SPEED. Most ID tests result within 8-12 hours of specimen receipt. This allows you to assess the severity of infection, adjust drug therapy regimens, and make decisions faster that are critical to outcomes of the patient.
QUALITY. Dual gene targets reduce false negatives and under quantification
SERVICE. Approximately 60% of transplant programs turn to us for their most critical patient testing and we accept a variety of validated specimen types to give healthcare providers more options
Molecular Assays Designed to Help You Reduce False Negatives and Under-quantification
The highly mutable nature of pathogens often proves challenging in molecular assay design. Traditional qPCR assays are designed so that a single primer and probe set targets one location within the pathogen genome. However, these single-target assays often prove inadequate to detect and quantify viral targets. Sequence polymorphisms in the assay target region can cause impaired primer or probe binding, which may result in significant under-quantification or a false negative result. To eliminate this possibility, Viracor’s qPCR assays often target two regions within the pathogen genome, utilizing unique primer and probe sets for each target site. The driving principle behind our multiple-target assay design is that when a polymorphism occurs in one assay target, the additional sets of primers and probes for the alternate target region will still detect and accurately quantify the pathogen, and thus reduces the likelihood of under-quantification or a false negative result.
Assay Refinement Helps You Account for New Strains or Mutations that Might Otherwise be Missed
At Viracor, we believe that ensuring the accuracy of each test is just as important as developing new ones, so pathogen surveillance and assay refinement is a top priority. By utilizing nucleic acid sequence databases, each qPCR assay is regularly assessed to verify that new pathogen strains or genetic polymorphisms that arise will not lead to a false negative result. If a new pathogen strain or genetic polymorphism is identified that would lead to a false-negative result, our current qPCR assay is refined and revalidated to ensure that accurate test results are always reported.
Viracor Eurofins designs each of our assays to account for all strains, serotypes, and clinical isolates - not just the most common ones. This is especially beneficial for immunocompromised patients who may be more likely to be infected with multiple or unusual strains. For example, the Viracor Eurofins Adenovirus qPCR assay detects all known viral serotypes with equal sensitivity. Additionally, Viracor Eurofins has designed and validated each assay to ensure there is no cross reactivity with other commonly occurring pathogens. This is critically important when testing for genetically similar but clinically divergent pathogens, such as BK virus and JC virus.
Variety of Accepted and Validated Specimen Types Give You More Options
Not only are Viracor’s assays extremely sensitive with rapid turnaround time, but they can identify pathogens using many different types of clinical specimens, such as plasma, urine, cerebrospinal fluid, lung tissue, bone marrow aspirate, throat specimens and fecal specimens, among other fluids and tissues. By providing you more options you can determine what is best for your patient and capture localized viral presentations. We pay as careful attention to our extraction methodology as we do to primer and probe design. Viracor understands that the sensitivity of PCR relies heavily on the efficiency of nucleic acid extraction. Therefore, we don't employ a "one size fits all" mentality. Our extraction methods are specimen-specific, ensuring maximum nucleic acid yields to provide the most efficient, reproducible, and sensitive results.
In immunocompromised patients, high mortality and morbidity of invasive mucormycosis (IM) remain significant healthcare issues due in part to confusion of IM with invasive aspergillosis (IA) and failure to initiate appropriate therapy. A validated Mucorales (MUC) PCR detects the causative agents of IM with good sensitivity and specificity, as reported previously (M-227, ICAAC 2013). Published studies have not definitively determined the frequency of patients for whom pulmonary IA is suspected but IM is present. We aimed to (1) estimate the frequency of MUC PCR positivity in bronchoalveolar lavage (BAL) samples submitted for Aspergillus (ASP) PCR panel testing.
Pulmonary nocardiosis is an infection targeting immunocompromised patients characterized by high mortality and requires non-frontline antibiotics for treatment. Nocardiosis is currently confirmed or excluded by BAL fluid culture followed by further phenotypic identification steps. A culture-independent method with more timely results would accelerate the administration of appropriate treatment. A rapid Nocardia (NOC) PCR assay for BAL has neither been previously validated nor offered for clinical testing to our knowledge.
Antiviral resistance to human cytomegalovirus (CMV) is a growing concern for immunocompromised patients on prolonged antiviral regimens, and CMV remains the most clinically significant infection following allogeneic hematopoietic-cell transplantation. Letermovir targets subunit 2 of the viral terminase complex (UL56) and is approved for CMV prophylaxis in adult stem cell transplant recipients. Resistance to letermovir is conferred by point mutations in the UL56 gene, and with the potential clinical need for antiviral resistance testing, we have developed a UL56 sequencing assay covering 23 identified resistance mutations. Here we summarize the performance characteristics of the UL56 antiviral resistance assay.
CMV T Cell Immunity
Cytomegalovirus (CMV) infection is a common opportunistic infection associated with significant morbidity, mortality, and risk of allograft loss. Early detection of viremia and initiation of treatment prior to disease progression is paramount. Alternatively, in the absence of treatment, many patients also control CMV infection, including low-level viremia, without progressing to disease. Thus, many treatment decisions (e.g. viremia thresholds to initiate treatment) are not currently well-defined. Given the excessive toxicities and costs of antiviral therapy, there is growing interest in assays that measure CMV-specific T-cell immunity (TCI), which may predict protection against infection. The Viracor ® CMV T-cell Immunity Panel (CMV-TCIP) uses flow cytometry and intracellular cytokine staining (ICS) to measure % of CMV-specific CD4+ and CD8+ T-cells. Other currently available TCI commercial assays measure only aggregate (CD4+ and CD8+) or CD8+ immune responses only.
Want to know more about Viracor's CMV Test menu? CLICK HERE
Utility of Serum Beta-D Glucan Assay for Diagnosis of Invasive Fungal Infections in Solid Organ Transplant Recipients Beta-D glucan (BDG) assay is a noninvasive test for presumptive diagnosis of invasive fungal infections (IFI). The utility of BDG assay and cut off values for positive, intermediate or negative test has been primarily studied in patients with hematological malignancies. However, the role of BDG in solid organ transplant (SOT) recipients is not well described. The aim of this study is to evaluate the utility of serum BDG assay for IFI diagnosis in SOT recipients.
Isavuconazole is a broad-spectrum antifungal available in both intravenous (IV) and oral capsule formulations for the treatment of invasive aspergillosis and mucormycosis. Oral administration can be challenging as FDA prescribing information states capsules should not be chewed, crushed, dissolved, or opened. We describe the first two cases, to our knowledge, of patients who received isavuconazonium capsules sprinkled via NGT with concomitant therapeutic drug monitoring (TDM).
Higher peak adenovirus (ADV) viral loads (VL) have correlated with higher mortality in allogeneic hematopoietic cell transplant (HCT) recipients. ADV viral dynamics may inform trial design of new treatment strategies. We examined the relationship between cumulative viral burden expressed as average area under the curve (AAUC) and mortality.
With over 30 years of specialized expertise in infectious disease, immunology and allergy testing for immunocompromised and critical patients, Viracor is committed to helping medical professionals, transplant teams, reference labs and biopharmaceutical companies get results faster, when it matters most.
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