tetano
Editor, Senior Moderator
Sci Rep
. 2024 Dec 28;14(1):30792.
doi: 10.1038/s41598-024-81019-4. Direct detection of 4-dimensions of SARS-CoV-2: infection (vRNA), infectivity (antigen), binding antibody, and functional neutralizing antibody in saliva
Aida Mohammadi[SUP] 1 [/SUP], Samantha Chiang[SUP] 1 [/SUP], Feng Li[SUP] 1 [/SUP], Fang Wei[SUP] 1 [/SUP], Chang S Lau[SUP] 2 [/SUP], Mohammad Aziz[SUP] 1 [/SUP], Francisco J Ibarrondo[SUP] 3 [/SUP], Jennifer A Fulcher[SUP] 3 [/SUP], Otto O Yang[SUP] 3 [/SUP], David Chia[SUP] 1 [/SUP], Yong Kim[SUP] 4 [/SUP], David T W Wong[SUP] 5 [/SUP]
Affiliations
We developed a 4-parameter clinical assay using Electric Field Induced Release and Measurement (EFIRM) technology to simultaneously assess SARS-CoV-2 RNA (vRNA), nucleocapsid antigen, host binding (BAb) and neutralizing antibody (NAb) levels from a drop of saliva with performance that equals or surpasses current EUA-approved tests. The vRNA and antigen assays achieved lower limit of detection (LOD) of 100 copies/reaction and 3.5 TCID₅₀/mL, respectively. The vRNA assay differentiated between acutely infected (n = 10) and infection-naïve patients (n = 33) with an AUC of 0.9818, sensitivity of 90%, and specificity of 100%. The antigen assay similarly differentiated these patient populations with an AUC of 1.000. The BAb assay detected BAbs with an LOD of 39 pg/mL and distinguished acutely infected (n = 35), vaccinated with prior infection (n = 13), and vaccinated infection-naïve patients (n = 13) from pre-pandemic (n = 81) with AUC of 0.9481, 1.000, and 0.9962, respectively. The NAb assay detected NAbs with a LOD of 31.6 Unit/mL and differentiated between COVID-19 recovered or vaccinated patients (n = 31) and pre-pandemic controls (n = 60) with an AUC 0.923, sensitivity of 87.10%, and specificity of 86.67%. Our combo assay represents a significant technological advancement to simultaneously address SARS-CoV-2 infection and immunity, and it lays the foundation for tackling potential future pandemics.
. 2024 Dec 28;14(1):30792.
doi: 10.1038/s41598-024-81019-4. Direct detection of 4-dimensions of SARS-CoV-2: infection (vRNA), infectivity (antigen), binding antibody, and functional neutralizing antibody in saliva
Aida Mohammadi[SUP] 1 [/SUP], Samantha Chiang[SUP] 1 [/SUP], Feng Li[SUP] 1 [/SUP], Fang Wei[SUP] 1 [/SUP], Chang S Lau[SUP] 2 [/SUP], Mohammad Aziz[SUP] 1 [/SUP], Francisco J Ibarrondo[SUP] 3 [/SUP], Jennifer A Fulcher[SUP] 3 [/SUP], Otto O Yang[SUP] 3 [/SUP], David Chia[SUP] 1 [/SUP], Yong Kim[SUP] 4 [/SUP], David T W Wong[SUP] 5 [/SUP]
Affiliations
- PMID: 39730575
- PMCID: PMC11681011
- DOI: 10.1038/s41598-024-81019-4
We developed a 4-parameter clinical assay using Electric Field Induced Release and Measurement (EFIRM) technology to simultaneously assess SARS-CoV-2 RNA (vRNA), nucleocapsid antigen, host binding (BAb) and neutralizing antibody (NAb) levels from a drop of saliva with performance that equals or surpasses current EUA-approved tests. The vRNA and antigen assays achieved lower limit of detection (LOD) of 100 copies/reaction and 3.5 TCID₅₀/mL, respectively. The vRNA assay differentiated between acutely infected (n = 10) and infection-naïve patients (n = 33) with an AUC of 0.9818, sensitivity of 90%, and specificity of 100%. The antigen assay similarly differentiated these patient populations with an AUC of 1.000. The BAb assay detected BAbs with an LOD of 39 pg/mL and distinguished acutely infected (n = 35), vaccinated with prior infection (n = 13), and vaccinated infection-naïve patients (n = 13) from pre-pandemic (n = 81) with AUC of 0.9481, 1.000, and 0.9962, respectively. The NAb assay detected NAbs with a LOD of 31.6 Unit/mL and differentiated between COVID-19 recovered or vaccinated patients (n = 31) and pre-pandemic controls (n = 60) with an AUC 0.923, sensitivity of 87.10%, and specificity of 86.67%. Our combo assay represents a significant technological advancement to simultaneously address SARS-CoV-2 infection and immunity, and it lays the foundation for tackling potential future pandemics.