Your browser doesn't support javascript.
[Diagnostic value of rapid antigen testing for the detection of SARS-CoV-2 infection].
Li, J J; Zeng, M; Xu, J; Ge, Y L; Tian, H; Wang, Z L; Liu, G B; Zhai, X W; Zhang, X B; Zhu, Q R; Chang, H L.
  • Li JJ; Department of Infectious Diseases, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
  • Zeng M; Department of Infectious Diseases, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
  • Xu J; Department of Clinical Laboratory, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
  • Ge YL; Department of Infectious Diseases, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
  • Tian H; Department of Infectious Diseases, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
  • Wang ZL; Department of Infectious Diseases, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
  • Liu GB; Department of Medical Affairs, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
  • Zhai XW; Department of Hematology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
  • Zhang XB; Department of Respiratory Medicine, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
  • Zhu QR; Department of Infectious Diseases, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
  • Chang HL; Department of Infectious Diseases, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201102, China.
Zhonghua Er Ke Za Zhi ; 60(11): 1153-1157, 2022 Nov 02.
Article in Chinese | MEDLINE | ID: covidwho-2099941
ABSTRACT

Objective:

To investigate the diagnostic value of rapid antigen test based on colloidal gold immunochromatographic assay for the detection of SARS-CoV-2 infection in symptomatic patients.

Methods:

From May 20 to June 5 2022, 76 hospitalized children and their 55 accompanying family members with confirmed SARS-CoV-2 infection in the COVID-19 isolation unit of the Children's Hospital of Fudan University (designated referral hospital for SARS-CoV-2 infection in Shanghai) enrolled. Their nasopharyngeal swab specimens were consecutively collected. The samples were tested for SARS-CoV-2 nucleic acid by real-time quantitative. SARS-CoV-2 antigen was tested by immunochromatography. The correlation between the antigen detection results and the change of the cycle threshold (Ct) values were evaluated, as well as the sensitivity and specificity of SARS-CoV-2 antigen detection at different periods after the onset of the disease. Kappa consistency test was conducted to investigate the consistency between the 2 diagnostic methods.

Results:

Of the enrolled SARS-CoV-2 symptomatic infections, 76 were children, including 41 males and 35 females, with an age of 5 (2, 9) years; 55 were accompanying families, including 8 males and 47 females, with an age of 38 (32, 41) years. All 478 samples were simultaneously tested for SARS-CoV-2 antigen and nucleic acid. In any period from disease onset to negative conversion of viral nucleic acid, the overall sensitivity of the rapid antigen test was 48.2% (119/247), the specificity was 98.3% (227/231), and antigen test and nucleic acid test showed moderate consistency (κ=0.46, P<0.05). The sensitivity of antigen test was 100% (82/82) when the Ct value was ≤25. And the sensitivity of antigen test was 8/10, 4/15 and 8.3% (3/36) when the Ct value was 26, 30 and 35, respectively. All antigen tests were negative when Ct value was >35. During the period of 1-2 days, 3-5 days, 6-7 days, 8-10 days and >10 days after onset, the sensitivity and specificity of SARS-CoV-2 antigen test were 5/8 and 5/5, 90.2% (37/41) and 5/5, 88.9% (24/27) and 2/5, 45.0% (36/80) and 94.1% (32/34), 18.7% (17/91) and 98.9% (183/185) respectively. The Ct values of nasopharyngeal swabs were<26 during 2 to 7 days after onset, 28.7±5.0 on day 8, 34.5±2.9 on day 13 and > 35 after 14 days, respectively.

Conclusion:

SARS-CoV-2 antigen test in the patients with SARS-CoV-2 infection shows acceptable sensitivity and specificity within 7 days after onset of disease, and the sensitivity was positively correlated with viral load and negatively correlated with onset time.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Nucleic Acids / COVID-19 Type of study: Diagnostic study / Experimental Studies Limits: Child / Female / Humans / Male Country/Region as subject: Asia Language: Chinese Journal: Zhonghua Er Ke Za Zhi Year: 2022 Document Type: Article Affiliation country: Cma.j.cn112140-20220628-00598

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: Nucleic Acids / COVID-19 Type of study: Diagnostic study / Experimental Studies Limits: Child / Female / Humans / Male Country/Region as subject: Asia Language: Chinese Journal: Zhonghua Er Ke Za Zhi Year: 2022 Document Type: Article Affiliation country: Cma.j.cn112140-20220628-00598