Draft Performance Work Statement.docx

Performance-Based Work Statement

Title: Nine-Month MASS Study: Multistate Assessment of SARS-CoV-2 Seroprevalence Period of Performance: Ten months; Nine months of sample testing and one month to finalize final report prior to submission.

I. BACKGROUND:

Several U.S. seroprevalence studies have suggested that the majority of persons have not been infected with SARS-CoV-2. However, there has been wide variability in seroprevalence estimates due to several factors including the use of different assays, participant selection methods, time period conducted, and regional differences in the burden of disease. In this work, CDC will conduct a nine-month longitudinal serologic survey using convenience samples collected from commercial laboratories across the United States.

II. PROJECT OBJECTIVE:

The CDC’s work in this contract will use offeror(s) residual/remnant/excess, deidentified blood specimens to obtain nine months of laboratory testing toward determining U.S. seroprevalence by geographic region, age group, and timing. CDC will not provide samples to any vendor.

III. DESCRIPTION OF WORK (organized by TASK/CLIN):

CDC reserves the right to award multiple contracts to multiple offerors to achieve the geographic reach needed for studying seroprevalence across 50 states, Washington DC and Puerto Rico. Offeror(s) shall complete and include with their technical proposals Attachment A which includes questions on offeror(s) capabilities and residual specimen descriptions. Offeror(s) shall include in their technical proposal an appendix of all offered test protocols.

CDC will not be able to provide residual samples to contractors. CDC will not pay for contractors to obtain residual samples.

Task 1: COVID-19 IgG and/or IgM ELISA Testing Task 1.1 Residual Specimen Selection

a. Contractor(s) shall identify excess, remnant, or residual blood specimens from remaining volumes of previously obtained blood specimens for non-COVID-19 diagnostic or antibody testing. From this list, the contractor shall choose sufficient samples from each jurisdiction (50 US States, DC, and Puerto Rico) to achieve the target sample size within each age group.

a. Age groups: 0 months to ≤17 years, 18 to ≤49 years, 50 to ≤64 years, and 65+ years

b. Sample size may change based on proposals: approximately 245 samples every two weeks

c. Totaling ~980 samples every two weeks per jurisdiction Task 1.2 Residual Specimen Testing

a. The Contractor(s) shall test specimens to include CLIA-approved and/or EUA-approved ELISA, COVID-19 IgG and/or IgM serological assays. Tests (with specific test names) will be selected from offeror(s) proposals and identified in the contract award. The required sample matrix and sample volume should be specified for each offered test name.

a. Quantitative assays will receive priority.

b. Qualitative assays are acceptable for this work.

c. Any anticipated remnant handling costs such as accessioning work should be part of the testing cost estimated in the business proposal.

b. If qualitative testing is selected under task 1, the Contractor(s) shall ship any CDC-selected seropositive or seronegative specimens to CDC-designated facilities for reflexive testing described under tasks 2 and 3 (see Task 1.6).

Task 1.3 Draft Data Report and Meeting

a. Contractor(s) shall create sample draft data report and schedule meeting for review Task 1.4 Data Reporting

a. Contractor(s) shall provide data report bi-weekly to CDC.

Task 1.5: Identification of Specimens for Reflexive Testing

a. Offeror(s) will identify seropositive specimens from task 1.2 for further reflexive testing. Contractor(s) shall complete testing under tasks 2.1 and/or 3.1 or prepare and send shipments under task 1.6 to another offeror(s) facilities. A small subset of seronegative specimens may also be requested for reflexive testing.

Task 1.6 Specimen Shipping

a. If the remnant/excess/residual specimens selected under task 1.1 exceeds the Contractor(s)’ specimen two-week testing capacity under task 2.1, the Contractor(s) shall ship the selected residual specimens that exceed its testing capacity to another testing facility designated by CDC.

b. Contractor(s) with any COVID-19 seropositive specimens identified from task 1.2 and selected for reflexive testing in tasks 2.1 and 3.1 shall ship those samples to a CDC designated facility for reflexive testing, if different than the facility where specimens were tested under task 1.2, meaning that the Contractor(s) cannot perform reflexive testing or was not awarded Task 2 or 3.

c. In general, Contractor(s) should pack and ship suspected and confirmed SARS-CoV-2 specimens, as UN 3373 Biological Substance, Category B, in accordance with the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulations and U.S. Department of Transportation’s (DOT) Transporting Infectious Substances Safely. Personnel must be trained to pack and ship according to the regulations and in a manner that corresponds to their function-specific responsibilities.

a. The estimated sample volume to plan for reflexive testing is 0.5 mL

b. The estimated shipping temperature to plan for this work is -20 ˚C

c. The U.S. shipping address for reflexive testing will be provided within 4 weeks of contract award Task 1.7 Draft Final Report and Review Meeting

a. Contractor(s) shall create and submit a sample final report and schedule a draft final report meeting with CDC to discuss. The draft final report should be submitted at least _10__days in advance of the meeting.

Task 1.8 Final Report

a. Contractor(s) shall create and submit a final report

Task 2 Reflexive COVID-19 Microneutralization Assay Testing Task 2.1

a. The Contractor(s) shall provide microneutralization testing for seropositive specimens. Tests (with specific test names) will be selected from offeror(s) proposals and identified in the contract award.

b. The Contractor(s) shall provide microneutralization testing for seronegative specimens

c. As needed, the Contractor(s) may use specimens identified in Task 1.2, or they may identify excess, remnant, or residual blood specimens from samples submitted for COVID-19 antibody testing. Any anticipated remnant handling costs such as accessioning work should be part of the testing cost estimated in the business proposal. If residual specimens are not available, the contractor(s) will test specimens shipped from CDC or other contracted labs.

Task 2.2 Draft Data Report and Meeting

a. Contractor(s) shall create sample draft data report and schedule meeting for review Task 2.3 Data Reporting

a. Contractor(s) shall provide data report bi-weekly to CDC.

Task 2.4 Draft Final Report and Review Meeting

a. Contractor(s) shall create and submit a sample final report and schedule a draft final report meeting with CDC to discuss. The draft final report should be submitted at least _10_days in advance of the meeting Task 2.5 Final Report

Task 3 Reflexive COVID-19 Quantitative IgG Testing (Task Area 3 under IDIQ) Task 3.1

a. The Contractor(s) shall provide Quantitative IgG testing for seropositive specimens. Tests (with specific test names) will be selected from offeror(s) proposals and identified in the contract award.

b. The Contractor(s) shall provide Quantitative IgG testing for seronegative specimens.

c. As needed, the Contractor(s) may use specimens identified in Task 1.2, or they may identify excess, remnant, or residual blood specimens from samples submitted for COVID-19 antibody testing. Any anticipated remnant handling costs such as accessioning work should be part of the testing cost estimated in the business proposal. If residual specimens are not available, the contractor(s) will test specimens shipped from CDC or other contracted labs.

d.

Task 3.2 Draft Data Report and Meeting

a. Contractor(s) shall create sample draft data report and schedule meeting for review Task 3.3 Data Reporting

a. Contractor(s) shall provide data report bi-weekly to CDC.

Task 3.4 Draft Final Report and Review Meeting

a. Contractor(s) shall create and submit a sample final report and schedule a draft final report meeting with CDC to discuss. The draft final report should be submitted at least _10_days in advance of the meeting Task 3.5 Final Report

IV. DELIVERABLES:

See Attachment B for Deliverables Table. Offeror(s) should also use the list of deliverables provided in Attachment B as a guide for the preparation of technical and business proposals in addition to the PWS. Offeror may propose revised language for the Deliverables Table and attach as an appendix to their proposal

Laboratory Reporting In accordance with deliverables and tasks as listed, the Contractor(s) shall transmit data to CDC every 2 weeks by either a CDC-designated secure email or SFTP. The Contractor(s) shall submit aggregate information on age and gender by jurisdiction for all samples available for selection for this study. Additionally, labs shall submit sample-level data for all tested specimens. Files will be submitted as 1) a locked Excel file, 2) an unlocked Excel file, and 3) a .CSV file. In addition to the specimen information requested in Attachment A, the following data elements (if available) are wanted at the sample level and should also be included in the data report deliverables described in Attachment B:

· Race and ethnicity (if available)

· 5-digit zip code of patient residence; provider zip code if residence not available

· The name of the original laboratory test (e.g. basic metabolic panel, lipid panel)

· ICD10 diagnosis associated with the original laboratory test

· Results (including collection date) of any previous COVID-19 testing on the same patient

· Information on if the specimen came from an outpatient or inpatient facility (if available)

· Unique patient identifier to allow for deduplication of sample results from the same patient

Time Schedule The proposed time schedule for this work is as follows. Offerors must clarify whether testing can begin on the first sample cycle start date in their technical proposal. :