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.).
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.
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.
Eligible laboratories include all public health laboratories with the following capabilities, resources, and facilities in place:
- 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
- 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
- Availability of adequate laboratory space and necessary equipment (including infrastructure for unidirectional workflow for molecular testing);
- Sufficient workforce capacity for testing volume or the ability to hire additional qualified staff;
- Ability to receive and test specimens from other laboratories;
- Willingness to increase frequency of performing certain methods (if required) to meet expected turnaround times;
- Willingness to use provided specimen submission form(s) for samples submitted to the Reference Center;
- Willingness to alter existing reporting language to a standardized reporting language with input from APHL/CDC;
- Willingness to share copies of quality assurance (QA) or biosafety documentation associated with relevant procedures to APHL and CDC upon request;
- 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
Expectations for National HIV NAT Reference Center and
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).
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.
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
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 (email@example.com). 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 (firstname.lastname@example.org) no later than 5:00 pm ET on
Friday, May 1, 2020.
Applications are due to Anne Gaynor at APHL (email@example.com) 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 firstname.lastname@example.org or email@example.com no later than
3:00pm ET on Friday April 24, 2020to receive the calendar invitation.
Join Zoom Meeting
Meeting ID: 564 449 328
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
What is the current and/or estimated monthly volume of tests for the National HIV and HCV NAT Reference Centers?
A: For the National HIV NAT Reference Center, the average monthly volume for the last 18 months has been about 50 specimens per month for HIV-1 NAT (split between the two current reference centers) and between 2-5 specimens for HIV-2 NAT per month.
For the HCV NAT Reference Center the average monthly volume for the last 18 months has been about 65 specimens per month.
What is the expected turnaround time for the NAT testing?
A: As stated in the RFP, Appendix A (pg 16) and Appendix B (pg 22), in the Specimen Testing and Reporting Procedures for Reference Laboratories to Submitters section, the turnaround time requirement for both reference centers is the same.
“The Reference Center will perform testing as needed to meet an average TAT of two (2) calendar days after specimen receipt in the laboratory and no more than two (2) business days.”
What is the requirement for the mechanism of reporting of results?
A: While APHL would prefer that the reference centers have the capacity to report results electronically, we do not have a required mechanism as long as it meets the regulatory requirements of the jurisdiction(s)—including both the reference laboratory and the submitting laboratory and it is done in a timely manner.