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Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip.
PLoS One. 2020; 15(9):e0237694.Plos

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.

Authors+Show Affiliations

Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.Department of Virology, CHR Orleans, Orléans, France.Department of Virology, CHR Orleans, Orléans, France.Department of Infectious Diseases, Hôpital Tenon, Assistance Publique des Hôpitaux de Paris, Paris, France.Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.

Pub Type(s)

Journal Article
Observational Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32941461

Citation

Prazuck, Thierry, et al. "Evaluation of Performance of Two SARS-CoV-2 Rapid IgM-IgG Combined Antibody Tests On Capillary Whole Blood Samples From the Fingertip." PloS One, vol. 15, no. 9, 2020, pp. e0237694.
Prazuck T, Colin M, Giachè S, et al. Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip. PLoS One. 2020;15(9):e0237694.
Prazuck, T., Colin, M., Giachè, S., Gubavu, C., Seve, A., Rzepecki, V., Chevereau-Choquet, M., Kiani, C., Rodot, V., Lionnet, E., Courtellemont, L., Guinard, J., Pialoux, G., & Hocqueloux, L. (2020). Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip. PloS One, 15(9), e0237694. https://doi.org/10.1371/journal.pone.0237694
Prazuck T, et al. Evaluation of Performance of Two SARS-CoV-2 Rapid IgM-IgG Combined Antibody Tests On Capillary Whole Blood Samples From the Fingertip. PLoS One. 2020;15(9):e0237694. PubMed PMID: 32941461.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip. AU - Prazuck,Thierry, AU - Colin,Mathilda, AU - Giachè,Susanna, AU - Gubavu,Camélia, AU - Seve,Aymeric, AU - Rzepecki,Vincent, AU - Chevereau-Choquet,Marie, AU - Kiani,Catherine, AU - Rodot,Victor, AU - Lionnet,Elsa, AU - Courtellemont,Laura, AU - Guinard,Jérôme, AU - Pialoux,Gilles, AU - Hocqueloux,Laurent, Y1 - 2020/09/17/ PY - 2020/05/22/received PY - 2020/08/01/accepted PY - 2020/9/17/entrez PY - 2020/9/18/pubmed PY - 2020/9/26/medline SP - e0237694 EP - e0237694 JF - PloS one JO - PLoS One VL - 15 IS - 9 N2 - 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. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/32941461/Evaluation_of_performance_of_two_SARS_CoV_2_Rapid_IgM_IgG_combined_antibody_tests_on_capillary_whole_blood_samples_from_the_fingertip_ L2 - https://dx.plos.org/10.1371/journal.pone.0237694 DB - PRIME DP - Unbound Medicine ER -