Longitudinal Evaluation of SARS-CoV-2 Antibody Kit Performance in Unvaccinated Individuals Infected with Omicron Variant Strains

doi:10.3969/j.issn.1671-2587.2026.01.012

JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE ›› 2026, Vol. 28 ›› Issue (1): 75-84.DOI: 10.3969/j.issn.1671-2587.2026.01.012

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Longitudinal Evaluation of SARS-CoV-2 Antibody Kit Performance in Unvaccinated Individuals Infected with Omicron Variant Strains

LIU Qian¹, SHANA Halemubieke^2,3,4, ABUDULIMUTAILIPU Nuermaimaiti^2,3,4, LIU Xinru^2,3,4, CHANG Le^2,3,4, JI Huimin^2,3, SUN Huizhen^2,3, YAN Ying^2,3, WANG Lunan^2,3,4

¹Department of Laboratory Medicine, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, 100730;
²National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, 100730;
³Beijing Engineering Research Center of Laboratory Medicine, Beijing, 100730;
⁴National Center for Clinical Laboratories, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730

Received:2025-07-03 Published:2026-02-13

Abstract

Abstract: Objective This study aimed to evaluate the performance of SARS-CoV-2 antibody detection kits based on the wild-type strain and Omicron variants in people living with HIV (PLWH) who were unvaccinated and infected with the Omicron variant. Methods This study recruited 45 unvaccinated PLWH who were infected with the Omicron BA.5 variant for the first time and conducted a follow up four months later. Antibody levels were measured using eight kits targeting the wild-type strain and two kits specific to Omicron variants. Pseudovirus neutralization assays targeting the wild-type (WT), BA.4/5, and XBB.1.5 variants were used as the gold standard. Agreement of qualitative results was assessed using McNemar and Kappa tests, while quantitative correlations were analyzed using Spearman correlation analysis. Results The wild-type antibody kits showed the highest agreement with WT-neutralizing antibody (nAb) (maximum κ=0.483), but significantly lower agreement with Omicron-nAb. Quantitatively, strong correlations were observed between wild-type kits and WT-nAb (r_s=0.69~0.85), while correlations with BA.4/5 (r_s=0.40~0.57) and XBB.1.5 (r_s=0.43~0.63) -nAb were weaker. After second infection, the correlation between wild-type kits and Omicron-nAb was improved. Omicron-specific antibody kits demonstrated narrower 95% limits of agreement with Omicron-nAb neutralization assays. Conclusion In unvaccinated PLWH, antibody detection kits based on the wild-type strain showed limited effectiveness in assessing immune responses after Omicron infection. These findings support the development and application of variant-specific antibody kits for more accurate immune monitoring and evaluation.

Key words: SARS-CoV-2, Antibody kits, Omicron strains, Unvaccinated people living with HIV, Pseudovirus neutralization assay

CLC Number:

R446

LIU Qian, SHANA Halemubieke, ABUDULIMUTAILIPU Nuermaimaiti, LIU Xinru, CHANG Le, JI Huimin, SUN Huizhen, YAN Ying, WANG Lunan. Longitudinal Evaluation of SARS-CoV-2 Antibody Kit Performance in Unvaccinated Individuals Infected with Omicron Variant Strains[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2026, 28(1): 75-84.

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Longitudinal Evaluation of SARS-CoV-2 Antibody Kit Performance in Unvaccinated Individuals Infected with Omicron Variant Strains

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