Evaluation of the automated LIAISON® SARS-CoV-2 TrimericS IgG assay for the detection of circulating antibodies.

OBJECTIVES: COVID-19 has brought about tests from many manufacturers. While molecular and rapid antigen tests are targeted for early diagnosis, immunoassays have a larger role in epidemiological studies, understanding longitudinal immunity, and in vaccine development and response. METHODS: The performance of the LIAISON® SARS-CoV-2 TrimericS IgG assay was evaluated against the Beckman ACCESS SARS-CoV-2 IgG assay in New Mexico, and against the Siemens ADVIA Centaur COV2G assay in New York. Discordant samples were parsed using a microneutralization assay. RESULTS: A SARS-CoV-2 antibody positivity rate of 23.8% was observed in the samples tested in New York (September 2020), while in the same month the positivity rate was 1.5% in New Mexico. Positive and negative agreement were 67.6% (95% CI 49.5-82.6%) and 99.8% (95% CI 99.5-99.9%), respectively, with the Beckman test, and 98.0% (95% CI 95.7-99.3%) and 94.8% (95% CI 93.4-96.0%), respectively, with the Siemens test. Receiver operating characteristic analysis for the detection of SARS-CoV-2 antibodies discloses an AUC, area under the curve, of 0.996 (95% CI 0.992-0.999) for the LIAISON® SARS-CoV-2 TrimericS IgG assay. The criterion associated to the Youden Index was determined to be >12.9 kAU/L with a sensitivity of 99.44% and a specificity of 99.82%. CONCLUSIONS: The LIAISON® SARS-CoV-2 TrimericS IgG assay is highly sensitive and specific. The balance of these parameters, without emphasis on high specificity alone, is particularly important when applied to high prevalence populations, where a highly sensitive assay will result in reporting a lower number of false negative subjects.

Soft Tooling-Friendly Inductive Mold Heating-A Novel Concept.

In order to economize injection molded prototypes, additive manufacturing of, e.g., curable plastics based tools, can be employed, which is known as soft tooling. However, one disadvantage of such tools is that the variothermal process, which is needed to produce polymeric parts with small features, can lead to a shorter lifespan of the tooling due to its thermally impaired material properties. Here, a novel concept is proposed, which allows to locally heat the mold cavity via induction to circumvent the thermal impairment of the tooling material. The developed fabrication process consists of additive manufacturing of the tooling, PVD coating the mold cavity with an adhesion promoting layer and a seed layer, electroplating of a ferromagnetic metal layer, and finally patterning the metal layer via laser ablation to enhance the quality and efficiency of the energy transfer as well as the longevity by geometric measures. This process chain is investigated on 2D test specimens to find suitable fabrication parameters, backed by adhesion tests as well as environmental and induction tests. The results of these investigations serve as proof of concept and form the base for the investigation of such induction layers in actual soft tooling cavities.