1. A point-of-need platform for rapid measurement of a host-protein score that differentiates bacterial from viral infection: Analytical evaluation
- Author
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Mary, Hainrichson, Noa, Avni, Eran, Eden, Paul, Feigin, Amir, Gelman, Salim, Halabi, Efrat, Hartog-David, Kristina G, Hulten, Ashkar, Jalal, Roy, Kalfon, Linda, Lamberth, Shawna, Lewis, Roy, Navon, Kfir, Oved, Ayelet, Raz-Pasteur, Naftalie, Senderovich, Oded, Shaham, Meytal, Shraga, Einav, Simon, Lauren M, Sommer, Oren, Zarchin, Karen C, Carroll, and Tanya M, Gottlieb
- Subjects
Clinical Biochemistry ,General Medicine - 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.
- Published
- 2023