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

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 1 st 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.

SARS-CoV-2 infection in Ivory Coast: a serosurveillance survey among gold mine workers

“…Performances of this test have already been assessed in real life, regardless of the manufacturer’s instructions. The sensitivity of COVID-PRESTO® test ranged from 10% for patients having experienced their first symptoms from 0 to 5 days earlier to 100% in patients whose symptoms occurred more than 15 days earlier 5 .…”

Evaluation of the practicability of a finger-stick whole-blood SARS-Cov-2 self-test adapted for the general population

“…The blood sample is then collected with a capillary micropipette and deposited in the appropriate well of the test cassette. COVID-PRESTO ® ’s performance has been evaluated in a recent clinical study, and the test showed a specificity of 100% and a sensitivity ranging from 10% (when the test was done 0–5 days after symptoms onset) to 100% (when performed ≥15 days after experiencing the first symptoms) [ 11 ]. Those results were obtained in a controlled setting where the test was performed by trained professionals.…”

Performance of two rapid point of care SARS-COV-2 antibody assays against laboratory-based automated chemiluminescent immunoassays for SARS-COV-2 IG-G, IG-M and total antibodies

“…It is essential that the performance of newly developed POCT assays be thoroughly evaluated before use. Performance between different POCT assays varies greatly (see Supplementary Table 4 ) [ [5] , [6] , [7] , [8] , [9] , [10] , [11] , [12] ] with a range of different assay sensitivities. The meta-analysis by ML Bastos in July 2020 [ 3 ] showed that POCT assays up till April 2020 had varied sensitivities (36.4%–100%).…”