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Validation of a multi-analyte immunoassay for distinguishing bacterial vs. viral infections in a pediatric cohort
Anil K Chokkalla1, Estella Tam2, Rommel Liang2
1Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX, USA; Department of Pathology, Texas Children's Hospital, Houston, TX, USA.
Background:
Clinical presentation of viral and bacterial infections or co-infections overlaps significantly. Pathogen identification is the gold standard for appropriate treatment. Recently, FDA cleared a multivariate index test called MeMed-BV that distinguishes viral and bacterial infections based on the differential expression of 3 host proteins. Here, we sought to validate MeMed-BV immunoassay on MeMed Key analyzer in our pediatric hospital following guidelines from the Clinical and Laboratory Standards Institute.
Methods:
The analytical performance of the MeMed-BV test was evaluated with precision (intra- and inter-assay), method comparison and interference studies. The clinical performance (diagnostic sensitivity and specificity) of the MeMed-BV test was assessed by conducting a retrospective cohort study (n = 60) using plasma samples from pediatric patients with acute febrile illness who visited the emergency department of our hospital.
Results:
MeMed-BV showed acceptable intra- and inter-assay precision with a range of < 3 score units in both the high-score bacterial as well as the low-score viral controls. Diagnostic accuracy studies revealed a sensitivity of 94% and specificity of 88% for identifying bacterial infections or co-infections. Our MeMed-BV results showed an excellent agreement (R = 0.998) with manufacturer's laboratory data and compared well with ELISA studies. Gross hemolysis and icterus did not affect the assay, but gross lipemia showed a considerable bias in samples with moderate likelihood of viral infection. Importantly, the MeMed-BV test performed better than routinely measured infection-related biomarkers like white blood cell counts, procalcitonin and C-reactive protein in classifying bacterial infections.
Conclusion:
MeMed-BV immunoassay demonstrated acceptable analytical performance and is reliable for distinguishing viral and bacterial infections or co-infections in pediatric patients. Future studies are warranted to examine the clinical utility, especially with respect to reducing the need for blood cultures and time to treatment for the patient.
Insights
The MeMed-BV test accurately distinguishes viral and bacterial infections in children. This host-protein based immunoassay showed high sensitivity and specificity, outperforming traditional biomarkers.
Area of Science:
- Clinical diagnostics
- Infectious disease research
- Biomarker analysis
Background:
- Distinguishing viral from bacterial infections is challenging due to overlapping symptoms.
- Accurate pathogen identification is crucial for effective treatment.
- The MeMed-BV test, an FDA-cleared multivariate index assay, uses host protein expression to differentiate infection types.
Purpose of the Study:
- To validate the MeMed-BV immunoassay on the MeMed Key analyzer in a pediatric hospital setting.
- To assess the analytical and clinical performance of the MeMed-BV test according to CLSI guidelines.
Main Methods:
- Analytical performance was evaluated through precision, method comparison, and interference studies.
- Clinical performance was assessed using a retrospective cohort study of 60 pediatric patients with acute febrile illness.
- Plasma samples were analyzed using the MeMed-BV test on the MeMed Key analyzer.
Main Results:
- The MeMed-BV test demonstrated acceptable precision (intra- and inter-assay) within <3 score units.
- Diagnostic accuracy showed 94% sensitivity and 88% specificity for bacterial infections or co-infections.
- The assay showed excellent agreement with manufacturer data (R=0.998) and outperformed WBC, PCT, and CRP in classifying bacterial infections.
Conclusions:
- The MeMed-BV immunoassay exhibits reliable analytical performance for differentiating viral and bacterial infections in pediatric patients.
- Further research is needed to confirm its clinical utility in reducing blood cultures and treatment times.
