Optical Biosensor Predicts Sepsis or Severe Infection in Patients at Risk

Investigators found a new optical biosensor (OB) was effective at stratifying infection severity among patients with symptoms of a viral infection. These results from a clinical study were published in BMC Infectious Disease.

Patients (n=142) at high risk for sepsis who presented with symptoms of infection were assessed by clinicians using the OB at 4 study sites between November 2019 and February 2020. A second stage of this study was performed in March 2020 among 67 patients to assess the OB device performance with coronavirus 2019 (COVID-19). The accuracy of the OB device for predicting sepsis or severe COVID-19 were analyzed.

The OB was an oximeter-like device that assessed vasoconstriction and vasodilation as measured by optical absorptions in 5 wavelengths (940 nm infrared, 660 nm red, 530 nm green, 465 nm blue, and 395±10 nm ultraviolet).

During the first stage of this study, patients who developed sepsis (n=17) differed significantly from those who did not (n=125) for mean admission Acute Physiology and Chronic Health Evaluation II (APACHE II) scores (P <.0001), admission Sequential Organ Failure Assessment (SOFA) scores (P <.0001), creatinine (P =.001), median procalcitonin (P =.025), proportion of chronic heart failure comorbidities (P =.045), and instance of intra-abdominal infection (P =.019).

The algorithm based on the OB device assessment predicted sepsis among 12 of the 17 positive cases, which equated to a sensitivity of 70.6% and positive predictive value of 100%. The algorithm predicted no sepsis among all of the negative cases, indicating a specificity of 100% and negative predictive value of 96.2%. No instances of false positives and 5 of false negatives were observed.

During the second stage of this study, patients who had a severe (n=12) or nonsevere (n=26) COVID-19 case differed significantly for mean admission SOFA scores (P =.001), white blood cell count (P =.010), partial oxygen pressure to fraction of inspired oxygen ratio (P <.001), previous antibiotic use (P =.040), and median C-reactive protein concentration (P =.006).

The algorithm based on the OB-measured characteristics predicted severe COVID-19 among 10 of the 12 severe cases (sensitivity, 83.3%; positive predictive value, 45.5%) and mild COVID-19 among 14 of the 27 cases (specificity, 83.8%; negative predictive value, 87.5%).

This study was limited by its small sample size and the investigators cautioned the readers that the OB device may not be effective for use with patients having preexisting conditions such as arrhythmia, chronic renal disease, or chronic liver failure.

These results indicated the OB device can rapidly assess patients at risk for sepsis and may even be useful for stratifying risk for COVID-19 severity. This device may be especially useful in situations where physician motility is limited by personal protective equipment.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Doulou S, Leventogiannis K, Tsilika M, et al. A novel optical biosensor for the early diagnosis of sepsis and severe Covid-19: the PROUD study. BMC Infect Dis. 2020;20(1):860. doi:10.1186/s12879-020-05607-1