Maryland Bids > Bid Detail

qRT-PCR on human blood samples testing services

Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Level of Government: Federal
Category:
  • Q - Medical Services
Opps ID: NBD00159911573579834
Posted Date: Nov 22, 2022
Due Date: Nov 30, 2022
Solicitation No: NOI-NIAID-2152673
Source: https://sam.gov/opp/d6cb64470d...
Follow
qRT-PCR on human blood samples testing services
Active
Contract Opportunity
Notice ID
NOI-NIAID-2152673
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
NATIONAL INSTITUTES OF HEALTH
Office
NATIONAL INSTITUTES OF HEALTH NIAID
Looking for contract opportunity help?

Procurement Technical Assistance Centers (PTACs) are an official government contracting resource for small businesses. Find your local PTAC (opens in new window) for free government expertise related to contract opportunities.

General Information
  • Contract Opportunity Type: Presolicitation (Original)
  • All Dates/Times are: (UTC-08:00) PACIFIC STANDARD TIME, LOS ANGELES, USA
  • Original Published Date: Nov 22, 2022 09:00 am PST
  • Original Response Date: Nov 30, 2022 05:00 pm PST
  • Inactive Policy: 15 days after response date
  • Original Inactive Date:
  • Initiative:
    • None
Classification
  • Original Set Aside:
  • Product Service Code: Q301 - MEDICAL- LABORATORY TESTING
  • NAICS Code:
    • 541380 - Testing Laboratories and Services
  • Place of Performance:
    Rockville , MD 20852
    USA
Description

PRE-SOLICITATION NOTICE **NOTICE OF INTENT



NOI-NIAID-2152673



NAICS – 541380



This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with the University of Washington School of Medicine to procure the continuation of qRT-PCR on human blood samples collected over the course of a monoclonal antibody clinical trial in Mali.



The University of Washington laboratory performs the only qRT-PCR assay for the detection and quantification of Plasmodium parasites that has received Drug Development Tool Biomarker Qualification through the U.S. FDA and furthermore has already conducted some of the services for the earlier samples. Their qRT-PCR assay is recognized as among the most sensitive and robust molecular diagnostic assays for malaria in the world, allowing for the detection of malaria parasites in human blood up to 3-4 days earlier than by conventional blood smears. The analytical limit of detection for dried blood spots is 20-100 estimated P. falciparum parasites/ml. Their qRT-PCR assay uses a contact-free laser cutting system that effectively eliminates cross-contamination during dried blood spot processing. Their assay validation data demonstrated that the TaqMan probe-based assay on the Abbott m2000 automated extraction/amplification platform is highly sensitive and specific across a wide range of parasite densities for dried blood spot samples. The University of Washington laboratory is actively working with FDA to further expand the qualified context of use for this assay including for use in endemic field studies. The assay has been validated with respect to accuracy, correlation, precision, analytical sensitivity, analytical specificity, and carryover.



The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-2152673 to Dana Monroe at dana.monroe@nih.gov, by 5:00 pm pacific time November 30, 2022. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.


Attachments/Links
Contact Information
Contracting Office Address
  • 5601 FISHERS LANE, SUITE 3D11
  • BETHESDA , MD 20892
  • USA
Primary Point of Contact
Secondary Point of Contact


History
  • Nov 22, 2022 09:00 am PSTPresolicitation (Original)

TRY FOR FREE

Not a USAOPPS Member Yet?

Get unlimited access to thousands of active local, state and federal government bids and awards in All 50 States.

Start Free Trial Today >