​​​​​​Summary

The Association of Public Health Laboratories (APHL), in cooperation with the US Centers for Disease Control and Prevention (CDC) Division of HIV 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, 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.
    • For HIV-1 testing, there is a preference for use of an FDA approved test.
  • 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.​

​Anticipated RFP Schedule

November 18, 2024 – RFP Issued

December 6, 2024 – Informational Teleconference (Q&A)

December 16, 2024 – Letter of Intent Due to APHL (see below)

January 17, 2025 – RFP Responses Due

February 10, 2025 – Proposal review completed

February 11-16, 2025 – If needed, follow-up interviews and updated proposals due

February 21, 2025 – Final review completed and awardees selected

July 1, 2025 – First year contract awarded


Send Letter of Intent, Applications and Questions to Erin Estes (erin.estes@aphl.org) and infectious.diseases@aphl.org​.

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 requires that prospective applicants submit a brief email statement indicating an intent to submit a proposal. APHL must receive this email by no later than 11:59pm EST on the date indicated in the RFP Schedule above. To allow for appropriate review process planning, a letter of intent is required for consideration.

Final Response

APHL must receive complete responses by 11:59 pm EST on the date indicated in the RFP Schedule above. Please see Proposal-Required Submissions section for items that must be included in the completed proposal. Applicants may send proposals via email to the email addresses provided in the RFP Schedule above. APHL will send an email acknowledging the receipt of your application; if you do not receive an acknowledgement within 48 hours, please email the RFP point of contact above to confirm receipt.​

RFP Materials​

The Official RFP Document​​​ (updated version 12/4/2024) will provide detailed information. APHL will post all RFP-related documents, current schedule information, and answers to submitted questions and clarifications on APHL's procurement site, www.aphl.org/rfp​​​.​​


​Questions and Answers

​What lab is the current HCV Reference Center?

Page 6 states that max reimbursement for the HIV reference center is $75,000. However, I think it should be $51,000 ($15,000 + $60 x 600)

What should be included in the emailed letter of intent?

Confirming that the flat fee of $15,000 is paid each year of project and not just once at the beginning?

Is it possible for the HIV and HCV reference center to be awarded to the same lab? Or is your preference to give these reference centers to different labs?

Can we include figures as part of our 10 page response?

On Page 11 of the RFP – Question 7f – this is confusing – please define “Describe the following specimen requirements” What tests is this referring to?

On Page 11 of the RFP – Question 7i regarding contingency plan – how much detail is needed here? Solid plans for what we would do? Or rough outline?

In Appendix A the turnaround time requirements for the HIV Reference Center are stated as: ‘The Reference Center will perform testing as needed to meet an average TAT of 2 days after specimen receipt in the laboratory and no more than 2 business days.”  When considering the minimum requirements for eligibility in Appendix C and answering the question, “Is your laboratory able to report results in accordance with turnaround times as outlined in Appendix A and/or B?” should labs consider the average of both their HIV-1 and HIV-2 turnaround times?

On Page 11 of RFP –Question 8ci – what are the TAT goals for HIV-2? Not defined here or on page 17. 2 days from specimen receipt or from reflex to HIV-2 if internal reflex.

Does APHL have an estimate of the sample volume for either program?

Is it expected for labs to have already established this capacity to be competitive in the application or is it ok for the lab to establish capacity after the RFP is awarded?

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