scholarly journals Evaluation of the Practicability of a Finger-Stick Whole-Blood SARS-Cov-2 Self-Test Adapted for the General Population.

2020 ◽  
Author(s):  
thierry prazuck ◽  
Jean Phan Van ◽  
Florence sinturel ◽  
frederique levray ◽  
Allan Elie ◽  
...  
Keyword(s):  
General Population ◽  
Whole Blood ◽  
Real Life ◽  
High Sensitivity ◽  
University Hospital ◽  
Life Study ◽  
Health Authorities ◽  
Self Test ◽  
Finger Stick ◽  
Instructions For Use

Background COVID-19 (COronaVIrus Disease 2019) is an infectious respiratory disease caused by the novel SARS-CoV-2 virus. Rapid Diagnostic Tests (RDTs) have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood and easily usable by the general population are needed in order to alleviate the lockdown that many countries have initiated in response to the growing COVID-19 pandemic. A real-life study has been conducted in order to evaluate the performance of the COVID-PRESTO RDT and the results have been submitted for publication and are currently under review. Even if this test showed very high sensitivity and specificity in a laboratory setting when used by trained professionals, it needs to be further evaluated for practicability when used by common folk in order to be approved by health authorities for in-home use Methods 142 participants were recruited between March 2020 and April 2020 among non-medical populations in central France (nuclear plants workers, individuals attending the Orleans University Hospital vaccination clinic and Orleans University Hospital non-medical staff). Instructions for use with or without a tutorial video was made available to the volunteers. Two separate objectives were pursued: evaluation of the capability of participants to obtain an interpretable result, and evaluation of the users ability to read the results. Results 88.4 % of the test users judged the instruction for use leaflet to be clear and understandable. 99.3 % of the users obtained a valid results and according to the supervisors 92.7% of the tests were properly performed by the user. Overall, 95% of the users gave positive feedback toward the COVID PRESTO as a potential self-test. No influence of age and education was observed. Conclusion COVID-PRESTO was successfully used by an overwhelming majority of participants and its utilization was judged very satisfactory, therefore showing a promising potential as a self-test to be used by the general population. This RDT can become an easy-to-use tool to help know whether individuals are protected or not, particularly in the perspective of a second wave or a mass vaccination program.

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

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0245848
Author(s):  
Thierry Prazuck ◽  
Jean Phan Van ◽  
Florence Sinturel ◽  
Frederique Levray ◽  
Allan Elie ◽  
...  
Keyword(s):  
General Population ◽  
Whole Blood ◽  
Point Of Care ◽  
Real Life ◽  
High Sensitivity ◽  
University Hospital ◽  
Life Study ◽  
Self Test ◽  
Finger Stick ◽  
Instructions For Use

Background COVID-19 (COronaVIrus Disease 2019) is an infectious respiratory disease caused by the novel SARS-CoV-2 virus. Point of Care (POC) tests have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. They need to be easily usable by the general population in order to alleviate the lockdown that many countries have initiated in response to the growing COVID-19 pandemic. A real-life study has been conducted in order to evaluate the performance of the COVID-PRESTO® POC test and the results were recently published. Even if this test showed very high sensitivity and specificity in a laboratory setting when used by trained professionals, it needs to be further evaluated for practicability when used by the general public in order to be approved by health authorities for in-home use. Methods 143 participants were recruited between March 2020 and April 2020 among non-medical populations in central France (nuclear plant workers, individuals attending the Orleans University Hospital vaccination clinic and Orleans University Hospital non-medical staff). Instructions for use, with or without a tutorial video, were made available to the volunteers. Two separate objectives were pursued: evaluation of the capability of participants to obtain an interpretable result, and evaluation of the users’ ability to read the results. Results 88.4% of the test users judged the instructions for use leaflet to be clear and understandable. 99.3% of the users obtained a valid result and, according to the supervisors, 92.7% of the tests were properly performed by the users. Overall, 95% of the users gave positive feedback on the COVID PRESTO® as a potential self-test. Neither age nor education had an influence. Conclusion COVID-PRESTO® was successfully used by an overwhelming majority of participants and its use was judged very satisfactory, therefore showing promising potential as a self-test to be used by the general population. This POC test can become an easy-to-use tool to help detect whether individuals are protected or not, particularly in the context of a second wave or a mass vaccination program.

scholarly journals Evaluation of performance of two SARS-CoV-2 Rapid whole-blood finger-stick IgM-IgG Combined Antibody Tests

2020 ◽  
Author(s):  
Thierry Prazuck ◽  
Mathilda Colin ◽  
Susanna Giachè ◽  
Camélia Gubavu ◽  
Aymeric Seve ◽  
...  
Keyword(s):  
Whole Blood ◽  
Real Life ◽  
Rapid Test ◽  
Nasopharyngeal Swab ◽  
Rt Pcr ◽  
Life Study ◽  
Negative Results ◽  
Specificity And Sensitivity ◽  
Capillary Blood Sample ◽  
Finger Stick

AbstractBackgroundThe SARS-CoV-2 virus is responsible for the infectious respiratory disease called COVID-19 (COronaVIrus Disease). In response to the growing COVID-19 pandemic, Rapid Diagnostic Tests (RDTs) have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. We conducted a real-life study to evaluate the performance of two RDTs, COVID-PRESTO® and COVID-DUO®, compared to the gold standard, RT-PCR.MethodsRT-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). Fingertip whole blood samples taken at different time points after onset of the disease were tested with RDTs. The specificity and sensitivity of the rapid test kits compared to test of reference (RT-PCR) were calculated.ResultsAmong 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 RDTs were all negative for these patients, indicating a specificity of 100% for both RDTs.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).ConclusionCOVID-PRESTO® and DUO® RDTs 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 capillary blood sample, by typing from a finger prick. These rapid tests are particularly interesting for screening in low resource settings.

scholarly journals Diagnostic Accuracy of SARS-CoV-2 Antigen Detection Test in Children: A Real-Life Study

2021 ◽  
Vol 9 ◽  
Author(s):  
Camille Jung ◽  
Corinne Levy ◽  
Emmanuelle Varon ◽  
Sandra Biscardi ◽  
Christophe Batard ◽  
...  
Keyword(s):  
Real Life ◽  
University Hospital ◽  
Rt Pcr ◽  
Life Study ◽  
Mean Delay ◽  
Positive Person ◽  
The Mean ◽  
Real Life Study ◽  
The University ◽  
Positive Groups

Naso-pharyngeal RT-PCR is the gold standard for the diagnosis of COVID-19, but there is a need for rapid and reliable tests. Some validation studies have used frozen aliquots mainly from adults. The aim of this real-life study was to test the performance of a SARS-CoV-2 rapid antigen test (SC2-RAT) in children. Symptomatic patients aged 0 to 17 years were recruited in the emergency department of the University Hospital of Creteil and in primary care pediatric practices from October 10, 2020 for 7 weeks. Each enrolled child had a SARS-CoV-2 RT-PCR test and a SC2-RAT from two distinct nasopharyngeal swabs. Among the 308 patients (mean [SD] age 4.9 [5.3] years), fever was the main symptom (73.4%), with no difference between COVID-19–negative and –positive groups. The prevalence of COVID-19 was 10.7% (95% CI 7.5–14.7). On the whole cohort, the sensitivity and specificity of the SC2-RAT compared to RT-PCR was 87.9% (95% CI 71.8–96.6) and 98.5% (95% CI 96.3–99.6). Considering samples with cycle threshold >25, the sensibility was lower: 63.6% (95% CI 30.8–89.1) and the specificity 99.6% (95% CI 98.0–100.0). The mean delay to obtain an SC2-RAT result was <15 min but was 3.2 h (SD 5.5) for an RT-PCR result. Contact with a COVID-19–positive person was more frequent for COVID-19–positive than –negative patients (n = 21, 61.6%, vs. n = 64, 24.6%; p < 0.01). In real life, SC2-RAT seems reliable for symptomatic children, allowing to detect contagious children.

scholarly journals Evaluation of Two Rapid Antigenic Tests for the Detection of SARS-CoV-2 in Nasopharyngeal Swabs

2021 ◽  
Vol 10 (13) ◽  
pp. 2774
Author(s):  
Ysaline Seynaeve ◽  
Justine Heylen ◽  
Corentin Fontaine ◽  
François Maclot ◽  
Cécile Meex ◽  
...  
Keyword(s):  
Real Life ◽  
Rapid Test ◽  
High Sensitivity ◽  
Antigen Detection ◽  
Ease Of Use ◽  
University Hospital ◽  
Performance Criteria ◽  
World Health ◽  
Diagnostic Tools ◽  
The University

(1) Background: In the current context of the COVID-19 crisis, there is a need for fast, easy-to-use, and sensitive diagnostic tools in addition to molecular methods. We have therefore decided to evaluate the performance of newly available antigen detection kits in “real-life” laboratory conditions. (2) Methods: The sensitivity and specificity of two rapid diagnostic tests (RDT)—the COVID-19 Ag Respi-Strip from Coris Bioconcept, Belgium (CoRDT), and the coronavirus antigen rapid test cassette from Healgen Scientific, LLC, USA (HeRDT)—were evaluated on 193 nasopharyngeal samples using RT-PCR as the gold standard. (3) Results: The sensitivity obtained for HeRDT was 88% for all collected samples and 91.1% for samples with Ct ≤ 31. For the CoRDT test, the sensitivity obtained was 62% for all collected samples and 68.9% for samples with Ct ≤ 31. (4) Conclusions: Despite the excellent specificity obtained for both kits, the poor sensitivity of the CoRDT did not allow for its use in the rapid diagnosis of COVID-19. HeRDT satisfied the World Health Organization’s performance criteria for rapid antigen detection tests. Its high sensitivity, quick response, and ease of use allowed for the implementation of HeRDT at the laboratory of the University Hospital of Liège.

scholarly journals A Finger-Stick Whole-Blood HIV Self-Test as an HIV Screening Tool Adapted to the General Public

PLoS ONE ◽  
2016 ◽  
Vol 11 (2) ◽  
pp. e0146755 ◽  
Author(s):  
Thierry Prazuck ◽  
Stephen Karon ◽  
Camelia Gubavu ◽  
Jerome Andre ◽  
Jean Marie Legall ◽  
...  
Keyword(s):  
Whole Blood ◽  
General Public ◽  
Screening Tool ◽  
Hiv Screening ◽  
Self Test ◽  
Finger Stick

scholarly journals Multimodal Prehabilitation in Radioactive Iodine-refractory Differentiated Thyroid Cancer Treated With Lenvatinib.

2021 ◽  
Author(s):  
Alejandra Perez-Montes de Oca ◽  
Clara Joaquin ◽  
Federico Vazquez ◽  
Eva Martinez ◽  
Olatz Etxanitz ◽  
...  
Keyword(s):  
Weight Loss ◽  
Thyroid Cancer ◽  
Differentiated Thyroid Cancer ◽  
Radioactive Iodine ◽  
Real Life ◽  
Common Adverse Event ◽  
University Hospital ◽  
Consecutive Series ◽  
Life Study ◽  
Treatment And Prevention

Abstract Purpose This study describes our clinical experience with lenvatinib for the treatment of radioactive iodine refractory differentiated thyroid cancer (RR-DTC) using a multimodal patient-centered prehabilitation multidisciplinary approach assessing its effectiveness and patient outcomes. Methods and design This is a retrospective observational real-life study of a consecutive series of RR-DTC patients treated with lenvatinib as first-line treatment at Germans Trias i Pujol University Hospital. Results Partial response was observed in 6 patients (46.1%), stable disease in 5 patients (38.5%) and disease progression in 2 patients (15.4%). PFS and OS were 16.3 and 17.9 months respectively. AEs occurred in all patients. The most common adverse event (AE) was fatigue (69%), followed by diarrhea (46%), hypertension (46%) and anorexia (38.3%). Weight loss was present in 30.7% of the patients and only 7.7% was grade 3. Conclusion In our experience, prehabilitation can be useful to decrease not only the incidence but the severity of important side effects such as weight loss, anorexia and hypertension. For these complex patients, a multidisciplinary team is useful for follow-up, treatment and prevention of possible AEs.

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