Distinguishing Viral and Bacterial Infections Made Easy Through the Food and Drug Administration Approved Technology-Assisted Diagnosis : International Journal of Applied and Basic Medical Research

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Editorial

Distinguishing Viral and Bacterial Infections Made Easy Through the Food and Drug Administration Approved Technology-Assisted Diagnosis

Mahajan, Rajiv

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International Journal of Applied and Basic Medical Research: Oct–Dec 2021 - Volume 11 - Issue 4 - p 205
doi: 10.4103/ijabmr.ijabmr_662_21
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Recently, the United States Food and Drug Administration granted approval to a technology for distinguishing between viral and bacterial infections within minutes. The technology, MeMed BV, works through MeMed key platform, decoding the host immune response to the infection to differentiate between viral and bacterial infection.[1]

The MeMed Key platform, which enables rapid and sensitive measurements of multiple proteins at the point-of-the need, has been approved for both children and adults.[1] The test is an automated, semiquantitative, immunoassay (chemiluminescence-based analyte measurements of patient serum samples) that measures three host proteins – TNF-related apoptosis-inducing ligand (TRAIL), interferon γ-induced protein 10 kDa (IP-10), and C-reactive protein (CRP) - in adult and pediatric serum samples. The test is indicated for use in conjunction with clinical assessments and other laboratory findings, in patients with suspected acute bacterial or viral infection, who have had symptoms for less than 7 days.[2]

Many a times, the initial symptoms produced by both viruses and bacteria are similar, namely fever, sore throat, and cough, thus making them clinically indistinguishable. This may result in inadvertent use of antibiotics for viral infections, for which they are ineffective. This misuse of antibiotics may lead to emergence of resistance to antibiotics. Thus, timely and proper diagnosis is the key for effective management and this test promotes timely diagnosis when the infection site is inaccessible or when the pathogen is undetectable using conventional tests. This test will be handy even when the cause of infection is new emerging pathogen. As such, this test will enable timely and better informed antibiotic treatment decision, thus promoting rational use of antibiotics.

The MeMed BV test result is a score between 0 and 100 derived from computational integration of the measurements of the three proteins, namely TRAIL, IP-10, and CRP, where low scores are indicative of viral infection and high score of bacterial infection – 0 ≤ score ≤10: high likelihood of viral infection (or other non-bacterial etiology); 10 < score <35: moderate likelihood of viral infection (or other non-bacterial etiology); 35 ≤ score ≤65: equivocal; 65 < score <90: moderate likelihood of bacterial infection (or co-infection); 90 ≤ score ≤100: high likelihood of bacterial infection (or co-infection). The test run time is approximately 15 mins.[2]

The Food and Drug Administration clearance was based upon a prospective, multicentric, observational, blinded study, carried out by enrolling both pediatric and adult patients.[3] The test provides highly accurate results with area under the curve of 90% and 97% for primary and secondary endpoints, respectively. The test will prove highly useful for distinguishing viral from bacterial infections in pediatric population, particularly in emergency setting.

1. Kohli K FDA Clears First Ever Technology to Distinguish Between Bacterial and Viral Infections. Medical Dialogues, 22nd September. 2021Last accessed on 2021 Sep 29 Available from: https://medicaldialogues.in/medicine/news/fda-clears-first-technology-to-distinguish-between-bacterial-and-viral-infections-82202
2. Food and Drug Administration. 510(k) Substantial Equivalence Determination Decision Summary – Assay and Instrument.Last accessed on 2021 Sep 29 Available from: https://www.accessdata.fda.gov/cdrh_docs/reviews/K210254.pdf
3. ClinicalTrials.gov. Establish MeMed BV™ Performance for Differentiating Bacterial From Viral Infection in Suspected Acute Infection Patients (APOLLO STUDY) (Apollo).Last accessed on 2021 Sep 29 Available from: https://clinicaltrials.gov/ct2/show/study/NCT04690569
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