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J. Med. Virol., Dec 2023, 95 (12) | https://doi.org/10.1002/jmv.29329 Clinical utility of quantitative immunoassays and surrogate virus neutralization tests for predicting neutralizing activity against the SARS-CoV-2 Omicron BA.1 and BA.5 variants

Beomki Lee ^1,2, Jae-Hoon Ko ³, Yong Chan Kim ⁴, Jin Yang Baek ^3,5, Yoon Soo Park ⁴, Kyoung-Ho Song ⁶, Eu Suk Kim ⁶, Kyoung Hwa Lee⁷, Young Goo Song ⁷, Jin Young Ahn ⁸, Jun Yong Choi ⁸, Won Suk Choi ⁹, Seongman Bae ¹⁰, Sung-Han Kim ¹⁰, Hye Won Jeong ¹¹, Young Jae Lee ¹², Hye-Jin Kim ¹², Ju-Yeon Choi ¹², Byoungguk Kim ¹², Shin-Woo Kim ¹³, Ki Tae Kwon ¹⁴, Kyong Ran Peck ³, Eun-Suk Kang ¹

¹Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.

²Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology (KAIST), Daejeon, South Korea.

³Division of Infectious Diseases, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.

⁴Division of Infectious Diseases, Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, South Korea.

⁵Asia Pacific Foundation for Infectious Diseases (APFID), Seoul, South Korea.

⁶Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.

⁷Division of Infectious Diseases, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.

⁸Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.

⁹Division of Infectious Diseases, Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, South Korea.

¹⁰Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.

¹¹Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, South Korea.

¹²Division of Vaccine Clinical Research, Center for Vaccine Research, National Institute of Infectious Diseases, Korea National Institute of Health, Cheongju, South Korea.

¹³Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.

¹⁴Division of Infectious Diseases, Department of Internal Medicine, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, South Korea.

Beomki Lee, Jae-Hoon Ko, and Yong Chan Kim contributed equally to this study and share first authorship.

Shin-Woo Kim, Ki Tae Kwon, Kyong Ran Peck, and Eun-SukKang contributed equally to this study.

Abstract

Developing new antibody assays for emerging SARS-CoV-2 variants is challenging. SARS-CoV-2 surrogate virus neutralization tests (sVNT) targeting Omicron BA.1 and BA.5 have been devised, but their performance needs to be validated in comparison with quantitative immunoassays. First, using 1749 PRNT-positive sera, we noticed that log-transformed optical density (OD) ratio of wild-type (WT) sVNT exhibited better titer-correlation with plaque reduction neutralization test (PRNT) than % inhibition value. Second, we tried 798 dilutional titration tests with 103 sera, but nonlinear correlation between OD ratio and antibody concentration limited titration of sVNT. Third, the titer-correlations of two sVNT kits for BA.1 and two quantitative immunoassays for WT were evaluated with BA.1 and BA.5 PRNT. All tested kits exhibited a linear correlation with PRNT titers, but the sVNT kits exhibited high false-negative rates (cPass-BA.1 kit, 45.4% for BA.1 and 44.2% for BA.5; STANDARD F-BA.1 kit, 1.9% for BA.1 and 2.2% for BA.5), while quantitative immunoassays showed 100% sensitivity. Linear mixed-effects model suggested superior titer-correlation with PRNT for quantitative immunoassays compared to sVNT kits. Taken together, the use of quantitative immunoassays for WT, rather than rapid development of new kits, would be practical for predicting neutralizing activities against emerging new variants.

논문정보

형식Research article
게재일2023년 12월 (BRIC 등록일 2024-01-02)
연구진국내 연구진
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