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For many expectant mothers, the greatest concern is not morning sickness or sleepless nights, but hearing one sentence during a prenatal visit: "We need to evaluate the possibility of an infection."

Maternal and Fetal Health

During pregnancy, pathogens such as Toxoplasma gondii (Toxo), rubella virus (RV), cytomegalovirus (CMV), herpes simplex virus (HSV), and other pathogens such as parvovirus B19 - collectively known as TORCH infections- pose significant risks to fetal development. The infection may lead to developmental abnormalities in mild cases, and miscarriage or congenital malformations in severe cases, making them a major concern for expectant parents. To safeguard the maternal infant health, accurate and comprehensive TORCH testing is the key to healthy pregnancy and improving maternal and fetal outcomes. Amid a wide range of TORCH testing solutions on the market, what makes Autobio's TORCH panel stand out? The answer lies in our two industry-leading advantages: a comprehensive test menu and high-precision diagnostic performance.

17 Industry-First Assays

Autobio's TORCH testing portfolio offers the industry's most comprehensive menu of 17 TORCH-related assays, covering 6 key pathogens. In addition to established targets such as Toxo and RV, the portfolio addresses two previously unmet gaps in our assay portfolio.

Autobio's TORCH testing portfolio

First, we were the first in China to obtain regulatory approval for chemiluminescent microparticle immunoassay (CLIA Microparticles) targeting human parvovirus B19 IgM and IgG. These assays have been fully integrated into the TORCH screening panel and are compatible with automated CLIA platforms.

Second, we, Autobio, were the first domestic manufacturer to achieve regulatory approval for a complete panel of 5 IgG avidity assays. Avidity is a key indicator for differentiating primary infection from past infection and plays an essential role in the accurate assessment of fetal risk. Through continuous in-house R&D, we successfully brought the full TORCH avidity panel (Toxo, Rubella, CMV, HSV-I & HSV-II) to market, addressing a longstanding gap in high-end domestic diagnostic solutions.

Ranked First in EQA Participation for 13 Consecutive Years

The quality of a diagnostic test portfolio is reflected not only in the breadth of its assay menu, but also in customer recognition and market adoption. In the External Quality Assessment (EQA) program organized by the National Center for Clinical Laboratories (NCCL) - The highest standard for laboratory performance evaluation in China - Autobio's TORCH assays have consistently recorded the highest proportion of participating laboratories from 2013 to 2025. This sustained leadership over 13 consecutive years reflects the strong performance, analytical reliability, and broad clinical acceptance of our TORCH testing solutions in routine laboratory practice.

Advantages of Autobio's Torch Panel

In addition, we were the first manufacturer in China to launch a full set of 10 TORCH quality control (QC) materials and obtain regulatory approval for a multiplex QC material. These QC materials integrate natural-source antigens with recombinant antibodies, enabling precise coverage of key antigenic epitopes. Our matrix design closely mimics clinical specimens, effectively minimizing matrix-related interference. A two-level QC material enables quality control across 10 assays, providing a comprehensive and precise solution for internal quality assurance in TORCH testing.

Deep Expertise and Continuous Innovation

For more than two decades, Autobio has been dedicated to advancing TORCH diagnostics, with a sustained focus on technological innovation and product optimization. We have established a comprehensive solution portfolio spanning from routine screening assays to IgG avidity assays. Guided by a commitment to accuracy, our R&D team applies proteomics analysis, precise epitope identification, and peptide synthesis to systematically investigate pathogen molecular architecture and antigenic epitopes. In parallel, extensive evaluation of specialized clinical specimens and internationally reference standardized serum panels has strengthened the technical foundation of product quality at the molecular level, ensuring high reliability and reproducibility of results.

Autobio's Torch Diagnostics

In addition, by systematically reviewing international authoritative literature and guidelines, utilizing international validated reference serum panels as benchmark materials, and collaborating with leading global institutions, our team has innovatively developed an integrated multi-method verification strategy for difficult samples (e.g., immunoblot, immunofluorescence, immunoagglutination). Through continuous cross-validation, this approach continuously enhances diagnostic accuracy, providing a reproducible technical paradigm for standardized laboratory testing.

CE marked Torch Panel

Besides, we have contributed to the development of the Expert Consensus on Standardized Laboratory Testing and Clinical Application of TORCH in collaboration with leading national authoritative institutions. This consensus defines quantitative dynamic monitoring and IgG avidity testing as key diagnostic strategies, providing a solid basis for clinical decision-making and avoiding unnecessary clinical interventions. On this foundation, we have established an integrated end-to-end solution encompassing testing, result interpretation, and clinical management. This solution includes quantitative IgG/IgM testing, avidity testing, a dynamic monitoring database, and an AI-assisted result interpretation system. Together, we provide a comprehensive support across the full clinical pathway - from initial TORCH screening and diagnosis to prognostic assessment.

From an accurate test report to a complete health management solution, from a single technological breakthrough to an industry-wide standard upgrade, Autobio has spent more than two decades driving continuous advances in TORCH diagnostics through innovation and scientific excellence. Every technological advance and every quality improvement reflects our enduring commitment to the protection of life. Going forward, we will remain patient-focused and innovation-driven, continuing to advance diagnostic technologies and contribute to better healthcare outcomes worldwide.