Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX, USA; Department of Pathology, Texas Children's Hospital, Houston, TX, USA.
Department of Pathology, Texas Children's Hospital, Houston, TX, USA.
Clin Chim Acta. 2023 Jun 1;546:117387. doi: 10.1016/j.cca.2023.117387. Epub 2023 May 16.
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.
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.
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.
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.
病毒和细菌感染或合并感染的临床表现有很大的重叠。病原体鉴定是进行适当治疗的金标准。最近，FDA 批准了一种称为 MeMed-BV 的多元指数检测方法，该方法基于 3 种宿主蛋白的差异表达来区分病毒和细菌感染。在此，我们按照临床和实验室标准协会的指南，在我们的儿童医院的 MeMed Key 分析仪上对 MeMed-BV 免疫检测进行了验证。
我们通过精密度（室内和室间）、方法比较和干扰研究评估了 MeMed-BV 检测的分析性能。我们通过对我院急诊科急性发热患儿的血浆样本进行回顾性队列研究（n=60）来评估 MeMed-BV 检测的临床性能（诊断敏感性和特异性）。
MeMed-BV 在高评分细菌和低评分病毒对照中均显示出可接受的室内和室间精密度，范围均小于 3 个评分单位。诊断准确性研究表明，该方法识别细菌感染或合并感染的敏感性为 94%，特异性为 88%。我们的 MeMed-BV 结果与制造商的实验室数据具有极好的一致性（R=0.998），并且与 ELISA 研究相比表现良好。大量溶血和黄疸不会影响检测，但大量脂血会导致中度可能发生病毒感染的样本出现相当大的偏差。重要的是，与常规测量的感染相关生物标志物（如白细胞计数、降钙素原和 C 反应蛋白）相比，MeMed-BV 检测在区分细菌感染方面表现更好。
MeMed-BV 免疫检测显示出可接受的分析性能，可可靠地区分儿科患者的病毒和细菌感染或合并感染。未来的研究需要检验其临床实用性，特别是在减少血液培养的需求和患者的治疗时间方面。
