Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants

Meyers, Kathrine; Purpura, Lawrence; Nguyen, Nadia; Mohri, Hiroshi; Chang, Joseph; Annavajhala, Medini K.; Lopez, Leo; Lee, Sang Won; Shah, Jainil P.; Lane, Benjamin; Cantos, Anyelina; Tukuru, Sade A.; Guo, Yicheng; Ford, Kenra; Chiu, Yueh‐Hsia; Sheng, Zizheng; Choesang, Tenzin; Castor, Delivette; Wang, Maple; Pili, Christina; Hoy, Michael N Van; Wallach, Andrew; Horton, J. C.; Chen, Zhiqiang; Rosenthal, Susan L.; McLaren, Son H.; Jiang, Baowei; Wang, Frank; Lu, Helen; Uhlemann, Anne‐Catrin; Ho, David D.; Yin, Michael T.

doi:10.1016/j.jcvp.2022.100080

“…Among the 49 studies on nasal swabs containing 79,073 samples [ [2] , [3] , [4] , 6 , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] ], all of them were published between 2021 and 2022, and twenty-one studies were conducted in the USA [ 12 , 14 , 15 , 18 , 21 , 22 , [25] , [26] , [27] , [32] , [33] , [34] , [35] , 39 , 44 , 45 , [47] ...…”

Section: Resultsmentioning

confidence: 99%

Nasal swab is a good alternative sample for detecting SARS-CoV-2 with rapid antigen test: A meta-analysis

Xie

¹

,

Zheng

²

,

Wang

³

et al. 2023

Travel Medicine and Infectious Disease

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“…Lateral Flow Assay. SARS-CoV-2 (N-antigen, anti-SARS-CoV-2 spike protein IgG/IgM) were detected in TW/saliva using LFA cartridges according to manufacturer's instructions (BioMedomics, Research Triangle Park, NC) 16,17 . Bands were visualized and quantitated using ImageJ.…”

Section: Methodsmentioning

confidence: 99%

Oral SARS-CoV-2 host responses predict the early COVID-19 disease course

Seaman

¹

,

Keener

²

,

Me

³

et al. 2023

Preprint

Self Cite

0

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Objectives: Oral fluids provide ready detection of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and host responses. This study sought to determine relationships between oral virus, oral anti-SARS-CoV-2-specific antibodies, and symptoms. Methods: Saliva/throat wash (saliva/TW) were collected from asymptomatic and symptomatic, nasopharyngeal (NP) SARS-CoV-2 RT-qPCR+, subjects (n=47). SARS-CoV-2 RT-qPCR, N-antigen detection by immunoblot and lateral flow assay (LFA) were performed. RT-qPCR targeting viral subgenomic RNA (sgRNA) was sequence confirmed. SARS-CoV-2-anti-S protein RBD LFA assessed IgM and IgG responses. Structural analysis identified host salivary molecules analogous to SARS-CoV-2-N-antigen. Statistical analyses were performed. Results: At baseline, LFA-detected N-antigen was immunoblot-confirmed in 82% of TW. However, only 3/17 were saliva/TW qPCR+. Sixty percent of saliva and 83% of TW demonstrated persistent N-antigen at 4 weeks. N-antigen LFA signal in three negative subjects suggested potential cross-detection of 4 structurally analogous salivary RNA binding proteins (alignment 19-29aa, RMSD 1-1.5 Angstroms). At entry, symptomatic subjects demonstrated replication-associated sgRNA junctions, were IgG+ (94%/100% in saliva/TW), and IgM+ (75%/63%). At 4 weeks, SARS-CoV-2 IgG (100%/83%) and IgM (80%/67%) persisted. Oral IgG correlated 100% with NP+PCR status. Cough and fatigue severity (p=0.0008 and 0.016), and presence of nausea, weakness, and composite upper respiratory symptoms (p=0.005, 0.037 and 0.017) were negatively associated with oral IgM. Female oral IgM levels were higher than male (p=0.056). Conclusion: Important to transmission and disease course, oral viral replication and persistence showed clear relationships with select symptoms, early Ig responses, and gender during early infection. N-antigen cross-reactivity may reflect mimicry of structurally analogous host proteins.

show abstract

Oral SARS-CoV-2 host responses predict the early COVID-19 disease course

Seaman,

Keener,

Mei

et al. 2023

Preprint

Self Cite

1

0

View full text Add to dashboard Cite

Objectives: Oral fluids provide ready detection of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and host responses. This study sought to determine relationships between oral virus, oral anti-SARS-CoV-2-specific antibodies, and symptoms. Methods: Saliva/throat wash (saliva/TW) were collected from asymptomatic and symptomatic, nasopharyngeal (NP) SARS-CoV-2 RT-qPCR+, subjects (n=47). SARS-CoV-2 RT-qPCR, N-antigen detection by immunoblot and lateral flow assay (LFA) were performed. RT-qPCR targeting viral subgenomic RNA (sgRNA) was sequence confirmed. SARS-CoV-2-anti-S protein RBD LFA assessed IgM and IgG responses. Structural analysis identified host salivary molecules analogous to SARS-CoV-2-N-antigen. Statistical analyses were performed. Results: At baseline, LFA-detected N-antigen was immunoblot-confirmed in 82% of TW. However, only 3/17 were saliva/TW qPCR+. Sixty percent of saliva and 83% of TW demonstrated persistent N-antigen at 4 weeks. N-antigen LFA signal in three negative subjects suggested potential cross-detection of 4 structurally analogous salivary RNA binding proteins (alignment 19-29aa, RMSD 1-1.5 Angstroms). At entry, symptomatic subjects demonstrated replication-associated sgRNA junctions, were IgG+ (94%/100% in saliva/TW), and IgM+ (75%/63%). At 4 weeks, SARS-CoV-2 IgG (100%/83%) and IgM (80%/67%) persisted. Oral IgG correlated 100% with NP+PCR status. Cough and fatigue severity (p=0.0008 and 0.016), and presence of nausea, weakness, and composite upper respiratory symptoms (p=0.005, 0.037 and 0.017) were negatively associated with oral IgM. Female oral IgM levels were higher than male (p=0.056). Conclusion: Important to transmission and disease course, oral viral replication and persistence showed clear relationships with select symptoms, early Ig responses, and gender during early infection. N-antigen cross-reactivity may reflect mimicry of structurally analogous host proteins.

show abstract

Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants

Cited by 4 publications

References 24 publications

Nasal swab is a good alternative sample for detecting SARS-CoV-2 with rapid antigen test: A meta-analysis

Nasal swab is a good alternative sample for detecting SARS-CoV-2 with rapid antigen test: A meta-analysis

Oral SARS-CoV-2 host responses predict the early COVID-19 disease course

Oral SARS-CoV-2 host responses predict the early COVID-19 disease course

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