tetano
Editor, Senior Moderator
Int J Infect Dis
. 2021 Nov 7;S1201-9712(21)00853-5.
doi: 10.1016/j.ijid.2021.11.006. Online ahead of print.
SARS-CoV-2 Variants with T135I Nucleocapsid Mutations may Affect Antigen Test Performance
Ming-Jr Jian[SUP] 1 [/SUP], Hsing-Yi Chung[SUP] 1 [/SUP], Chih-Kai Chang[SUP] 1 [/SUP], Jung-Chung Lin[SUP] 2 [/SUP], Kuo-Ming Yeh[SUP] 2 [/SUP], Chien-Wen Chen[SUP] 3 [/SUP], De-Yu Lin[SUP] 2 [/SUP], Feng-Yee Chang[SUP] 2 [/SUP], Kuo-Sheng Hung[SUP] 4 [/SUP], Cherng-Lih Perng[SUP] 1 [/SUP], Hung-Sheng Shang[SUP] 5 [/SUP]
Affiliations
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a pandemic. Additionally, several SARS-CoV-2 variants have continuously challenged diagnostic testing due to viral diversity in spike and nucleocapsid (N) protein mutations. SARS-CoV-2-variant proliferation potentially affects N protein-targeted rapid antigen testing. We performed rapid antigen and reverse transcription polymerase chain reaction (RT-PCR) tests simultaneously in patients with suspected coronavirus disease 2019 (COVID-19). To determine the N protein variations, direct whole-genome sequencing was performed, and the viral assemblies were uploaded to GISAID. We compared their genomes with those of global virus strains from GISAID. These isolates belonged to the B.1.1.7 variant, exhibiting several amino acid substitutions, including D3L, R203K, G204R, and S235F N protein mutations. We also identified the T135I mutation in one variant case in which rapid antigen and RT-PCR tests were discordantly negative and positive, respectively. Our findings suggest that the variants undetected by the Panbio[SUP]TM[/SUP] COVID-19 rapid antigen test may be due to N-protein T135I mutations, posing a potential diagnostic risk to commercially available antigen tests. Hence, we recommend concomitant paired rapid antigen tests and molecular diagnostic methods to detect SARS-CoV-2. False-negative results could be rapidly corrected using confirmatory RT-PCR results to prevent future COVID-19 outbreaks.
Keywords: B.1.1.7 variant; COVID-19; N protein; SARS-CoV-2; rapid antigen test.
. 2021 Nov 7;S1201-9712(21)00853-5.
doi: 10.1016/j.ijid.2021.11.006. Online ahead of print.
SARS-CoV-2 Variants with T135I Nucleocapsid Mutations may Affect Antigen Test Performance
Ming-Jr Jian[SUP] 1 [/SUP], Hsing-Yi Chung[SUP] 1 [/SUP], Chih-Kai Chang[SUP] 1 [/SUP], Jung-Chung Lin[SUP] 2 [/SUP], Kuo-Ming Yeh[SUP] 2 [/SUP], Chien-Wen Chen[SUP] 3 [/SUP], De-Yu Lin[SUP] 2 [/SUP], Feng-Yee Chang[SUP] 2 [/SUP], Kuo-Sheng Hung[SUP] 4 [/SUP], Cherng-Lih Perng[SUP] 1 [/SUP], Hung-Sheng Shang[SUP] 5 [/SUP]
Affiliations
- PMID: 34758391
- DOI: 10.1016/j.ijid.2021.11.006
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a pandemic. Additionally, several SARS-CoV-2 variants have continuously challenged diagnostic testing due to viral diversity in spike and nucleocapsid (N) protein mutations. SARS-CoV-2-variant proliferation potentially affects N protein-targeted rapid antigen testing. We performed rapid antigen and reverse transcription polymerase chain reaction (RT-PCR) tests simultaneously in patients with suspected coronavirus disease 2019 (COVID-19). To determine the N protein variations, direct whole-genome sequencing was performed, and the viral assemblies were uploaded to GISAID. We compared their genomes with those of global virus strains from GISAID. These isolates belonged to the B.1.1.7 variant, exhibiting several amino acid substitutions, including D3L, R203K, G204R, and S235F N protein mutations. We also identified the T135I mutation in one variant case in which rapid antigen and RT-PCR tests were discordantly negative and positive, respectively. Our findings suggest that the variants undetected by the Panbio[SUP]TM[/SUP] COVID-19 rapid antigen test may be due to N-protein T135I mutations, posing a potential diagnostic risk to commercially available antigen tests. Hence, we recommend concomitant paired rapid antigen tests and molecular diagnostic methods to detect SARS-CoV-2. False-negative results could be rapidly corrected using confirmatory RT-PCR results to prevent future COVID-19 outbreaks.
Keywords: B.1.1.7 variant; COVID-19; N protein; SARS-CoV-2; rapid antigen test.