Language
English
Publication Date
7-1-2023
Journal
Clinical Biochemistry
DOI
10.1016/j.clinbiochem.2022.04.012
PMID
35487256
Abstract
The objective was to evaluate the analytical performance of a new point-of-need platform for rapid and accurate measurement of a host-protein score that differentiates between bacterial and viral infection. The system comprises a dedicated test cartridge (MeMed BV®) and an analyzer (MeMed Key®). In each run, three host proteins (TRAIL, IP-10 and CRP) are measured quantitatively and a combinational score (0-100) computed that indicates the likelihood of Bacterial versus Viral infection (BV score). Serum samples collected from patients with acute infection representing viral (0 ≤ score < 35), equivocal (35 ≤ score ≤ 65), or bacterial (65 < score ≤ 100) scores based on pre-defined score cutoffs were employed for the analytical evaluation studies as well as samples from healthy individuals. To assess reproducibility, triplicate runs were conducted at 3 different sites, on 2 analyzers per site over 5 non-consecutive days. Lower limit of quantitation (LLoQ) and analytical measurement range were established utilizing recombinant proteins. Sample stability was evaluated using patient samples representative of BV score range (0-100). MeMed Key® and MeMed BV® passed the acceptance criteria for each study. In the reproducibility study, TRAIL, IP-10 and CRP measurements ranged with coefficient of variation from 9.7 to 12.7%, 4.6 to 6.2% and 5.0 to 11.6%, respectively. LLoQ concentrations were established as 15 pg/mL, 100 pg/mL and 1 mg/L for TRAIL, IP-10 and CRP, respectively. In summary, the analytical performance reported here, along with diagnostic accuracy established in the Apollo clinical validation study (NCT04690569), supports that MeMed BV® run on MeMed Key® can serve as a tool to assist clinicians in differentiating between bacterial and viral infection.
Keywords
Humans, C-Reactive Protein, Reproducibility of Results, Chemokine CXCL10, Virus Diseases, CRP, Chemiluminescence, IP-10, MeMed BV, MeMed Key, Rapid immunoassay platform, TRAIL
Published Open-Access
yes
Recommended Citation
Hainrichson, Mary; Avni, Noa; Eden, Eran; et al., "A Point-of-Need Platform for Rapid Measurement of a Host-Protein Score That Differentiates Bacterial From Viral Infection: Analytical Evaluation" (2023). Faculty, Staff and Students Publications. 6507.
https://digitalcommons.library.tmc.edu/baylor_docs/6507