Different performance of three point-of-care SARS-CoV-2 antigen detection devices in symptomatic patients and close asymptomatic contacts : a real-life study
Copyright © 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved..
OBJECTIVES: PCR on nasopharyngeal exudates, the cornerstone of the detection of SARS-CoV-2, is time-consuming and commonly unavailable at primary health care centres. Detection of viral nucleocapsid antigens using lateral flow point-of-care tests is helpful for the early triage of patients who attend health care facilities.
METHODS: This was a prospective study carried out in clinically suspected cases and close asymptomatic contacts who attended a primary care centre (Madrid, Spain) for SARS-CoV-2 detection. Patients were divided into three 300-patient cohorts (n = 200 symptomatic cases and n = 100 close asymptomatic contacts per cohort). Three antigen detection tests (SGTI-Flex COVID-19 Ag, Panbio COVID-19 Ag Rapid Test Device, and GSD NovaGen SARS-CoV-2 Ag Rapid Test) were used and compared. Paired nasopharyngeal exudates were obtained, one swab for PCR and the other for antigen detection. Each antigen detection test was evaluated on one cohort.
RESULTS: All tests showed invariably 100% specificity. Sensitivity was 68.9% (95% CI: 55.7-80; SGTI-Flex), 71.1% (95% CI: 55.6-83.6; Panbio), and 84.6% (95% CI: 72-93.1; NovaGen) in clinically suspected patients and 84.6% (95% CI: 54.5-98.1), 33.3% (95% CI: 11.8-61.6), and 55.6% (95% CI: 30.7-78.4) in close asymptomatic contacts, respectively. Sensitivity was systematically higher in samples yielding positive PCR results with Ct ≤ 20.
DISCUSSION: We found considerable test-to-test antigen detection variations among patients with clinical suspicion of COVID-19 and close asymptomatic contacts. Negative antigen results, regardless of the test used, should be confirmed by PCR.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:28 |
|---|---|
| Enthalten in: |
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases - 28(2022), 6 vom: 10. Juni, Seite 865-870 |
| Sprache: |
Englisch |
|---|
| Links: |
|---|
| Themen: |
Antigen detection |
|---|
| Anmerkungen: |
Date Completed 26.05.2022 Date Revised 28.03.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.cmi.2022.02.014 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM33734339X |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM33734339X | ||
| 003 | DE-627 | ||
| 005 | 20231225234211.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.cmi.2022.02.014 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1124.xml |
| 035 | |a (DE-627)NLM33734339X | ||
| 035 | |a (NLM)35202788 | ||
| 035 | |a (PII)S1198-743X(22)00088-X | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Escribano, Pilar |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Different performance of three point-of-care SARS-CoV-2 antigen detection devices in symptomatic patients and close asymptomatic contacts |b a real-life study |
| 264 | 1 | |c 2022 | |
| 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 Completed 26.05.2022 | ||
| 500 | |a Date Revised 28.03.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved. | ||
| 520 | |a OBJECTIVES: PCR on nasopharyngeal exudates, the cornerstone of the detection of SARS-CoV-2, is time-consuming and commonly unavailable at primary health care centres. Detection of viral nucleocapsid antigens using lateral flow point-of-care tests is helpful for the early triage of patients who attend health care facilities | ||
| 520 | |a METHODS: This was a prospective study carried out in clinically suspected cases and close asymptomatic contacts who attended a primary care centre (Madrid, Spain) for SARS-CoV-2 detection. Patients were divided into three 300-patient cohorts (n = 200 symptomatic cases and n = 100 close asymptomatic contacts per cohort). Three antigen detection tests (SGTI-Flex COVID-19 Ag, Panbio COVID-19 Ag Rapid Test Device, and GSD NovaGen SARS-CoV-2 Ag Rapid Test) were used and compared. Paired nasopharyngeal exudates were obtained, one swab for PCR and the other for antigen detection. Each antigen detection test was evaluated on one cohort | ||
| 520 | |a RESULTS: All tests showed invariably 100% specificity. Sensitivity was 68.9% (95% CI: 55.7-80; SGTI-Flex), 71.1% (95% CI: 55.6-83.6; Panbio), and 84.6% (95% CI: 72-93.1; NovaGen) in clinically suspected patients and 84.6% (95% CI: 54.5-98.1), 33.3% (95% CI: 11.8-61.6), and 55.6% (95% CI: 30.7-78.4) in close asymptomatic contacts, respectively. Sensitivity was systematically higher in samples yielding positive PCR results with Ct ≤ 20 | ||
| 520 | |a DISCUSSION: We found considerable test-to-test antigen detection variations among patients with clinical suspicion of COVID-19 and close asymptomatic contacts. Negative antigen results, regardless of the test used, should be confirmed by PCR | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Antigen detection | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Close asymptomatic contact | |
| 650 | 4 | |a Point of care | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 7 | |a Antigens, Viral |2 NLM | |
| 700 | 1 | |a Sánchez-Pulido, Ana-Erika |e verfasserin |4 aut | |
| 700 | 1 | |a González-Leiva, José |e verfasserin |4 aut | |
| 700 | 1 | |a Valero-López, Iván |e verfasserin |4 aut | |
| 700 | 1 | |a Catalán, Pilar |e verfasserin |4 aut | |
| 700 | 1 | |a Muñoz, Patricia |e verfasserin |4 aut | |
| 700 | 1 | |a Guinea, Jesús |e verfasserin |4 aut | |
| 700 | 0 | |a COVID-19 study group Hospital Gregorio Marañón |e verfasserin |4 aut | |
| 700 | 0 | |a COVID-19 study group Pavones care centre |e verfasserin |4 aut | |
| 700 | 1 | |a Adán, Iván |e investigator |4 oth | |
| 700 | 1 | |a Adán, Javier |e investigator |4 oth | |
| 700 | 1 | |a Alcalá, Luis |e investigator |4 oth | |
| 700 | 1 | |a Alonso, Roberto |e investigator |4 oth | |
| 700 | 1 | |a Álvarez-Uría, Ana |e investigator |4 oth | |
| 700 | 1 | |a Bouza, Emilio |e investigator |4 oth | |
| 700 | 1 | |a Catalán, Pilar |e investigator |4 oth | |
| 700 | 1 | |a Escribano, Pilar |e investigator |4 oth | |
| 700 | 1 | |a Estévez, Agustín |e investigator |4 oth | |
| 700 | 1 | |a Fernández-Del Rey, Rocío |e investigator |4 oth | |
| 700 | 1 | |a Galar, Alicia |e investigator |4 oth | |
| 700 | 1 | |a García de Viedma, Darío |e investigator |4 oth | |
| 700 | 1 | |a González, Pedro |e investigator |4 oth | |
| 700 | 1 | |a Gómez-Núñez, Ana |e investigator |4 oth | |
| 700 | 1 | |a Guinea, Jesús |e investigator |4 oth | |
| 700 | 1 | |a Herranz, Marta |e investigator |4 oth | |
| 700 | 1 | |a Kestler, Marta |e investigator |4 oth | |
| 700 | 1 | |a Machado, Marina |e investigator |4 oth | |
| 700 | 1 | |a Marín, Mercedes |e investigator |4 oth | |
| 700 | 1 | |a Muñoz, Patricia |e investigator |4 oth | |
| 700 | 1 | |a Olmedo, María |e investigator |4 oth | |
| 700 | 1 | |a Ortiz, Javier |e investigator |4 oth | |
| 700 | 1 | |a Palomo, María |e investigator |4 oth | |
| 700 | 1 | |a Pérez-Granda, María Jesús |e investigator |4 oth | |
| 700 | 1 | |a Pérez, Laura |e investigator |4 oth | |
| 700 | 1 | |a Rincón, Cristina |e investigator |4 oth | |
| 700 | 1 | |a Rodríguez, Sara |e investigator |4 oth | |
| 700 | 1 | |a Rodríguez, Belén |e investigator |4 oth | |
| 700 | 1 | |a Ruiz-Serrano, María Jesús |e investigator |4 oth | |
| 700 | 1 | |a Valerio, Maricela |e investigator |4 oth | |
| 700 | 1 | |a Vidán, Maite |e investigator |4 oth | |
| 700 | 1 | |a María Alonso Blanco, Ana |e investigator |4 oth | |
| 700 | 1 | |a Coca Escribano, Elena |e investigator |4 oth | |
| 700 | 1 | |a Blázquez Andrés, Susana |e investigator |4 oth | |
| 700 | 1 | |a Sastre Páez, María Sonsoles |e investigator |4 oth | |
| 700 | 1 | |a Vega López, Patricia |e investigator |4 oth | |
| 700 | 1 | |a Díez Vaquero, Lorena |e investigator |4 oth | |
| 700 | 1 | |a Sandoval Montejo, María Carmen |e investigator |4 oth | |
| 700 | 1 | |a Pinto Zurita, Jannet |e investigator |4 oth | |
| 700 | 1 | |a Jiménez Otero, Estefanía |e investigator |4 oth | |
| 700 | 1 | |a Cañón Cañón, Carolina |e investigator |4 oth | |
| 700 | 1 | |a Castro Romaní, Marisol |e investigator |4 oth | |
| 700 | 1 | |a Villamañán Lobo, David |e investigator |4 oth | |
| 700 | 1 | |a Roca Sánchez, Susana |e investigator |4 oth | |
| 700 | 1 | |a López Rodríguez, M Estrella |e investigator |4 oth | |
| 700 | 1 | |a Jiménez Morillo, Raquel |e investigator |4 oth | |
| 700 | 1 | |a Plaza Rivera, Sara |e investigator |4 oth | |
| 700 | 1 | |a Zaragoza Vargas, Natalia |e investigator |4 oth | |
| 700 | 1 | |a Sánchez Sánchez, José Alejandro |e investigator |4 oth | |
| 700 | 1 | |a Sánchez Carrasco, Cristina |e investigator |4 oth | |
| 700 | 1 | |a Corral Martínez, Pedro |e investigator |4 oth | |
| 700 | 1 | |a Valero López, Iván |e investigator |4 oth | |
| 700 | 1 | |a Ramos Del, Río Lourdes |e investigator |4 oth | |
| 700 | 1 | |a Huertas Uhagón, María |e investigator |4 oth | |
| 700 | 1 | |a Martín Francisco María de la, Peña |e investigator |4 oth | |
| 700 | 1 | |a Cañas Zuluaga, Ángela Bibiana |e investigator |4 oth | |
| 700 | 1 | |a Heras Martín, Laura |e investigator |4 oth | |
| 700 | 1 | |a García García, Ana Isabel |e investigator |4 oth | |
| 700 | 1 | |a Sevilla Aguerre, Ainhoa |e investigator |4 oth | |
| 700 | 1 | |a López Alonso, Ana Belén |e investigator |4 oth | |
| 700 | 1 | |a Sánchez Sánchez, Luis Alberto |e investigator |4 oth | |
| 700 | 1 | |a Cánovas Martínez, Miriam |e investigator |4 oth | |
| 700 | 1 | |a Roy Zafra, Rut |e investigator |4 oth | |
| 700 | 1 | |a García Ramos, Aitor |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases |d 1995 |g 28(2022), 6 vom: 10. Juni, Seite 865-870 |w (DE-627)NLM094580014 |x 1469-0691 |7 nnns |
| 773 | 1 | 8 | |g volume:28 |g year:2022 |g number:6 |g day:10 |g month:06 |g pages:865-870 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.cmi.2022.02.014 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 28 |j 2022 |e 6 |b 10 |c 06 |h 865-870 | ||