Mindray Launches High-Sensitivity and High-Specificity ToRCH Panel

By LabMedica International staff writers
Posted on 28 Sep 2022

Image: Mindray ToRCH reagents deliver excellent seroconversion sensitivity (Photo courtesy of Mindray)

Mindray (Shenzhen, China) has launched the ToRCH Panel that provides high-quality assays to meet different clinical needs. Thanks to the improved raw materials, processes, formulas, reaction models, and standardized traceability, Mindray ToRCH reagents deliver excellent seroconversion sensitivity. Mindray ToRCH has a good detection rate for both samples that are positive in multiple systems and true positive samples such as seroconversion panels. Mindray ToRCH kits support diverse sample types with less quality controls and sample volumes, which ensures great ease and convenience during clinical detection. By bringing the clinical benefits of ToRCH Panel into play and addressing the key requirements for the reagents, Mindray has solved the ToRCH detection challenges facing clinical laboratories and made Mindray ToRCH assays accessible in clinical application.

To achieve high sensitivity and specificity, Mindray has been working consistently to improve the raw materials, processes, formulas, and reaction models. High quality materials are fundamental to ensure high sensitivity and specificity of CLIA assays. To cater to different projects and process requirements, Mindray invested significant resources in the design and development of immunodominant proteins and immunodominant epitopes. Mature, stable and innovative technology is another guarantee of satisfactory performance. For the coating and labeling processes, the Mindray R&D team selected the particles and ALPs that can best meet the assay requirements. To improve the sensitivity and specificity, the Mindray experts spent a considerable amount of time thoroughly studying the parameters using a DOE approach. With a robust design, the boundary of each parameter was determined to ensure the reproducibility of the process.

At the formulation level, the Mindray R&D experts investigated the interference mechanism and classified the interference into four different types to help enhance the anti-interference capacity. Hundreds of commercial and uniquely designed blockers were studied and applied to minimize each type of interference. For instance, the Mindray R&D team designed a capture method for the IgM assay to minimize the interference of IgG and RF (Rheumatoid Factor). The Toxo IgG, CMV IgG and RV IgG quantitative kits of the Mindray ToRCH panel are fabricated with materials with international standard units and the latest standardized traceability. Toxo IgG contains specific IgG and features DT test standardization. CMV IgG adopts the first international standard and features long-term stability. RV IgG comes with a cutoff value of 10 IU/mL as recommended by WHO. The combined examination by Mindray ToRCH IgG and IgM can accurately reveal previous infections and promptly detect ToRCH infections that failed to be ruled out previously.

To demonstrate the sensitivity and specificity of the Mindray ToRCH kits, Mindray conducted tests in over five clinical sites both in and outside China. Although the positive rate varies among different countries and regions, Mindray ToRCH kits have exhibited great specificity for Toxo IgG and ToRCH IgM and excellent sensitivity for RV IgG and CMV IgG. In addition, given the wide coverage of the clinical tests, there are no significant differences between the Chinese and international sites.

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