. 2021 Jul:108:263-269.

doi: 10.1016/j.ijid.2021.05.067. Epub 2021 Jun 1.

Comparison of Roche and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19

Yosuke Hirotsu¹, Hiroki Sugiura², Makoto Maejima³, Miyoko Hayakawa⁴, Hitoshi Mochizuki⁵, Toshiharu Tsutsui⁶, Yumiko Kakizaki⁶, Yoshihiro Miyashita⁶, Masao Omata⁷

Affiliations

¹ Genome Analysis Center, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan. Electronic address: hirotsu-bdyu@ych.pref.yamanashi.jp.
² Division of Clinical Biochemistry and Immunology, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
³ Division of Microbiology, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
⁴ Central Clinical Laboratory, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
⁵ Genome Analysis Center, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan; Central Clinical Laboratory, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan; Department of Gastroenterology, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
⁶ Lung Cancer and Respiratory Disease Center, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
⁷ Department of Gastroenterology, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan; The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.

PMID: 34082089
PMCID: PMC8166457
DOI: 10.1016/j.ijid.2021.05.067

Comparison of Roche and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19

Yosuke Hirotsu et al. Int J Infect Dis. 2021 Jul.

. 2021 Jul:108:263-269.

doi: 10.1016/j.ijid.2021.05.067. Epub 2021 Jun 1.

Authors

Yosuke Hirotsu¹, Hiroki Sugiura², Makoto Maejima³, Miyoko Hayakawa⁴, Hitoshi Mochizuki⁵, Toshiharu Tsutsui⁶, Yumiko Kakizaki⁶, Yoshihiro Miyashita⁶, Masao Omata⁷

Affiliations

¹ Genome Analysis Center, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan. Electronic address: hirotsu-bdyu@ych.pref.yamanashi.jp.
² Division of Clinical Biochemistry and Immunology, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
³ Division of Microbiology, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
⁴ Central Clinical Laboratory, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
⁵ Genome Analysis Center, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan; Central Clinical Laboratory, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan; Department of Gastroenterology, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
⁶ Lung Cancer and Respiratory Disease Center, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
⁷ Department of Gastroenterology, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan; The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.

PMID: 34082089
PMCID: PMC8166457
DOI: 10.1016/j.ijid.2021.05.067

Abstract

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread worldwide. Here, we evaluated the performance of two quantitative antigen (Ag) tests, the Roche and Lumipulse Ag tests, using automated platforms.

Methods: We collected 637 nasopharyngeal swab samples from 274 individuals. Samples were subjected to quantitative reverse transcription PCR (RT-qPCR), the Roche Ag test and Lumipulse Ag test.

Results: When RT-qPCR was used as a reference, the overall concordance rate of the Roche Ag test was 77.1% (491/637) with 70.0% (341/487) sensitivity and 100% specificity (150/150). When inconclusive results of the Lumipulse Ag test were excluded, the overall concordance rate of the Lumipulse Ag test was 88.3% (467/529) with 84.8% (330/389) sensitivity and 97.9% (137/140) specificity. The overall concordance rate between the Roche and Lumipulse Ag tests was 97.9% (518/529) with 96.7% (322/333) sensitivity and 100% (196/196) specificity. Quantitative Ag levels determined using the Roche and Lumipulse Ag tests were highly correlated (R² = 0.922). The Roche and Lumipulse Ag tests showed high concordance up to nine days after symptom onset, with progressively lower concordance after that.

Conclusions: The Roche and Lumipulse Ag tests showed equivalent assay performance and represent promising approaches for diagnosing coronavirus disease 2019.

Keywords: Antigen; COVID-19; Lumipulse; Roche; SARS-CoV-2.

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Figures

**Figure 1**
Comparison of the results of RT-qPCR, the Roche Ag test, and the Lumipulse Ag test. (A) Overview of results of the Roche and Lumipulse Ag tests for RT-qPCR-positive samples. (B–E) Dot plots show SARS-CoV-2 Ag levels in the tested samples. (B, C) COI values of the Roche Ag test were plotted in samples positive by RT-qPCR (n = 487) (B) or negative by RT-qPCR (n = 150) (C). (D, E) Ag levels determined using the Lumipulse Ag test were plotted for samples positive by RT-qPCR (D) or negative by RT-qPCR (E). The red dashed lines indicate the decision threshold for the antigen test. *Abbreviations*: RT-qPCR, reverse transcription-quantitative polymerase chain reaction; Ag, antigen; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; COI, cut-off index.

**Figure 2**
Correlation between Ag levels and viral load or Ct values. (A–C) The dot plots show quantitative values for the Ag test and viral copy numbers determined by RT-qPCR. (A) Correlation between COI values determined using the Roche Ag test and viral loads (left) or Ct values (right) determined by RT-qPCR. (B) Correlations between antigen levels determined using the Lumipulse Ag test and viral loads (left) or Ct values (right) determined by RT-qPCR. (C) Correlations between COI values determined using the Roche Ag test and antigen levels determined using the Lumipulse Ag test. *Abbreviations*: Ag, antigen; Ct, threshold cycle; RT-qPCR, reverse transcription-quantitative polymerase chain reaction; COI, cut-off index.

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Comparison of Roche and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19

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Comparison of Roche and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19

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