CUSTOMER TESTIMONIALS & SCIENTIFIC PUBLICATIONS

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Alinity m Customer Testimonials
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Lancet Laboratories, South Africa

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SCIENTIFIC PUBLICATIONS

Explore scientific publications from your peers on the performance of Abbott’s product offering.

HIV
 

Evaluation of the Alinity m HIV-1 assay for the quantification of HIV-1 RNA plasma viral load in a high-throughput molecular laboratory in South Africa

L. Maree et al
Journal of Clinical Virology, Volume 132, 2020, 104644
Published Online: 18 Sep 2020

This study, conducted at Lancet Labs (South Africa), evaluated the performance of the Alinity m HIV-1 assay versus cobas 4800 and 6800 HIV-1 assays by testing residual sample material and reported:

  • Excellent agreement was seen between Alinity and both cobas assays at 200 copies/mL / 1000 copies/mL* (~99% / ~98%) thresholds, while it was slightly lower at 50 copies/mL (c4800: ~93%; c6800: ~91%).
  • High correlation and minimal bias between Alinity and cobas results was observed (c4800 [N=961): r=0.98, -0.004 Log10 copies/ml; c6800 [N=389]: r=0.99, 0.22 Log10 copies/mL). 

*WHO threshold

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HBV
 

Multicenter clinical evaluation of Alinity m HBV assay performance

S. Bonanzinga et al
Journal of Clinical Virology, Volume 129, 2020, 104514
Published Online: 03 Jul 2020

This paper summarizes the results of the multicenter Alinity m study. 

It demonstrates excellent linearity, precision (SD ≤0.15 Log10 IU/mL; CV 4.1-8.8%), reproducibility (HiPos/ LoPos: SD ≤0.23 Log10 IU/mL; CV ≤6.7%) and a high detection rate around LOD (≥88.9%) of Alinity m HBV. 

With overall 1542 clinical plasma and serum samples, Alinity m HBV showed comparable performance to Abbott RealTime HBV, Roche CAP/CTM HBV v2, Roche cobas 6800 HBV, and Aptima HBV (r≥0.947) with a low mean of bias (range -0.07 to 0.17 Log10 IU/mL). 

No impact of HBV GT A-E was observed.

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HCV
 

Multicenter clinical evaluation of Alinity m HCV assay performance

S. Chevaliez et al
Journal of Clinical Virology, Volume 129, 2020, 104531
Published Online: 03 Jul 2020

This paper summarizes the results of the multicenter Alinity m study. 

It demonstrates excellent linearity, precision (SD ≤0.21 Log10 IU/mL; CV 6.6-13.5%), reproducibility (HiPos/LoPos: SD ≤0.12 Log10 IU/mL; CV ≤4.3%) and a high detection rate at 25 IU/mL (≥98.3%) of Alinity m HCV. 

With overall 1807 clinical plasma and serum samples, Alinity m HCV showed comparable performance to Abbott RealTime HCV, Roche cobas 6800 HCV, and Aptima HCV (r≥0.959) with a low bias (range -0.01 to 0.14 Log10 IU/mL). 

No impact of HCV GT 1-6 was observed.

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SARS-CoV-2
 

Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance

E. Degli-Angeli et al
Journal of Clinical Virology, Volume 129, 2020, 104474
Published Online: 28 May 2020

 

This paper demonstrates the high sensitivity (93%) and specificity (100%) of the FDA EUA Abbott RealTime SARS-CoV-2 assay. 

Detection rate exceeded LOD (95% at 50 copies/mL). 24 non-SARS-CoV-2 samples were negative.

In comparison to a CDC-based in-house assay, 100% specificity and 93% sensitivity was observed (the two discordant positive samples had late cycle numbers, including one with inconclusive results in addition, were diluted 1:2 and subsequently found negative with m2000).

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