Responses to Vendor QA - Att D_Question and Answer Template.xlsx

XLSX spreadsheet 21 KB Posted Jan 12, 2022

Attached to: MASS-C Study: CDC Multistate Assessment of SARS-CoV-2 Seroprevalence (Commercial Labs)
Solicitation number: 75D301-22-R-72117
Issued by: Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services

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Written by GovTribe AI · Dec 27, 2023

This document contains a question and answer template for a Centers for Disease Control and Prevention (CDC) solicitation seeking one or more contractors to conduct a repeat serologic survey to estimate SARS-CoV-2 infection and vaccination rates nationally and by location over time. Key requirements include the contractor collecting excess blood specimens from commercial laboratories across the United States, distributing samples by age, state, and eight-week period, and testing specimens using ELISA, IgG, and microneutralization assays. Contractors may propose on any or all tests and will report aggregate findings every eight weeks plus a final report. The base period of performance is eleven months with a twelve-month option. Questions are due by January 6, 2022 and proposals are due January 24, 2022.

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Other files

File	Type	Posted
Att B (amended) _ Task Deliverables Table.xlsx	XLSX spreadsheet	Jan 19, 2022
Att C (amended) _ Pricing Table.xlsx	XLSX spreadsheet	Jan 19, 2022
Solicitation Amendment _ Sec. D PWS - RFP 75D301-22-R-72117.docx	DOCX document	Jan 12, 2022
RFP 75301-22-R-72117 - MASS-C Serology.doc	DOC document	Dec 29, 2021
Att C _ RFP 72117 - Pricing Table.xlsx	XLSX spreadsheet	Dec 29, 2021
Att D _ RFP 72117 - Question and Answer Template.xlsx	XLSX spreadsheet	Dec 29, 2021
Att A _ RFP 72117 - Offeror Capabilities and Specimens.xlsx	XLSX spreadsheet	Dec 29, 2021
Att B _ RFP 72117 - Task Deliverables Table.xlsx	XLSX spreadsheet	Dec 29, 2021

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Sheet1

		Question and Answer Template
		RFP 75D301-22-R-72117
	Question
Number	RFP

Reference

(if applicable)	Question	CDC Response
	1	Sec. B (Line Items), Item 0001 & 1001	Is the CDC monitoring antibody titers in response to vaccination?	Yes, however that is not a part of this particular study since data are deidentified and we don't know which individuals have been vaccinated, the date of vaccination, or vaccine received in this dataset. There are other studies examining this important question.
	2	Sec. B (Line Items), Item 0001 & 1001	Does the CDC want to monitor antibody activity against specific variants, for example omicron? If yes, should Contractors submit validation of an omicron specific quant assay? We note that WHO calibration standards are not yet available for Omicron, and that assays calibrated against earlier strains may underestimate anti-Omicron titers.	We are most interested in an assay calibrated to WHO standards; submission of materials for this assay type is a requirement. Optionally, we would also consider any evidence presented about existing quantitative assays failing to flag omicron convalescent sera appropriately, and labs could submit validation of an omicron-specific quant assay if available for consideration by CDC. Ideally a quantitative assay would be able to measure anti-S antibody for wild type, previous variants, vaccination, omicron, and future variants.
	3	Sec. B (Line Items), Item 0003 & 1003	What is the number and identity of pseudovirus variants the CDC will be requesting per sample?	Ancestral strain (vaccine), Delta, Omicron, and future VOC
	4	Sec. B (Line Items), Item 0004 & 1004	What assays are requested in items 0004 and 1004, "Additional Pediatric Specimens"?	Items 0004 and 1004 are for the acquisition of additional pediatric specimens through subcontracts. The testing of these specimens are already included in the tasks 0001, 1001, 0002, and 1002 ; this item is to subcontract to obtain properly stored pediatric residuals in jurisdictions where adequate sample within the age group and jurisdiction is not consistently obtained or estimated to be feasible through the offeror's own operations.
	5	Sec. B (Line Items),Item 0004 & 1004	This item/CLIN is for "additional pediatric specimens." Will the CDC specify the jurisdiction from which these additional samples will be selected, or will the Offeror have the opportunity to select the jurisdiction(s)?	The offeror will be able to subcontract to obtain additional specimens in any jurisdictions they have been assigned in which they are not able to obtain the requested sample size via their own operations.
	6	Sec. B (Line Items), Item 0004 & 1004	This item/CLIN is for "additional pediatric specimens." Will the CDC specify volumes of additional specimens to be distributed across time periods, or will the Offeror collect all available over the course of the project until reaching the target 84,728?	The offeror will be able to subcontract to obtain additional specimens in any jurisdictions they have been assigned in which they are not able to obtain the requested sample size per age group per time period via their own operations.
	7	Sec. B (Line Items), Item 1006	Optional adult samples - Are there any additional sampling criteria besides age bins (eg by State)?	Yes these sample sizes would be by age category per jurisdiction over the specified data collection period if this option is exercised.
	8	Sec. D (PWS), Task 2.1	Request removal of 'within 5 days' for reflexive testing	Agree and appreciate this being flagged again. We would request that samples undergoing reflexive microneutralization testing be frozen within one week of collection, and then stored frozen to be batched monthly for testing.
	8	Sec. D (PWS), General	If we know from our viral sequencing what strain a patient was previously infected with, should we prioritize inclusion of such samples, provide deidentified keys and strain identities in the results to allow CDC to correlate quantitative serology results to strains?	While this information would be interesting and valuable, it is outside the scope of this contract and surveillance system. For this study, we would not request this as it may bias our sample.
	9	RFP Att. A (Excel) - Capabilities & Specimens	Is there a maximum or minimum volume needed per State, age group per 8 week period?	Yes; please see pages 17-18 for these details
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File details come from the government source that posted it. Updated Jan 12, 2022.