This paper demonstrates that consolidating HIV‐1, HCV, HBV, STI, and HR HPV testing onto a single Alinity m substantially reduced the turnaround times in a high-throughput laboratory in Brazil: After sample arrival in the lab, Alinity m reported 100% of the results within 9 hours compared to 80 hours needed by m2000 instruments. Alinity m eliminated the need for sorting and batching, allowing for independent processing of any sample at any time. Sample onboard TAT, from sample loading to 95 % of results, was 5:15 hours for Alinity m and 7:30 hours for m2000 while 100% of STAT samples were reported within 4 hours. Furthermore, Alinity m reported all results within 117 minutes after sample aspiration.
For Alinity m HCV, it demonstrates excellent precision, reproducibility, and overall detection rates around the LOD of Alinity m HCV. With overall 130 quantified clinical plasma samples, Alinity m HCV showed comparable performance to Abbott RealTi me HCV (r=0.976; concordance 96.5%) and a low bias (0.16 log IU/ml).
For Alinity m HBV, it demonstrates excellent precision, reproducibility, and an overall detection rate of 93% around the LOD of Alinity m HBV. With 68 quantified clinical plasma samples, Alinity m HBV showed comparable performance to Abbott RealTi me HBV (r=0.990; concordance 94%) and a low bias (-0.11 log IU/ml).
For HIV/Hepatitis Viral Load assays it demonstrated:
- High precision with a panel of clinical samples (HIV-1 subtypes B, C and CRF02-AG)
- Excellent correlation of Viral Load results between Alinity m and RealTime HIV-1 assays (N=188 plasma samples; R2 0.983) with minimal bias (N=137; 0.11 log cp/mL)
- A higher detection/quantification rate with Alinity m vs RealTime HIV-1
- Significant reduction of sample onboard TAT with Alinity m vs m2000