PAXGENE Ribonucleic acid extraction, quality control and aliquoting services​

• 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.