FAQ

A strong proteomics grant should clearly define the biological question, justify the use of high-throughput proteomics, describe study design and cohort selection, and include detailed methodology for data generation and analysis. Reviewers expect clarity on reproducibility, statistical power, and biological relevance.

High-throughput proteomics can be justified by its ability to measure thousands of proteins simultaneously, enabling comprehensive biomarker discovery, pathway analysis, and systems-level insights that are not achievable with targeted approaches.

Proteomics research is supported by major funding bodies including NIH institutes (e.g., NCI, NIAID), Horizon Europe, ERC, UKRI councils, and national research agencies across Europe, North America, and Asia-Pacific.

The methods section should include sample preparation, assay technology, data acquisition, quality control, and statistical analysis plans. Providing validated, reviewer-ready language can significantly strengthen your proposal.

Yes, using well-structured, customizable templates can save time and improve clarity, as long as the content is adapted to your specific research aims and funding requirements.

User roles are managed by authorized Manager-level users. On the Olink Signature Q100, Manager users manage local user accounts and permissions when authentication is enabled.

In Olink Shield mode in NPX Signature, Manager users use the Manager Panel to add users, deactivate users, assign or remove roles, and manage panel data archives and files. If Active Directory is configured, users can be searched and added from the directory, but Olink Shield roles are still assigned in the application.

Your organization hosts and administers the database environment used by Olink Shield. The database supports shared project access, automatic saving of changes, audit trails, and role-based workflows in NPX Signature. Installation and configuration should be performed with your IT team because the setup requires SQL Server connectivity, database permissions, access-control decisions, and, when used, Active Directory configuration.

Database implementation is described in Chapter 6, Installation and setup, of the Olink Shield User Manual. Installation should be performed by qualified IT personnel. Before installation, confirm that Microsoft SQL Server is installed and reachable, required permissions are available, the appropriate SQL Server port is open, and the client’s workstations meet the software requirements. Customers are also responsible for protecting configuration files, database access, backups, and procedural controls in their regulated environment.

No. Olink Shield, Olink Signature Q100, NPX Signature, and associated Olink assay products are For Research Use Only (RUO) and not for use in diagnostic procedures.

Olink Shield provides technical controls that support regulated research workflows but does not change the RUO status of Olink products.

Depending on their assigned role, users can generate: 

• Standard and Extended CSV exports 

• Analysis Reports (PDF) following project approval 

• System and Project Audit Trail exports (role dependent) 

Standard and Extended Exports include additional information about the Olink Signature Q100 run (Operator, instrument and timestamp). 

Analysis Reports include project approval information, instrument details, panel information, and report integrity verification.

Olink Shield operates using a database hosted within your organization’s IT environment. Installation typically requires Microsoft SQL Server, appropriate user permissions, and network connectivity. We recommend involving your IT team during planning and installation to ensure the system is configured according to your organization’s security and compliance requirements.

Detailed installation instructions, software prerequisites, and configuration guidance are provided in the Olink Shield User Manual, which should be used as the primary reference when planning and deploying Olink Shield.

Olink Shield is licensed on a perpetual, per-instrument basis. Each Olink Signature Q100 instrument requires its own Olink Shield license, which is tied to that instrument and does not expire.

There is no limit to the number of users or operators who can use Olink Shield. Once licensed, your organization can create and manage as many user accounts as needed, with appropriate roles and permissions assigned by a Manager.

If an instrument is replaced or a license needs to be reissued, please contact Olink Support for assistance.

Olink Shield maintains two audit trails: 

• System Audit Trail – Records system activities such as user management, logins, and configuration changes. 

• Project Audit Trail – Records project-specific actions including quality control, approvals, electronic signatures, and report generation. 

Audit trail entries are automatically recorded and cannot be modified within Olink Shield.

Olink Shield enforces an independent review process by ensuring that the person who performs plate quality control cannot approve their own work. This supports traceability, accountability, and good laboratory practices.

Olink Shield includes five user roles: 

• Manager – Manages users, roles, and system configuration 

• Operator – Creates projects and performs quality control 

• Reviewer – Reviews and approves quality control 

• Approver – Performs final project approval 

• Read-only – Views project information without making changes 

These roles help support clear separation of responsibilities throughout the review process.

The underlying NPX Signature data analysis (quality control & normalization) workflow remains the same. Olink Shield adds structured review and approval steps with electronic signatures and role-based permissions to support regulated laboratory workflows.

Olink Shield provides technical controls designed to support operation in accordance with 21 CFR Part 11, including secure user authentication, role-based permissions, audit trails, electronic signatures, and record integrity.

Compliance with 21 CFR Part 11 depends on your organization’s implementation, including validation, standard operating procedures (SOPs), IT infrastructure, and quality management processes.

For more information on implementation, please refer to our Compliance Assessment available in our documents section or reach out to Olink Support.

Olink Shield is an optional software add-on that can be purchased for the Olink Signature Q100 platform & NPX Signature software. Olink Shield enables operation in regulated research environments. It provides role-based user access, audit trails, electronic records, electronic signatures, and enhanced reporting features to support laboratories working under regulated quality systems.

The NPX files use periods (.) as separator, in some regional configurations Excel uses comma (,) as decimal separator instead of period. In this case values can be misinterpreted as thousands. Please ensure decimal separator settings in Excel:

1. Open Excel
2. Navigate to File => Options => Advanced=> Editing Options
3. Confirm that the decimal separator matches the format used in the exported NPX file, which is the period (.).

An assay can show a bimodal distribution pattern in human plasma and serum. The most likely natural cause for this modality is connected to gender (e.g. males and female), age (old versus young), or healthy versus disease. When assays show bimodality in high-plex products, we recommend users to use PC normalization instead of intensity normalization for bimodal assays to maintain sample variance. Examples on bimodal assays are TDGF1 on panel Explore NEURO, FOLR3 on Panel Explore ONC, FOLR3 on Panel Explore ONC and PNLIPRP2 on panel Explore ONC. In Explore 3072, Intensity normalization is not performed for assays that show a bimodal distribution of NPX values. For these assays, the NPX value is PC normalized. If reported, data points for these assays are labelled as Plate Control normalized in the column where normalization method is indicated, even if the project was intensity normalized otherwise. For further assistance, please contact our support team.

An assay can show a bimodal distribution pattern in human plasma and serum. The most likely natural cause for this modality is connected to gender (e.g. males and female), age (old versus young), or healthy versus disease. NPX Signature v2.x does not use a pre-defined list of bimodal or multimodal assays. High assay CV and distribution in the Plate Variation view may be indicative of a bimodal assay. For assays showing bimodality, it is recommended to use Interplate Controls (IPC) Normalized NPX values for these assays. The extended report includes both Intensity normalized (NPX) and IPC normalized NPX. For further assistance, please contact our support team.