PAXGENE Ribonucleic acid extraction, quality control and aliquoting services
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
This contract is focused on procuring specialized laboratory services to support the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) clinical research activities. Specifically, it requires the extraction, quantitation, normalization, quality control, aliquoting, frozen storage, and shipment of ribonucleic acid (RNA) from 122 PAXgene tubes collected from 50 clinical participants. The services are essential for advancing gene expression profiling, molecular characterization of biospecimens, and subsequent transcriptomic analyses aimed at understanding disease mechanisms and therapeutic targets. The contractor must adhere to rigorous quality control standards, including performing DNase treatment to remove DNA contaminants, ensuring RNA integrity via Agilent instrumentation, and maintaining secure frozen storage conditions. They are also responsible for complete documentation and traceability throughout the processing stages and must notify NIDDK promptly if any specimen is compromised upon receipt. Additionally, the contractor will provide certificates of analysis, donor documentation, shipment records, and maintain the cold chain during storage and shipment. Regular communication with NIDDK personnel regarding order status and shipment tracking is also required to ensure smooth project execution. The contract is managed under the Department of Health and Human Services and will be performed in Maryland.
General Info
Agency
NAICS
Place of Performance
MD, 20892, USASet-Aside
Timeline
Response Deadline
Organization & Contact Information
Full Description
Requirements
3.0 OBJECTIVE
The objective of this requirement is to procure PAXgene ribonucleic acid extraction, quantitation, normalization, Agilent quality control, and aliquoting services for samples collected from 50 clinical participants in support of ongoing NIDDK clinical protocol research and downstream transcriptomic analysis.
These services are necessary to support research involving gene expression profiling, molecular characterization of biospecimens, identification of disease mechanisms, and evaluation of potential therapeutic targets through transcriptomic analysis.
4.0 CONTRACTOR REQUIREMENTS
- The contractor shall provide PAXgene ribonucleic acid extraction and aliquoting services for 122 PAXgene tube units collected from 50 clinical participants. Services shall include ribonucleic acid extraction, quantitation, normalization, Agilent quality control testing, aliquoting, frozen storage, and shipment on dry ice.
- The contractor shall perform high-quality ribonucleic acid extraction from PAXgene tubes using validated protocols and established laboratory procedures.
- The contractor shall perform ribonucleic acid quantitation and normalization to ensure consistent sample concentrations suitable for downstream transcriptomic analysis.
- The contractor shall perform deoxyribonuclease (DNase) treatment to remove genomic deoxyribonucleic acid contaminants and ensure clean ribonucleic acid preparations.
- The contractor shall perform ribonucleic acid integrity and quality assessments using Agilent instrumentation to verify sample suitability for downstream transcriptomic analysis.
- The contractor shall aliquot up to twenty-one (21) aliquots per sample and provide secure frozen storage conditions to prevent sample degradation prior to shipment.
- The contractor shall maintain complete documentation and traceability records, including logging of processing steps and sample status throughout all stages of handling and processing.
Quality Control
- Upon receipt, all specimens shall meet the contractor’s established quality control acceptance criteria for processing.
- The contractor shall inspect all specimens upon receipt and immediately notify NIDDK of any compromised, damaged, or nonconforming specimens requiring replacement.
- The contractor shall verify specimen integrity upon delivery through visual inspection and temperature monitoring procedures.
Repository Management
- The contractor shall provide certificates of analysis and donor documentation for each specimen, as applicable.
- The contractor shall provide shipping documentation and chain-of-custody records to NIDDK upon delivery.
- The contractor shall ensure specimens are maintained and stored under appropriate frozen conditions throughout handling, storage, and shipment activities.
- The contractor shall provide order status updates and shipment tracking information to designated NIDDK personnel throughout the period of performance.
