Pre-analytical considerations in the development of a prototype SARS-CoV-2 antigen ARCHITECT automated immunoassay.

OBJECTIVES: To evaluate pre-analytical challenges related to high-volume central laboratory SARS-CoV-2 antigen testing with a prototype qualitative SARS-CoV-2 antigen immunoassay run on the automated Abbott ARCHITECT instrument. METHODS: Contrived positive and negative specimens and de-identified nasal and nasopharyngeal specimens in transport media were used to evaluate specimen and reagent on-board stability, assay analytical performance and interference, and clinical performance. RESULTS: TCID50/mL values were similar for specimens in various transport media. Inactivated positive clinical specimens and viral lysate (USA-WA1/2020) were positive on the prototype immunoassay. Within-laboratory imprecision was ≤0.10 SD (<1.00 S/C) with a ≤10% CV (≥1.00 S/C). Assay reagents were stable on board the instrument for 14 days. No high-dose hook effect was observed with a SARS-CoV-2 stock of Ct 13.0 (RLU>1.0 × 106). No interference was observed from mucin, whole blood, 12 drugs, and more than 20 cross-reactants. While specimen stability was limited at room temperature for specimens with or without viral inactivation, a single freeze/thaw cycle or long-term storage (>30 days) at -20 °C did not adversely impact specimen stability or assay performance. Specificity of the prototype SARS-CoV-2 antigen immunoassay was ≥98.5% and sensitivity was ≥89.5% across two ARCHITECT instruments. Assay sensitivity was inversely correlated with Ct and was similar to that reported for the Roche Elecsys® SARS-CoV-2 Ag immunoassay. CONCLUSIONS: The prototype SARS-CoV-2 antigen ARCHITECT immunoassay is sensitive and specific for detection of SARS-CoV-2 in nasal and nasopharyngeal specimens. Endogenous proteases in mucus may degrade the target antigen, which limits specimen storage and transport times and complicates assay workflow.

Bridging disciplines, knowledge systems and cultures in pest management.

The success of research in integrated environmental and natural resource management relies on the participation and involvement of different disciplines and stakeholders. This can be difficult to achieve in practice because many initiatives fail to address the underlying social processes required for successful engagement and social learning. We used an action research approach to support a research-based group with a range of disciplinary and stakeholder expertise to critically reflect on their engagement practice and identify lessons around how to collaborate more effectively. This approach is provided here as a guide that can be used to support reflective research practice for engagement in other integration-based initiatives. This paper is set in the context of an integrated wildlife management research case study in New Zealand. We illustrate how multi-, inter- and trans-disciplinary approaches can provide a framework for considering the different conversations that need to occur in an integrated research program. We then outline rubrics that list the criteria required in inter- and trans-disciplinary collaborations, along with examples of effective engagement processes that directly support integration through such efforts. Finally, we discuss the implications of these experiences for other researchers and managers seeking to improve engagement and collaboration in integrated science, management and policy initiatives. Our experiences reaffirm the need for those involved in integrative initiatives to attend to the processes of engagement in both formal and informal settings, to provide opportunities for critical reflective practice, and to look for measures of success that acknowledge the importance of effective social process.