APHL 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.
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.
- Applicant must agree to provide a 50-100 residual GUD specimens after routine HSV or syphilis testing
- 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.
- Applicant must agree to test a minimum of 40 GUD swab during the project period from patients presenting with suspected primary syphilis or HSV.
- 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.
- 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.
- 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
Phone: 866.822.6061 Passcode: 858376#
Request for Proposal Materials
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.
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?
A: Yes, CDC will provide the complete protocol. Applicants are required to follow the protocol and provide data to CDC and APHL.
If the Public Health Laboratory is using a different thermocycler than described in the published protocol should that be included in the application?
A: Yes, the protocol may need to be slightly modified based on the different thermocyclers that are used. Therefore, applicants need to be specific in their application about the exact thermocycler that they will use for the project.
What is the time frame in which the specimens must be collected?
A: All specimen collection, testing and results must be completed by June 30, 2019. Specimens can be collected as early as the beginning of the project period (estimated August 2018) and up to 3 months prior to the date of initial testing as long as the samples have been stored at -70oC.
What is the recommendation for shipment of viral lesions?
A: Specimens should be stored according to the package insert for the transport media that is being used. Specimens should be shipped on frozen ice packs from the site of collection to the laboratory. Specimens being shipped to the CDC should be shipped on dry ice every two-three months.
Are vesicular swabs acceptable for the RFP?
A: For Option 1 vesicular lesion specimens are not allowed. However, if you are applying for Option 2 (Evaluation of the GUD M-PCR) the residual specimens from vesicular swabs are acceptable if they were collected for HSV PCR testing.
What is the minimum sample volume for testing? What is the minimum sample volume for CDC?
A: The minimum volume for each specimen is at least 1 mL for Option 2. The site should keep 500ul (which is sufficient for 2 extractions of 200ul each) and the remaining 500ul should be sent to CDC.
Is there any reason that Haemophilus ducreyi is not included in the PCR?
A: H. ducreyi is included in the multiplex PCR assay. The assay detects T. pallidum, HSV and H. ducreyi.
If my lab has access to multiple thermocyclers should I include that in my application?
A: Yes, include the number of instruments (and type) that you have access to in your laboratory. If there are other thermocyclers outside of your group, unit, etc. that you could access for the project, please list them as well. If you do not have access to an instrument, please do not include it in your application.
Should the PHL provide the IRB for sample collection to APHL? Will CDC handle the IRB?
A: CDC lab will provide a draft study protocol, consent form, and patient history/chart abstraction form for comment from sites, and once finalized it will be submitted for CDC approval. Sites can then use the CDC approval to obtain local IRB approval.
Would oral or perianal ulcer swabs be acceptable as specimens from persons presenting with GUD?
A: Perianal specimens are acceptable for inclusion. Oral lesion or white patches are also acceptable if syphilis is suspected.