Antigen rapid tests, nasopharyngeal PCR and saliva PCR to detect SARS-CoV-2: A prospective comparative clinical trial.
<h4>Background</h4>Nasopharyngeal antigen Rapid Diagnostic Tests (RDTs), saliva RT-PCR and nasopharyngeal (NP) RT-PCR have shown different performance characteristics to detect patients infected by SARS-CoV-2, according to the viral load (VL)-and thus transmissibility.<h4>Methods&l...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2023-01-01
|
| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0282150 |
| _version_ | 1797848098336145408 |
|---|---|
| author | Jean-Marc Schwob Alix Miauton Dusan Petrovic Jean Perdrix Nicolas Senn Alexandre Gouveia Katia Jaton Onya Opota Alain Maillard Gianni Minghelli Jacques Cornuz Gilbert Greub Blaise Genton Valérie D'Acremont |
| author_facet | Jean-Marc Schwob Alix Miauton Dusan Petrovic Jean Perdrix Nicolas Senn Alexandre Gouveia Katia Jaton Onya Opota Alain Maillard Gianni Minghelli Jacques Cornuz Gilbert Greub Blaise Genton Valérie D'Acremont |
| author_sort | Jean-Marc Schwob |
| collection | DOAJ |
| description | <h4>Background</h4>Nasopharyngeal antigen Rapid Diagnostic Tests (RDTs), saliva RT-PCR and nasopharyngeal (NP) RT-PCR have shown different performance characteristics to detect patients infected by SARS-CoV-2, according to the viral load (VL)-and thus transmissibility.<h4>Methods</h4>In October 2020, we conducted a prospective trial involving patients presenting at testing centres with symptoms of COVID-19. We compared detection rates and performance of RDT, saliva PCR and nasopharyngeal (NP) PCR, according to VL and symptoms duration.<h4>Results</h4>Out of 949 patients enrolled, 928 patients had all three tests performed. Detection rates were 35.2% (95%CI 32.2-38.4%) by RDT, 39.8% (36.6-43.0%) by saliva PCR, 40.1% (36.9-43.3%) by NP PCR, and 41.5% (38.3-44.7%) by any test. For those with viral loads (VL) ≥106 copies/ml, detection rates were 30.3% (27.3-33.3), 31.4% (28.4-34.5), 31.5% (28.5-34.6), and 31.6% (28.6-34.7%) respectively. Sensitivity of RDT compared to NP PCR was 87.4% (83.6-90.6%) for all positive patients, 94.5% (91.5-96.7%) for those with VL≥105 and 96.5% (93.6-98.3%) for those with VL≥106. Sensitivity of STANDARD-Q®, Panbio™ and COVID-VIRO® Ag tests were 92.9% (86.4-96.9%), 86.1% (78.6-91.7%) and 84.1% (76.9-89.7%), respectively. For those with VL≥106, sensitivity was 96.6% (90.5-99.3%), 97.8% (92.1-99.7%) and 95.3% (89.4-98.5%) respectively. No patient with VL<104 was detected by RDT. Specificity of RDT was 100% (99.3-100%) compared to any PCR. RDT sensitivity was similar <4 days (87.8%, 83.5-91.3%) and ≥4 days (85.7%, 75.9-92.6%) after symptoms onset (p = 0.6). Sensitivity of saliva and NP PCR were 95.7% (93.1-97.5%) and 96.5% (94.1-98.1%), respectively, compared to the other PCR.<h4>Conclusions</h4>RDT results allow rapid identification of COVID cases with immediate isolation of most contagious individuals. RDT can thus be a game changer both in ambulatory care and community testing aimed at stopping transmission chains, and even more so in resource-constrained settings thanks to its very low price. When PCR is performed, saliva could replace NP swabbing.<h4>Trial registration</h4>ClinicalTrial.gov Identifier: NCT04613310 (03/11/2020). |
| first_indexed | 2024-04-09T18:21:55Z |
| format | Article |
| id | doaj.art-3f6c382c332c4373b61a86a1db2ef66e |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-04-09T18:21:55Z |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-3f6c382c332c4373b61a86a1db2ef66e2023-04-12T05:33:07ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-01182e028215010.1371/journal.pone.0282150Antigen rapid tests, nasopharyngeal PCR and saliva PCR to detect SARS-CoV-2: A prospective comparative clinical trial.Jean-Marc SchwobAlix MiautonDusan PetrovicJean PerdrixNicolas SennAlexandre GouveiaKatia JatonOnya OpotaAlain MaillardGianni MinghelliJacques CornuzGilbert GreubBlaise GentonValérie D'Acremont<h4>Background</h4>Nasopharyngeal antigen Rapid Diagnostic Tests (RDTs), saliva RT-PCR and nasopharyngeal (NP) RT-PCR have shown different performance characteristics to detect patients infected by SARS-CoV-2, according to the viral load (VL)-and thus transmissibility.<h4>Methods</h4>In October 2020, we conducted a prospective trial involving patients presenting at testing centres with symptoms of COVID-19. We compared detection rates and performance of RDT, saliva PCR and nasopharyngeal (NP) PCR, according to VL and symptoms duration.<h4>Results</h4>Out of 949 patients enrolled, 928 patients had all three tests performed. Detection rates were 35.2% (95%CI 32.2-38.4%) by RDT, 39.8% (36.6-43.0%) by saliva PCR, 40.1% (36.9-43.3%) by NP PCR, and 41.5% (38.3-44.7%) by any test. For those with viral loads (VL) ≥106 copies/ml, detection rates were 30.3% (27.3-33.3), 31.4% (28.4-34.5), 31.5% (28.5-34.6), and 31.6% (28.6-34.7%) respectively. Sensitivity of RDT compared to NP PCR was 87.4% (83.6-90.6%) for all positive patients, 94.5% (91.5-96.7%) for those with VL≥105 and 96.5% (93.6-98.3%) for those with VL≥106. Sensitivity of STANDARD-Q®, Panbio™ and COVID-VIRO® Ag tests were 92.9% (86.4-96.9%), 86.1% (78.6-91.7%) and 84.1% (76.9-89.7%), respectively. For those with VL≥106, sensitivity was 96.6% (90.5-99.3%), 97.8% (92.1-99.7%) and 95.3% (89.4-98.5%) respectively. No patient with VL<104 was detected by RDT. Specificity of RDT was 100% (99.3-100%) compared to any PCR. RDT sensitivity was similar <4 days (87.8%, 83.5-91.3%) and ≥4 days (85.7%, 75.9-92.6%) after symptoms onset (p = 0.6). Sensitivity of saliva and NP PCR were 95.7% (93.1-97.5%) and 96.5% (94.1-98.1%), respectively, compared to the other PCR.<h4>Conclusions</h4>RDT results allow rapid identification of COVID cases with immediate isolation of most contagious individuals. RDT can thus be a game changer both in ambulatory care and community testing aimed at stopping transmission chains, and even more so in resource-constrained settings thanks to its very low price. When PCR is performed, saliva could replace NP swabbing.<h4>Trial registration</h4>ClinicalTrial.gov Identifier: NCT04613310 (03/11/2020).https://doi.org/10.1371/journal.pone.0282150 |
| spellingShingle | Jean-Marc Schwob Alix Miauton Dusan Petrovic Jean Perdrix Nicolas Senn Alexandre Gouveia Katia Jaton Onya Opota Alain Maillard Gianni Minghelli Jacques Cornuz Gilbert Greub Blaise Genton Valérie D'Acremont Antigen rapid tests, nasopharyngeal PCR and saliva PCR to detect SARS-CoV-2: A prospective comparative clinical trial. PLoS ONE |
| title | Antigen rapid tests, nasopharyngeal PCR and saliva PCR to detect SARS-CoV-2: A prospective comparative clinical trial. |
| title_full | Antigen rapid tests, nasopharyngeal PCR and saliva PCR to detect SARS-CoV-2: A prospective comparative clinical trial. |
| title_fullStr | Antigen rapid tests, nasopharyngeal PCR and saliva PCR to detect SARS-CoV-2: A prospective comparative clinical trial. |
| title_full_unstemmed | Antigen rapid tests, nasopharyngeal PCR and saliva PCR to detect SARS-CoV-2: A prospective comparative clinical trial. |
| title_short | Antigen rapid tests, nasopharyngeal PCR and saliva PCR to detect SARS-CoV-2: A prospective comparative clinical trial. |
| title_sort | antigen rapid tests nasopharyngeal pcr and saliva pcr to detect sars cov 2 a prospective comparative clinical trial |
| url | https://doi.org/10.1371/journal.pone.0282150 |
| work_keys_str_mv | AT jeanmarcschwob antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT alixmiauton antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT dusanpetrovic antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT jeanperdrix antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT nicolassenn antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT alexandregouveia antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT katiajaton antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT onyaopota antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT alainmaillard antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT gianniminghelli antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT jacquescornuz antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT gilbertgreub antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT blaisegenton antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial AT valeriedacremont antigenrapidtestsnasopharyngealpcrandsalivapcrtodetectsarscov2aprospectivecomparativeclinicaltrial |