H_Brand_Name_JOFOC.docx

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold Brand Name Project Title: Automated extraction of DNA and RNA from human specimens.

I. Identification of the agency and contracting activity

DHHS, NIH, NIAID,

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action. Check the appropriate box:

☒ New requirement ☐ Follow-on

· Name of the previous contractor(s): ________________________________

· Sequence number(s), if available: ____________________________________

· Was the initial and any subsequent awards competed? ☐ Yes ☐ No B. AMBIS Sequence number for this requirement: 1 8 9 5 6 4 2 C. Period of performance, inclusive of options: 30 days ARO D. Project Background The Center for Human Immunology (CHI) is developing a standardized pipeline for analysis of gene expression in blood and tissues from human subjects. Blood for this type of analysis is collected into PAXgene tubes, containing special solution that stabilizes RNA. The CHI staff extracts RNA from PAXgene tubes manually. It causes limited throughput and variability between samples or sample batches, prepared by different people. In addition, special care must be taken to prevent contamination of samples with foreign DNA or RNA. Chance of contamination is higher with manual processing. The CHI is aimed to improve quality of extractions, reduce variability and increase throughput by procurement of automated system capable of high throughput RNA extractions, particularly from PAXgene Blood RNA Tubes.

E. Description of the supplies or services to be purchased

The sample preparation robot must be able to process up to 96 samples in one run. It must be capable of Extraction of RNA, DNA, viral and bacterial nucleic acids from a wide range of starting materials, including PAXgene blood. The instrument must be operated by a software that guides the user through setting up a sample preparation run. Reagents for extraction must come in pre-loaded cartridges. Robot must be able to scan barcodes on samples and reagents, track sample position and keep detailed records about each run. Work table must be enclosed in a hood and have built-in UV light for effective decontamination. All consumables - filter tips, plastic troughs etc., must be disposable. Waste must be isolated from clean work area.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) (This section is to be completed by the purchasing agent.)

☒ 41 USC 1901(e)(2) and FAR Part 13.106-1: Only one responsible source

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Describe why only the requested Product will meet the government’s needs

The QIAsymphony SP, manufactured by QIAGEN (cat# 9001297) can process 1-96 samples in batches of 24, with the option of continuous loading. The instrument is enclosed in transparent hood, worktable has a few drawers that separate clean plasticware from used. Built-in UV light enables worktable decontamination Tip guards help to minimize the risk of cross-contamination. Used tips are ejected into external waste container through a chute. Instrument tracks all changes in reagents and consumables by scanning worktable. It knows how much reagents are in the cartridge by sensing liquid level.

The QIAsymphony SP can be used for RNA, DNA and protein extraction from a wide range of sources: blood, tissues, plasma, serum, buffy coat, PAXgene blood, eukaryotic and bacterial cells, respiratory samples, swabs, urine and transport media. The purification procedure is designed to ensure safe and reproducible handling of potentially infectious samples. QIAsymphony SP operating software guides the user step-by-step through setting up preparation run, with option to select and adapt standardized protocols. It also calculates required volumes of buffers and reagents, number and types of consumables to be loaded. The QIAsymphony SP software has user friendly interface and allows import and export of files. All information about every run is saved in chronological order.