SEQ Buffer

In accordance with FAR subpart 6.302-1(c) (ii), the Centers for Disease Control and Prevention (CDC) intends to issue a sole contract to Applied Biosystems for the SEQ Buffer In order to determine the hepatitis virus genotype of patients infected with HBV and HCV, it is necessary to sequence the appropriate amplicon. Sequencing is the golden standard for genotype and subtype determination. Applied Biosystems is the recognized leader in the sequencing industry and all of our PCR and sequencing equipment is manufactured by ABI. Current CDC recommendations suggest confirmation of each antibody positive patient with a supplemental assay such as a Polymerase Chain Reaction (PCR) assay or an additional antibody assay followed by sequencing. In situations where infection with HCV or HBV needs to be confirmed, the PCR assay is the only option. This assay will confirm on-going viral infection. These PCR assays can be used to help in studies conducted by the epidemiology branch to determine the extent of hepatitis infection within certain populations. The use of these assays in the past within this lab has increased the number of requests. This in turn has also led to an increase in the number of epidemiological studies conducted in the Hepatitis Division to examine the extent of current and past infection in the public health of citizens of the United States. Our Branch does extensive tests to determine the hepatitis virus genotype of patients infected with HAV, HBV and HCV, and HEV and their complete genome sequence. Sequencing is the golden standard for genotype and subtype determination and chain termination sequencing as performed with the needed reagents is the best method for sequencing de novo. We have consistent protocols that use materials supplied by Applied Biosystems, we use the equipment of the same company, which is the industry leader in medium to high throughput sequencing, and in our experience those are the most suitable consumables. The materials are required for the operation of our core sequencing laboratory during the course of one year. Applied Biosystems offer very competitive bulk pricing of the needed materials and additional volume discount for Standing order purchases. Use of alternative means and sources to accomplish the same testing objectives would require extensive validation and expense on the part of CDC. The pricing of ABI is approximately 27-43% lower (depending on the purchase volume) that the one of Fisher Scientific. Applied Biosystems is the original manufacturer of the supplies and the one company that can provide all required components at the needed schedule. These kits are proprietary to Applied Biosystems and are not available through another known source. Our sequencing equipment is designed to operate optimally with the use of these specific reagents. Other companies that offer those reagents are resellers of the same components and none has competitive pricing. It is the understanding of the Government that an award to any other source would cause unacceptable delays in meeting the requirements of the Government. Interested parties who feel that they possess the capabilities to provide the services described above should submit a capability statement demonstrating their abilities to provide the services. The information received in response to this notice will be considered solely for the purpose of determining whether or not to conduct a competitive requirement. Please send your documentation to Deborah Workman by fax (770) 488-2889, or email to [email protected]. Documentation should be received within fifteen (15) days after the date of publication of this synopsis to be considered by CDC. A determination by the CDC not to compete this proposed contract, based upon responses to this notification, is solely within discretion of the government.