Attachment 4 - Statement of Need.pdf

Statement of Need – PCR based Proximity Extension Assay

This Statement of Need is for the procurement of a PCR-based proximity extension assay system and associated software and kits. The system must be a benchtop instrument for multiplexing protein measurements, with a software and analysis platform designed to analyze specific biological processes with multiplex immunoassay panels.

Size: The system must have a small footprint of 21.6in height x 10.6in width x 23.6 in depth, allowing for benchtop or BSC use.

Capability: The system must be able to analyze just 1uL of sample to allow for more versatile use and preservation of limited sample supply, as it will be used in analyzing data for clinical studies where samples are limited and experiment replication is necessary for accuracy. The system shall oƯer high specificity and sensitivity by combining antibody-based detection with PCR amplification (high plex and not prone to cross-reactivity like bead-based technologies). The system shall be validated using EDTA plasma and serum samples and be compatible with over 20 unique sample types such as citrate plasma, heparin plasma, tissue and cell lysates, CSF, saliva.

Streamlined Workflow: The system workflow shall limit break points in the assay such as washing steps and hands-on instrument handling.

Kit Integration: The system must have a minimum of 15 uniquely designed panels built for specific disease areas and biological processes, each providing simultaneous analysis of 92 specific protein biomarkers. These panels must be thoroughly validated in more than 1100 peer-reviewed publications. The panels shall address specific disease areas of key biological processes (immunology, biological processes, inflammation, and metabolism) with multiplex immunoassay panels.

Normalization and Controls: The system must provide quality control measures via software integration for in-built normalization via calibration, internal controls, and external controls.

o In-built data normalization via relative units allows for tracking of relative changes in analytes of interest and reduces technical variation and plate-to-plate variations.

o The system shall provide four internal controls to monitor individual sample performance and identify outliers without the need for replicate samples. The controls shall monitor all three steps of the extension assay protocol; immuno reaction / incubation (control for technical variation), extension (control for signal variation independent of the immune reaction), and amplification / detection (to assure successful detection).

o The system shall provide three types of external controls, each in replicate. There shall be an inter-plate control (to normalize each assay and compensate for potential variation between runs and plates), a negative control (to set the background levels through noise adjustment and calculate the Limit of Detection), and a sample control (to assess potential variation between runs and plates, conduct troubleshooting, and assess inter-assay and intra-assay CV) o and integrated controls monitor every step of the workflow for each sample.

Maintenance and Training: Training and regular maintenance shall come standard with instrumentation, and instruments shall self-calibrate with no daily/weekly/monthly maintenance. Plug and play installation shall require no service engineers.

Continuity: The laboratory section currently uses instrumentation from Olink. The System must be seamlessly compatible with the current connections, capabilities, the 10x Genomics kits, and Olink Target 96 technologies to ensure the continuity of the ongoing research studies.

Commented [SJ([1]: Like the others, we have already invested in the Olink system. This is less critical here than in the Illumina system as the other technical specifications are strong enough with Olink (it is the only system of its kind) but still relevant. Please feel free to edit this as you see fit, or remove entirely if not suitable.