Abstract Background Vitamins can be crucial for diagnosing and managing health conditions related to low or excessive intake and for monitoring the effectiveness of dietary changes or supplement strategies. Abbott provides an extensive menu of vitamin assays which aid in the diagnosis and management of many health conditions such as deficiency or excess. Assays such as Vitamin D, Vitamin B12 and Vitamin C are used to monitor bone health, neurological function and immune system function respectively. Thus, vitamins are valuable for disease risk assessment. Homocysteine is an amino acid that plays a crucial role in cell metabolism and its levels are closely linked to vitamins B12 and folate (vit B9) deficiencies. Recent guideline changes to Vitamin D (Endo Society 2024) and B12 (Nice 2024) support the need for accurate assay performance. The Alinity ci system is part of a unified family of systems that are engineered for flexibility, efficiency, and decreased system down time. The design is based on insights from customers, resulting in a number of benefits including a smaller footprint, improved workflow, and great throughput with up to 200 tests per hour. The objective of this study is to demonstrate the analytical performance of representative assays from the Vitamin Panel of the Alinity i system, which consists of assays that utilize photometric technology for the quantitative determination of analytes in human serum or plasma. Methods Key performance testing including precision, limit of quantitation (LoQ), endogenous interferents, linearity and method comparison were assessed per Clinical and Laboratory Standards Institute (CLSI) protocols. Precision was assessed by testing controls and panels twice per day for 20 days on 2 instruments. Sensitivity was determined with 3 reagent lots on 2 instruments. Endogenous compounds were evaluated at a minimum of one analyte concentration. Linearity was assessed using a minimum of 6 panels that spanned the measuring interval. Method comparison was performed by measuring a minimum of 100 specimens on Alinity and the comparator method. The assay measuring interval was defined by the range for which acceptable performance for bias, imprecision, and linearity was met. Results The observed results for precision were 4.1 to 9%. Alinity method comparison vs ARCHITECT demonstrated slopes of 0.95 to 1.04 with correlation coefficients of 0.96 to 1.00. All assays demonstrated equivalent sensitivities, linearity, interferents and measuring intervals to ARCHITECT. Conclusion Standardization of the Abbott assays ensures the assays meet current guidelines. The vitamin panel of assays on the Abbott Alinity i platform demonstrated acceptable performance for precision, sensitivity, interferents and linearity. Method comparison data showed equivalency with the on-market assays, which verified the performance of these products on the Alinity i system.
Marvin Berman (Wed,) studied this question.