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Varicella-Zoster Virus (VZV) Reactivation Assay Service

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Chimeric Antigen Receptor (CAR) T-cell therapy has revolutionized the treatment of various hematologic malignancies. However, it comes with unique toxicities, including a heightened risk of infections. Among these, Varicella-Zoster Virus (VZV) reactivation is a common and potentially serious complication after CAR T-cell therapy. Creative Biolabs offers the VZV reactivation assay service to mitigate clinical risks associated with advanced biotherapies and streamlines viral safety assessments through advanced cell-based assays and highly sensitive detection platforms.

Overview

Gene therapies, particularly CAR T-cell therapy, induce profound immunosuppression, making patients highly susceptible to opportunistic infections, including Varicella-Zoster Virus (VZV) reactivation, which endangers patient safety. Clinical evidence shows this immunosuppressive state significantly elevates VZV reactivation risk, leading to severe complications like herpes zoster, encephalitis, or disseminated disease. Therefore, developing and applying highly sensitive VZV reactivation assays is paramount. These assays are indispensable for timely detection, enabling prompt antiviral intervention, safeguarding patient health, and ensuring the success of these transformative biopharmaceutical treatments.

Fig.1 Model of Simian Varicella Virus (SVV) pathogenesis in rhesus macaques following intrabronchial inoculation. (OA Literature) Fig.1 Pathophysiological model of Simian Varicella Virus (SVV) in rhesus macaques after intrabronchial injection.¹

VZV Reactivation Assay Service at Creative Biolabs

Creative Biolabs' VZV reactivation assay service offers comprehensive solutions for accurate VZV detection and quantification, critical for viral safety in advanced therapeutic development. Our service begins with sample preparation and clinical data review, progressing to cell culture and co-culture setups for VZV induction and monitoring. We utilize highly sensitive qPCR for viral load and immunological assays (ELISA/Flow Cytometry) for host-virus insights. This workflow provides precise VZV reactivation data, supporting robust risk assessment, preventing complications, and supplying essential information for regulatory submissions (IND/BLA). Projects typically take 6-10 weeks, depending on complexity, empowering effective patient monitoring and ensuring biopharmaceutical safety.

Workflow

Step 1

Sample Receipt & Preparation

Description: Upon secure receipt, client-provided samples undergo rigorous quality control checks for integrity and viability. Samples are then processed, which may involve cell isolation (e.g., PBMCs from whole blood) or nucleic acid extraction, ensuring they are optimally prepared for the downstream assay.
Expected Outcome: High-quality, prepared samples ready for assay initiation, minimizing pre-analytical variability and ensuring accurate detection of VZV.

Step 2

Cell Culture & Co-culture Setup

Description: Target cells relevant to VZV latency and reactivation (e.g., primary human neurons, T cells) are isolated or procured and established in appropriate cell culture conditions. If applicable, co-culture systems are set up involving VZV-infected cells or latency models to mimic in vivo conditions, particularly focusing on the immunosuppressed environment.
Expected Outcome: Robust and viable cellular models or co-culture systems primed for VZV reactivation studies, reflecting the clinical scenario.

Step 3

VZV Reactivation Induction & Monitoring

Description: Latent VZV reactivation is precisely induced using specific stimuli, which may include immunosuppressive agents relevant to CAR T-cell therapy, pro-inflammatory cytokines, or other relevant physiological activators. The cultures are then meticulously monitored over time for signs of viral replication, such as cytopathic effects (CPE) or expression of viral antigens.
Expected Outcome: Controlled and quantifiable induction of VZV reactivation within the in vitro model, providing a reliable platform for assessment.

Step 4

Viral Load Quantification

Description: Highly sensitive molecular techniques, such as quantitative Polymerase Chain Reaction (qPCR), are employed to detect and precisely quantify VZV DNA or RNA. This provides an accurate measure of viral load and replication kinetics, crucial for early detection in immunosuppressed patients.
Expected Outcome: Precise quantitative data on VZV viral load (e.g., VZV DNA copies per milliliter or per cell), enabling robust comparative analysis and risk assessment.

Step 5

Immunological Readouts

Description: For a comprehensive understanding of host-virus interaction, immunological assays like Enzyme-Linked Immunosorbent Assay (ELISA) or flow cytometry are performed. These methods assess host immune responses to VZV, including the quantification of VZV-specific antibodies or the characterization of VZV-specific T-cell responses, which are often altered in immunosuppressed individuals.
Expected Outcome: Detailed insights into the host's immune status against VZV, complementing viral load data and informing patient management strategies.

Step 6

Data Analysis & Reporting

Description: All generated data from molecular and immunological assays undergo rigorous statistical analysis and expert interpretation. This culminates in a comprehensive, detailed, and easy-to-understand report that includes raw data, analyzed results, and scientific conclusions, specifically highlighting implications for patient safety.
Expected Outcome: Actionable insights, clear interpretations, and a complete, professional project report suitable for regulatory submissions or publication, supporting patient safety initiatives.

Our Service Advantages

High Sensitivity & Specificity
Comprehensive Analysis
Customizable Solutions
Reliable Data
Accelerated Timelines

Case Study

Case One

A leading gene therapy company partnered with Creative Biolabs for their VZV Reactivation Assay Service. Through our service, they successfully identified multiple instances of VZV reactivation in their patient cohort undergoing novel CAR T-cell therapy, enabling timely prophylactic intervention and preventing severe clinical complications within 8 weeks. This critical data significantly enhanced their patient safety monitoring protocols, directly addressing the risks of immunosuppression.

Customer Review

Review One----Comprehensive Insights into Immune Status

The comprehensive data provided by Creative Biolabs, including both viral load quantification and immunological markers, greatly facilitated our understanding of the altered host-virus interaction in our gene therapy studies, offering a distinct advantage over standard PCR methods by providing a more complete picture of VZV risk in immunosuppressed individuals

----- 2025-3-25, Ms. S***h

FAQs

Q1: What types of samples are suitable for the VZV Reactivation Assay Service, especially from immunocompromised patients?

A1: Our service is versatile and can accommodate various sample types, including peripheral blood mononuclear cells (PBMCs), plasma, and cerebrospinal fluid (CSF), depending on your specific research needs and the clinical context of immunosuppression. We recommend discussing your sample type with our experts to ensure optimal results and assay compatibility for these sensitive samples.

Q2: How sensitive is Creative Biolabs' VZV Reactivation Assay compared to traditional methods for detecting VZV in immunosuppressed individuals?

A2: Our assay utilizes advanced molecular and cell-based techniques, offering superior sensitivity and specificity compared to traditional methods. This allows for the detection of even low levels of VZV reactivation, providing critical early insights that are often missed by less sensitive approaches, thus enabling more timely clinical decisions and enhanced patient safety in immunosuppressed populations.

Q3: What specific information or materials are required to initiate the VZV Reactivation Assay Service?

A3: To begin, we require patient-derived samples such as PBMCs, plasma, or CSF, collected and handled under sterile conditions. Additionally, relevant clinical data, including patient history, current treatment regimen (e.g., CAR T-cell therapy), and detailed immunosuppression status, are essential for contextualizing results and assessing patient risk. Any specific assay requirements or desired readouts should also be communicated.

Related Services

In addition, we also provide a suite of services to monitor other microorganisms, which includes:

Contact Us

At Creative Biolabs, our VZV reactivation assay service provides an essential, high-sensitivity tool for monitoring viral safety in advanced biopharmaceutical development, directly addressing the critical patient safety concerns arising from immunosuppression in treatments like CAR T-cell therapy. If you are interested in our service, please click the link to get in touch with us.

Reference

Sorel, Océane, and Ilhem Messaoudi. "Varicella Virus-Host Interactions During Latency and Reactivation: Lessons From Simian Varicella Virus." Frontiers in microbiology vol. 9 3170. 21 Dec. 2018, doi:10.3389/fmicb.2018.03170. Distributed under Open Access License CC BY 4.0, without modification.

All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.