Neisseria gonorrhoeae, causative agent of gonorrhea, is the second most commonly reported notifiable disease in the United States with over half a million cases reported per year. Up to 30% of new infections are reported as resistant to at least one drug currently or previously recommended for treatment.
One of the aspects of preparing for potential new treatment regimens is ensuring that the diagnostic tools to assess antibiotic susceptibility are in place. This funding announcement is designed to identify laboratories to participate in a multi-site study to determine the acceptable variability of gentamicin MIC by agar dilution using
N. gonorrhoeae QC strains leading to a proposed gentamicin QC range for
N. gonorrhoeae based on CLSI M23 guidelines. Please note this is a one-time funding opportunity.
APHL is looking for nine eligible laboratories, including all member public health, hospital, and academic laboratories with the following capabilities and facilities in place. Specific expectations regarding methodologies to be used by the awardees are outlined in Appendix A: Establishing a Quality Control Range for Gentamicin Susceptibility Testing of
Neisseria gonorrhoeae. All applicants are required to agree to the minimum requirements (as outlined in Appendix B) for the option they are applying for. Applicants may apply for Option 1, Option 2, or both.
Option 1: Provide gentamicin MIC ranges determined by agar dilution for
N. gonorrhoeae QC strains
[Nine laboratories requested]
Applicants must perform agar dilution for ten replicates of each of the three
N. gonorrhoeae QC strains on three lots of media containing gentamicin;
Applicants must perform agar dilution for ten replicates of each of the three
N. gonorrhoeae QC strains (using the same prepared inoculum) using 1 lot of media containing spectinomycin (control antimicrobial)
The applicant must be well equipped and with sufficient laboratory space, equipment and workforce capacity for the proposed work
Note: Access to a CMI-Promex Steer's Replicator is preferred; CDC can loan appropriate model
Applicants must conduct testing and provide all data to APHL and CDC prior to the end of the project period.
Option 2: Prepare and distribute antibiotic plates used for agar dilution
[Two laboratories requested]
Applicants must prepare GC II base plates with 1% Isovitelex containing gentamicin or spectinomycin according to CLSI M07 guideline.
Note: CDC will provide all antibiotics and GC II base powder.
Applicants must QC the antibiotic plates and send results to CDC for analysis.
Note: CDC will provide the QC isolates required for QC procedure.
Applicants must ship all antibiotic plates overnight to their assigned laboratories within one week of passing QC.
The applicant must be well equipped and with sufficient laboratory space, equipment and workforce capacity for the proposed work.
Applicants must agree to conduct testing and provide all data to APHL/CDC prior to the end of project period.
Anticipated RFP Schedule
April 18, 2019 – RFP Issued
April 29, 2019 – Informational Teleconference (Q&A)
May 3, 2019 – Letter of Intent Due to APHL (see below)
May 31, 2019 – RFP Responses Due
June 14, 2019 – Proposal review completed
June 14-17, 2019 – If needed, follow-up interviews and updated proposals due
June 18, 2019 – Final review completed and awardees selected
August 1, 2019 – Draft contracts submitted to APHL Legal Dept. for final internal review
APHL will communicate any modification to this anticipated schedule on
APHL's procurement website and via an email blast to the public health laboratories.
Confirmation of Intent to Respond
Prospective applicants must submit a letter of intent to submit a proposal via email to
Anne.Gaynor@aphl.org. APHL must receive the email indicating intent by no later than
5:00 pm ET on May 3, 2019. APHL will not accept a proposal from an applicant that did not submit a letter of intent.
APHL must receive complete responses by
5:00 pm ET on May 31, 2019. Please see referd to Proposal-Required Submissions section on the official PDF linked below, for items that must be included in the completed proposal. Applicants may send proposals via email to
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 points of contact above to confirm receipt.
Official RFP Document will provide detailed information in regards to this request, please read it on its entirety. Feel free to contact Anne Gaynor, Manager of HIV, Viral Hepatitis, STD and TB (Anne.Gaynor@aphl.org) with any questions.
Questions and Asnwers
When does the project start? On the informational call you stated that the project would start on August 1, 2019 but in the RFP it states September 1, 2019.
A: We expect to submit contracts on August 1, 2019 for the project but the project period will begin on or around September 1, 2019.
What is the second antibiotic that is being tested?
A: CLSI requires that for these types of evaluations a control drug with a similar spectrum of activity be used to test minimum inhibitory concentrations (MIC) on one lot of media. For this evaluation the control drug will be spectinomycin.
What is the anticipated shelf-life for the agar dilution plates?
A: The plates are expected to be used within 5 weeks of production. The timeline listed in the RFP (Appendix A-Estimated Timelines) has the work being conducted within 4 weeks with the last week as back-up for testing.
What Isolates will be tested during this evaluation? Will they be provided?
A: CDC will provide the 3 QC strains that will be used throughout the evaluation. The 3 strains will include ATCC 49226 reference strain and 2 WHO reference strains.
My laboratory doesn’t have a Steers Replicator-- How long does it take to order one? Who do they need to contact about borrowing one?
A: It takes about 5 months on average to order a Steers Replicators. Laboratories that do not have a Steers Replicator should note in their application that they would need to borrow one. You do not need to reach out to APHL or CDC prior to submission of your application regarding your need to borrow a Steers Replicator.
Option 2 Questions
Do the Option 2 laboratories need to make all of the plates for a single lot of media in one day?
A: No. As outlined in Appendix A Option 2 (and Figure 2) the plates will need to be made within a week and a procedure has been outlined to produce the necessary plates in 1-2 days.
Can CDC provide detailed SOPs for laboratories applying for Option 2 prior to the May 31st deadline?
A: CDC is working on the SOP(s) but cannot promise that they will be completed before May 31st. They are happy to answer any additional questions in the meantime. Please also see the rest of the Q&A relating to Option 2 for more details as well as the newly shared
Is there a particular method or way the plates should be labeled? Can an adhesive label on the lid of the plate be used?
A: Plates should be labeled on the lower portion of the plate (not lid). Because of the limited number of isolates and replicates being tested at one time, an adhesive label could be used on the bottom part of the plate but making sure it does not block inoculation spots.
Currently, the most plates we make at a time is 12 sets equaling approximately 124 plates. How do you recommend we make 25 sets of 200 plates within the timeframe of an hour due to the degradation of the antibiotics once made?
A: Please see the
schematics of how to make the antibiotic plates. In short, labs will only be performing serial dilutions once per day because there is only one antibiotic. This should be able to be accomplished within one hour, but antibiotic dilutions can be kept on ice as a precaution.
For this volume, how does the antibiotics and added ingredients stay in suspension without having pockets with and without these added ingredients?
A: One gentamicin concentration will be combined with 600 mL of GC agar; the working concentration of gentamicin (or spectinomycin) will be added to GC agar in a 1:10 dilution. Mixing/Swirling should evenly distribute the GEN/SPEC and IsoVitaleX. Please see the
schematics for further explanation on how to make plates.
In the directions it says to dispense 20 mL per plate instead of 25 mL per plate, is that a change from agar dilution plates presently made?
A: After further consideration, we agree that plates should contain 25 mL of media. This will require labs to make 600 mL of agar instead of the 500 ml that was proposed in the RFP. Please see the
schematics to help you visualize how we expect the plates to be made. And please reach out with additional questions if anything is still unclear.
Are the shipping containers supplied? If not, what specifications do you have for the containers? How do you want the plates packaged for shipping? In bags or the original plate sleeves?
A: The CDC will not provide shipping containers, nor do we have strict guidelines for their dimensions. We only ask that the plates are placed in either a bag or original sleeve to maintain sterility, and that the stacks of plates are secured or packed tightly to ensure they do not crack/break during transit.
Should ice packs or dry ice used to maintain the 4oC temperature for shipping?
To document the inoculum for each QC strain each day of testing, will we use a set volume to inoculate a plate to obtain counts?
A: Yes, laboratories should serially dilute each suspension in phosphate buffered saline (PBS) from 10-2 to 10-6. Add 0.1mL of each serial dilution onto chocolate agar or supplemented GC agar medium in duplicate and spread the liquid on the agar for lawn growth. The dilution with a “countable” number of colonies should be used to determine original inoculum concentration.