Evaluating The Performance Of Two Rapid Antigen Detection Tests in Diagnosis of SARS- COV- 2 Infection

Abstract

Background: Rapid antigen detection tests for SARS-CoV-2 infection could promote the clinical and public health policies to handle the COVID-19 pandemic. Rapid antigen detection and molecular approaches could expand entry to checking and initial evidence of issues and playing an essential role in public health managing choices that may decrease the transmission. Objectives: We evaluated the diagnostic accurateness of couple of rapid antigen recognition tests equated with the molecular-based assays for verdict of SARS-CoV-2 infection. Methods: The 100 nasopharyngeal swabs were verified by the SARS-CoV-2 RT-PCR kit as a gold standard for COVID-19 recognition. SARS-CoV-2 antigen (Ag) was evaluated in the nasopharyngeal swabs using iFlash and UNICELL-2019-nCoV antigen methods. The iFlash-2019-nCoV antigen assay, which is a chemiluminescent immunoassay (CLIA), was used to qualitatively determine the nucleocapsid protein antigen, where the other one was used to identify the nucleocapsid protein antigen by lateral flow immunofluorescent test. Results: Out of the 100 samples, 62% were positive by RT-PCR. Amongst 62 confirmed COVID-19 cases, 43 (69.4%) were positive by iFlash and 40 samples (64.5%) were positive by the UNICELL-2019-nCoV antigen assay. The specificity of both I Flash-2019-nCoV antigen assay & UNICELL-2019-nCoV antigen assay with RT-PCR were 100% and sensitivity were 69.35 and 64.52%, respectively. This sensitivity was augmented to 100% compared with the PCR with Ct-value of ≤25 and specificity of 80.28 and 84.51%, respectively. Conclusion: Antigen detection rapid diagnostic tests may be motivating in the initial stage of the infection when the viral load is elevated, and the risk of SARS-CoV-2 transmission be high.

Diagnostic value and characteristic analysis of serum nucleocapsid antigen in COVID-19 patients

“…According to the cut-off value (1 COI) recommended by the manufacturer, the specificity of the serum N-Ag assay was 100%, but the sensitivity only reached 64.75%. Yasmin et al (2022) tested nasopharyngeal swab N-Ag in COVID-19 patients by using the iFlash-2019-nCoV Antigen Assay and the same cut-off values (1 COI), and the specificity (100%) and sensitivity (64.52%) were similar to our results, which suggests that this antigen assay may have the same detection performance for nasopharyngeal swabs or blood. It has to be mentioned that according to the manufacturer’s instruction, the iFlash-2019-nCoV Antigen Assay was originally developed to confirm SARS-CoV-2 infection by detecting nasopharyngeal swab N-Ag.…”

Rigorous Quality Assessment of Clinical Practice Guidelines for Microfluidic Technologies as Rapid Tests during COVID-19 using the AGREE II Instrument

“…This process resulted in six principal articles for critical review. The selected articles were published in the following journals: Annals of Laboratory Medicine (Hong et al, 2022), American Journal of Forensic Medicine & Pathology (Matsumoto et al, 2022), Nanomaterials (Sayed et al, 2022), Microbes and Infectious Diseases (Elmahdy et al, 2022), and Srpski Medicinski Casopis Lekarske Komore (Mrdović, n.d.).…”