SOW - High Throughput Biosensor Calibrator.pdf

PANRSA-25-P-0000 005118

Statement of Work For

Robust Sensing Chips and High-Throughput Multiplex Biosensor Calibrator December 3, 2024

1.0 INTRODUCTION

US Army Product Director – Test, Measurement, and Diagnostic Equipment (PD-TMDE) is responsible for providing calibration standards for US Army personnel performing maintenance on US Army weapon systems. PD-TMDE has a requirement to develop automated test equipment (ATE) and calibration instrumentation (standards) in the biological agent defense parameter to the fullest extent possible. PD-TMDE requires the development, test, evaluation, and training of engineering prototypes to support emerging gaps in calibration capability with high stability and accuracy.

1.1 Purpose development

The PD-TMDE has a requirement to develop biological detection calibration capability to work with the modernized calibration sets and meet current and future biological detection calibration and repair requirements. The Biosensor Calibrator is a calibration standard for fielded and future DoD biological warfare agent sensors that use laser induced fluorescence (LIF) technology. The Joint Biological Point Detection System (JBPDS) and the Joint Biological Tactical Detection System (JBTDS) are examples of currently fielded items that this calibration standard will support. The PD-TMDE has an urgent need to develop an engineering prototype of a Biosensor Calibrator capable of producing positive identification of aerosolized, surface, and human surrogate pathogen contamination samples. The prototype must be capable of passing all performance parameters with accuracy traceable to the National Institute of Standards and Technology (NIST) and to transfer those accuracies to the Joint Force field biodetectors.

1.2 Scope

The Contractor shall design, acquire, implement, test, deliver, and support the integration of robust sensing chips and a high-throughput (HT) and multiplex Biosensor Calibrator and the associated documentation as specified in the following paragraphs.

The Contractor shall use an automated bioaerosol detection method with Localized Surface Plasmon Resonance (LSPR) technology to sense airborne biological material. The automation shall include aerosol to hydrosol sampling, hydrosol liquid sample transport to sensor chip, and sensing algorithm.

2.0 TECHNICAL REQUIREMENTS

2.1 Technical Requirements: Robust Sensing Chips

2.1.1 The Contractor shall develop robust, functionalized, high-throughput and multiplex LSPR sensing chips that are reusable and can be shipped at ambient temperature and stored for at least 3 months. If possible, the Contractor shall develop a regeneration process for the robust chip design.

2.1.2 The robust sensing chips shall be functionalized to measure either total bioaerosols using succinimidyl-ester gold nanoislands (AuNI), and/or bacteria using antibody/antigen functionalized AuNI, and/or bacteria/virus using AuNI with DNA or RNA hybridization schemes, and/or using functionalized AuNI to target a label molecule that is attached to an aerosol particle in a laboratory generated test aerosol.

2.1.3 The Contractor shall deliver protocol to fabricate and functionalize the robust multiplex and high throughput sensing chips as described in 2.1. The Contractor shall provide model and OEM for all necessary to fabricate and functionalize hardware.

2.1.4 The Contractor shall provide general project oversight, prepare quarterly reports, briefings, project technical reviews, and prepare and maintain a project schedule.

2.2 Technical Requirements: High-throughput and multiplex Biosensor Calibrator

2.2.1 The Contractor shall manufacture an automated High-throughput Biosensor Calibrator using plasmonic sensor chips with specific surface functionalization for sensitive bioaerosol detection.

2.2.2 The Contractor shall develop a miniaturized and integrated air sampler for the Biosensor Calibrator.

2.2.3 The system shall utilize robust sensing chips (2.1).

2.2.4 The Contractor shall upgrade the automated system to measure multiple samples one after another, unattended, for at least 6 samples and up to the number of samples that is practical.

2.2.5 The automated system shall be capable of running for at least three hours unattended. The high-throughput Biosensor Calibrator with high-throughput plasmonic chips shall operate in the following way: collect the sample from an aerosol into a liquid solution (collection), measure the sample (measurement), collection, measurement, etc.

2.2.6 The Contractor shall establish two methods for analyzing the obtained data, one for a quick alarm signal with shorter time and less quantitative accuracy, and the other for more accurate and quantitative analysis with saturated response under longer reaction time.

2.2.7 The Contactor shall develop sensor chips fabricated with different surface functionalization of various receptors towards different targets on different channels. The response of each channel can correspond to the pre-defined specific target and provide the concentration of each target in the sample tested simultaneously.

2.2.8 The Contractor shall establish the standard testing protocol with the multiplex sensing chips (2.2.8) with optimized sampling frequency, acquisition time on different channels which align with the automated multi-channel sensing stage to achieve the capability of measuring two or more specific targets simultaneously and identifiably in one sensing unit.

2.2.9 The Contractor shall develop a new processing algorithm for collected data so that the phase response from each sensing channel can be calculated continuously and separately, which will ultimately lead to the response towards different sensing targets.

2.2.10 The Contractor shall validate the system performance and provide a calibration certificate with system response to concentrations of E. coli, and/or B. Subtilis, and/or influenza A, and/or SARS-CoV-2.

2.2.11 The Contractor shall provide general project oversight, prepare quarterly reports, briefings, project technical reviews, and prepare and maintain a project schedule.

3.0 HARDWARE DELIVERABLES

3.1 Hardware Deliverables: High-throughput and multiplex Biosensor Calibrator

3.1.1 The Contractor shall deliver a High-throughput Biosensor Calibrator as described in the technical requirements (2.2). It is permissible to modify the automated biosensor calibrator that is currently under development for the Army.

3.1.2 The High-throughput Biosensor Calibrator shall include Robust Sensing Chips that meet requirements in 2.1.

4.0 DOCUMENTATION DELIVERABLES

4.1 Documentation Deliverables: Robust Sensing Chips

4.1.1 The Contractor shall deliver a report with the protocol to fabricate and functionalize the robust sensing chips that meet technical requirements in 2.1 above. The Contractor shall provide model and manufacturer for all hardware necessary to fabricate and functionalize. The report shall document the following: measurements performed, hardware and processes developed to prove that the robust sensing chips can be shipped at ambient temperature and stored for at least three months and will document how many times a chip can be reused. (CDRL A001).

4.2 Documentation Deliverables: High-throughput and multiplex Biosensor Calibrator

4.2.1 The Contractor shall deliver an engineering manual with written operating procedures for the High-Throughput and multiplex Biosensor Calibrator in Contractor format that provides instructions on using the product (i.e. SW graphical user interface, hardware controls, and basic operations). The engineering manual shall also include a parts listing with a description, model, and manufacturer for all hardware necessary to fabricate. (CDL A002)

4.2.2 The Contractor shall deliver a calibration report for system. The calibration report shall contain a multi-point curve fit of system response to concentrations of E. coli, and/or B. Subtilis, and/or influenza A, and/or SARS-CoV-2. (CDRL A003)

5.0 SOFTWARE DELIVERABLES

5.1 Software Deliverables: High-throughput and multiplex Biosensor Calibrator

5.1.1 The Contractor shall deliver any software necessary to operate High-throughput and multiplex Biosensor Calibrator as described in the technical requirements (2.2). (CDRL A004)

6.0 DELIVERY REQUIREMENTS

6.1 Document Marking: All documents containing technical information shall be marked as follows unless approved for public release:

Distribution Statement D:

Distribution authorized to the Department of Defense and U.S. DoD Contractors only due to the need to protect technical or operational data and/or export limitations as determined on 2 October 2017.

6.2 Delivery Instructions: The Contractor shall deliver to U.S. Army TMDE Activity (USATA) Army Primary Standards Laboratory (APSL), Building 5435 Fowler Road, Redstone Arsenal, Alabama 35898-5000. DoDAAC W80RA6.

6.3 The period of performance for this effort is not to exceed 24 months after receipt of order

(ARO).