National HIV and HCV Nucleic Acid Test (NAT) Reference Centers

The Association of Public Health Laboratories (APHL), in cooperation with the US Centers for Disease Control and Prevention (CDC) Division of HIV/AIDS Prevention and Division of Viral Hepatitis are seeking to recompete the National HIV and HCV Nucleic Acid Test (NAT) Reference Centers. APHL is seeking to identify one or two state or local public health laboratories (PHL) to serve as the HIV NAT Reference Center(s) and one state or local PHL to serve as the HCV NAT Reference Center. These Reference Centers will perform testing validated according to jurisdictionally appropriate regulatory criteria (CLIA/CAP/CLEP etc.).

• The National HIV NAT Reference Center(s) will perform an HIV-1 NAT and HIV-2 NAT or an HIV-1/HIV-2 NAT that is either Food and Drug Administration (FDA)-approved for use as a diagnostic, an a modified FDA-approved method that has been validated for off-label use as a diagnostic test, or a laboratory developed test that has been validated according to jurisdictionally appropriate regulatory criteria (CLIA/CAP/CLEP etc.) for serum or plasma specimens from US PHLs that meet specimen submission requirements.
  If two Reference Centers are chosen, only one will be required to offer an HIV-2 NAT Method.
• The National HCV NAT Reference Center will perform an HCV NAT that is either FDA-approved, or a modified FDA-approved, method that has been validated according to jurisdictionally appropriate regulatory criteria (CLIA/CAP/CLEP etc.) as a diagnostic method for serum or plasma specimens from US PHLs that are reactive for HCV antibody on an FDA-approved anti-HCV assay. ​

Eligibility

Eligible laboratories include all public health laboratories with the following capabilities, resources, and facilities in place:   

1. Established capacity to perform an FDA-approved  or modified FDA-approved NAT method that detects HIV-1 RNA and is validated to provide  results to aid in diagnosis for serum and plasma specimens for HIV-1 (HIV NAT Reference Center Only), see Appendix A: Expectations for National HIV NAT Reference Center for complete details AND/OR
2. Established capacity to perform an FDA-approved or modified FDA-approved NAT method that detects HCV RNA and is validated to provide results to aid in diagnosis for serum and plasma specimens for HCV (HCV NAT Reference Center Only), see Appendix B: Expectations for National HCV NAT Reference Center for complete details
3. Availability of adequate laboratory space and necessary equipment (including infrastructure for unidirectional workflow for molecular testing);
4. Sufficient workforce capacity for testing volume or the ability to hire additional qualified staff;
5. Ability to receive and test specimens from other laboratories;
6. Willingness to increase frequency of performing certain methods (if required) to meet expected turnaround times;
7. Willingness to use provided specimen submission form(s) for samples submitted to the Reference Center;
8. Willingness to alter existing reporting language to a standardized reporting language with input from APHL/CDC;
9. Willingness to share copies of quality assurance (QA) or biosafety documentation associated with relevant procedures to APHL and CDC upon request;
10. Ability to report results to submitter in a timely manner, ideally electronically.

Specific expectations regarding the methodologies to be used by the Reference Center are outlined in Appendix A: Expectations for National HIV NAT Reference Center and Appendix B: Expectations for National HCV NAT Reference Center. All applicants are required to agree to the minimum requirements for the Reference Center they are applying to, which are outlined in Appendix C: Minimum Requirements for National HIV NAT Reference Center and/or National HCV NAT Reference Center. Applicants may apply for either the National HIV NAT Reference Center, the National HCV NAT Reference Center or both.    

*Disclaimer: All bolded sections below this section have been updated on 3/16/2020 to reflect changes on the RFP

Anticipated RFP Schedule

• March 9, 2020 – RFP Issued
• April 27, 2020 – Informational Teleconference (Q&A)      
• May 1, 2020 – Letter of Intent Due to APHL (see below)
• May 26, 2020 – RFP Responses Due
• June 17, 2020 – Proposal review completed
• June 18-26, 2020 – If needed, follow-up interviews and updated proposals due
• June 29, 2020 – Final review completed and awardees selected
• January 1, 2021 – First year contract awarded        

APHL will communicate any modification to this anticipated schedule on APHL's procurement website (www.aphl.org/rfp) and via an email blast to the public health laboratories (PHLs).

Response Submittal

Confirmation of Intent to Respond

APHL requests that prospective applicants submit a brief email statement indicating an intent to submit a proposal. APHL must receive this email by no later than 5:00 pm EST on Friday, May 1, 2020.

Final Response

APHL must receive complete responses by 5:00 pm EST on Tuesday May 26, 2020. Please see Proposal-Required Submissions section in the Official RFP PDF for items that must be included in the completed proposal. Applicants must send proposals via email to Anne.Gaynor@aphl.org 

APHL will send an email acknowledging the receipt of your application. If you do not receive an acknowledgement within two (2) business days, call 240.485.2739 to confirm receipt.

Additional Information and Deadlines for Application Submission

Applicants must direct all questions to Anne Gaynor (anne.gaynor@aphl.org). APHL will post questions received from interested PHLs, together with the answers provided by APHL or CDC staff to APHL's procurement website associated with the specific RFP (www.aphl.org/rfp).

To allow for appropriate review process planning, a letter of intent is required for consideration. Applicants should submit letters by email to Anne Gaynor at APHL (anne.gaynor@aphl.org) no later than 5:00 pm ET on Friday, May 1, 2020.

Applications are due to Anne Gaynor at APHL (anne.gaynor@aphl.org) no later than 5:00pm ET Tuesday May 26, 2020. APHL will send an email acknowledging the receipt of your application. If you do not receive an acknowledgement within two (2) business days, call 240.485.2739 to confirm receipt.

APHL will hold an optional teleconference on Monday April 27, 2020 at 2:00pm ET. The purpose of this call will be to provide a brief overview of the project and to allow potential applicants to ask CDC and APHL questions. Please come with questions prepared.

Teleconference Call-in Information is below, or please contact anne.gaynor@aphl.org or infectious.diseases@aphl.org no later than 3:00pm ET on Friday April 24, 2020to receive the calendar invitation.

Join Zoom Meeting
https://aphl.zoom.us/j/564449328

Call-in Information
1-646-876-9923 OR 1-669-900-6833

Meeting ID: 564 449 328

Materials

The National HIV and HCV Nucleic Acid Test (NAT) Reference Centers RFP Document (Updated 03/16/2020) will provide detailed information in regards to this request, please read it in its entirety. Additionally, feel free to contact Anne Gaynor at Anne.Gaynor@aphl.org with any questions.

Questions and Answers