Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip.
Identifieur interne : 000586 ( Main/Exploration ); précédent : 000585; suivant : 000587Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip.
Auteurs : Thierry Prazuck [France] ; Mathilda Colin [France] ; Susanna Giachè [France] ; Camélia Gubavu [France] ; Aymeric Seve [France] ; Vincent Rzepecki [France] ; Marie Chevereau-Choquet [France] ; Catherine Kiani [France] ; Victor Rodot [France] ; Elsa Lionnet [France] ; Laura Courtellemont [France] ; Jérôme Guinard [France] ; Gilles Pialoux [France] ; Laurent Hocqueloux [France]Source :
- PloS one [ 1932-6203 ] ; 2020.
Descripteurs français
- KwdFr :
- Adulte (MeSH), Adulte d'âge moyen (MeSH), Analyse sur le lieu d'intervention (MeSH), Anticorps antiviraux (sang), Betacoronavirus (génétique), Betacoronavirus (immunologie), Betacoronavirus (isolement et purification), Doigts (vascularisation), Dosage immunologique (méthodes), Humains (MeSH), Immunoglobuline G (sang), Immunoglobuline M (sang), Infections à coronavirus (diagnostic), Infections à coronavirus (sang), Jeune adulte (MeSH), Pandémies (MeSH), Partie nasale du pharynx (virologie), Pneumopathie virale (diagnostic), Pneumopathie virale (sang), Réaction de polymérisation en chaine en temps réel (MeSH), Sensibilité et spécificité (MeSH), Spécificité des anticorps (MeSH), Sujet âgé (MeSH), Techniques de laboratoire clinique (méthodes), Trousses de réactifs pour diagnostic (MeSH), Vaisseaux capillaires (MeSH), Études prospectives (MeSH).
- MESH :
- diagnostic : Infections à coronavirus, Pneumopathie virale.
- génétique : Betacoronavirus.
- immunologie : Betacoronavirus.
- isolement et purification : Betacoronavirus.
- méthodes : Dosage immunologique, Techniques de laboratoire clinique.
- sang : Anticorps antiviraux, Immunoglobuline G, Immunoglobuline M, Infections à coronavirus, Pneumopathie virale.
- vascularisation : Doigts.
- virologie : Partie nasale du pharynx.
- Adulte, Adulte d'âge moyen, Analyse sur le lieu d'intervention, Humains, Jeune adulte, Pandémies, Réaction de polymérisation en chaine en temps réel, Sensibilité et spécificité, Spécificité des anticorps, Sujet âgé, Trousses de réactifs pour diagnostic, Vaisseaux capillaires, Études prospectives.
English descriptors
- KwdEn :
- Adult (MeSH), Aged (MeSH), Antibodies, Viral (blood), Antibody Specificity (MeSH), Betacoronavirus (genetics), Betacoronavirus (immunology), Betacoronavirus (isolation & purification), Capillaries (MeSH), Clinical Laboratory Techniques (methods), Coronavirus Infections (blood), Coronavirus Infections (diagnosis), Fingers (blood supply), Humans (MeSH), Immunoassay (methods), Immunoglobulin G (blood), Immunoglobulin M (blood), Middle Aged (MeSH), Nasopharynx (virology), Pandemics (MeSH), Pneumonia, Viral (blood), Pneumonia, Viral (diagnosis), Point-of-Care Testing (MeSH), Prospective Studies (MeSH), Reagent Kits, Diagnostic (MeSH), Real-Time Polymerase Chain Reaction (MeSH), Sensitivity and Specificity (MeSH), Young Adult (MeSH).
- MESH :
- chemical , blood : Antibodies, Viral, Immunoglobulin G, Immunoglobulin M.
- blood : Coronavirus Infections, Pneumonia, Viral.
- blood supply : Fingers.
- diagnosis : Coronavirus Infections, Pneumonia, Viral.
- genetics : Betacoronavirus.
- immunology : Betacoronavirus.
- isolation & purification : Betacoronavirus.
- methods : Clinical Laboratory Techniques, Immunoassay.
- virology : Nasopharynx.
- Adult, Aged, Antibody Specificity, Capillaries, Humans, Middle Aged, Pandemics, Point-of-Care Testing, Prospective Studies, Reagent Kits, Diagnostic, Real-Time Polymerase Chain Reaction, Sensitivity and Specificity, Young Adult.
Abstract
BACKGROUND
The SARS-CoV-2 (Severe Acute Respiratory Syndrome CoronaVirus 2) is responsible for the infectious respiratory disease called COVID-19 (COronaVIrus Disease 2019). In response to the growing COVID-19 pandemic, point-of-care (POC) tests have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. We conducted a prospective observational study to evaluate the performance of two POC tests, COVID-PRESTO® and COVID-DUO®, compared to the gold standard, RT-PCR (real-time reverse transcriptase polymerase chain reaction).
METHODS
RT-PCR testing of SARS-Cov-2 was performed from nasopharyngeal swab specimens collected in adult patients visiting the infectious disease department at the hospital (Orléans, France). Capillary whole blood (CWB) samples from the fingertip taken at different time points after onset of the disease were tested with POC tests. The specificity and sensitivity of the rapid test kits compared to test of reference (RT-PCR) were calculated.
RESULTS
Among 381 patients with symptoms of COVID-19 who went to the hospital for a diagnostic, 143 patients were RT-PCR negative. Results of test with POC tests were all negative for these patients, indicating a specificity of 100% for both POC tests. In the RT-PCR positive subgroup (n = 238), 133 patients were tested with COVID-PRESTO® and 129 patients were tested with COVID-DUO® (24 patients tested with both). The further the onset of symptoms was from the date of collection, the greater the sensitivity. The sensitivity of COVID-PRESTO® test ranged from 10.00% for patients having experienced their 1st symptoms from 0 to 5 days ago to 100% in patients where symptoms had occurred more than 15 days before the date of tests. For COVID-DUO® test, the sensitivity ranged from 35.71% [0-5 days] to 100% (> 15 days).
CONCLUSION
COVID-PRESTO® and DUO® POC tests turned out to be very specific (none false positive) and to be sensitive enough after 15 days from onset of symptom. These easy to use IgG/IgM combined test kits are the first ones allowing a screening with CWB sample, by typing from a finger prick. These rapid tests are particularly interesting for screening in low resource settings.
DOI: 10.1371/journal.pone.0237694
PubMed: 32941461
PubMed Central: PMC7498027
Affiliations:
Links toward previous steps (curation, corpus...)
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type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Guinard, Jerome" sort="Guinard, Jerome" uniqKey="Guinard J" first="Jérôme" last="Guinard">Jérôme Guinard</name><affiliation wicri:level="3"><nlm:affiliation>Department of Virology, CHR Orleans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Virology, CHR Orleans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Pialoux, Gilles" sort="Pialoux, Gilles" uniqKey="Pialoux G" first="Gilles" last="Pialoux">Gilles Pialoux</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious Diseases, Hôpital Tenon, Assistance Publique des Hôpitaux de Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious Diseases, Hôpital Tenon, Assistance Publique des Hôpitaux de Paris, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Hocqueloux, Laurent" sort="Hocqueloux, Laurent" uniqKey="Hocqueloux L" first="Laurent" last="Hocqueloux">Laurent Hocqueloux</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32941461</idno><idno type="pmid">32941461</idno><idno type="doi">10.1371/journal.pone.0237694</idno><idno type="pmc">PMC7498027</idno><idno type="wicri:Area/Main/Corpus">000178</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000178</idno><idno type="wicri:Area/Main/Curation">000178</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000178</idno><idno type="wicri:Area/Main/Exploration">000178</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip.</title><author><name sortKey="Prazuck, Thierry" sort="Prazuck, Thierry" uniqKey="Prazuck T" first="Thierry" last="Prazuck">Thierry Prazuck</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Colin, Mathilda" sort="Colin, Mathilda" uniqKey="Colin M" first="Mathilda" last="Colin">Mathilda Colin</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Giache, Susanna" sort="Giache, Susanna" uniqKey="Giache S" first="Susanna" last="Giachè">Susanna Giachè</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Gubavu, Camelia" sort="Gubavu, Camelia" uniqKey="Gubavu C" first="Camélia" last="Gubavu">Camélia Gubavu</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Seve, Aymeric" sort="Seve, Aymeric" uniqKey="Seve A" first="Aymeric" last="Seve">Aymeric Seve</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Rzepecki, Vincent" sort="Rzepecki, Vincent" uniqKey="Rzepecki V" first="Vincent" last="Rzepecki">Vincent Rzepecki</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Chevereau Choquet, Marie" sort="Chevereau Choquet, Marie" uniqKey="Chevereau Choquet M" first="Marie" last="Chevereau-Choquet">Marie Chevereau-Choquet</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Kiani, Catherine" sort="Kiani, Catherine" uniqKey="Kiani C" first="Catherine" last="Kiani">Catherine Kiani</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Rodot, Victor" sort="Rodot, Victor" uniqKey="Rodot V" first="Victor" last="Rodot">Victor Rodot</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Lionnet, Elsa" sort="Lionnet, Elsa" uniqKey="Lionnet E" first="Elsa" last="Lionnet">Elsa Lionnet</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Courtellemont, Laura" sort="Courtellemont, Laura" uniqKey="Courtellemont L" first="Laura" last="Courtellemont">Laura Courtellemont</name><affiliation wicri:level="3"><nlm:affiliation>Department of Virology, CHR Orleans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Virology, CHR Orleans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Guinard, Jerome" sort="Guinard, Jerome" uniqKey="Guinard J" first="Jérôme" last="Guinard">Jérôme Guinard</name><affiliation wicri:level="3"><nlm:affiliation>Department of Virology, CHR Orleans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Virology, CHR Orleans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Pialoux, Gilles" sort="Pialoux, Gilles" uniqKey="Pialoux G" first="Gilles" last="Pialoux">Gilles Pialoux</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious Diseases, Hôpital Tenon, Assistance Publique des Hôpitaux de Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious Diseases, Hôpital Tenon, Assistance Publique des Hôpitaux de Paris, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Hocqueloux, Laurent" sort="Hocqueloux, Laurent" uniqKey="Hocqueloux L" first="Laurent" last="Hocqueloux">Laurent Hocqueloux</name><affiliation wicri:level="3"><nlm:affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author></analytic><series><title level="j">PloS one</title><idno type="eISSN">1932-6203</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term><term>Aged (MeSH)</term><term>Antibodies, Viral (blood)</term><term>Antibody Specificity (MeSH)</term><term>Betacoronavirus (genetics)</term><term>Betacoronavirus (immunology)</term><term>Betacoronavirus (isolation & purification)</term><term>Capillaries (MeSH)</term><term>Clinical Laboratory Techniques (methods)</term><term>Coronavirus Infections (blood)</term><term>Coronavirus Infections (diagnosis)</term><term>Fingers (blood supply)</term><term>Humans (MeSH)</term><term>Immunoassay (methods)</term><term>Immunoglobulin G (blood)</term><term>Immunoglobulin M (blood)</term><term>Middle Aged (MeSH)</term><term>Nasopharynx (virology)</term><term>Pandemics (MeSH)</term><term>Pneumonia, Viral (blood)</term><term>Pneumonia, Viral (diagnosis)</term><term>Point-of-Care Testing (MeSH)</term><term>Prospective Studies (MeSH)</term><term>Reagent Kits, Diagnostic (MeSH)</term><term>Real-Time Polymerase Chain Reaction (MeSH)</term><term>Sensitivity and Specificity (MeSH)</term><term>Young Adult (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte (MeSH)</term><term>Adulte d'âge moyen (MeSH)</term><term>Analyse sur le lieu d'intervention (MeSH)</term><term>Anticorps antiviraux (sang)</term><term>Betacoronavirus (génétique)</term><term>Betacoronavirus (immunologie)</term><term>Betacoronavirus (isolement et purification)</term><term>Doigts (vascularisation)</term><term>Dosage immunologique (méthodes)</term><term>Humains (MeSH)</term><term>Immunoglobuline G (sang)</term><term>Immunoglobuline M (sang)</term><term>Infections à coronavirus (diagnostic)</term><term>Infections à coronavirus (sang)</term><term>Jeune adulte (MeSH)</term><term>Pandémies (MeSH)</term><term>Partie nasale du pharynx (virologie)</term><term>Pneumopathie virale (diagnostic)</term><term>Pneumopathie virale (sang)</term><term>Réaction de polymérisation en chaine en temps réel (MeSH)</term><term>Sensibilité et spécificité (MeSH)</term><term>Spécificité des anticorps (MeSH)</term><term>Sujet âgé (MeSH)</term><term>Techniques de laboratoire clinique (méthodes)</term><term>Trousses de réactifs pour diagnostic (MeSH)</term><term>Vaisseaux capillaires (MeSH)</term><term>Études prospectives (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term><term>Immunoglobulin G</term><term>Immunoglobulin M</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="blood supply" xml:lang="en"><term>Fingers</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Infections à coronavirus</term><term>Pneumopathie virale</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Betacoronavirus</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Betacoronavirus</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Betacoronavirus</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Betacoronavirus</term></keywords><keywords scheme="MESH" qualifier="isolation & purification" xml:lang="en"><term>Betacoronavirus</term></keywords><keywords scheme="MESH" qualifier="isolement et purification" xml:lang="fr"><term>Betacoronavirus</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Clinical Laboratory Techniques</term><term>Immunoassay</term></keywords><keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Dosage immunologique</term><term>Techniques de laboratoire clinique</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps antiviraux</term><term>Immunoglobuline G</term><term>Immunoglobuline M</term><term>Infections à coronavirus</term><term>Pneumopathie virale</term></keywords><keywords scheme="MESH" qualifier="vascularisation" xml:lang="fr"><term>Doigts</term></keywords><keywords scheme="MESH" qualifier="virologie" xml:lang="fr"><term>Partie nasale du pharynx</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Nasopharynx</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antibody Specificity</term><term>Capillaries</term><term>Humans</term><term>Middle Aged</term><term>Pandemics</term><term>Point-of-Care Testing</term><term>Prospective Studies</term><term>Reagent Kits, Diagnostic</term><term>Real-Time Polymerase Chain Reaction</term><term>Sensitivity and Specificity</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Analyse sur le lieu d'intervention</term><term>Humains</term><term>Jeune adulte</term><term>Pandémies</term><term>Réaction de polymérisation en chaine en temps réel</term><term>Sensibilité et spécificité</term><term>Spécificité des anticorps</term><term>Sujet âgé</term><term>Trousses de réactifs pour diagnostic</term><term>Vaisseaux capillaires</term><term>Études prospectives</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>The SARS-CoV-2 (Severe Acute Respiratory Syndrome CoronaVirus 2) is responsible for the infectious respiratory disease called COVID-19 (COronaVIrus Disease 2019). In response to the growing COVID-19 pandemic, point-of-care (POC) tests have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. We conducted a prospective observational study to evaluate the performance of two POC tests, COVID-PRESTO® and COVID-DUO®, compared to the gold standard, RT-PCR (real-time reverse transcriptase polymerase chain reaction).</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>RT-PCR testing of SARS-Cov-2 was performed from nasopharyngeal swab specimens collected in adult patients visiting the infectious disease department at the hospital (Orléans, France). Capillary whole blood (CWB) samples from the fingertip taken at different time points after onset of the disease were tested with POC tests. The specificity and sensitivity of the rapid test kits compared to test of reference (RT-PCR) were calculated.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Among 381 patients with symptoms of COVID-19 who went to the hospital for a diagnostic, 143 patients were RT-PCR negative. Results of test with POC tests were all negative for these patients, indicating a specificity of 100% for both POC tests. In the RT-PCR positive subgroup (n = 238), 133 patients were tested with COVID-PRESTO® and 129 patients were tested with COVID-DUO® (24 patients tested with both). The further the onset of symptoms was from the date of collection, the greater the sensitivity. The sensitivity of COVID-PRESTO® test ranged from 10.00% for patients having experienced their 1st symptoms from 0 to 5 days ago to 100% in patients where symptoms had occurred more than 15 days before the date of tests. For COVID-DUO® test, the sensitivity ranged from 35.71% [0-5 days] to 100% (> 15 days).</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>COVID-PRESTO® and DUO® POC tests turned out to be very specific (none false positive) and to be sensitive enough after 15 days from onset of symptom. These easy to use IgG/IgM combined test kits are the first ones allowing a screening with CWB sample, by typing from a finger prick. These rapid tests are particularly interesting for screening in low resource settings.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32941461</PMID><DateCompleted><Year>2020</Year><Month>09</Month><Day>25</Day></DateCompleted><DateRevised><Year>2020</Year><Month>10</Month><Day>01</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Electronic">1932-6203</ISSN><JournalIssue CitedMedium="Internet"><Volume>15</Volume><Issue>9</Issue><PubDate><Year>2020</Year></PubDate></JournalIssue><Title>PloS one</Title><ISOAbbreviation>PLoS One</ISOAbbreviation></Journal><ArticleTitle>Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip.</ArticleTitle><Pagination><MedlinePgn>e0237694</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1371/journal.pone.0237694</ELocationID><Abstract><AbstractText Label="BACKGROUND">The SARS-CoV-2 (Severe Acute Respiratory Syndrome CoronaVirus 2) is responsible for the infectious respiratory disease called COVID-19 (COronaVIrus Disease 2019). In response to the growing COVID-19 pandemic, point-of-care (POC) tests have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. We conducted a prospective observational study to evaluate the performance of two POC tests, COVID-PRESTO® and COVID-DUO®, compared to the gold standard, RT-PCR (real-time reverse transcriptase polymerase chain reaction).</AbstractText><AbstractText Label="METHODS">RT-PCR testing of SARS-Cov-2 was performed from nasopharyngeal swab specimens collected in adult patients visiting the infectious disease department at the hospital (Orléans, France). Capillary whole blood (CWB) samples from the fingertip taken at different time points after onset of the disease were tested with POC tests. The specificity and sensitivity of the rapid test kits compared to test of reference (RT-PCR) were calculated.</AbstractText><AbstractText Label="RESULTS">Among 381 patients with symptoms of COVID-19 who went to the hospital for a diagnostic, 143 patients were RT-PCR negative. Results of test with POC tests were all negative for these patients, indicating a specificity of 100% for both POC tests. In the RT-PCR positive subgroup (n = 238), 133 patients were tested with COVID-PRESTO® and 129 patients were tested with COVID-DUO® (24 patients tested with both). The further the onset of symptoms was from the date of collection, the greater the sensitivity. The sensitivity of COVID-PRESTO® test ranged from 10.00% for patients having experienced their 1st symptoms from 0 to 5 days ago to 100% in patients where symptoms had occurred more than 15 days before the date of tests. For COVID-DUO® test, the sensitivity ranged from 35.71% [0-5 days] to 100% (> 15 days).</AbstractText><AbstractText Label="CONCLUSION">COVID-PRESTO® and DUO® POC tests turned out to be very specific (none false positive) and to be sensitive enough after 15 days from onset of symptom. These easy to use IgG/IgM combined test kits are the first ones allowing a screening with CWB sample, by typing from a finger prick. These rapid tests are particularly interesting for screening in low resource settings.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Prazuck</LastName><ForeName>Thierry</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Colin</LastName><ForeName>Mathilda</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Giachè</LastName><ForeName>Susanna</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gubavu</LastName><ForeName>Camélia</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Seve</LastName><ForeName>Aymeric</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rzepecki</LastName><ForeName>Vincent</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chevereau-Choquet</LastName><ForeName>Marie</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kiani</LastName><ForeName>Catherine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rodot</LastName><ForeName>Victor</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lionnet</LastName><ForeName>Elsa</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Courtellemont</LastName><ForeName>Laura</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Department of Virology, CHR Orleans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Guinard</LastName><ForeName>Jérôme</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Virology, CHR Orleans, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pialoux</LastName><ForeName>Gilles</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Hôpital Tenon, Assistance Publique des Hôpitaux de Paris, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hocqueloux</LastName><ForeName>Laurent</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D064888">Observational Study</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>09</Month><Day>17</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>PLoS One</MedlineTA><NlmUniqueID>101285081</NlmUniqueID><ISSNLinking>1932-6203</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007074">Immunoglobulin G</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007075">Immunoglobulin M</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011933">Reagent Kits, Diagnostic</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Disease" UI="C000657245">COVID-19</SupplMeshName><SupplMeshName Type="Protocol" UI="C000657964">COVID-19 diagnostic testing</SupplMeshName><SupplMeshName Type="Organism" UI="C000656484">severe acute respiratory syndrome coronavirus 2</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000918" MajorTopicYN="N">Antibody Specificity</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000073640" MajorTopicYN="N">Betacoronavirus</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName><QualifierName UI="Q000302" MajorTopicYN="N">isolation & purification</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002196" MajorTopicYN="N">Capillaries</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019411" MajorTopicYN="N">Clinical Laboratory Techniques</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000175" MajorTopicYN="Y">diagnosis</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005385" MajorTopicYN="N">Fingers</DescriptorName><QualifierName UI="Q000098" MajorTopicYN="N">blood supply</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007118" MajorTopicYN="N">Immunoassay</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007074" MajorTopicYN="N">Immunoglobulin G</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007075" MajorTopicYN="N">Immunoglobulin M</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009305" MajorTopicYN="N">Nasopharynx</DescriptorName><QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000175" MajorTopicYN="Y">diagnosis</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000067716" MajorTopicYN="N">Point-of-Care Testing</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011933" MajorTopicYN="Y">Reagent Kits, Diagnostic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D060888" MajorTopicYN="N">Real-Time Polymerase Chain Reaction</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012680" MajorTopicYN="N">Sensitivity and Specificity</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><CoiStatement>The point-of-care tests were provided free of charge by AAZ-LMB. This does not alter our adherence to PLOS ONE policies on sharing data and materials.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>05</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>08</Month><Day>01</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>9</Month><Day>17</Day><Hour>17</Hour><Minute>17</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>9</Month><Day>18</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>9</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32941461</ArticleId><ArticleId IdType="doi">10.1371/journal.pone.0237694</ArticleId><ArticleId IdType="pii">PONE-D-20-15374</ArticleId><ArticleId 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Infect Dis. 2020 Mar 28;:</Citation><ArticleIdList><ArticleId IdType="pubmed">32221519</ArticleId></ArticleIdList></Reference><Reference><Citation>J Infect. 2020 Jul;81(1):e28-e32</Citation><ArticleIdList><ArticleId IdType="pubmed">32283141</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2020 Aug 22;396(10250):535-544</Citation><ArticleIdList><ArticleId IdType="pubmed">32645347</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>France</li></country><region><li>Centre-Val de Loire</li><li>Région Centre</li><li>Île-de-France</li></region><settlement><li>Orléans</li><li>Paris</li></settlement></list><tree><country name="France"><region name="Centre-Val de Loire"><name sortKey="Prazuck, Thierry" sort="Prazuck, Thierry" uniqKey="Prazuck T" first="Thierry" last="Prazuck">Thierry Prazuck</name></region><name sortKey="Chevereau Choquet, Marie" sort="Chevereau Choquet, Marie" uniqKey="Chevereau Choquet M" first="Marie" last="Chevereau-Choquet">Marie Chevereau-Choquet</name><name sortKey="Colin, Mathilda" sort="Colin, Mathilda" uniqKey="Colin M" first="Mathilda" last="Colin">Mathilda Colin</name><name sortKey="Courtellemont, Laura" sort="Courtellemont, Laura" uniqKey="Courtellemont L" first="Laura" last="Courtellemont">Laura Courtellemont</name><name sortKey="Giache, Susanna" sort="Giache, Susanna" uniqKey="Giache S" first="Susanna" last="Giachè">Susanna Giachè</name><name sortKey="Gubavu, Camelia" sort="Gubavu, Camelia" uniqKey="Gubavu C" first="Camélia" last="Gubavu">Camélia Gubavu</name><name sortKey="Guinard, Jerome" sort="Guinard, Jerome" uniqKey="Guinard J" first="Jérôme" last="Guinard">Jérôme Guinard</name><name sortKey="Hocqueloux, Laurent" sort="Hocqueloux, Laurent" uniqKey="Hocqueloux L" first="Laurent" last="Hocqueloux">Laurent Hocqueloux</name><name sortKey="Kiani, Catherine" sort="Kiani, Catherine" uniqKey="Kiani C" first="Catherine" last="Kiani">Catherine Kiani</name><name sortKey="Lionnet, Elsa" sort="Lionnet, Elsa" uniqKey="Lionnet E" first="Elsa" last="Lionnet">Elsa Lionnet</name><name sortKey="Pialoux, Gilles" sort="Pialoux, Gilles" uniqKey="Pialoux G" first="Gilles" last="Pialoux">Gilles Pialoux</name><name sortKey="Rodot, Victor" sort="Rodot, Victor" uniqKey="Rodot V" first="Victor" last="Rodot">Victor Rodot</name><name sortKey="Rzepecki, Vincent" sort="Rzepecki, Vincent" uniqKey="Rzepecki V" first="Vincent" last="Rzepecki">Vincent Rzepecki</name><name sortKey="Seve, Aymeric" sort="Seve, Aymeric" uniqKey="Seve A" first="Aymeric" last="Seve">Aymeric Seve</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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