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. 2022 Jan:299:114338.
doi: 10.1016/j.jviromet.2021.114338. Epub 2021 Oct 22.

Clinical evaluation of the automated Abbott RealTime SARS-CoV-2, Alinity m SARS-CoV-2, and Alinity m Resp-4-Plex assays

Robert Ehret  1 , Stefan Breuer  1 , Jens Dhein  2 , Birgit Reinhardt  2 , Martin Obermeier  3
Affiliations

Clinical evaluation of the automated Abbott RealTime SARS-CoV-2, Alinity m SARS-CoV-2, and Alinity m Resp-4-Plex assays

Robert Ehret et al. J Virol Methods. 2022 Jan.

Abstract

Background: Detection of SARS-CoV-2 infections relies on the use of sensitive, accurate and high throughput RT-PCR assays.

Objectives: We assessed the analytical performance of the Abbott RealTime SARS-CoV-2 (RT-SARS), Alinity m SARS-CoV-2 (AlinSARS) assays and compared the clinical performance of the RT-SARS, AlinSARS, and Alinity m Resp-4-Plex (Alin4Plex) assays to the Seegene Allplex assay (Allplex) and an inhouse test (Inhouse).

Results: We found 100 % positive percent agreement (PPA) and 100 % negative percent agreement (NPA) comparing RT-SARS and Allplex. RT-SARS, AlinSARS and Inhouse showed 100 % NPA and 100 % PPA across all assays, except for the RdRp target of Inhouse (PPA = 84 %). Similarly, Alin4Plex and Allplex showed high agreement with specimens containing either SARS-CoV-2, influenza A, influenza B, or RSV. Detection rates of 100 % for SARS-CoV-2 at 50 copies/mL, high precision, and no cross-reactivity with non-SARS-CoV-2 respiratory pathogens were observed for RT-SARS and AlinSARS. AlinSARS detected SARS-CoV-2 in spiked throat washes and in specimens infected with SARS-CoV-2 Alpha or Beta variants.

Conclusions: The newly developed RT-SARS, AlinSARS, and Alin4Plex assays proved to be useful for detecting SARS-CoV-2 RNA in clinical samples.

Keywords: Alinity m; Real-Time PCR; SARS-CoV-2; Turnaround time; multiplex.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: RE and SB have no competing interests. MO has received speaker honorariums from Roche, Abbott, Hologic, Cepheid and Siemens, received travel grants from Roche, Abbott, Hologic and Vela Diagnostics, and acted as advisor for Cepheid, Siemens and Abbott. JD and BR are employees of Abbott GmbH.

Figures

Fig. 1
Fig. 1
Comparison of RT-SARS and Allplex cycle thresholds in positive SARS-CoV-2 specimens. Twenty-nine positive samples by Allplex were retested with RT-SARS showing concordantly positive results (100 % PPA). The mean Ct difference (mean of Allplex target regions minus RT-SARS) was 9.6 Ct which is in the range of the 10 unread cycles of RT-SARS. The positive samples in the figure are presented in ascending order of Ct values by RT-SARS. Additionally, 29 SARS-CoV-2 negative specimens by Allplex retested with RT-SARS were found negative (100 % NPA).
Fig. 2
Fig. 2
Comparison of RT-SARS, AlinSARS and Inhouse cycle thresholds in positive SARS-CoV-2 specimens. Fifty samples positive for SARS-CoV-2 by Inhouse were retested with RT-SARS and AlinSARS showing concordantly positive results with the Inhouse E gene target (100 % PPA). Eight samples were negative in the RdRp gene target of Inhouse (84 % PPA). However, samples with one or two positive targets by Inhouse had been considered positive after confirmation by Allplex. The observed mean Ct differences between the assays were 1.2 Ct (mean of Inhouse target regions minus AlinSARS), 13.9 Ct (mean of Inhouse target regions minus RT-SARS), and 12.7 Ct (AlinSARS minus RT-SARS), the latter two mean Ct differences reflecting the 10 unread cycles of RT-SARS. The positive samples in the figure are presented in ascending order of Ct values by RT-SARS. In addition, 50 SARS-CoV-2 negative specimens by Inhouse retested with RT-SARS and AlinSARS were found negative, respectively (100 % NPA).
Fig. 3
Fig. 3
Comparison of cycle thresholds in clinical specimens positive for SARS-CoV-2 across Allplex, Alin4Plex, and AlinSARS. Positive SARS-CoV-2 samples by Allplex were retested with Alin4Plex (n = 20) and AlinSARS (n = 11) and showed concordant positive results (100 % PPA). The mean Ct differences between the assays were 1.0 Ct (mean of Allplex target regions minus Alin4Plex), 4.6 Ct (AlinSARS minus Alin4Plex), and 4.0 Ct (AlinSARS minus mean of Allplex target regions), respectively. The positive samples in the figure are presented in ascending order of Allplex Ct values. Additionally, a set of 19 SARS-CoV-2 negative specimens by Allplex was retested by Alin4Plex confirming all negative results for SARS-CoV-2 (100 % NPA).
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References

    1. Abbott Molecular Inc . 2020. Package Insert Abbott RealTime SARS-CoV-2, 51-608442/R2.
    1. Abbott Molecular Inc . 2020. Package Insert Alinity m SARS-CoV-2 AMP Kit, 53-608193/R3.
    1. Abbott Molecular Inc . 2020. Package Insert Alinity m Resp-4-Plex AMP Kit, 53-608209/R1.
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Supplementary concepts