‚ÄčAPHL seeks to identify and select up to five state or local public health laboratories to assist with evaluation of a laboratory developed molecular test for detection of STD pathogens associated with genital ulcer disease (GUD), especially the causative agent of syphilis.

Requirements

This funding announcement has two aspects. The first provides an opportunity to collect additional specimens from patients with GUD to aid in the evaluation and development of better tests. Please note this is a one-time funding opportunity. The second provides an opportunity for the evaluation of a TaqMan-based GUD M-PCR test at state or local public health laboratories to better understand performance in a real-life setting and enable access to better laboratory diagnostic options, especially for P&S syphilis, please note this is a one-time funding opportunity. Proposals will be evaluated based on the laboratory's existing capability and facilities and applicants must have:

Option 1: Collection and Submission of GUD Specimens to CDC for development/evaluation of novel diagnostic tests or genotyping assays.

    1. Applicant must agree to provide a 50-100 residual GUD specimens after routine HSV or syphilis testing and/or;
    2. Applicant must agree to collect additional 30-50 syphilis specimens from patients presenting with moist/exudative primary or secondary syphilis genital lesions using Aptima Multitest Swab Specimen Collection Kit which can be provided by CDC.

Option 2: Evaluation of the GUD M-PCR* at the public health laboratory.

  1. Applicant must agree to test a minimum of 40 GUD swab during the project period from patients presenting with suspected primary syphilis or HSV.
  2. Applicant must send half the volume or 1 mL (whichever is greater) of each residual sample after GUD M-PCR testing to CDC for quality assurance testing.
  3. Applicant must have unrestricted access to a real-time PCR instrument (Rotor-Gene 6000/Q, ABI 7500 or similar instrument equipped with a minimum of 4 channel detection) and demonstrated competency and capacity using real-time PCR to perform bacterial and viral identification; well-equipped and with sufficient laboratory space and workforce capacity for the proposed work.
  4. Applicants must agree to conduct testing and provide all data to APHL/CDC prior to end of project period.

*GUD-M-PCR Protocol Reference: Chen CY, Ballard RC. The Molecular Diagnosis of Sexually Transmitted Genital Ulcer Disease. In: MacKenzie C, Henrich B (eds). Diagnosis of Sexually Transmitted Diseases. Methods in Molecular Biology (Methods and Protocols). 2012 vol 903. Humana Press, Totowa, NJ.

If you are unable to access the reference due to a paywall please contact APHL to request.

Anticipated RFP Schedule

May 1, 2018         -             RFP Issued

May 16, 2018       -             *Informational Teleconference (Q&A)  

May 18, 2018      -             Letter of Intent Due to APHL (see below)

June 15, 2018     -             RFP Responses Due

July 2, 2018          -             Proposal review completed

July 2-9, 2018       -             If needed, follow-up interviews and updated proposals due

July 9, 2018          -             Final review completed and awardees selected

August 1, 2018    -             Draft contracts submitted to APHL Legal Dept. for final internal review

An optional teleconference will be held Wednesday May 16 at 3:00pm 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.

For the teleconference there are a limited number of lines, please use only one (1) line per Laboratory.

Phone: 866.822.6061 Passcode: 858376#

Request for Proposal Materials

The Evaluation of a laboratory developed molecular test for the diagnosis of genital ulcer disease (GUD) provides details on how to complete this RFP. The RFP contains a copy of the scoring criteria that will be used for evaluation of proposals in Appendix C. The details for expectations are contained in Appendix A.

Contact 

If you have any questions, please contact Nicholas Ancona for assistance.

Questions and Answers

Will CDC Provide the Specific Protocol for the Evaluation of the GUD M-PCR?

If the Public Health Laboratory is using a different thermocycler than described in the published protocol should that be included in the application?

What is the time frame in which the specimens must be collected?

What is the recommendation for shipment of viral lesions?

Are vesicular swabs acceptable for the RFP?

What is the minimum sample volume for testing? What is the minimum sample volume for CDC?

Is there any reason that Haemophilus ducreyi is not included in the PCR?

If my lab has access to multiple thermocyclers should I include that in my application?

Should the PHL provide the IRB for sample collection to APHL? Will CDC handle the IRB?

Would oral or perianal ulcer swabs be acceptable as specimens from persons presenting with GUD?