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"The studies on HIV-1, HCV and HBV presented in the respective articles were conducted outside of U.S. with products specific to the region."
LT. Galindo et al
Journal of Clinical Virology, Volume 137, April 2021, 104786
Published Online: 05 March 2021
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:
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.VIEW PUBLICATION
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:
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.
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.
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.
TM. Pryce et al
European Journal of Clinical Microbiology & Infectious Diseases 2021 Jan;40(1):67-75.
Published Online: 07 August 2020
This study investigated NG confirmation rates of cobas 4800 and RealTime CT/NG assays applying an expanded gold standard on NG positives (344 multi-collect samples; 744 cobas PCR media samples): All samples were tested with an in-house duplex NG PCR (opa & por-A). In addition, 344 cobas samples were also tested with RealTime and Xpert and 400 cobas samples were tested with cobas 6800. Culture results from inhouse duplex NG PCR-negative samples (extra-genital) were also considered, when available.
The NG confirmation rate for RealTime results (98%) was higher than that of both cobas 4800 series (92.7% and 93.2%) and exceeded 90% for all anatomical sites, with the exception of 78% for oropharyngeal specimens tested with cobas 4800.View Publication
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.View Publication
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).View Publication
GA. Perchetti et al
Journal of Clinical Virology, Volume 140, July 2021, 104869
Published Online: 14 May 2021
This paper demonstrates the good assay performance of Alinity m SARS-CoV-2 vs. Roche cobas 6800 and Hologic Panther Fusion in nasopharyngeal swabs. Overall agreement was 100% with Panther Fusion, while compared to c6800, Alinity detected 8 samples as positive that were either negative (n=1), only presumptive positive (n=5; only sarbecovirus target positive) or only positive by the SARS-CoV-2 target (n=2). Alinity m SARS-CoV-2 showed high sensitivity (100% detection rates at 50 cp/ml), specificity (no detection of nonSARS-CoV-2 viruses), linearity (R²>0.99), and agreement between two Alinity m instruments (0.4 Ct difference). Precision (CVs<2%;PPA/NPA=100%) was higher with Alinity m than LDT (CV<3%).
CAVE: Non-CE-marked assaysView Publication
A. Cheng et al
MediRxiv 2021 April.
Published Online: 22 April 2021
This reprint demonstrates how Alinity m Resp-4-Plex assay is a welcome addition to targeted respiratory panel options that will be necessary in a post-COVID world when the signs and symptoms of respiratory diseases overlap. It appeared highly accurate, sensitive and precise in detecting SARS-CoV-2, influenza A, influenza B and RSV.
Data showed that clinical samples that were identified as positive by other assays were positive by Alinity m Resp-4-Plex. Good agreement with other assays.
In influenza B positive samples, Alinity m Resp-4-Plex detected RSV positive which was missed by comparator assay.View Publication
JW. Hirschhorn et al
Journal of Clinical Microbiology 2021 Apr 20;59(5):e03119-20.
Published Online: 20 April 2021
This paper demonstrates the analytical performance of the FDA EUA Abbott RealTime SARS-CoV-2: linearity: R²=0.99; reproducibility: CV<5%; confirmed LOD=100 cp/ml; no cross reaction with common respiratory pathogens.
Data showed good clinical performance compared to the CDC (91% PPA, 100% NPA) and ThermoFisher TaqPath assays (100% PPA, 95% NPA). Furthermore, authors confirmed LOD=100 cp/ml for Alinity m SARS-CoV-2 and demonstrated equivalent clinical performance with RealTime SARS-CoV-2 (PPA and NPA ≥92%).
Frequency distribution of Cn values of first positive clinical specimens revealed 8% of specimens with low viral burdens (<100 cp/ml) which can only be detected with a highly sensitive assay.View Publication
N. Kohmer et al
Journal of Virologic Methods Volume 291, May 2021, 114102
Published Online: 16 February 2021
This paper to demonstrate the excellent sensitivity of the Alinity m SARS-CoV-2 assay compared toa number of alternative assays. Alinity m detected very low Viral Loads s of a dilution panel or an INSTAND EQA panel.View Publication
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.
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:
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.
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