Abstract
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). 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. 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). 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.
Highlights
At the end of 2019, a pneumonia of unknown cause detected in Wuhan, China was first reported to the World Health Organization (WHO) Country Office in China
Capillary whole blood (CWB) samples from the fingertip taken at different time points after onset of the disease were tested with POC tests
Among 381 patients with symptoms of COVID-19 who went to the hospital for a diagnostic, 143 patients were RT-PCR negative
Summary
At the end of 2019, a pneumonia of unknown cause detected in Wuhan, China was first reported to the WHO Country Office in China. On January 9th, 2020, the Chinese health authorities and the World Health Organization (WHO) officially announced the discovery of a novel coronavirus, first named 2019-nCoV, officially termed SARS-CoV-2 (Severe Acute Respiratory Syndrome CoronaVirus 2). This virus, belonging to the coronavirus family, differs from the viruses SARS-CoV, responsible for the SARS outbreak in 2003, and MERSCoV, responsible for an ongoing outbreak that began in 2012 in the Middle East. The SARS-CoV-2 virus causes the infectious respiratory disease called COVID-19 (COronaVIrus Disease 2019) This infection mainly results in pneumonia and upper/lower respiratory tract infection. 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)
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