Life Technologies HID 7500 Real-Time PCR systems

This notice announces the intent by the U.S. Army Medical Acquisition Activity (USAMRAA), 820 Chandler St, Fort Detrick, Maryland, 21702, to award a sole source contract to Life Technologies Corporation under the statutory authority 13.501(a). This contract is for the purchase, delivery, and installation of two HID 7500 Real-Time PCR systems for use at the Armed Forces Medical Examiner System DoD DNA Operations (AFMES-DNAOps). The Armed Forces Medical Examiner System DoD DNA Operations (AFMES-DNAOps) is requiring the purchase of two new 7500 HID Real-Time PCR instruments, tower computers, associated software, installation, calibration chemistries, and extended maintenance to replace two existing 7500 HID Real-Time PCR that are 6 years past their defined End of Life (EOL) cycle replacement. The required instrumentation, computers and software are used to support AFMES-DNAOps mission of assisting AFMES and the Defense POW/MIA Accounting Agency (DPAA) with human remains DNA testing for the identification of U.S. Service members as mandated under title 10 USC, chapter 75, 1471 and 10 USC, Chapter 76, 1501-1513; NDAA 2010, Section 541 (d)(2) and DODI 5154.30. AFMES-DNAOps requires instruments that provide robust, reliable and reproducible quantification performance as the quantification step is a critical step in the amplification of Short Tandem Repeat used in the identification of human remains. To minimize the variation between 7500 HID Real-Time PCR instruments Life Technologies instruments are made using GLP/GMP process as well as following and being ISO 18385 compliant. The Life Technologies 7500 HID Real-Time PCR instruments is a 96 well, 5 color platform that uses increased fluorescence-based polymerase chain reaction (PCR) to determine the quantity of DNA. Quantity is determined through the qualitative detection of nucleic acid sequences coupled with an endpoint detection of the known targets. It offers high-quality data and efficient sample processing. The instrument is used in determining the total human and male DNA present in the DNA extracted from a human remain sample. This quantity allows for the scientist to normalize the DNA input to match the forensically validated DNA input determined by the AFMES-DNAOps to guarantee results for the human remains samples typically process for the identification of U.S. current day and past conflict losses. In addition, the quantification software has previously been validated and is easy to use, has already been configured to the existing laboratory information management system and is streamlined for use in determining the optimal input DNA quantity for all four of the forensic short tandem repeat (STR) kits validated for use at the AFMES-DNAOps and on the 3500XL Genetic Analyzer and GeneMapper ID-X software. The 7500 HID Real-Time PCR instruments and associated quantification software have been validated in accordance with the Federal Bureau of Investigations - Quality Assurance Standards (FBI-QAS) and the ISO-17025 Accreditation standards by AFMES-DNAOps to work in conjunction with the Promega Plexor HY quantification kit. The Plexor HY quantification kit is used to determine the total quantity of Human and Male DNA from extracted human remains and has been optimized and validated for determining the optimal quantity of DNA for amplification with the forensically validated Promega Fusion and Life Technology Globalfiler and MiniFiler autosomal STR kits and the Life Technology Y-Chromosomal STR kit, and analysis on the AB 3500XL Genetic Analyzer and Gene Mapper IDX. The quantification step is critical in that it allows scientist to determine the total amount of DNA present and to normalize the input DNA into downstream applications. The DNA quantification step is required by the FBI-QAS and ISO-17025 accreditation standards prior to amplification and analysis of human remains. The quantification step allows the laboratory to identify the range of DNA inputs that will generate full DNA profiles that are well balanced and within the optimal range of the 3500XL genetic analyzer and allows for the robust detection of mixtures within samples. During proof of concept and development of the automated and manual STR amplification and AB 3500XL analysis methods validated at AFMES-DNAOps, the 7500 HID Real-Time PCR instruments and quantification software were proven by the government to be: reproducible; robust; reliable from lot to lot; and free from human nuclear and mitochondrial DNA contamination. Vendors that produce contamination free, reproducible and reliable reagents and instrumentation are essential for processing forensic casework samples and meeting AFMES-DNAOps mission requirements. Development, optimization and validation of the automated and manual STR amplification and AB 3500XL analysis methods used to identify missing individuals were performed using the 7500 HID Real-Time PCR instruments and Promega Plexo quantification reagents and consumables according to the ISO-17025 and FBI-QAS standards. The 7500 HID Real-Time PCR instruments along with the Promega Plexor HY quantification reagents and consumables have been validated and in use in a variety of forensically validated methods for the past 14 years and the AFMES-DNAOps requires sustained ability to purchase 7500 HID Real-Time PCR instruments and associated quantification software for ongoing mission requirements. The associated Promega Plexor HY quantification and ProwerPlex Fusion STR reagents are purchased under sole source BPA contract W81XWH-20-A-0008 and the associated Life Technologies AmpFlSTR Globalfiler, MiniFiler and YFiler STR kits and 3500XL Genetic Analyzer reagents are purchased under sole source IDIQ contract W81XWH-18-D-0012. The Promega Plexor HY coupled with the 7500 HID Real-Time PCR instrument is the only validated quantification system (reagent and instrument) for use with the currently validated STR and 3500XL Genetic Analyzer instruments required to identify unknown service members for current day and past conflict losses. Failure to purchase this instrument and software will lead to mission degradation. The North American Industry Classification System (NAICS) for this requirement is 334516 and the size standard is 1,000. This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to award a contract no sooner than 15 days after publishing this synopsis. This Special Request for Information is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the expiration date listed in this notice, which reflects at least fifteen (15) days after the publication of this notice, the award will be issued as sole source. All questions and responses concerning this notice shall be emailed to Mr. Christopher L. Cook at christopher.l.cook68.civ@mail.mil.