Method for assaying lower respiratory tract infection or inflammation
Inventors
Stolz, Daiana • Lajaunias, Frederic
Assignees
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Publication Number
US-11402390-B2
Publication Date
2022-08-02
Expiration Date
Abstract
The present invention relates to a reliable method of prediction of lower respiratory tract infection or inflammation in humans, wherein the level of pancreatic stone protein/regenerating protein (PSP/reg) is determined in serum, and a high level is indicative of the development and the severity of the disease, allowing the classification of patients according to risk.
Core Innovation
The document describes a biomarker-based approach that detects pancreatic stone protein/regenerating protein (PSP/reg) in a body fluid sample from a patient in the context of ventilator-acquired pneumonia (VAP) and related complications. The approach determines whether PSP/reg is present in a quantity equal to or higher than specified thresholds, including measurements optionally on the day of VAP onset and/or across days 2 through 6, and also on day 7 after the VAP onset.
In the VAP context, the document states that diagnosing the patient with VAP-associated complications is performed with reference to an odds ratio for mortality from day 7 to day 28. The stated diagnostic criterion is that the odds ratio reaches 13.8 with a 95% confidence interval when the quantity of PSP/reg present on day 7 after the VAP onset is equal to or higher than 177 ng/mL.
The document also connects elevated PSP/reg with COPD-associated disease severity and positive sputum microbiology in COPD, and it frames the PSP/reg assessment as supporting prognosis and stratification in inflammatory lower respiratory tract conditions. Preferred PSP/reg targets are described in terms of specific PSP/reg isoforms, including SEQ ID NO:1 and SEQ ID NO:2, and the detection can be performed using assay modalities such as ELISA, RIA, or EIA.
Claims Coverage
The document provides two independent claims that share the same core diagnostic-and-treatment workflow using PSP/reg detection in a body fluid sample and an odds-ratio mortality criterion at day 7; both claims include administering an effective amount of an antibiotic to treat the diagnosed patient. The main inventive features differ primarily by whether the claim explicitly ties the diagnostic criterion to day-7-based mortality only or includes a broader diagnostic procedure that includes a PSP/reg presence threshold as part of diagnosing VAP-associated complications.
Psp/reg detection around VAP onset with body fluid sampling
Obtaining a body fluid sample from a patient, optionally on a day of VAP onset and/or on day 2, 3, 4, 5, 6 after the VAP onset and on day 7 after the VAP onset; determining whether PSP/reg is present in said sample optionally on the day of VAP onset and/or on day 2, 3, 4, 5, 6 after the VAP onset and on day 7 after the VAP onset.
Day-7 mortality odds-ratio diagnostic rule for VAP and complications
Diagnosing the patient with an odd ratio for the patient's mortality at day 7 to day 28 of 13.8 with a 95% confidence interval when the quantity of PSP/reg present in said sample on day 7 after the VAP onset is a quantity equal or higher than 177 ng/ml.
Antibiotic administration following PSP/reg-based diagnosis of VAP
Administering an effective amount of an antibiotic to treat the diagnosed patient.
Psp/reg quantity presence threshold used for diagnosis of VAP-associated complications
Diagnosing the patient with VAP indicative of VAP-associated complications and an odd ratio for the patient's mortality at day 7 to day 28 of 13.8 with a 95% confidence interval when the quantity of PSP/reg present in said sample on day 7 after the VAP onset is a quantity equal or higher than 177 ng/ml, with determination of whether PSP/reg is present in a quantity equal or higher than 150 ng/ml.
Across both independent claims, the coverage is directed to diagnosing ventilator-acquired pneumonia based on detecting PSP/reg in a patient body fluid sample with an explicit day-7 mortality odds-ratio criterion, and then treating the diagnosed patient by administering an effective amount of an antibiotic.
Stated Advantages
Supports diagnosis of VAP-associated complications using an odds ratio for mortality from day 7 to day 28.
Enables antibiotic treatment for the diagnosed patient based on PSP/reg-based diagnostic criteria.
Provides a stratification/prognostic relationship between PSP/reg measurements and mortality outcomes as described via an odds ratio and ROC-based performance.
Documented Applications
Use of PSP/reg detection in a patient body fluid sample to diagnose and treat ventilator-acquired pneumonia (VAP) using a day-7 mortality-based odds-ratio criterion.
Linking elevated PSP/reg with COPD-associated disease severity and positive sputum microbiology in COPD, as described in the document’s background/summary content.
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