Publications > Validation

MolecuLight®'s Bacterial Detection
Validation

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A listing of key peer reviewed research featuring MolecuLight®

Validation

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Validation

Instantly evaluating bacterial infections on skin ulcers in an Asian population using a fluorescence-emitting device

Kurokami, Y et al. J Cutan Imminol Allergy 2023

This study validated fluorescence imaging for detecting bacterial burden in diverse wound types, extending its application to an Asian population for the first time.

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Validation

Diagnostic accuracy of point-of-care fluorescence imaging for the detection of bacterial burden in wounds: Results from the 350-patient FLAAG trial

Le, L et al. Adv Wound Care 2021

A multi-site trial validating MolecuLight fluorescence imaging demonstrated significant improvement in detection of bacterial burden compared to standard assessment. 69% of treatment plans were informed by fluorescence imaging.

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Validation

Rapid diagnosis of Pseudomonas aeruginosa in wounds with point-of-care fluorescence imaging

Raizman, R et al. Diagnostics 2021

Cyan detected on MolecuLight fluorescence images reliably predicted presence of Pseudomonas aeruginosa with a PPV of 93%. Less than 20% of wounds with Pseudomonas exhibited the ‘classic’ symptoms of this pathogen.

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Validation

Efficacy of a bacterial fluorescence imaging device in an outpatient wound care clinic: a pilot study

Hurley, CM et al. J Wound Care 2019

MolecuLight imaging demonstrated a sensitivity of 100%, specificity of 78%, PPV of 95% and NPV of 100% for identification of pathologic bacteria in wounds.

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Validation

Point-of-care fluorescence imaging predicts the presence of pathogenic bacteria in wounds: a clinical study

Rennie, MY et al. J Wound Care 2017

MolecuLight-guided curettage or biopsy sampling positively predicted bacterial presence in wounds at potentially harmful levels, entirely eliminating the risk of false negative sampling.

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Validation

A prospective multi-site observational study incorporating bacterial fluorescence information into the UPPER/LOWER wound infection checklists​

Hill, R and Woo, K. Wounds 2020

All wounds positive for UPPER/LOWER were also positive with MolecuLight. In many cases the fluorescence information added a third check to the UPPER/LOWER score, turning a negative diagnosis of infection into a positive one.

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Validation, Venous Wounds

Real-time bacterial fluorescence imaging accurately identifies wounds with moderate-to-heavy bacterial burden

Serena, TE et al. J Wound Care 2019

This pilot study set the stage for the larger, 350-patient FLAAG clinical validation trial, critical for achieving FDA De Novo clearance.

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Validation

Efficacy of an imaging device at identifying the presence of bacteria in wounds at a plastic surgery outpatients clinic

Blackshaw, EL et al. J Wound Care 2018

In this validation study, clinicians found that MolecuLight was easy to use and greatly reduced the time taken waiting for microbiology results.

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Validation, Diabetic Wounds

Point-of-care fluorescence imaging reveals extent of bacterial load in diabetic foot ulcers

Armstrong, DG et al. Int Wound J 2023

This study reveals the limitations of relying on clinical signs and symptoms for detecting harmful bacteria in DFUs. The concept of “chronic inhibitory bacterial load” (CIBL) is introduced, with MolecuLight imaging vastly improving its detection for better wound care.

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Validation, Diabetic Wounds

Use of a bacterial fluorescence imaging device: wound measurement, bacterial detection, and targeted debridement

Raizman, R et al. J Wound Care 2019

Wound measurement accuracy was validated at >95% using the MolecuLight i:X device,​ and fluorescence imaging before and after standard debridement revealed persistence​ of bacterial fluorescence in 100% of DFUs.