ABSTRACT
Background: Based on the current prevalence of Coronavirus Disease 2019 (COVID-19), early diagnosis, isolation, and treatment are important methods to prevent and control infectious diseases. The establishment of convenient and efficient immunochromatographic detection techniques is essential for the prevention and control of COVID-19 epidemic. Objective: To establish a method for the detection of SARS-CoV-2 anti-N protein IgG antibody by immun of luorescence chromatography method based on quantum dots labeling technology in August, 2020. In order to determine whether the detected persons had been infected with COVID-19 or been injected with SARS-CoV-2 inactivated vaccine. Methods The prepared rat anti-human secondary antibody and anti-N protein antibody were immobilized on a Nitrocellulose (NC) membrane as detection line (T) and quality control line (C), respectively. Then the SARS-CoV-2 N protein labeled by quantum dots was evenly sprayed on glass fiber, which was assembled, cut and packaged into test strips after drying. The test strips were used to detect the clinical serum of 35 COVID-19 patients and 50 healthy individuals, the results of the initial screening of the ELISA kit were used as a control to calculate the detection specificity and sensitivity of quantum dots fluorescence immunochromatography. The sensitivity of the test strip was detected by using the N protein antibody standard. Results The specificity and sensitivity of the strip were 100.00%, 94.29%, and the susceptibility was 8.53-17.06 ng/ml antibody concentration. Conclusion: The detection of anti-N protein IgG antibody in serum by quantum dots labeling is simple, fast, with strong sensitivity and specificity. Copyright © 2022 by the Chinese General Practice.
ABSTRACT
The ongoing coronavirus disease 2019 (COVID-19) epidemic has made a huge impact on health, economies, and societies all over the world. Although reverse transcription-polymerase chain reaction (RT-PCR)-based nucleic acid detection has been primarily used in the diagnosis of COVID-19, it is time-consuming with limited application scenarios and must be operated by qualified personnel. Antibody test, particularly point-of-care antibody testing, is a suitable complement to nucleic acid test as it provides rapid, portable, and cost-effective detection of infections. In this study, a Rapid Antibody Test Kit was developed based on fluorescence immunochromatography for the sensitive, accurate, and automated detection of immunoglobulin M (IgM) and IgG antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma, and whole blood samples within 10 min. The sensitivity, specificity, precision, and stability of the test kit were of good performance. No cross-activity and no interference was observed. In the multiple-center parallel study, 223 samples from hospitalized patients were used to evaluate the clinical specificity of the test. Both SARS-CoV-2 IgM and IgG achieved a clinical specificity of 98.21%. The clinical sensitivities of SARS-CoV-2 IgM and IgG were 79.54% and 87.45%, respectively, among 733 reverse transcription-polymerase chain reaction (RT-PCR) confirmed SARS-CoV-2 samples. For the combined IgM and IgG assays, the sensitivity and specificity were 89.22% and 96.86%, respectively. Our results demonstrate that the combined use of IgM and IgG could serve as a more suitable alternative detection method for patients with COVID-19, and the developed kit is of great public health significance for the prevention and control of the COVID-19 pandemic.