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Urinary tract infection diagnostic

A urinary tract infection, horizontal technology, applied in the direction of disease diagnosis, medical automated diagnosis, instruments, etc.

Active Publication Date: 2019-11-26
MOLOGIC LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The gold standard test for UTI is microscopic analysis and urine culture (Wilson & Gaido, Clinical Infectious Diseases (2004) 38(8): 1150-1158), but there is usually a 2-day delay before culture results are available, making this method in large mostly useless

Method used

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  • Urinary tract infection diagnostic
  • Urinary tract infection diagnostic
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0281] Example 1 - Selection of biomarkers

[0282] Samples were collected as part of an I4I-funded project in which a total of 189 urine samples from adult women presenting with suspected uncomplicated UTI were comprehensively analyzed for 60 biomarkers.

[0283] There are two goals:

[0284] i. Define a panel of biomarkers to differentiate between negative and positive cultures;

[0285] ii. Select the biomarker that provides the best discrimination between suspected UTI samples and samples from recovered patients (healthy).

[0286] To differentiate between patients presenting with different types of infection, binary logistic regression was used to predict which biomarkers were significant for the outcome on their own without interaction with other parameters. Significant markers in this analysis were then further analyzed using R language Stuttgart Neural Network Simulation (RSNNS) (Stuttgart Neural Network Simulation in R), where self-significant biomarkers were weight...

Embodiment 2

[0303] Example 2 - Development of a Lateral Flow Assay

[0304] For lateral flow development, three selected biomarkers, HNE, MMP8 and cystatin C, were employed. Using a standard lateral flow format, three lateral flow assays were developed and optimized, packaged into single-well plastic housings supplied by Bibby sterylin.

[0305] HNE lateral flow

[0306] Preparation of materials: Capture line (anti-HNE BSA-PEG Fab (Alere San Diego, cat. no. 01241)) and control line (BSA-biotin) were immobilized at 1 mg / ml in PBS+1% sucrose using an Imagene Isoflow dispenser on a nitrocellulose membrane (Sartorius, CN140). Membranes were then dried in a tunnel dryer (Hedinair) at 60°C and stored with desiccant until use.

[0307] Gold conjugates were prepared according to known experimental procedures. Anti-HNE BSA-PEG Fab (Alere San Diego, Cat. No. 01871) was conjugated to 40 nm gold colloids to a final concentration of 15 μg / ml in suspension buffer of 20 mM MES, pH 5.3. After 10 m...

Embodiment 3

[0325] Example 3 - Statistical Analysis and Algorithm Development

[0326] In the Cardiff POETIC study (Bates 2014), a total of 424 samples were collected: 204 were Visit 1 samples and 220 were Visit 2 samples (not all of these were matched samples). In total, there are 93 matching Visit 1 and Visit 2 samples.

[0327] Sample information is available for a total of 194 samples: 175 samples are Visit 1 samples and 19 samples are Visit 2 samples. Of the 93 matched samples, 81 Visit 1 samples had incidental clinical information.

[0328] Of the 81 Visit 1 samples, 32 samples were UTI positive and 49 samples were UTI negative. Status based on microbiological results:

[0329] No growth = no growth found

[0330] · No significant growth = growth of pure isolate 5

[0331] · Mixed 2 kinds of microorganisms (orgs) = 2 kinds of microorganisms in 10 5 cfu / mL or more growth

[0332] Mixed > 2 microorganisms = 3 or more isolates with 10 5 cfu / mL or more growth

[0333] · POS = p...

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Abstract

Method for detecting a urinary tract infection (UTI) in a subject comprising determining levels of one or more biomarkers selected from MMP8, HNE,Cystatin C, MMP9, HSA, IL-8, interleukin-6 (IL-6),interleukin-1 beta (IL-1b), fibrinogen, RBP4, active MMP9 and MMP2, NGAL, Desmosine, MPO and CRP in a urine sample obtained from the subject. The determined levels may then be compared with a threshold level, wherein increased levels of at least one of the biomarkers in the urine sample relative to the threshold level is indicative of the presence of a urinary tract infection. Methods for monitoring aUTI and monitoring treatment of a UTI are also provided as are companion systems or test kits.

Description

technical field [0001] The present invention relates to the detection of urinary tract infection (UTI) and companion methods for monitoring UTI in a subject based on measuring the levels of various biomarkers in the subject, including at multiple time points. Background technique [0002] A urinary tract infection (UTI) is an infection that affects part of the urinary tract. It is also called a bladder infection (cystitis) when it affects the lower urinary tract and a kidney infection (pyelonephritis) when it affects the upper urinary tract. Lower urinary tract symptoms include painful urination, frequent urination, and a feeling of need to urinate despite an empty bladder. Symptoms of a kidney infection often include fever and flank pain in addition to symptoms of a lower UTI. In some cases, urine may appear bloody. In the elderly and young children, symptoms may be vague or nonspecific. A common cause of infection is the presence of pathogenic E. coli in the urinary tr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/569
CPCA61K38/00G01N33/56911G01N2333/96494G01N2333/966G01N2800/348G01N2800/52G01N2800/56Y02A90/10G16H10/40G16H50/20G01N33/54366G01N33/6893G01N2333/5412G01N2333/5421G01N2333/545G01N2333/75G01N2333/765G01N2333/908G01N2333/96486
Inventor 吉塔·帕瑞克保罗·戴维斯朱莉·汤普森安妮丽丝·杜沃克
Owner MOLOGIC LTD