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The contractor will recruit institutions that regularly test respiratory specimens for Mp by Biofire® or another validated assay. Institutions could serve both adult and pediatric populations. The goal is to recruit institutions from a wide geographic area of the United States since the prevalence of infections and resistance patterns may vary by location. After recruiting institutional participants, the contractor shall collect Mp-positive specimens and data on Mp-positive cases as specified below.
Case definition
A case of Mp infection would be defined by a positive Mp clinical respiratory specimen (nasopharyngeal (NP), oropharyngeal (OP), nasal aspirates/washes, bronchoalveolar lavage (BAL) or sputum) from a patient at a sentinel site. If a patient had more than one positive Mp test (either of the same specimen type or a different one) <60 days from the first positive test, this would be considered "persistent" disease and counted as a single case. If specimens from the same patient are collected ≥60 days apart, then each positive test would be considered a new case.
Data and specimen collection
For each Mp case identified, a case report form (CRF) would be completed by staff (e.g. infectious disease fellows, medical residents or students, etc.) at each of the sites (see CRF in appendix 2). The data would be entered into a CDC-developed database and securely transmitted to CDC. The contractor would be responsible for making sure that at ≥85% of Mp-positive cases have a CRF filled out at each participating institution. The CRF includes laboratory information as well as epidemiologic and clinical data (age, gender, race/ethnicity, inpatient/outpatient status, clinical signs and symptoms, treatments administered, underlying conditions and outcomes-see Form). These data would be used to describe clinical and epidemiological characteristics of Mp infections and to compare the clinical severity of MRMp patients to MSMp patients.
Clinical respiratory specimens from cases (patients who test positive for Mp) obtained as part of routine clinical care and that would otherwise be discarded would also be collected by the contractor. The contractor would be responsible for making sure that procedures are in place at each of the sites to appropriately save Mp-positive specimens as specified below. It is the contractors responsibility to obtain a total of at least 50 specimens across participating institutions. All specimens would be sent to the contractor's laboratory to verify detection of Mp and test for resistance to macrolides and other (see laboratory testing below). A material transfer agreement (MTA) would be agreed upon and signed by CDC and participating institutions, as required. If a patient has more than one respiratory specimen obtained within 60 days of their illness, an attempt should be made to collect all specimens (including all specimen types). This is important because resistance may develop over time. Instructions for storing and shipping specimens are outlined in Appendix 1.
It is the responsibility of the contractor to have each institution assign a unique identifier ("Patient ID") that would be linked to the all forms and specimens obtained from that patient. Labels for the specimens and forms would be provided by CDC. All data except patient's name and any other identifying information would be entered into a CDC-developed database and de-identified data would be transmitted to CDC through a secure file transfer protocol site or a Secure Access Management Services (SAMS) system.
Laboratory testing
It will be the responsibility of the contractor to extract total nucleic acids from each specimen in order to confirm detection of M. pneumoniae using a validated real-time PCR assay that detects M. pneumonia. It is the contractor's responsibility to use a validated molecular assay to detect point mutations that are commonly associated with MRMp.8 The contractor will be responsible for transmitting the laboratory results data securely to CDC using a secured method that will be specified by CDC.
This notice of intent is not a request for competitive quotations; however, all quotations/responses received within fifteen (15) days of the issuance of this notice will be considered by the government. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to contract specialist at [email protected] by 3:30 pm EST 24 June 2016.