Evaluation of the Diagnostic Performances of Spike Antigen for Diagnosis of Coronavirus 2019 Disease in Egyptian Patients | ||
| Egyptian Academic Journal of Biological Sciences. C, Physiology and Molecular Biology | ||
| Volume 16, Issue 2, December 2024, Pages 181-194 PDF (666.81 K) | ||
| Document Type: Original Article | ||
| DOI: 10.21608/eajbsc.2024.381635 | ||
| Authors | ||
| Mayada A. Soliman1; Amal A. Mohammed2; Manar S. Foda3; Hala H. Eldeeb4; Wafaa S. M. Hegab5; Azza M. Fared6; Aya H. Khalil7; Mohammed M. Omran8 | ||
| 1Bioassay lab, Central administration of biological and innovative products and clinical studies, Egyptian Drug Authority, Cairo, Egypt. | ||
| 2Biochemistry Department, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt. | ||
| 3Chemistry Department, Faculty of Science, Helwan University, Ain Helwan, Cairo, Egypt. | ||
| 4Clinical and Chemical Pathology Department, El Sahel Teaching Hospital, Egypt. | ||
| 5Internal Medicine Department, National Institute of Diabetes, Egypt. | ||
| 6Tropical Medicine Department, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt. | ||
| 7Teaching Radiology department, Sahel Teaching Hospital, Egypt. | ||
| 8Chemistry Department, Faculty of Science, Helwan University, Ain Helwan, 11795, Cairo, Egypt. | ||
| Abstract | ||
| The Coronavirus Disease 2019 (COVID-19) has created serious risks to human health and public safety. Hence, there is a pressing demand for uncomplicated and precise diagnostic assays to ensure accurate identification of the infection. SARS-CoV-2, like other coronaviruses, is classified as a single-stranded, positive-sense RNA virus with four key structural proteins: the spike (S), envelope (E), membrane (M), and nucleocapsid (N) proteins. The spike protein holds significant importance in early diagnosis of SARS-COV-2 infection due to its role in viral attachment, fusion, and cellular entry. In the current study, the diagnostic performance of SARS-CoV-2 Spike Protein S1 RBD was evaluated. Clinical samples (n =75) (nasopharyngeal and blood specimens) were collected from confirmed infected patients using reverse transcription polymerase chain reaction RT-PCR. In addition, 25 healthy participants were included as controls. Routine laboratory markers were evaluated for all participants and the SARS-CoV-2 Spike Protein S1 RBD was determined using sandwich ELISA for all participants. The result showed that the spike protein level demonstrated a statistically significant difference (p < 0.0001) in COVID-19 patients compared to healthy participants. Furthermore, the variables D-Dimer and CRP demonstrated a statistically significant difference (p < 0.0001) with the existence of COVID-19. In contrast, the analysis revealed no differences regarding LDH, body mass index, or gender among the studied groups. In addition, there was a significant positive correlation between D-dimer (r = 0.57, p<0.0001) and spike antigen. Spike antigen was the most effective biomarker in distinguishing COVID from healthy participants, with an AUC of 0.99, sensitivity of 98%, and specificity of 94%. Additionally, D-dimer has a sensitivity of 93%, a specificity of 92%, and an AUC of 0.96, and CRP has a sensitivity of 87%, a specificity of 80%, AUC=0.88. And finally, ferritin has a sensitivity of 61%, a specificity of 64%, and an AUC of 0.64. SARS-COV-2.Spike antigen can be used as a suitable diagnostic test for identifying COVID-19 infection with higher sensitivity and specificity. | ||
| Keywords | ||
| SARS-CoV-2 Spike Protein S1 RBD; Severe acute respiratory syndrome coronavirus 2; sandwich ELISA; reverse transcription polymerase chain reaction RT-PCR | ||
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