[en] The practicability of a prototype capillary whole-blood IgG-IgM COVID-19 self-test (Exacto® COVID-19 self-test, Biosynex Swiss SA, Freiburg, Switzerland) as a serological screening tool for SARS-CoV-2 infection adapted to the general public was evaluated in across-sectional, general adult population study performed between April and May 2020 in Strasbourg, France, consisting of face-to-face, paper-based, semi-structured, and selfadministrated questionnaires. Practicability was defined as the correct use of the self-test and the correct interpretation of the result. The correct use of self-test was conditioned by the presence of the control band after 15-min of migration. The correct interpretation of the tests was defined by the percent agreement between the tests results read and interpret by the participants compared to the expected results coded by the numbers and verified by trained observers. A total of 167 participants (52.7% female; median age, 35.8 years; 82% with post-graduate level) were enrolled, including 83 and 84 for usability and test results interpretation substudies, respectively. All participants (100%; 95% CI: 95.6–
100) correctly used the self-test. However, 12 (14.5%; 95% CI: 8.5–23.6) asked for verbal
help. The percent agreement between the tests results read and interpret by the participants compared to the expected results was 98.5% (95% CI: 96.5–99.4). However, misinterpretation occurred in only 2.3% of positive and 1.2% of invalid test results. Finally, all (100%) participants found that performing the COVID-19 self-test was easy; and 98.8% found the interpretation of the self-test results easy. Taken together, these pilot observations demonstrated for the first-time, high practicability and satisfaction of COVID-19 selftesting for serological IgG and IgM immune status, indicating its potential for use by the general public to complete the arsenal of available SARS-CoV-2 serological assays in the urgent context of the COVID-19 epidemic.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Tonen-Wolyec, Serge; Ecole Doctorale Régionale D’Afrique Centrale en Infectiologie Tropicale, Franceville, Gabon ; Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, The Democratic Republic of the Congo
Dupont, Raphael; BioSynex, Strasbourg, France
Batina-Agasa, Salomon; Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, The Democratic Republic of the Congo
HAYETTE, Marie-Pierre ; Centre Hospitalier Universitaire de Liège - CHU > Unilab > Service de microbiologie clinique
Bélec, Laurent; Laboratoire de Virologie, Hôpital Europeen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France ; Université Paris Descartes, Sorbonne Paris Cité, Paris, France
Language :
English
Title :
Capillary whole-blood IgG-IgM COVID-19 selftest as a serological screening tool for SARSCoV-2 infection adapted to the general public
Publication date :
15 October 2020
Journal title :
PLoS ONE
eISSN :
1932-6203
Publisher :
Public Library of Science, United States - California
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020; 382:727–733. https://doi.org/10.1056/NEJMoa2001017 PMID: 31978945
Guan W, Ni Z, Hu Y, Liang W, Ou C, He J, et al. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020; 382:1708–1720. https://doi.org/10.1056/NEJMoa2002032 PMID: 32109013
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020; 395:497–506. https://doi.org/10.1016/S0140-6736(20) 30183-5 PMID: 31986264
World Health Organization. Coronavirus disease (COVID-19) outbreak. Available from: https://www.who.int (last access 13 June 2020).
Wölfel R, Corman VM, Guggemos W, Seilmaier M, Zange S, Müller MA, et al. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020; 581:465–469. https://doi.org/10.1038/s41586-020-2196-x PMID: 32235945
Péré H, Podglajen I, Wack M, Flamarion E, Mirault T, Goudot G, et al. Nasal Swab Sampling for SARSCoV-2: a Convenient Alternative in Times of Nasopharyngeal Swab Shortage. J Clin Microbiol. 2020 May 26; 58(6):e00721–20. https://doi.org/10.1128/JCM.00721-20 PMID: 32295896
Amanat F, Stadlbauer D, Strohmeier S, Nguyen THO, Chromikova V, McMahon M, et al. A serological assay to detect SARS-CoV-2 seroconversion in humans. Nat Med. 2020 May 12. https://doi.org/10.1038/s41591-020-0913-5 Online ahead of print. PMID: 32398876
Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun; 26(6):845–848. https://doi.org/10.1038/s41591-020-0897-1 PMID: 32350462
Petherick A. 2020. Developing antibody tests for SARS-CoV-2. Lancet 395:1101–1102. https://doi.org/10.1016/S0140-6736(20)30788-1 PMID: 32247384
World Health Organization. 2020. Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases: interim guidance, 2 March 2020. World Health Organization. Available from: https://apps.who.int/iris/bitstream/handle/10665/331329/WHO-COVID-19-laboratory-2020.4-eng.pdf?sequence=1&isAllowed=y (last access 21 June 2020).
Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, et al. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol. 2020 Feb 27; https://doi.org/10.1002/jmv.25727 PMID: 32104917
Pérez-García F, Pérez-Tanoira R, Romanyk J, Arroyo T, Gómez-Herruz P, Cuadros-González J. Alltest rapid lateral flow immunoassays is reliable in diagnosing SARS-CoV-2 infection from 14 days after symptom onset: A prospective single-center study. J Clin Virol. 2020 May 27; 129:104473. https://doi.org/10.1016/j.jcv.2020.104473 PMID: 32504945
Dellière S, Salmona M, Minier M, Gabassi A, Alanio A, Le Goff J, et al. Evaluation of COVID-19 IgG/IgM Rapid Test from Orient Gene Biotech. J Clin Microbiol. 2020 Jun 9:JCM.01233-20.
Zainol Rashid Z, Othman SN, Abdul Samat MN, Ali UK, Wong KK. Diagnostic Performance of COVID-19 Serology Assays. Malays J Pathol. 2020 Apr; 42(1):13–21. PMID: 32342927
World Health Organization. Guidelines on HIV self-testing and partner notification: supplement to consolidated guidelines on HIV testing services. December 2016. Available from: http://apps.who.int/iris/bitstream/handle/10665/251655/9789241549868-eng.pdf;jsessionid=B043673B59952F021C313F07 6554ABA6?sequence=1. (last access 28 May 2020).
World Health Organization & UNITAID. Market and Technology Landscape. HIV rapid diagnostic tests for self-testing, 4th Edition. July 2018. Available from: https://unitaid.org/assets/HIVST-landscapereport.pdf (last access 18 June 2020).
Prazuck T, Karon S, Gubavu C, Andre J, Legall JM, Bouvet E, et al. A finger-stick whole-blood HIV self-test as an HIV screening tool adapted to the general public. PloS One. 2016; 11(2):e0146755. https://doi.org/10.1371/journal.pone.0146755 PMID: 26882229
Tonen-Wolyec S, Batina-Agasa S, Muwonga J, Fwamba N’kulu F, Mboumba Bouassa RS, Belec L. Evaluation of the practicability and virological performance of finger-stick whole-blood HIV self-testing in French-speaking sub-Saharan Africa. PLoS One 2018; 13: e0189475. https://doi.org/10.1371/journal.pone.0189475 PMID: 29320504
Tonen-Wolyec S, Batina-Agasa S, Longo JD, Mboumba Bouassa RS, Bélec L. Insufficient education is a key factor of incorrect interpretation of HIV self-test results by female sex workers in Democratic Republic of the Congo: A multicenter cross-sectional study. Medicine (Baltimore). 2019 Feb; 98(6):e14218.
Tonen-Wolyec S, Batina-Agasa S, Muwonga J, Mboumba Bouassa RS, Kayembe Tshilumba C, Bélec L. Acceptability, feasibility, and individual preferences of blood-based HIV self-testing in a population-based sample of adolescents in Kisangani, Democratic Republic of the Congo. PLoS One. 2019 Jul 1; 14(7):e0218795. https://doi.org/10.1371/journal.pone.0218795 PMID: 31260480
Tonen-Wolyec S, Mboumba Bouassa RS, Batina-Agasa S, Tepungipame AT, Tshilumba CK, Bélec L. Sociodemographic characteristics of adolescents preferring home-based HIV self-testing over facility-based voluntary counseling and testing: a cross-sectional study in Kisangani, Democratic Republic of the Congo. Int J STD AIDS. 2020 Apr; 31(5):481–487. https://doi.org/10.1177/0956462419898616 PMID: 32131704
Ministère des Solidarités et de santé. Tests COVID-19, guider votre choix parmi les 155 tests Covid-19 du marché. France 2020. Available from: https://covid-19.sante.gouv.fr/tests. (last access 20 June 2020)
Haute Autorité de Santé. Cahier des charges définissant les modalités d’évaluation des performances des tests sérologiques détectant les anticorps dirigés contre le SARS-CoV-2. Saint-Denis, France, 2020. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2020-04/cahier_des_ charges_test_serologique_covid19.pdf. (last access 20 June 2020).
Santé publique France. COVID-19: point épidémiologique du 2 juillet 2020. Available from: https://www.santepubliquefrance.fr/maladies-et-traumatismes/maladies-et-infections-respiratoires/infection-acoronavirus/documents/bulletin-national/covid-19-point-epidemiologique-du-2-juillet-2020. (last access 02 July 2020)
World Health Organization (WHO) WHO prequalification: Sample product dossier for an IVD intended for HIV self-testing. SIMU™ self-test for HIV 12O working document, December 2015. http://www.who.int/sample_dos_self_testinghiv_for_public_c__comment_v1_pdf. 2015. (last access 13 June 2020).
Cohen J. A coefficient of agreement for nominal scales. Educ. Psychol. Meas. 1960; 20:37–46.
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics.1997; 33:159–174.
Neves BS, Altermann C, Gonçalves R, Lara MV, Mello-Carpes PB. Home-based vs. Laboratory-Based Practical Activities in the Learning of Human Physiology: The Perception of Students. Adv Physiol Educ. 2017 Mar 1; 41(1):89–93. https://doi.org/10.1152/advan.00018.2016 PMID: 28143828
Tonen-Wolyec S, Mboup S, Grésenguet G, Bouassa RB, Bélec L. Insufficient education is a challenge for HIV self-testing. Lancet HIV. 2018; 5(7):e341.
Figueroa C, Johnson C, Ford N, Sands A, Dalal S, Meurant R, et al. Reliability of HIV rapid diagnostic tests for self-testing performed by self-testers compared to health-care workers: a systematic review and meta-analysis. Lancet HIV. 2018; 5(6):e277–e290. https://doi.org/10.1016/S2352-3018(18)30044-4 PMID: 29703707
Simwinga M, Kumwenda MK, Dacombe RJ, Kayira L, Muzumara A, Johnson CC, et al. Ability to understand and correctly follow HIV self-test kit instructions for use: applying the cognitive interview technique in Malawi and Zambia. J Int AIDS Soc. 2019 Mar; 22(Suppl Suppl 1): e25253.
Pant Pai N, Sharma J, Shivkumar S, Pillay S, Vadnais C, Joseph L, et al. Supervised and unsupervised self-testing for HIV in high- and low-risk populations: a systematic review. PLoS Med. 2013; 10(4): e1001414. https://doi.org/10.1371/journal.pmed.1001414 PMID: 23565066
Ortblad KF, Musoke DK, Ngabirano T, Nakitende A, Haberer JE, McConnell M, et al. Female sex workers often incorrectly interpret HIV self-test results in Uganda. J Acquir Immune Defic Syndr 2018; 79: e42–5. https://doi.org/10.1097/QAI.0000000000001765 PMID: 29847478
Tahlil KM, Ong JJ, Rosenberg NE, Tang W, Conserve DF, Nkengasong S, et al. Verification of HIV Self-Testing Use and Results: A Global Systematic Review. AIDS Patient Care STDS. 2020 Apr; 34 (4):147–156. https://doi.org/10.1089/apc.2019.0283 PMID: 32324482
CDC, WHO, APL. Guidelines for Appropriate Evaluations of HIV Testing Technologies in Africa. 2001.
Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020 May 6. https://doi.org/10.1001/jama.2020.8259 PMID: 32374370
Rogers JP, Chesney E, Oliver D, Pollak TA, McGuire P, Fusar-Poli P, et al. Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic. Lancet Psychiatry. 2020 Jul; 7(7):611–627. https://doi.org/10.1016/S2215-0366(20)30203-0 PMID: 32437679
Atchison C, Pristerà P, Cooper E, Papageorgiou V, Redd R, Piggin M, et al. Usability and acceptability of home-based self-testing for SARS-CoV-2 antibodies for population surveillance. Clin Infect Dis. 2020 Aug 12:ciaa1178. https://doi.org/10.1093/cid/ciaa1178 PMID: 32785665
World Health Organization. Laboratory testing strategy recommendations for COVID-19. 22 Mar 2020. Available at: https://apps.who.int/iris/bitstream/handle/10665/331509/WHO-COVID-19-lab_testing2020.1-eng.pdf (last access 24 June 2020).
Lee CY, Lin RTP, Renia L, Ng LFP. Serological Approaches for COVID-19: Epidemiologic Perspective on Surveillance and Control. Front Immunol. 2020 Apr 24; 11:879. https://doi.org/10.3389/fimmu.2020. 00879 PMID: 32391022
Adeniji AA. ‘Self-collected upper respiratory tract swabs for COVID-19 test’: A feasible way to increase overall testing rate and conserve resources in South Africa. Afr J Prim Health Care Fam Med. 2020 May 28; 12(1):e1–e4.
Food and Drug Administration. FDA NEWS RELEASE. Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens. United states of America, 2020. Available at: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-using-home-collection-saliva (last access: 24 June 2020).
Faezipour M, Abuzneid A. Smartphone-Based Self-Testing of COVID-19 Using Breathing Sounds. Telemed J E Health. 2020 Jun 2. https://doi.org/10.1089/tmj.2020.0114 PMID: 32487005
McCullough PA, Eidt J, Rangaswami J, Lerma E, Tumlin J, Wheelan K, et al. Urgent need for individual mobile phone and institutional reporting of at home, hospitalized, and intensive care unit cases of SARS-CoV-2 (COVID-19) infection. Rev Cardiovasc Med. 2020 Mar 30; 21(1):1–7. https://doi.org/10.31083/j.rcm.2020.01.42 PMID: 32259899
Mashamba-Thompson TP, Crayton ED. Blockchain and Artificial Intelligence Technology for Novel Coronavirus Disease-19 Self-Testing. Diagnostics (Basel). 2020 Apr 1; 10(4):198.
Bélec L, Péré H, Mboumba Bouassa RS, Veyer D, Jenabian MA. Potential pitfalls of routine SARSCoV-2 serology for mass screening. J Med Virol. 2020 Jun 2: https://doi.org/10.1002/jmv.26034 PMID: 32484942
Farnsworth CW, Anderson NW. SARS-CoV-2 Serology: Much Hype, Little Data. Clin Chem. 2020 Apr 28:hvaa107.
Food and Drug Administration. FDA STATEMENT. Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits. United states of America, 2020. Available at: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alertsconsumers-about-unauthorized-fraudulent-covid-19-test-kits (last access: 24 June 2020).
Jiang S, Hillyer C, Du L. Neutralizing Antibodies against SARS-CoV-2 and Other Human Coronaviruses. Trends Immunol. 2020 Apr 2.
NATURE VIDEO. We test a home antibody kit for tracking Covid-19. Easy-to-use postal tests may be important for monitoring community transmission. 04 JUNE 2020. Available at: https://www.nature.com/articles/d41586-020-01677-y (last access: 24 June 2020).
