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A 29-mRNA host response test from blood accurately distinguishes bacterial and viral infections among emergency department patients.
Safarika, Asimina; Wacker, James W; Katsaros, Konstantinos; Solomonidi, Nicky; Giannikopoulos, George; Kotsaki, Antigone; Koutelidakis, Ioannis M; Coyle, Sabrina M; Cheng, Henry K; Liesenfeld, Oliver; Sweeney, Timothy E; Giamarellos-Bourboulis, Evangelos J.
  • Safarika A; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, ATTIKON University Hospital, 1 Rimini Str, 12462, Athens, Greece.
  • Wacker JW; Inflammatix Inc, Clinical Affairs, Burlingame, CA, USA.
  • Katsaros K; Department of Surgery, Nafplion General Hospital, Athens, Greece.
  • Solomonidi N; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, ATTIKON University Hospital, 1 Rimini Str, 12462, Athens, Greece.
  • Giannikopoulos G; Department of Internal Medicine, Syros General Hospital, Athens, Greece.
  • Kotsaki A; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, ATTIKON University Hospital, 1 Rimini Str, 12462, Athens, Greece.
  • Koutelidakis IM; 2nd Department of Surgery, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • Coyle SM; Inflammatix Inc, Clinical Affairs, Burlingame, CA, USA.
  • Cheng HK; Inflammatix Inc, Clinical Affairs, Burlingame, CA, USA.
  • Liesenfeld O; Inflammatix Inc, Clinical Affairs, Burlingame, CA, USA.
  • Sweeney TE; Inflammatix Inc, Clinical Affairs, Burlingame, CA, USA.
  • Giamarellos-Bourboulis EJ; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, ATTIKON University Hospital, 1 Rimini Str, 12462, Athens, Greece. egiamarel@med.uoa.gr.
Intensive Care Med Exp ; 9(1): 31, 2021 Jun 18.
Article in English | MEDLINE | ID: covidwho-1376600
Semantic information from SemMedBD (by NLM)
1. Virus Diseases PROCESS_OF Patients
Subject
Virus Diseases
Predicate
PROCESS_OF
Object
Patients
2. Infection PROCESS_OF Patients
Subject
Infection
Predicate
PROCESS_OF
Object
Patients
3. Decision PROCESS_OF Patients
Subject
Decision
Predicate
PROCESS_OF
Object
Patients
4. Septicemia PROCESS_OF Patients
Subject
Septicemia
Predicate
PROCESS_OF
Object
Patients
5. Acute infectious disease PROCESS_OF Patients
Subject
Acute infectious disease
Predicate
PROCESS_OF
Object
Patients
6. Virus Diseases PROCESS_OF Patients
Subject
Virus Diseases
Predicate
PROCESS_OF
Object
Patients
7. Infection PROCESS_OF Patients
Subject
Infection
Predicate
PROCESS_OF
Object
Patients
8. Decision PROCESS_OF Patients
Subject
Decision
Predicate
PROCESS_OF
Object
Patients
9. Septicemia PROCESS_OF Patients
Subject
Septicemia
Predicate
PROCESS_OF
Object
Patients
10. Acute infectious disease PROCESS_OF Patients
Subject
Acute infectious disease
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PROCESS_OF
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Patients
ABSTRACT

BACKGROUND:

Whether or not to administer antibiotics is a common and challenging clinical decision in patients with suspected infections presenting to the emergency department (ED). We prospectively validate InSep, a 29-mRNA blood-based host response test for the prediction of bacterial and viral infections.

METHODS:

The PROMPT trial is a prospective, non-interventional, multi-center clinical study that enrolled 397 adult patients presenting to the ED with signs of acute infection and at least one vital sign change. The infection status was adjudicated using chart review (including a syndromic molecular respiratory panel, procalcitonin and C-reactive protein) by three infectious disease physicians blinded to InSep results. InSep (version BVN-2) was performed using PAXgene Blood RNA processed and quantified on NanoString nCounter SPRINT. InSep results (likelihood of bacterial and viral infection) were compared to the adjudicated infection status.

RESULTS:

Subject mean age was 64 years, comorbidities were significant for diabetes (17.1%), chronic obstructive pulmonary disease (13.6%), and severe neurological disease (6.8%); 16.9% of subjects were immunocompromised. Infections were adjudicated as bacterial (14.1%), viral (11.3%) and noninfected (0.25%) 74.1% of subjects were adjudicated as indeterminate. InSep distinguished bacterial vs. viral/noninfected patients and viral vs. bacterial/noninfected patients using consensus adjudication with AUROCs of 0.94 (95% CI 0.90-0.99) and 0.90 (95% CI 0.83-0.96), respectively. AUROCs for bacterial vs. viral/noninfected patients were 0.88 (95% CI 0.79-0.96) for PCT, 0.80 (95% CI 0.72-89) for CRP and 0.78 (95% CI 0.69-0.87) for white blood cell counts (of note, the latter biomarkers were provided as part of clinical adjudication). To enable clinical actionability, InSep incorporates score cutoffs to allocate patients into interpretation bands. The Very Likely (rule in) InSep bacterial band showed a specificity of 98% compared to 94% for the corresponding PCT band (> 0.5 µg/L); the Very Unlikely (rule-out) band showed a sensitivity of 95% for InSep compared to 86% for PCT. For the detection of viral infections, InSep demonstrated a specificity of 93% for the Very Likely band (rule in) and a sensitivity of 96% for the Very Unlikely band (rule out).

CONCLUSIONS:

InSep demonstrated high accuracy for predicting the presence of both bacterial and viral infections in ED patients with suspected acute infections or suspected sepsis. When translated into a rapid, point-of-care test, InSep will provide ED physicians with actionable results supporting early informed treatment decisions to improve patient outcomes while upholding antimicrobial stewardship. Registration number at Clinicaltrials.gov NCT03295825.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Type of study: Prognostic study Language: English Journal: Intensive Care Med Exp Clinical aspect: Diagnosis / Prediction / Prognosis Year: 2021

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Type of study: Prognostic study Language: English Journal: Intensive Care Med Exp Clinical aspect: Diagnosis / Prediction / Prognosis Year: 2021
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