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Point-of-Care Diagnostic for Spontaneous Bacterial Peritonitis

Award Number: R43AI186674
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: 09/05/2025
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Point-of-Care Diagnostic for Spontaneous Bacterial Peritonitis - PROJECT SUMMARY Spontaneous bacterial peritonitis (SBP) is a frequent and severe complication of liver disease, in which an infection occurs in the ascitic fluid of the peritoneal cavity without an identifiable source of infection. Chronic liver disease is a leading cause of mortality and affects over 120 million people worldwide. Hospitalizations resulting from complications of chronic liver disease carry an economic burden of over $80 billion annually in the US, with the majority of these resources directed towards patients with cirrhosis. SBP affects around 10- 30% of patients hospitalized with cirrhosis and ascites and carries a substantial in-hospital mortality rate ranging from 17 to 30%. Prompt diagnosis and treatment are critical to prevent potential complications, including renal failure and sepsis. SBP is diagnosed when the polymorphonuclear leukocyte (PMN, also known as granulocytes) count is 250 cells/mm3 or greater. Currently, it can take days to diagnose SBP after presentation of symptoms, with testing delays leading to significantly increased mortality. Diagnosis without PMN is ineffective, as approximately a third of patients presenting with ascites lack any additional symptoms to indicate SBP. A rapid point-of-care (POC) diagnostic tool would enable immediate clinical decision-making, facilitating prompt initiation of antibiotic therapy and enhancing the overall management of SBP. We propose an innovative methodology building upon our recent breakthrough in label-free deep ultraviolet (UV) assay technology. This approach integrates microfluidic-based sample preparation and advanced algorithm-driven cell classification, facilitating on-the-spot cell counting in ascitic fluid. Our earlier research successfully utilized label-free deep UV microscopy for comprehensive 5-part white blood cell differentials, red blood cell quantification, and platelet identification in peripheral blood samples. The imaging system, characterized by a straightforward optical path, allows differential cell analysis using images captured from a single wavelength LED light source. Pseudo-colorized UV images, derived from deep-UV microscopy, have demonstrated diagnostic efficacy equivalent to the gold standard Giemsa-stained images in manual blood cell differentials. Leveraging our proprietary cell segmentation and classification algorithms, we can analyze these images to categorize various blood cell types, enabling automated differentials in ~3 minutes. This pioneering approach holds significant promise for the development of a POC SBP diagnostic with equivalent accuracy to a clinical pathology lab. In Phase I of this project, we propose to 1) visualize and identify PMNs and red blood cells (RBCs) in ascitic fluid using deep-UV microscopy and 2) automate the cell identification and classification using a machine learning-based algorithm. Phase II efforts will focus on optimization of sample preparation and translation of our prototype instrument into a user-friendly device. Successful commercialization of this device will enable faster diagnosis of SBP, which is critical for reduction of mortality.


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: 2025 ( Subtotal = $306,872 )
2025	2025	CELLIA SCIENCE, INC.	535 W RESEARCH CENTER BLVD STE 135	FAYETTEVILLE	AR	72701	WASHINGTON	USA	Allergy and Infectious Diseases Research	000	1	9/5/2025	NEW	$306,872
														Subtotal = $306,872

Grand Total All Awards = $306,872

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Point-of-Care Diagnostic for Spontaneous Bacterial Peritonitis

Award Number: R43AI186674

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: 09/05/2025

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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