针对未接种疫苗的Omicron感染者的SARS-CoV-2抗体检测试剂性能的纵向评估*

doi:10.3969/j.issn.1671-2587.2026.01.012

临床输血与检验 ›› 2026, Vol. 28 ›› Issue (1): 75-84.DOI: 10.3969/j.issn.1671-2587.2026.01.012

针对未接种疫苗的Omicron感染者的SARS-CoV-2抗体检测试剂性能的纵向评估^*

刘倩¹, 沙娜·哈勒木别克^2,3,4, 阿卜杜力穆太力普·努尔麦麦提^2,3,4, 刘新茹^2,3,4, 常乐^2,3,4, 姬慧敏^2,3, 孙慧珍^2,3, 闫颖^2,3, 王露楠^2,3,4

¹北京医院检验科，国家老年医学中心，中国医学科学院老年医学研究所，北京 100730;
²北京医院国家老年医学中心，国家卫生健康委临床检验中心，中国医学科学院老年医学研究所，北京 100730;
³北京市临床检验工程技术研究中心，北京 100730;
⁴国家卫生健康委临床检验中心，中国医学科学院北京协和医学院，北京 100730

收稿日期:2025-07-03 发布日期:2026-02-13
通讯作者: 闫颖，主要从事临床检验诊断学研究，（E-mail）yyan511@nccl.org.cn。共同通信作者：王露楠，主要从事临床检验诊断学、传染性疾病分子和血清学检测标准化、隐匿性乙肝分子机制的研究，（E-mail）lunan99@163.com。
作者简介:刘倩，主要从事临床检验诊断学研究，（E-mail）liuqian3529@bjhmoh.cn。并列第一作者：沙娜·哈勒木别克，主要从事临床检验诊断学研究，（E-mail）18810836185@163.com。
基金资助:
*本课题受北京市自然科学基金-海淀原始创新联合基金（No.L212012）、北京市自然科学基金面上项目（No.7232143）资助

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

摘要/Abstract

摘要： 目的本研究旨在评估基于新冠病毒原始毒株与奥密克戎（Omicron）变异株开发的SARS-CoV-2抗体检测试剂，在未接种疫苗的艾滋病病毒感染者（people living with HIV, PLWH）感染Omicron变异株后的检测性能。方法本研究招募了45名未接种新冠疫苗、首次感染Omicron BA.5毒株的PLWH，并在4个月后进行随访。使用八种针对原始毒株和两种针对Omicron毒株的抗体试剂检测抗体水平，并以针对原始毒株（wild-type, WT）、BA.4/5和XBB.1.5的假病毒中和实验为金标准，使用McNemar与Kappa检验定性结果的一致性，使用斯皮尔曼（Spearman）相关性分析定量结果的相关性。结果原始毒株抗体试剂与WT中和抗体（neutralizing antibody, nAb）的一致性最高（κ值最高为0.483），与Omicron-nAb的一致性明显较低。在定量分析中，原始毒株抗体试剂与WT-nAb呈强相关（r_s=0.69~0.85），而与BA.4/5（r_s=0.40~0.57）和XBB.1.5（r_s=0.43~0.63）-nAb的相关性较弱。二次感染后，原始毒株抗体试剂与Omicron-nAb之间的相关性有所提升。Omicron特异性抗体试剂与Omicron-nAb的95%一致性界限更窄。结论在未接种疫苗的PLWH中，原始毒株抗体试剂对Omicron感染后的免疫应答检测存在局限性，研究结果支持开发和应用变异株特异性抗体试剂，以实现更准确的免疫监测和评估。

关键词: 严重急性呼吸综合征冠状病毒2, 抗体检测试剂, 奥密克戎毒株, 未接种疫苗的艾滋病病毒感染者, 假病毒中和实验

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

中图分类号:

R446

刘倩, 沙娜·哈勒木别克, 阿卜杜力穆太力普·努尔麦麦提, 刘新茹, 常乐, 姬慧敏, 孙慧珍, 闫颖, 王露楠. 针对未接种疫苗的Omicron感染者的SARS-CoV-2抗体检测试剂性能的纵向评估^*[J]. 临床输血与检验, 2026, 28(1): 75-84.

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.

参考文献

[1] KIM D,LEE J Y,YANG J S,et al. The architecture of SARS-CoV-2 transcriptome[J]. Cell,2020,181(4):914-921.e10.
[2] YAN W Z,ZHENG Y H,ZENG X T,et al.Structural biology of SARS-CoV-2: open the door for novel therapies[J]. Signal Transduct Target Ther,2022,7(1):26.
[3] YANG H T,RAO Z H.Structural biology of SARS-CoV-2 and implications for therapeutic development[J]. Nat Rev Microbiol,2021,19(11):685-700.
[4] CARABELLI A M,PEACOCK T P,THORNE L G,et al.SARS-CoV-2 variant biology: immune escape,transmission and fitness[J]. Nat Rev Microbiol,2023,21(3): 162-177.
[5] 中国疾病预防控制中心.新冠病毒疫苗接种技术指南(第一版)[EB/OL].(2021-03-29).https://www.nhc.gov.cn/xcs/yqfkdt/202103/46cb94ccf60747618cbda6ab16d493ec.shtml.
[6] 国家卫生健康委员会.新冠疫苗加强免疫接种相关问答[EB/OL].(2021-11-15).https://www.nhc.gov.cn/xcs/c100122/202111/2953043da8e346eeb59e0d2b9e5127fd.shtml.
[7] 中华人民共和国中央人民政府. 关于进一步优化落实新冠肺炎疫情防控措施的通知[EB/OL].(2022-12-07) https://www.gov.cn/xinwen/2022-12/07/content_5730443.htm.
[8] LIU R Y,ZHANG Y,MA J X,et al.Epidemiological features of SARS-CoV-2 Omicron infection under new control strategy: a cross-sectional study of the outbreak since December 2022 in Sichuan,China[J]. BMC Public Health,2023,23(1):2463.
[9] TUEKPRAKHON A,NUTALAI R,DIJOKAITE-GURALIUC A,et al. Antibody escape of SARS-CoV-2 Omicron BA.4 and BA.5 from vaccine and BA.1 serum[J]. Cell,2022,185(14):2422-2433.e13.
[10] TAMURA T,ITO J,URIU K,et al.Virological characteristics of the SARS-CoV-2 XBB variant derived from recombination of two Omicron subvariants[J]. Nat Commun,2023,14(1):2800.
[11] HALFMANN P J,URAKI R,KURODA M,et al.Transmission and re-infection of Omicron variant XBB.1.5 in hamsters[J]. EBioMedicine,2023,93:104677.
[12] WANG Q,IKETANI S,LI Z T,et al. Alarming antibody evasion properties of rising SARS-CoV-2 BQ and XBB subvariants[J]. Cell,2023,186(2):279-286.e8.
[13] CUI Z,LIU P,WANG N,et al. Structural and functional characterizations of infectivity and immune evasion of SARS-CoV-2 Omicron[J]. Cell,2022,185(5):860-871.e13.
[14] SU J M,JIA Z W,WANG X W,et al.Acceptance of COVID-19 vaccination and influencing factors among people living with HIV in Guangxi,China: a cross-sectional survey[J]. BMC Infect Dis,2022,22(1):471.
[15] WANG G W,YAO Y,WANG Y F,et al.Determinants of COVID-19 vaccination status and hesitancy among older adults in China[J]. Nat Med,2023,29(3):623-631.
[16] LIU Y,HAN J Y,LI X,et al.COVID-19 vaccination in people living with HIV (PLWH) in China: a cross sectional study of vaccine hesitancy,safety,and immunogenicity[J]. Vaccines,2021,9(12):1458.
[17] KAIDA A,BROTTO L A,MURRAY M C M,et al. Intention to receive a COVID-19 vaccine by HIV status among a population-based sample of women and gender diverse individuals in British Columbia,Canada[J]. AIDS Behav,2022,26(7):2242-2255.
[18] LIPPI G,ADELI K,PLEBANI M.Commercial immunoassays for detection of anti-SARS-CoV-2 spike and RBD antibodies: urgent call for validation against new and highly mutated variants[J]. Clin Chem Lab Med,2022,60(3):338-342.
[19] NIE J H,LI Q Q,WU J J,et al.Quantification of SARS-CoV-2 neutralizing antibody by a pseudotyped virus-based assay[J]. Nat Protoc,2020,15(11):3699-3715.
[20] 中国疾病预防控制中心.全国新型冠状病毒感染疫情情况[EB/OL].[2025-10-21] https://www.chinacdc.cn/jksj/xgbdyq/index_1.html.
[21] Centers for Disease Control and Prevention (CDC). Interim guidelines for COVID-19 antibody testing[EB/OL].(2022-12-16).https://archive.cdc.gov/www_cdc_gov/coronavirus/2019-ncov/hcp/testing/antibody-tests-guidelines.html#:~:text=Indications%20for%20antibody%20testing&text=Persons%20suspected%20of%20having%20COVID,will%20test%20positive%20for%20antibody.
[22] ZHENG J X,DENG Y Y,ZHAO Z Y,et al.Characterization of SARS-CoV-2-specific humoral immunity and its potential applications and therapeutic prospects[J]. Cell Mol Immunol,2022,19(2):150-157.
[23] DESHPANDE P S,ABRAHAM I E,PITAMBERWALE A,et al.Review of clinical performance of serology based commercial diagnostic assays for detection of severe acute respiratory syndrome coronavirus 2 antibodies[J]. Viral Immunol,2022,35(2):82-111.
[24] FDA.EUA Authorized Serology Test Performance[EB/OL].(2022-08-22).https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance.
[25] OH S J,SANG WON O,CHOI Y J,et al.Neutralizing antibody responses in vaccinated and unvaccinated individuals infected with Omicron BA.1 variant[J]. J Clin Virol,2022,155:105253.
[26] GOTO T,CHONG Y,TANI N,et al.Distinct features of SARS-CoV-2 humoral immunity against Omicron breakthrough infection[J]. Vaccine,2023,41(47):7019-7025.
[27] World Health Organization.WHO COVID-19 dashboard[EB/OL]. [2025-10-21].https://data.who.int/dashboards/covid19/vaccines?m49=001&n=c.
[28] MIGUERES M,CHAPUY-REGAUD S,MIÉDOUGÉ M, et al. Current immunoassays and detection of antibodies elicited by Omicron SARS-CoV-2 infection[J]. J Med Virol,2023,95(1):e28200.
[29] SPRINGER D N,PERKMANN T,JANI C M,et al.Reduced sensitivity of commercial spike-specific antibody assays after primary infection with the SARS-CoV-2 Omicron Variant[J]. Microbiol Spectr,2022, 10(5):e02129-22.
[30] RICHARDSON S I,MZINDLE N,MOTLOU T,et al.SARS-CoV-2 BA.4/5 infection triggers more cross-reactive FcγRIIIa signaling and neutralization than BA.1,in the context of hybrid immunity[J]. J Virol,2024, 98(7):e00678-e00624.
[31] Chinese Center for Disease Control and Prevention. Epidemic situation of novel coronavirus infection in China[EB/OL].(2025-04-21). https://www.chinacdc.cn/jksj/xgbdyq/202504/t20250417_306020.html.
[32] ZENG Y B,LIN C R,LIU C,et al.Evaluating the value of anti-SARS-CoV-2 antibody detection and neutralizing responses with euvirus: A population of 10776 close contacts in the epidemic of Fujian[J]. Clin Chim Acta, 2023,539:237-243.
[33] CHANG L,HOU W H,ZHAO L,et al.The prevalence of antibodies to SARS-CoV-2 among blood donors in China[J]. Nat Commun,2021,12(1):1383.

针对未接种疫苗的Omicron感染者的SARS-CoV-2抗体检测试剂性能的纵向评估^*

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

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