The NMPA granted innovation approval to Roche’s Elecsys EBV VCA IgG and issued a review report on December 4, 2025.
The published review reports like this one serve as important references for you to understand what the regulatory authorities are thinking and evaluating during their review process. We have been following the list for the past several years and review the relevant ones for our clients’ specific products to gain more clarity and be more efficient in their submission and approval process. As NMPA standardizes and streamlines the review process for fast-track approval, domestic and overseas players can benefit from our expertise and experience.
Product overview
- Product structure and composition
- Intended Use
This product is intended for the in vitro qualitative detection of EB virus (EBV) IgG antibodies (including IgG antibodies against VCA, EA, and IEA antigens, without differentiation) in human serum and plasma.
It is used as an aid in diagnosing infectious mononucleosis and determining the stage of EBV infection.
- Model/Specification
- Working principle
Sandwich Method
Total Detection Time: 18 minutes
First Incubation:
The sample, biotinylated EBV-specific recombinant antigens, and ruthenium-labeled EBV-specific recombinant antigens form a sandwich complex.
Second Incubation:
Microparticles coated with streptavidin are added, and the complex binds to the solid phase through the interaction between biotin and streptavidin.
The reaction mixture is aspirated into the measuring cell, where the microparticles are magnetically captured on the electrode surface. Unbound substances are washed away.
A specific voltage is applied to the electrode, inducing chemiluminescence in the complex, and the light intensity is measured by a photomultiplier.
The instrument, using software, automatically calculates the test result by comparing the electrochemiluminescence signal value of the sample with the cutoff value obtained during prior calibration.
Pre-clinical
- Key Raw Materials
The primary raw materials for this product include biotinylated EBV-specific antigens (IEA/EA/VCA), ruthenium-labeled EBV-specific antigens (IEA/EA/VCA), and EBV VCA IgG-positive human serum. Given the diversity of EBV immune responses and the variability of antigen-specific IgG responses, the materials were carefully selected to ensure detection of rare samples lacking VCA IgG antibodies. To achieve this, early antigens (EA) and immediate early antigens (IEA) were added to supplement the VCA antigens. These materials were self-prepared, tested for functionality, and subjected to quality standards to ensure suitability.
- Manufacturing Process and Reaction System Optimization
Through internal trials, the applicant optimized the manufacturing process and reaction system, focusing on parameters such as sample volume, reagent components (R1, R2), and microparticle volume. This resulted in an efficient and robust reaction system.
- Analytical Performance Evaluation
The performance evaluation focused on accuracy, precision, analytical specificity, detection limits, and the potential hook effect.
- Accuracy: The product was compared with Abbott Architect EBV VCA IgG reagents, testing 1,571 samples. The positive, negative, and overall concordance rates exceeded 90%. Consistency between batches and device models was validated, with positive and negative concordance rates exceeding 98%, and overall concordance above 96%.
- Precision: Precision was evaluated across three batches on appropriate instruments using negative, cut-off, and positive serum samples. The criteria for repeatability, intermediate precision, and reproducibility were met, ensuring reliable results.
- Analytical Specificity: Cross-reactivity and interference studies were conducted. Cross-reactivity testing included pathogens such as herpes simplex viruses, cytomegalovirus, HIV, hepatitis viruses, and others. Results showed no significant cross-reactivity, and consistency with other products was verified. Interference studies evaluated substances like bilirubin, hemoglobin, and biotin, confirming no impact within specified concentration ranges. Of 17 tested drugs, only itraconazole showed a significant effect by lowering COI values.
- Detection Limits: LoB and LoD studies across three batches met all requirements.
- Hook Effect: Dilution tests were conducted on samples with potential for a hook effect. No false negatives due to high-dose effects were observed, but the possibility cannot be entirely excluded.
- Positive Cut-Off Value Research
The cut-off formula was developed through sensitivity and specificity analysis on patient samples with defined EBV infection statuses. Gray zones were established using seroconversion panels, and external clinical trials confirmed the cut-off values’ validity and appropriateness.
- Stability Studies
Studies on real-time, usage, transportation, and sample stability were conducted to determine the product’s effective storage conditions under various scenarios.
This comprehensive evaluation ensures the product’s reliability for detecting EBV IgG antibodies and aiding in the diagnosis of EBV infection.
Clinical
Clinical trials for the product were conducted at five institutions: Beijing Children’s Hospital affiliated with Capital Medical University, Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Tongji Hospital affiliated with Huazhong University of Science and Technology, Shanghai Children’s Hospital, and Hangzhou First People’s Hospital. These trials compared the investigational in vitro diagnostic reagent with clinical reference standards or marketed products to evaluate its clinical performance. A total of 1,621 blood samples from patients suspected of EBV infection were included.
The results demonstrated a 94.3% overall clinical concordance rate (95% CI: 93.2%, 95.4%) between the diagnostic reagent and the clinical reference standard across the defined EBV infection stages, with concordance rates exceeding 90% for each stage.
For the combined detection of EA IgG and VCA IgG, 381 samples were analyzed, including 227 positive and 154 negative samples. The investigational reagent achieved a 98.7% positive concordance rate (95% CI: 96.2%, 99.6%), an 88.3% negative concordance rate (95% CI: 82.3%, 92.5%), and a 94.5% overall concordance rate (95% CI: 91.7%, 96.4%) when compared to the reference reagent. Discrepant results were further analyzed using third-party validation.
In summary, the clinical trial results met the technical evaluation requirements, confirming the product’s reliability for detecting EBV antibodies and supporting its suitability for determining EBV infection stages.
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