Performance Evaluation of the Aptima CMV Quant Assay Using Plasma and Non-plasma Samples

Cytomegalovirus (CMV) is a ubiquitous herpes virus that infects a large majority of the world population with the highest prevalence found in developing countries [1]. Like other herpesviruses, CMV persists after primary infection in the human host by establishing a life-long latent infection that can periodically reactivate. Although CMV infection is generally asymptomatic and relatively benign in immunocompetent individuals, infection in immunocompromised patients such as those with acquired immunodeficiency syndrome (AIDS), solid organ transplant (SOT) as well as hematopoietic stem cell transplant (HCT) patients is associated with high morbidity and mortality [2], [3], [4], [5], [6].

Patients with CMV disease generally present with CMV syndrome characterized by fever, malaise, leukopenia, and higher than normal atypical lymphocytes [7]. Some patients develop organ-invasive diseases which can lead to not only acute and chronic graft injuries and rejection, but also opportunistic and invasive fungal infections [2,7,8]. Preventive strategies such as preemptive treatment (PET) and universal antiviral prophylaxis are used for SOT and HCT patients at risk for CMV infection and diseases

Despite considerable improvement made in prevention, diagnosis, and treatment over the years, CMV continues to negatively impact SOT and HCT transplant recipients. Early diagnostic and subsequent PET have been critical in reducing occurrences of CMV disease; however, of equal importance is the ability to measure CMV viral load for diagnosis, prognosis, and therapeutic management of those patients. In this study, we evaluated the performance of the Hologic Aptima CMV Quant assay (Aptima CMV) on the Panther system and compared the data with that of the standard of care test (SOC), ELITech MGB Alert® CMV (MGB CMV) on the ELITe InGenius® automated system. The Aptima CMV assay uses real-time transcription-mediated amplification (TMA) technology to detect and quantify CMV DNA genotypes 1-4. The primers were designed such that the highly conserved UL56 gene is targeted ensuring accurate quantification of the CMV DNA. The Panther system is a fully automated sample-to-answer, random-access, and high-throughput instrument with an easy-to-follow workflow.

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