Improved molecular laboratory productivity by consolidation of testing on the new random-access analyzer Alinity m

Abstract

ObjectivesAutomated molecular analyzers have accelerated diagnosis, allowing earlier intervention and better patient follow-up. A recently developed completely automated molecular analyzer, Alinity™ m (Abbott), offers consolidated, continuous, and random-access testing that may improve molecular laboratory workflow.MethodsAn international, multicenter study compared laboratory workflow metrics across various routine analyzers and Alinity m utilizing assays for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), hepatitis B virus (HBV), high-risk human papillomavirus (HR HPV), and sexually transmitted infection (STI) (Chlamydia trachomatis [CT]/Neisseria gonorrhoeae [NG]/Trichomonas vaginalis [TV]/Mycoplasma genitalium [MG]). Three turnaround times (TATs) were assessed: total TAT (sample arrival to result), sample onboard TAT (sample loading and test starting to result), and processing TAT (sample aspiration to result).ResultsTotal TAT was reduced from days with routine analyzers to hours with Alinity m, independent of requested assays. Sample onboard TATs for standard workflow using routine analyzers ranged from 7 to 32.5 h compared to 2.75–6 h for Alinity m. The mean sample onboard TAT for STAT samples on Alinity m was 2.36 h (±0.19 h). Processing TATs for Alinity m were independent of the combination of assays, with 100% of results reported within 117 min.ConclusionsThe consolidated, continuous, random-access workflow of Alinity m reduces TATs across various assays and is expected to improve both laboratory operational efficiency and patient care.

Validation of a rapid, saliva-based, and ultra-sensitive SARS-CoV-2 screening system for pandemic-scale infection surveillance

“…The capacity of conventional molecular diagnostic instruments is constrained by largely batch-based sample loading logistics, frequently resulting in rate-limiting queuing of microplates awaiting access to the instrument. This batch constraint also applies to large ‘continuous flow’ diagnostic instruments 31 , which sometimes include multiple incubation stations employed on a range of predetermined schedules to achieve faster cycle times, which can be less time- and cost-efficient, particularly at lower throughputs, while samples are accumulated to achieve optimal capacity.…”

Review of Current COVID-19 Diagnostics and Opportunities for Further Development

“…Additional personnel may also be required, which can create undesirable crowding. And inefficiencies in processing can occur as technicians multitask between analyzers, resulting in increased turnaround time (TAT) (80). Unfortunately, availability of automated RT-PCR for high-throughput platforms remains critically limited, especially for low-and middle-income countries (81).…”

Evaluation of the Alinity m Resp-4-Plex Assay for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2, Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus

“…The Alinity m resp-4-plex assay is a multiplex molecular assay for the qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus, influenza B virus, and RSV in nasopharyngeal (NP) specimens and nasal specimens ( 7 ) and is performed on the automated Alinity m system. This sample-to-answer system performs sample preparation, reverse transcription PCR (RT-PCR) assembly, amplification, detection, and result analysis ( 8 ). An unrelated RNA sequence is also spiked into the sample reaction mixture to serve as an internal control.…”

“…An unrelated RNA sequence is also spiked into the sample reaction mixture to serve as an internal control. The Alinity m system is an automated, high-throughput, sample-to-answer, random-access molecular platform ( 8 ) and uses real-time PCR and ReadiFlex technology, allowing the system to run statum (STAT) samples and process 300 samples in approximately 8 h, with a time to first result of <2 h. The system also has an amplification reagent capacity of 20 reagent packs that can be stored onboard for 4 days.…”