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Multiplex binding antibody assay for confirmatory HSV-1/2 serological diagnosis

Award Number: R21AI190539
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2026
PERIOD OF PERFORMANCE END DATE: 03/31/2028

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Multiplex binding antibody assay for confirmatory HSV-1/2 serological diagnosis - PROJECT SUMMARY/ABSTRACT Herpes simplex virus types 1 and 2 (HSV-1/2) are major human viral pathogens that cause one of the most common, debilitating, stigmatized and lifelong infections of humankind with more than 143 million new infections every year and affecting more than 4 billion people around the world and more than 100 million Americans. Determining infection status is challenging, as viral latency makes PCR screening both ineffective and costly, while the inadequate specificity of serological IgG assays has led the CDC to recommend a two-step process that includes high throughput, sensitive but low specificity tests followed by more specific but unscalable and labor-intensive confirmatory assays. One of the two CDC-recommended confirmatory assays is the University of Washington (UW) Virology HSV Western Blot test (HSV-WB). The HSV-WB remains the FDA-recognized gold standard for confirmatory serological diagnosis of HSV-1 and HSV-2 infections and detects serum responses to multiple proteins within a viral lysate. This assay is highly sensitive and specific, but it is laborious, and thus costly and only available in the United States at one reference lab. Recurrent quality control problems with another confirmatory assay, biokit gG2-based membrane test, caused product recalls and lack of availability of the test in commercial reference labs. Therefore, making convenient, one-step, high-quality HSV serological testing more accessible is of compelling interest for national and global public health and a key component for development of a national HSV prevention program. In this project, we propose to create a new, high-throughput, one-step HSV serology test that combined the advantages of current FDA-authorized binding assays with the high-content, multiplex-driven specificity of the UW HSV-WB. Specifically, we propose to develop and clinically validate an HSV serologic multiplex bead-based binding antibody assay (HSV Sero-MBAA) that matches the performance characteristics of the HSV-WB, including high sensitivity, specificity, and differentiation of HSV type, on a scalable, inexpensive platform. HSV Sero-MBAA can be run both in central labs and can be kitted and licensed for future regulatory submissions that would allow it to be run in hundreds of clinical laboratories around the United States and world on already existing instrumentation.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $270,591 )
2026	2026	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	1	4/1/2026	NEW	$270,591
														Subtotal = $270,591

Grand Total All Awards = $270,591

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Multiplex binding antibody assay for confirmatory HSV-1/2 serological diagnosis

Award Number: R21AI190539

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2026

PERIOD OF PERFORMANCE END DATE: 03/31/2028

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