Salient Characteristics Qiagen LIAISON QuantiFERON TB Gold Plus and Control.pdf
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- Solicitation number
- W81K0225QA107
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Department of the Army Medical Command
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This document outlines the salient characteristics of the QuantiFERON TB Gold-Plus assays for detecting Mycobacterium Tuberculosis (TB) immune responses using enzyme immunoassay (EIA). The key requirements specify an FDA-cleared, fully automated Interferon-gamma release assay that must be performed on the DiaSorin LIAISON XL platform, with bar-coded data entry capabilities and ready-to-use reagents.
The assay must align with Defense Health Agency (DHA) laboratory operations, including existing specimen collection procedures used across medical treatment facilities, and provide direct reporting of both qualitative (positive/negative) and quantitative (IU/mL) results to the Laboratory Information System (LIS). The system must minimize manual intervention, reduce labor requirements, limit error risks, and support high-volume operations while ensuring interoperability and consistency in TB testing across DHA medical facilities, with clinical interpretation handled by DHA Occupational Medicine and Infectious Disease departments.
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Salient Characteristics of the QuantiFERON TB Gold-Plus assays (reagents and controls) for the detection of Mycobacterium Tuberculosis (TB) immune responses by enzyme immunoassay (EIA) are as follows:
1. Characteristics:
1) Bar-coded data entry capabilities.
2) FDA-cleared Interferon-gamma release assay for the detection of Mycobacterium tuberculosis infection.
3) Assay must be fully automated, minimizing manual intervention during the analytical process to reduce labor requirements, limit the risk of error, and sustain high-volume operations.
4) Latent tuberculosis testing must align with existing Defense Health Agency (DHA) laboratory operations and reference testing mandates, ensuring interoperability and consistency across medical treatment facilities. Such established protocols include specimen collection procedures which have already been adopted across most DHA facilities and quantitative result reporting in MHS Genesis and clinical interpretation (in IU/mL units) by DHA Occupational Medicine and Infectious Disease.
5) Assay must run/performed on DiaSorin LIAISON XL.
6) FDA-approved assays for: QuantiFERON TB Gold Plus
7) Ready-to-use reagents, bar-coded cassettes.
8) Any calculations for results interpretation for the IGRA test are automatic (i.e. no manual manipulation of data or additional system hardware requirements) with direct reporting of both qualitative (positive/negative) and quantitative (IU/ml) results to the LIS.
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