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Accuracy of a nucleocapsid protein antigen rapid test in the diagnosis of SARS-CoV-2 infection.
Clin Microbiol Infect. 2021 Feb; 27(2):289.e1-289.e4.CM

Abstract

OBJECTIVES

Rapid, reliable and easy-to-implement diagnostics that can be adapted in early severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnosis are critical to combat the epidemic. SARS-CoV-2 nucleocapsid protein (NP) is an ideal target for viral antigen-based detection. A rapid and convenient method was developed based on fluorescence immunochromatographic (FIC) assay to detect the SARS-CoV-2 NP antigen. However, the accuracy of this diagnostic method needs to be examined.

METHODS

This prospective study was carried out between 10 and 15 February 2020 in seven hospitals in Wuhan and one hospital in Chongqing, China. Participants with clinically suspected SARS-CoV-2 infection were enrolled. NP antigen testing by FIC assay and nucleic acid (NA) testing by real-time reverse transcriptase PCR (RT-PCR) were performed simultaneously in a blinded manner with the same nasopharyngeal swab sample. The diagnostic accuracy of NP antigen testing was calculated by taking NA testing of RT-PCR as the reference standard, in which samples with a cycle threshold (Ct) value of ≤40 were interpreted as positive for SARS-CoV-2.

RESULTS

A total of 253 participants were enrolled; two participants were excluded from the analyses because of invalid NP testing results. Of 251 participants (99.2%) included in the diagnostic accuracy analysis, 201 (80.1%) had a Ct value of ≤40. With Ct value 40 as the cutoff of NA testing, the sensitivity, specificity and percentage agreement of the FIC assay was 75.6% (95% confidence interval, 69.0-81.3), 100% (95% confidence interval, 91.1-100) and 80.5% (95% confidence interval, 75.1-84.9) respectively.

CONCLUSIONS

With RT-PCR assay as the reference standard, NP antigen testing by FIC assay shows high specificity and relatively high sensitivity in SARS-CoV-2 diagnosis in the early phase of infection.

Authors+Show Affiliations

Department of Medical Laboratory Center, General Hospital of Central Theater Command, Wuhan, China.Microbiome Medicine Center, Division of Laboratory Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China.Institute of Immunology, PLA, Third Military Medical University, Chongqing, China.Institute of Immunology, PLA, Third Military Medical University, Chongqing, China.Institute of Immunology, PLA, Third Military Medical University, Chongqing, China.Institute of Immunology, PLA, Third Military Medical University, Chongqing, China.Institute of Immunology, PLA, Third Military Medical University, Chongqing, China.Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China.Microbiome Medicine Center, Division of Laboratory Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China. Electronic address: hzhou@smu.edu.cn.Institute of Immunology, PLA, Third Military Medical University, Chongqing, China. Electronic address: wuyuzhang@tmmu.edu.cn.

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

33031947

Citation

Diao, Bo, et al. "Accuracy of a Nucleocapsid Protein Antigen Rapid Test in the Diagnosis of SARS-CoV-2 Infection." Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases, vol. 27, no. 2, 2021, pp. 289.e1-289.e4.
Diao B, Wen K, Zhang J, et al. Accuracy of a nucleocapsid protein antigen rapid test in the diagnosis of SARS-CoV-2 infection. Clin Microbiol Infect. 2021;27(2):289.e1-289.e4.
Diao, B., Wen, K., Zhang, J., Chen, J., Han, C., Chen, Y., Wang, S., Deng, G., Zhou, H., & Wu, Y. (2021). Accuracy of a nucleocapsid protein antigen rapid test in the diagnosis of SARS-CoV-2 infection. Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases, 27(2), e1-e4. https://doi.org/10.1016/j.cmi.2020.09.057
Diao B, et al. Accuracy of a Nucleocapsid Protein Antigen Rapid Test in the Diagnosis of SARS-CoV-2 Infection. Clin Microbiol Infect. 2021;27(2):289.e1-289.e4. PubMed PMID: 33031947.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Accuracy of a nucleocapsid protein antigen rapid test in the diagnosis of SARS-CoV-2 infection. AU - Diao,Bo, AU - Wen,Kun, AU - Zhang,Ji, AU - Chen,Jian, AU - Han,Chao, AU - Chen,Yongwen, AU - Wang,Shufeng, AU - Deng,Guohong, AU - Zhou,Hongwei, AU - Wu,Yuzhang, Y1 - 2020/10/05/ PY - 2020/04/24/received PY - 2020/09/10/revised PY - 2020/09/28/accepted PY - 2020/10/9/pubmed PY - 2021/2/26/medline PY - 2020/10/8/entrez KW - Antigen detection KW - Diagnosis KW - Fluorescence immunochromatographic assay KW - Nucleocapsid protein KW - SARS-CoV-2 SP - 289.e1 EP - 289.e4 JF - Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases JO - Clin Microbiol Infect VL - 27 IS - 2 N2 - OBJECTIVES: Rapid, reliable and easy-to-implement diagnostics that can be adapted in early severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnosis are critical to combat the epidemic. SARS-CoV-2 nucleocapsid protein (NP) is an ideal target for viral antigen-based detection. A rapid and convenient method was developed based on fluorescence immunochromatographic (FIC) assay to detect the SARS-CoV-2 NP antigen. However, the accuracy of this diagnostic method needs to be examined. METHODS: This prospective study was carried out between 10 and 15 February 2020 in seven hospitals in Wuhan and one hospital in Chongqing, China. Participants with clinically suspected SARS-CoV-2 infection were enrolled. NP antigen testing by FIC assay and nucleic acid (NA) testing by real-time reverse transcriptase PCR (RT-PCR) were performed simultaneously in a blinded manner with the same nasopharyngeal swab sample. The diagnostic accuracy of NP antigen testing was calculated by taking NA testing of RT-PCR as the reference standard, in which samples with a cycle threshold (Ct) value of ≤40 were interpreted as positive for SARS-CoV-2. RESULTS: A total of 253 participants were enrolled; two participants were excluded from the analyses because of invalid NP testing results. Of 251 participants (99.2%) included in the diagnostic accuracy analysis, 201 (80.1%) had a Ct value of ≤40. With Ct value 40 as the cutoff of NA testing, the sensitivity, specificity and percentage agreement of the FIC assay was 75.6% (95% confidence interval, 69.0-81.3), 100% (95% confidence interval, 91.1-100) and 80.5% (95% confidence interval, 75.1-84.9) respectively. CONCLUSIONS: With RT-PCR assay as the reference standard, NP antigen testing by FIC assay shows high specificity and relatively high sensitivity in SARS-CoV-2 diagnosis in the early phase of infection. SN - 1469-0691 UR - https://www.unboundmedicine.com/medline/citation/33031947/Accuracy_of_a_nucleocapsid_protein_antigen_rapid_test_in_the_diagnosis_of_SARS_CoV_2_infection_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1198-743X(20)30611-X DB - PRIME DP - Unbound Medicine ER -