Virological validation of finger-stick whole blood HIV self-test Exacto® Test HIV: laboratory protocol v1

protocols.io ◽  
2017 ◽  
Author(s):  
not provided not provided
Keyword(s):  
Whole Blood ◽  
Self Test ◽  
Finger Stick ◽  
Laboratory Protocol

Laboratory protocol: Evaluation of the practicability and virological performances of finger-stick whole blood HIV self-test in French-speaking sub-Saharan Africa v1

protocols.io ◽  
2017 ◽  
Author(s):  
Serge Tonen ◽  
not provided not provided ◽  
not provided not provided ◽  
not provided not provided ◽  
Salomon Batina ◽  
...  
Keyword(s):  
Whole Blood ◽  
Sub Saharan Africa ◽  
French Speaking ◽  
Self Test ◽  
Protocol Evaluation ◽  
Sub Saharan ◽  
Finger Stick ◽  
Laboratory Protocol

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 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 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 Self-testing for HIV, HBV, and HCV using finger-stick whole-blood multiplex immunochromatographic rapid test: A pilot feasibility study in sub-Saharan Africa

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0249701
Author(s):  
Serge Tonen-Wolyec ◽  
Roland Marini Djang’eing’a ◽  
Salomon Batina-Agasa ◽  
Charles Kayembe Tshilumba ◽  
Jérémie Muwonga Masidi ◽  
...  
Keyword(s):  
Rural Areas ◽  
Whole Blood ◽  
Urban Areas ◽  
Sub Saharan Africa ◽  
Test Results ◽  
Multicentric Study ◽  
Self Testing ◽  
Self Test ◽  
Sub Saharan ◽  
Finger Stick

Background The burden of HIV, HBV, and HCV infections remains disproportionately high in sub-Saharan Africa, with high rates of co-infections. Multiplex rapid diagnostic tests for HIV, HBV and HCV serological testing with high analytical performances may improve the “cascade of screening” and quite possibly the linkage-to-care with reduced cost. Based on our previous field experience of HIV self-testing, we herein aimed at evaluating the practicability and acceptability of a prototype finger-stick whole-blood Triplex HIV/HCV/HBsAg self-test as a simultaneous serological screening tool for HIV, HBV, and HCV in the Democratic Republic of the Congo (DRC). Methods A cross-sectional multicentric study consisting of face-to-face, paper-based, and semi-structured questionnaires with a home-based and facility-based recruitment of untrained adult volunteers at risk of HIV, HBV, and HCV infections recruited from the general public was conducted in 2020 in urban and rural areas in the DRC. The practicability of the Triplex self-test was assessed by 3 substudies on the observation of self-test manipulation including the understanding of the instructions for use (IFU), on the interpretation of Triplex self-test results and on its acceptability. Results A total of 251 volunteers (mean age, 28 years; range, 18–49; 154 males) were included, from urban [160 (63.7%)] and rural [91 (36.3%)] areas. Overall, 242 (96.4%) participants performed the Triplex self-test and succeeded in obtaining a valid test result with an overall usability index of 89.2%. The correct use of the Triplex self-test was higher in urban areas than rural areas (51.2% versus 16.5%; aOR: 6.9). The use of video IFU in addition to paper-based IFU increased the correct manipulation and interpretation of the Triplex self-test. A total of 197 (78.5%) participants correctly interpreted the Triplex self-test results, whereas 54 (21.5%) misinterpreted their results, mainly the positive test results harboring low-intensity band (30/251; 12.0%), and preferentially the HBsAg band (12/44; 27.3%). The rates of acceptability of reuse, distribution of the Triplex self-test to third parties (partner, friend, or family member), linkage to the health care facility for confirmation of results and treatment, and confidence in the self-test results were very high, especially among participants from urban areas. Conclusions This pilot study shows evidence for the first time in sub-Saharan Africa on good practicability and high acceptability of a prototype Triplex HIV/HCV/HBsAg self-test for simultaneous diagnosis of three highly prevalent chronic viral infections, providing the rational basis of using self-test harboring four bands of interest, i.e. the control, HIV, HCV, and HBsAg bands. The relatively frequent misinterpretation of the Triplex self-test points however the necessity to improve the delivery of this prototype Triplex self-test probably in a supervised setting. Finally, these observations lay the foundations for the potential large-scale use of the Triplex self-test in populations living in sub-Saharan Africa at high risk for HIV, HBV, and HCV infections.

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