using previous calibration methods. This standardization was necessary to improve the accuracy and comparability of cystatin C measurements across different laboratory assays and to ensure that GFR estimation equations provide consistent and reliable results across clinical populations.
3. 3Two-factor authentication is a security measure that requires users to provide two forms of identification to access their EU Login accounts. This can be activated through the Security settings of the user's account in the F&T Portal. Users should set up two-factor authentication before the mandatory implementation date of 30 June 2026 to ensure continued access to the portal.
4. 4Research has demonstrated substantial method-specific biases in cystatin C measurement procedures across different manufacturers and assay platforms. For example, measured values for normal serum pools ranged from 0.780 mg/L for Siemens to 1.061 mg/L for Diazyme assays, despite using the same reference material. Manufacturers have been encouraged to improve the accuracy of cystatin C measurement procedures to enable cystatin C to achieve its full potential as a biomarker for estimating glomerular filtration rate.