CUSTOMER TESTIMONIALS & SCIENTIFIC PUBLICATIONS

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Alinity m Customer Testimonials
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Hôpital Henri-Mondor, France

Lancet Laboratories, South Africa

Victorian Infectious Diseases Laboratory (VIDRL), Australia

SCIENTIFIC PUBLICATIONS

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

ALINITY M
 

improved molecular laboratory productivity by consolidation of testing on the new random-access analyzer alinity m

M. Obermeier et al
Journal of Laboratory Medicine, Vol. 44 (Issue 6), pp. 319-328.
Published Online: 09 Nov 2020

 

 

 

 

This paper demonstrates that consolidating HIV‐1, HCV, HBV, STI, and HR HPV testing onto a single Alinity m substantially and consistently reduced the turnaround times in 8 laboratories.

After sample arrival in the lab, Alinity m reported 100% of the results within a few hours compared to several days needed by m2000 or the combination of multiple routine systems. 

Alinity m eliminated the need for sorting and batching, allowing for independent processing of any sample at any time. STAT samples were reported on average within 2.36 h. 

Furthermore, Alinity m reported 100% of results within 117 min after sample aspiration. 

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HIV
 

Multicenter clinical comparative evaluation of alinity m hiv-1 assay performance

P. Braun et al
Journal of Clinical Virology, Volume 129, 2020, 104530
Published Online: 03 Jul 2020

The Alinity m HIV-1 Viral Load assay was evaluated in an international multi-center study with 9 participating 9 laboratories. 

  • High precision and reproducibility was found with a panel of clinical samples comprising HIV-1 subtypes B, C and CRF02-AG tested across 4 study sites. 
  • Alinity m results correlated well with RealTime, Versant kPCR, CAPT/CTM 2.0 and Aptima (range r 0.96 to 0.98). 
  • Overall observed bias of Viral Load results was found between Alinity m and the four comparator tests (range -0.10 to 0.10 Log10 copies/mL). 
  • Alinity m and comparator tests showed a high level of agreement at clinical decision points of 200 and 50 copies/mL. 

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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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HPV
 

Commercially available molecular tests for human papillomaviruses: a global overview

M. Poljak et al
Clinical Microbiology and Infection, Volume 26, 2020, 1144e1150
Published Online: 02 April 2020

This overview of marketed HPV tests reports a total of 254 distinct assays being available globally. The author ranked tests along their validation (Meijer Guidelines, VALGENT framework) and approval status (FDA; WHO pre-qualification) [see supplemental data]. 

Abbott RealTime and Alinity m HR HPV rank among the few tests validated for cervical cancer screening (Meijer & VALGENT), while RealTime is also WHO pre-qualified. 

RealTime, HC2, cobas 4800, Onclarity and Xpert fulfil three criteria, while none of the tests fulfill all four criteria. 

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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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TB MTB RIF/INH
 

Comparative analytical evaluation of four centralized platforms for the detection of M. tuberculosis complex and resistance to rifampicin and isoniazid

M. de Vos et al
Journal of Clinical Microbiology, 2020, JCM.02168-20
Published Online: 02 Dec 2020

This study by FIND, assessed analytical sensitivity for MTBc and accuracy for RIF/INH detection of centralized tests using M.tuberculosis and M.bovis strains spiked into sputum and strains with high-confidence mutations accounting for >85% of first-line resistance globally: 

  • RealTime MTB demonstrated high sensitivity for H37Rv (322 genomes/mL), compared to BD MAX MDR-TB (826 genomes/mL), Roche cobas MTB (2,416 genomes/mL), Xpert (3,781 genomes/mL) and Hain FluoroType MTBDR (10,398 genomes/mL). 
  • RealTime and Roche MTB assays had higher and similar sensitivity for M. bovis (2,182 / 2,136 genomes/mL), compared to Xpert (2,926 genomes/mL), BD (4,301 genomes/mL) and Hain (23,139 genomes/mL). 

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The Performance of the Abbott Real Time MTB RIF/INH Compared to the MTBDR plus V2 for the Identification of MDR-TB Among Isolates

A. David et al
Infection and Drug Resistance, Volume 13, 2020, 3301-3308
Published Online: 28 Sep 2020

This study conducted at WITS/NHLS, South Africa compared the RealTime MTB Resistance assay with Hain MTBDRplus v2 (LPA) on 93 cultured isolates, of which 83 generated successful results with both tests.

  • RealTime showed high agreement for resistance detection with LPA (RIF, k: 0.765; INH, k: 0.919). 
  • Sequencing of 10 samples with discordant resistance results revealed a lower resistance misclassification rate with RealTime (2 RIF, 4 INH) compared to LPA (6 RIF, 3 INH). 

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Diagnostic accuracy of centralised assays for TB detection and detection of resistance to rifampicin and isoniazid: A systematic review and meta-analysis

M. Kohli et al
The European Respiratory Journal, 57(2), 2000747
Published Online: 04 Feb 2021

This manuscript highlights FIND's systematic review of new centralized molecular assays for MTB and RIF/INH resistance.

  • Data pool from previously published studies was significantly larger for RealTime versus comparator tests. 
  • Pooled estimates for KPIs of RealTime were comparable to those of the other tests. 
  • Since all three tests demonstrated sensitivity for smear-negative cases comparable to Xpert MTB/RIF, they are rated as “good contenders for this frequently difficult-to-diagnose use case” by the authors. 
  • m2000 platform has a broad menu among other systems and a higher throughput versus BD Max (24 per run). 

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