Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2020 Sep 17;15(9):e0237694.
doi: 10.1371/journal.pone.0237694. eCollection 2020.

Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip

Thierry Prazuck  1 , Mathilda Colin  1 , Susanna Giachè  1 , Camélia Gubavu  1 , Aymeric Seve  1 , Vincent Rzepecki  1 , Marie Chevereau-Choquet  1 , Catherine Kiani  1 , Victor Rodot  1 , Elsa Lionnet  1 , Laura Courtellemont  2 , Jérôme Guinard  2 , Gilles Pialoux  3 , Laurent Hocqueloux  1
Affiliations
Observational Study

Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip

Thierry Prazuck et al. PLoS One. .

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.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Fig 1
Fig 1. Interpretation of results for COVID-PRESTO®.
Fig 2
Fig 2. Interpretation of results for COVID-DUO®.
Fig 3
Fig 3. Number of samples screened with RT-PCR and Point-of-care (POC) tests.
Fig 4
Fig 4. Patients with a positive COVID-PRESTO® test: Distribution of IgM+ and IgG+ patterns.
Fig 5
Fig 5. Patients with a positive COVID-DUO® test: Distribution of IgM+ and IgG+ patterns.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. Journal of Autoimmunity. 2020;109: 102433 10.1016/j.jaut.2020.102433 - DOI - PMC - PubMed
    1. Gorbalenya AE, Baker SC, Baric RS, de Groot RJ, Drosten C, Gulyaeva AA, et al. Severe acute respiratory syndrome-related coronavirus: The species and its viruses–a statement of the Coronavirus Study Group. Microbiology; 2020. February 10.1101/2020.02.07.937862 - DOI
    1. World Health Organization 2020. Advice on the use of point-of-care immunodiagnostic tests for COVID-19. Scientific brief. 8 April 2020. Available from: https://www.who.int/news-room/commentaries/detail/advice-on-the-use-of-p.... Accessed 9 May 2020.
    1. World Health Organization 2020—Real-time RT-PCR assays for the detection of SARS-CoV-2, Institut Pasteur, Paris. Available from: https://www.who.int/docs/default-source/coronaviruse/real-time-rt-pcr-as.... Accessed 9 May 2020.
    1. Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Eurosurveillance. 2020;25 10.2807/1560-7917.ES.2020.25.3.2000045 - DOI - PMC - PubMed

Publication types

MeSH terms

Grants and funding

The study was funded by CHR Orleans (Orléans Regional Hospital Centre), a public hospital with no-profit status, of which all authors are employees. The point-of-care tests were provided free of charge by AAZ-LMB.