Sole source confirmation Abbott.pdf
PDF 226 KB Posted
- Attached to
- Abbott Molecular m2000 Viral Load Supplies
- Solicitation number
- 2026-Q-97958
About this file
This is a sole source verification letter from Abbott Laboratories, Inc. to the Centers for Disease Control and Prevention (CDC), dated March 11, 2026, confirming Abbott's exclusive capability to provide molecular diagnostic testing systems and associated reagents for infectious disease detection.
Abbott Laboratories asserts it is the sole manufacturer, distributor, and service provider of the Abbott m2000 RealTime PCR Platform, the only fully-automated molecular system capable of performing FDA-approved tests for HIV-1, HCV, HBV, CT/NG, HCV Genotype, and CMV on a single integrated platform. The letter lists all required components for system operation, including amplification reagent kits, control kits, calibrator kits, specimen collection kits, sample preparation packs, and consumable supplies such as pipette tips, reaction vessels, plates, optical seals, and biohazard bags. The document outlines unique system specifications including the Abbott multi-Collect Specimen Collection Kit as the only FDA-approved universal collection device for multiple specimen types, the maxRatio Data Analysis system for improved confidence in patient results through automated validity checks, and a control strategy requiring only one set of controls regardless of batch size. The letter establishes the basis for a sole-source procurement by the CDC's International Lab Branch, Division of Global HIV and TB Center of Global Health, asserting that no competitive alternatives possess equivalent capabilities for the specified infectious disease testing applications.
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Abbott Laboratories Inc.
Dept#A9H2/J55/6137
100 Abbott Park Road
Abbott Park, IL 60064
Marija Gjorgieva
Contracts & Pricing Manager marija.gjorgieva@Abbott.com
Marc 11, 2026
Katrina Sleeman, Ph.D.
International Lab Branch Division of Global HIV and TB Center of Global Health Centers for Disease Control and Prevention Atlanta, GA 30333
Dear Dr. Sleeman, Thank you for your consideration of Abbott Molecular’s solutions for Infectious Disease testing to meet your facility needs. Please consider this letter verification that Abbott Laboratories, Inc is the sole manufacturer, distributor, and service provider of the Abbott m2000 RealTime PCR Platform. It is the only system currently available that is capable of performing FDA approved tests which include HIV-1, HCV, HBV, CT/NG, HCV Genotype, and CMV on a single fully-automated molecular platform.
Additionally, the Abbott m2000 is an open system on both the back-end and front-end for your open mode and Laboratory Developed Testing needs
As the sole distributor of these products, the following components available from Abbott are required for system operation:
• RealTime HIV-1 Amplification Reagent Kit 06L18-090
• RealTime HIV-1 Control Kit 06L18-080
• RealTime HIV-1 Calibrator Kit 06L18-070
• RealTime HCV Amplification Reagent Kit IVD 01N30-090
• RealTime HCV Control Kit 01N30-080
• RealTime HCV Calibrator Kit 01N30-070
• RealTime HBV Amplification Reagent Kit 02N40-091
• RealTime HBV Control Kit 02N40-080
• RealTime HBV Calibrator Kit 02N40-070
• RealTime HCV Genotype II Amplification Reagent Kit 08L21-090
• RealTime HCV Genotype II Control Kit 08L21-080
• RealTime CT/NG Amplification Reagent Kit 08L07-091
• RealTime CT/NG Control Kit 08L07-080
• Abbott multi-Collect Specimen Collection Kit 09K12-004
Docusign Envelope ID: 9FFD2E22-4A4E-478E-B912-8C9419D41E45 mailto:marija.gjorgieva@Abbott.com
• RealTime CMV Amplification Reagent Kit 09N21-090
• RealTime CMV Control Kit 09N21-080
• RealTime CMV Calibrator Kit 09N21-070
• Sample Prep GPR Pack RNA 04J70-024
• Sample Prep GPR Pack DNA 06K12-024
• 1000ul Pipette Tip 04J71-010
• 200ul Pipette Tip 04J71-017
• Reaction Vessel 04J71-020
• 200ML Reaction Vessel 04J71-060
• 96 Deep Well Plate 04J71-030
• 96 Well Reaction Plate 04J71-070
• Optical Seal 04J71-075
• Master Mix Tubes 04J71-080
• Biohazard Bag 04J71-045
Please note that this system includes the following unique specifications not found in competitive systems:
• A single fully-automated molecular platform capable of performing FDA approved tests which include HIV-1, HCV, HBV, HCV Genotype, CT/NG, and CMV.
• The Abbott multi-Collect Specimen Collection Kit is the only universal collection device FDA approved for the collection and transportation of male and female urine specimens, endocervical swab, male urethral swab, and self-collected and clinician collected vaginal swab specimens for the co-detection of Chlamydia trachomatis and Neisseria gonorrhoeae.
• The m2000rt is the only system that uses the maxRatio Data Analysis which incorporates multiple validity checks for improved confidence in patient results. This validates the growth curves and performance of each reaction eliminating the subjectivity of manual interpretation of results.
• A control strategy where only one set of controls is required regardless of batch size and may be placed anywhere within the run – favoring patient samples and reducing overall costs.
Abbott Molecular is committed to molecular diagnostics and we thank you for your interest in our products. We look forward to a long-continued partnership.
Best regards, Marija Gjorgieva
Contracts and Pricing Manager
Docusign Envelope ID: 9FFD2E22-4A4E-478E-B912-8C9419D41E45
| 2026-03-11T07:48:17-0700 | |
| Digitally verifiable PDF exported from www.docusign.com |
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