Comparative diagnostic utility of SARS-CoV-2 rapid antigen and molecular testing in a community setting
© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprintsoup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com..
BACKGROUND: SARS-CoV-2 antigen-detection rapid diagnostic tests (Ag-RDTs) have become widely utilized but longitudinal characterization of their community-based performance remains incompletely understood.
METHODS: This prospective longitudinal study at a large public university in Seattle, WA utilized remote enrollment, online surveys, and self-collected nasal swab specimens to evaluate Ag-RDT performance against real-time reverse transcription polymerase chain reaction (rRT-PCR) in the context of SARS-CoV-2 Omicron. Ag-RDT sensitivity and specificity within 1 day of rRT-PCR were evaluated by symptom status throughout the illness episode and Orf1b cycle threshold (Ct).
RESULTS: From February to December 2022, 5,757 participants reported 17,572 Ag-RDT results and completed 12,674 rRT-PCR tests, of which 995 (7.9%) were rRT-PCR-positive. Overall sensitivity and specificity were 53.0% (95% CI: 49.6-56.4%) and 98.8% (98.5-99.0%), respectively. Sensitivity was comparatively higher for Ag-RDTs used 1 day after rRT-PCR (69.0%), 4 to 7 days post-symptom onset (70.1%), and Orf1b Ct ≤20 (82.7%). Serial Ag-RDT sensitivity increased with repeat testing ≥2 (68.5%) and ≥4 (75.8%) days after an initial Ag-RDT-negative result.
CONCLUSION: Ag-RDT performance varied by clinical characteristics and temporal testing patterns. Our findings support recommendations for serial testing following an initial Ag-RDT-negative result, especially among recently symptomatic persons or those at high-risk for SARS-CoV-2 infection.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
|---|---|
| Enthalten in: |
The Journal of infectious diseases - (2024) vom: 26. März |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Kim, Ashley E [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Ag-RDT |
|---|
| Anmerkungen: |
Date Revised 26.03.2024 published: Print-Electronic Citation Status Publisher |
|---|
| doi: |
10.1093/infdis/jiae150 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM370212339 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM370212339 | ||
| 003 | DE-627 | ||
| 005 | 20240328000753.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240328s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1093/infdis/jiae150 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1351.xml |
| 035 | |a (DE-627)NLM370212339 | ||
| 035 | |a (NLM)38531685 | ||
| 035 | |a (PII)jiae150 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Kim, Ashley E |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Comparative diagnostic utility of SARS-CoV-2 rapid antigen and molecular testing in a community setting |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 26.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprintsoup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. | ||
| 520 | |a BACKGROUND: SARS-CoV-2 antigen-detection rapid diagnostic tests (Ag-RDTs) have become widely utilized but longitudinal characterization of their community-based performance remains incompletely understood | ||
| 520 | |a METHODS: This prospective longitudinal study at a large public university in Seattle, WA utilized remote enrollment, online surveys, and self-collected nasal swab specimens to evaluate Ag-RDT performance against real-time reverse transcription polymerase chain reaction (rRT-PCR) in the context of SARS-CoV-2 Omicron. Ag-RDT sensitivity and specificity within 1 day of rRT-PCR were evaluated by symptom status throughout the illness episode and Orf1b cycle threshold (Ct) | ||
| 520 | |a RESULTS: From February to December 2022, 5,757 participants reported 17,572 Ag-RDT results and completed 12,674 rRT-PCR tests, of which 995 (7.9%) were rRT-PCR-positive. Overall sensitivity and specificity were 53.0% (95% CI: 49.6-56.4%) and 98.8% (98.5-99.0%), respectively. Sensitivity was comparatively higher for Ag-RDTs used 1 day after rRT-PCR (69.0%), 4 to 7 days post-symptom onset (70.1%), and Orf1b Ct ≤20 (82.7%). Serial Ag-RDT sensitivity increased with repeat testing ≥2 (68.5%) and ≥4 (75.8%) days after an initial Ag-RDT-negative result | ||
| 520 | |a CONCLUSION: Ag-RDT performance varied by clinical characteristics and temporal testing patterns. Our findings support recommendations for serial testing following an initial Ag-RDT-negative result, especially among recently symptomatic persons or those at high-risk for SARS-CoV-2 infection | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Ag-RDT | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Omicron | |
| 650 | 4 | |a PCR | |
| 650 | 4 | |a community setting | |
| 650 | 4 | |a concordance | |
| 650 | 4 | |a self-tests | |
| 650 | 4 | |a sensitivity | |
| 650 | 4 | |a serial testing | |
| 650 | 4 | |a symptom status | |
| 700 | 1 | |a Bennett, Julia C |e verfasserin |4 aut | |
| 700 | 1 | |a Luiten, Kyle |e verfasserin |4 aut | |
| 700 | 1 | |a O'Hanlon, Jessica A |e verfasserin |4 aut | |
| 700 | 1 | |a Wolf, Caitlin R |e verfasserin |4 aut | |
| 700 | 1 | |a Magedson, Ariana |e verfasserin |4 aut | |
| 700 | 1 | |a Han, Peter D |e verfasserin |4 aut | |
| 700 | 1 | |a Acker, Zack |e verfasserin |4 aut | |
| 700 | 1 | |a Regelbrugge, Lani |e verfasserin |4 aut | |
| 700 | 1 | |a McCaffrey, Kathryn M |e verfasserin |4 aut | |
| 700 | 1 | |a Stone, Jeremey |e verfasserin |4 aut | |
| 700 | 1 | |a Reinhart, David |e verfasserin |4 aut | |
| 700 | 1 | |a Capodanno, Benjamin J |e verfasserin |4 aut | |
| 700 | 1 | |a Morse, Stephen S |e verfasserin |4 aut | |
| 700 | 1 | |a Bedford, Trevor |e verfasserin |4 aut | |
| 700 | 1 | |a Englund, Janet A |e verfasserin |4 aut | |
| 700 | 1 | |a Boeckh, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Starita, Lea M |e verfasserin |4 aut | |
| 700 | 1 | |a Uyeki, Timothy M |e verfasserin |4 aut | |
| 700 | 1 | |a Carone, Marco |e verfasserin |4 aut | |
| 700 | 1 | |a Weil, Ana |e verfasserin |4 aut | |
| 700 | 1 | |a Chu, Helen Y |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t The Journal of infectious diseases |d 1945 |g (2024) vom: 26. März |w (DE-627)NLM000005819 |x 1537-6613 |7 nnns |
| 773 | 1 | 8 | |g year:2024 |g day:26 |g month:03 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1093/infdis/jiae150 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |j 2024 |b 26 |c 03 | ||