Abstract
Abstract Background Instrument immunoassay throughputs publicized in the industry are often theoretical, performed in relatively smaller scale, and/or in the best case generated only with fast assays, not representing the typical assay mix of routine activity. Infectious disease (ID) serology assays typically have long analytical times and have the potential to influence throughput capabilities and turnaround time (TAT) of other assays with shorter analytical times. The objective of this study is to utilize real world evidence across a large fleet of Atellica® IM 1300 and IM 1600 analyzers representing variously sized laboratories, using variations of ID assay mixes, to assess the impact on TAT on select STAT immunoassays. Methods Assay mix, test volumes and TAT data was mined from the Atellica® Smart Remote Services (SRS), a Siemens Healthineers proprietary remote connectivity platform over 3 distinct 14-day time windows. Real world data from >1800 Atellica IM and >8 million tests were queried per time window for the following ID assays: HIV, Hepatitis B, Hepatitis C, TORCH, Syphilis (long analytical time) and a selection of non-ID immunoassays: hs-troponin I (TNIH), Thyroid Stimulating Hormone (TSH3UL), total HCG (ThCG), and B-Type Natriuretic Peptide (BNP) (short analytical time). Median TAT for short assay was analyzed with 6 variations of ID assay mix (0%, <10%, <20%, <30%, <40%, <50%) in the run representing increasing percentages of assays requiring longer incubation times. TAT was represented as barcode to result and aspiration to result. Results The median TAT for TNIH remained consistent at 10.1 minutes across increasing % of ID assays (N=100961). The median TAT for TNIH for platforms not running ID assays (83237) remained consistent at 10.03 minutes. The median TAT for TSH remained consistent at 14.02 minutes across increasing % of ID assays (N=1183344). The median TAT for TSH for platforms not running ID assays (N=480219) remained consistent at 13.98 minutes. The median TAT for ThCG remained consistent at 10.28 minutes across increasing % of ID assays (N=24677). The median TAT for ThCG for platforms not running ID assays (N=79275) remained consistent at 10.27 minutes. The median TAT for BNP remained consistent at 10.1 minutes across increasing % of ID assays (N=42949). The median TAT for BNP for platforms not running ID assays (N=14990) remained consistent at 10.03 minutes. Conclusions Throughput and TAT on the Atellica IM Analyzer is relatively unaffected by mix of longer-incubation and shorter-incubation assays. The dual incubation rings allow more flexibility in the mix of incubation times with predictable and consistent TAT for all assays including STAT.
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