Capillary whole-blood IgG-IgM COVID-19 self-test as a serological screening tool for SARS-CoV-2 infection adapted to the general public

Tonen‐Wolyec, Serge; Dupont, Raphaël; Batina‐Agasa, Salomon; Hayette, Marie‐Pierre; Bélec, Laurent

doi:10.1371/journal.pone.0240779

Cited by 10 publications

(17 citation statements)

References 36 publications

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“…The post-test answers to the satisfaction questionnaire concerning the instructions for use (sub-study 1), performing the self-test (sub-study 2), and the interpretation of the results (sub-study 3), showed that the large majority of the COVID-19 self-testing steps were considered easy or very easy by the majority of participants, as previously reported for HIV self-testing using a similar rapid test cassette [28,30]. Watching a video before the test was particularly appreciated.…”

Section: Practicability Evaluationsupporting

confidence: 53%

“…This study aimed to evaluate the usability and clinical performance in the field of the Ag-RDST BIOSYNEX Antigen Self-Test COVID-19 Ag+ (Biosynex Swiss SA, Freiburg, Switzerland; reference 859271) for COVID-19 antigenic testing from self-collected NMT secretions in adults living in the Paris region during the third wave of the COVID-19 epidemic in France. For the first time to our knowledge, the usability of this novel Ag-RDST was evaluated according to a systematic approach based on our previous experience in assessing HIV and SARS-CoV-2 self-testing using capillary blood samples [ 27 , 28 , 29 , 30 ].…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France

Tonen‐Wolyec

Dupont²,

Awaida³

et al. 2021

Diagnostics

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Due to their ease-of-use, lateral flow assay SARS-CoV-2 antigen-detecting rapid diagnostic tests could be suitable candidates for antigen-detecting rapid diagnostic self-test (Ag-RDST). We evaluated the practicability of the Ag-RDST BIOSYNEX Antigen Self-Test COVID-19 Ag+ (Biosynex Swiss SA, Freiburg, Switzerland), using self-collected nasal secretions from the turbinate medium (NMT), in 106 prospectively included adult volunteers living in Paris, France. The majority of the participants correctly understood the instructions for use (94.4%; 95% confidence interval (CI): 88.3–97.4), showing a great ability to perform the entire self-test procedure to obtain a valid and interpretable result (100%; 95% CI: 96.5–100), and demonstrated the ability to correctly interpret test results (96.2%; 95% CI: 94.2–97.5) with a high level of general satisfaction. About one in eight participants (# 15%) needed verbal help to perform or interpret the test, and only 3.8% of test results were misinterpreted. By reference to multiplex real-time RT-PCR, the Ag-RDST showed 90.9% and 100% sensitivity and specificity, respectively, and high agreement (98.1%), reliability (0.94), and accuracy (90.9%) to detect SARS-CoV-2 antigen. Taken together, our study demonstrates the high usability and accuracy of BIOSYNEX Antigen Self-Test COVID-19 Ag+ for supervised self-collected NMT sampling in an unselected adult population living in France.

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Section: Practicability Evaluationsupporting

confidence: 53%

Section: Introductionmentioning

confidence: 99%

Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France

Tonen‐Wolyec

Dupont²,

Awaida³

et al. 2021

Diagnostics

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“…To date, there are two published works that evaluated the usability of SARS-CoV-2 antibodies self-testing at home 26 , 27 . In France, Tonen-Wolyec et al demonstrated high practicability of self-testing, but the performance of the self-test was supervised by an observer and the sample size was small (n = 167) 26 . In England, Atchison et al selected at random and posted rapid antibody tests to 14,400 subjects evaluating the usability through an online survey 27 .…”

Section: Discussionmentioning

confidence: 99%

Feasibility of large-scale population testing for SARS-CoV-2 detection by self-testing at home

Iruzubieta

Fernández-Lanas

Rasines

et al. 2021

Sci Rep

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The simplicity and low cost of rapid point-of-care tests greatly facilitate large-scale population testing, which can contribute to controlling the spread of the COVID-19 virus. We evaluated the applicability of a self-testing strategy for SARS-CoV2 in a population-based, cross-sectional study in Cantabria, Spain, between April and May 2020. For the self-testing strategy, participants received the necessary material for the self-collection of blood and performance of a rapid antibody test using lateral flow immunoassay at home without the supervision of healthcare personnel. A total of 1,022 participants were enrolled. Most participants correctly performed the COVID-19 self-test the first time (91.3% [95% CI 89.4–92.9]). Only a minority of the participants (0.7%) needed the help of healthcare personnel, while 6.9% required a second kit delivery, for a total valid test result in 96.9% of the participants. Incorrect use of the self-test was not associated with the educational level, age over 65, or housing area. Prevalence of IgG antibodies against SARS-CoV2 for subjects with a valid rapid test result was 3.1% (95% CI 2.2–4.4), similar to the seroprevalence result obtained using a conventional approach carried out by healthcare professionals. In conclusion, COVID-19 self-testing should be considered as a screening tool.

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“…Previous studies on HIV self-testing showed that misinterpretation occurred mainly with positive test results having a low-intensity band [39] or invalid results [26,31]. Similarly, the majority (80.0%) of misinterpreted results of COVID-19 self-test for IgG and IgM against SARS-CoV-2 concerned a weak positive IgM band [44]. This difficulty in reading some weak positive bands and in the final interpretation of HIV self-test results was previously reported in lay users as well as trained-users during professional testing [45].…”

Section: Substudymentioning

confidence: 94%

“…We previously reported that a high rate (90.2%) of adult volunteers in Kisangani and Bunia, DRC, correctly read and interpreted immunochromatographic HIV self-test using similar cassette with 2 bands of interest (HIV and control bands) [16]. Recently in France, the rate of correct interpretation of immunochromatographic self-test for IgG and IgM against SARS-CoV-2 serological screening, with 3 bands of interest (IgG and IgM to SARS-CoV-2 and control bands) was very high (98.8%) among adult volunteers [44]. The reading and interpretation of self-test for 3 diseases, as in the present, has never been yet reported in Africa.…”

Section: Substudymentioning

confidence: 99%

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

et al. 2021

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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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Capillary whole-blood IgG-IgM COVID-19 self-test as a serological screening tool for SARS-CoV-2 infection adapted to the general public

Cited by 10 publications

References 36 publications

Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France

Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France

Feasibility of large-scale population testing for SARS-CoV-2 detection by self-testing at home

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

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