Atch 3 Brand Name Justification Approved_Redacted.pdf
PDF 1 MB Posted
- Attached to
- Procleix Xpress Pipettor System Federal contract opportunity
- Solicitation number
- FA3016-21-U-0188
About this file
This document is a sole source justification for the Procleix Express System Pipettor. The Air Force Air Education and Training Command requires this fully automated master pool tube system from Grifols Diagnostic Solutions Inc. to test blood samples for various viruses including HIV, hepatitis, West Nile, Zika, and COVID-19 on their Procleix Panther systems at the Armed Services Blood Program-San Antonio. The Procleix Express System Pipettor will allow individual blood samples to be lysed, pooled, and archived on a single master pool tube or deep well plate for efficient batch testing. It also electronically transfers work lists and test results to reduce errors. This system is needed for the program's expanded role in manufacturing and supplying COVID-19 convalescent plasma to military treatment facilities. Without this pipettor, Babesia testing required for convalescent plasma screening would have to be sent out.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| SF 30 Form FA301621U0188 Amendment -01.pdf | ||
| Atch 2 Schedule of Supplies.pdf | ||
| Atch 1 Additional Terms and Conditions.pdf | ||
| Combined Synopsis Solicitation FA301621U0188.pdf |
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Text version
Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items
FOR OFFICIAL USE ONLY
18 Jun 2019 FOR OFFICIAL USE ONLY Page 2 of 5
Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items
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Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items
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At present, the ASBBC-SA utilizes two (2) Panther systems for Zika Virus only and one (1) Tigris system for HIV, HBV, HCV, and WNV testing. The Tigris system is not capable of testing for Zika Virus or Babesia, and they are being discontinued by the manufacturer. The Government requires a stand-alone, fully automated master pool tube system, which is FDA 510K approved for the use with the Procleix Panther Systems. The Procleix Express System Pipettor, as required by the Government, provides for lysing of blood for Babesia testing and pooling of blood specimen for the testing of Human Immunodeficiency, Hepatitis B & C, West Nile, Zika and Human T-Cell Lymphotropic viruses for the production of COVID-19 Convalescent Plasma (CCP). The Grifols Diagnostic Solutions Inc. Procleix Express System Pipettor provides: (1) pooling and archiving mechanism that transfers plasma or serum from individual samples to pool tubes for further testing and/or archiving on deep well plates, (2) the capability to create pools of human plasma or serum from individual samples into a single master pool tube, which is used for batch testing on the Procleix Panther system; (3) collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing a positive specimen identification and master pool tube composition; (4) the capability to dispense human plasma or serum aliquots into an archive plate; (5) a laboratory information system interface called NAT Manager, allowing work list and test results to be transferred electronically, reducing the chances of technician transcription errors and meets the blood banking industry requirement for good manufacturing practices.
Additionally, the ASBBC-SA has been selected as one of sites to manufacture and supply the CCP to Military Treatment Facilities across the DoD. Without the Procleix Express Pipettors, testing samples collected and received by the
Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items
18 Jun 2019 FOR OFFICIAL USE ONLY Page 5 of 5
ASBBC-SA would have to be sent out for Babesia testing. Babesia testing is required in order to screen samples before they can be used for convalescent plasma. Expaning the Procleix platform with this instrumentation will considerably reduce the turnaround time and allow patients to receive critical convalescent plasma quicker.
File details come from the government source that posted it. Updated .