Technical performance of a lateral flow immunoassay for detection of anti-SARS-CoV-2 IgG in the outpatient follow-up of non-severe cases and at different times after vaccination: comparison with enzyme and chemiluminescent immunoassays.

التفاصيل البيبلوغرافية
العنوان:	Technical performance of a lateral flow immunoassay for detection of anti-SARS-CoV-2 IgG in the outpatient follow-up of non-severe cases and at different times after vaccination: comparison with enzyme and chemiluminescent immunoassays.
المؤلفون:	Barreira GA; Universidade de São Paulo, Faculdade de Medicina, Instituto de Medicina Tropical de São Paulo, São Paulo, São Paulo, Brazil.; Faculdade Israelita de Ciências da Saúde Albert Einstein, São Paulo, São Paulo, Brazil., Santos EHD; Universidade de São Paulo, Faculdade de Medicina, Instituto de Medicina Tropical de São Paulo, São Paulo, São Paulo, Brazil.; Universidade de São Paulo, Faculdade de Medicina, Departamento de Pediatria, São Paulo, São Paulo, Brazil., Pereira MFB; Universidade de São Paulo, Faculdade de Medicina, Departamento de Pediatria, São Paulo, São Paulo, Brazil., Rodrigues KA; Universidade de São Paulo, Faculdade de Medicina, Instituto de Medicina Tropical de São Paulo, São Paulo, São Paulo, Brazil., Rocha MC; Universidade de São Paulo, Faculdade de Medicina, Instituto de Medicina Tropical de São Paulo, São Paulo, São Paulo, Brazil., Kanunfre KA; Universidade de São Paulo, Faculdade de Medicina, Instituto de Medicina Tropical de São Paulo, São Paulo, São Paulo, Brazil., Marques HHS; Universidade de São Paulo, Faculdade de Medicina, Departamento de Pediatria, São Paulo, São Paulo, Brazil., Okay TS; Universidade de São Paulo, Faculdade de Medicina, Instituto de Medicina Tropical de São Paulo, São Paulo, São Paulo, Brazil.; Universidade de São Paulo, Faculdade de Medicina, Departamento de Pediatria, São Paulo, São Paulo, Brazil., Eisencraft AP, Rossi Junior A, Fante AL, Cora AP, Costa Reis AGA, Ferrer APS, Andrade APM, Watanabe A, Gonçalves AMF, Waetge ARP, Silva CA, Ceneviva C, Lazari CDS, Abellan DM, Sabino EC, Bianchini FRM, Alcantara FFP, Ramos GF, Leal GN, Rodriguez IS, Pinho JRR, Carneiro JDA, Paz JA, Ferreira JC, Ferranti JF, Ferreira JOA, Framil JVS, Silva KRD, Bastos KLM, Galleti KV, Cristofani LM, Suzuki L, Campos LMA, Perondi MBM, Diniz MFR, Fonseca MFM, Cordon MNA, Pissolato M, Peres MS, Garanito MP, Imamura M, Dorna MB, Luglio M, Aikawa NE, Degaspare NV, Sakita NK, Udsen NL, Scudeller PG, Gaiolla PVV, Severini RDSG, Rodrigues RM, Toma RK, Paula RIC, Palmeira P, Forsait S, Farhat SCL, Sakano TMS, Koch VHK, Cobello Junior V
مؤلفون مشاركون:	Pediatric COVID-19 HC-FMUSP Study Group
المصدر:	Revista do Instituto de Medicina Tropical de Sao Paulo [Rev Inst Med Trop Sao Paulo] 2022 Jul 13; Vol. 64, pp. e49. Date of Electronic Publication: 2022 Jul 13 (Print Publication: 2022).
نوع المنشور:	Journal Article
اللغة:	English
بيانات الدورية:	Publisher: Universidade de São Paulo, Instituto de Medicina Tropical de São Paulo Country of Publication: Brazil NLM ID: 7507484 Publication Model: eCollection Cited Medium: Internet ISSN: 1678-9946 (Electronic) Linking ISSN: 00364665 NLM ISO Abbreviation: Rev Inst Med Trop Sao Paulo Subsets: MEDLINE
أسماء مطبوعة:	Original Publication: Sao Paulo : Universidade de São Paulo, Instituto de Medicina Tropical de São Paulo
مواضيع طبية MeSH:	COVID-19/diagnosis , COVID-19/prevention & control, Adult ; Antibodies, Viral ; Child ; Follow-Up Studies ; Humans ; Immunoassay/methods ; Immunoglobulin G ; Immunoglobulin M ; Outpatients ; Sensitivity and Specificity ; Vaccination
مستخلص:	This study assessed the technical performance of a rapid lateral flow immunochromatographic assay (LFIA) for the detection of anti-SARS-CoV-2 IgG and compared LFIA results with chemiluminescent immunoassay (CLIA) results and an in-house enzyme immunoassay (EIA). To this end, a total of 216 whole blood or serum samples from three groups were analyzed: the first group was composed of 68 true negative cases corresponding to blood bank donors, healthy young volunteers, and eight pediatric patients diagnosed with other coronavirus infections. The serum samples from these participants were obtained and stored in a pre-COVID-19 period, thus they were not expected to have COVID-19. In the second group of true positive cases, we chose to replace natural cases of COVID-19 by 96 participants who were expected to have produced anti-SARS-CoV-2 IgG antibodies 30-60 days after the vaccine booster dose. The serum samples were collected on the same day that LFIA were tested either by EIA or CLIA. The third study group was composed of 52 participants (12 adults and 40 children) who did or did not have anti-SARS-CoV-2 IgG antibodies due to specific clinical scenarios. The 12 adults had been vaccinated more than seven months before LFIA testing, and the 40 children had non-severe COVID-19 diagnosed using RT-PCR during the acute phase of infection. They were referred for outpatient follow-up and during this period the serum samples were collected and tested by CLIA and LFIA. All tests were performed by the same healthcare operator and there was no variation of LFIA results when tests were performed on finger prick whole blood or serum samples, so that results were grouped for analysis. LFIA's sensitivity in detecting anti-SARS-CoV-2 IgG antibodies was 90%, specificity 97.6%, efficiency 93%, PPV 98.3%, NPV 86.6%, and likelihood ratio for a positive or a negative result were 37.5 and 0.01 respectively. There was a good agreement (Kappa index of 0.677) between LFIA results and serological (EIA or CLIA) results. In conclusion, LFIA analyzed in this study showed a good technical performance and agreement with reference serological assays (EIA or CLIA), therefore it can be recommended for use in the outpatient follow-up of non-severe cases of COVID-19 and to assess anti-SARS-CoV-2 IgG antibody production induced by vaccination and the antibodies decrease over time. However, LFIAs should be confirmed by using reference serological assays whenever possible.
References:	Cell Rep Med. 2021 Apr 20;2(4):100253. (PMID: 33842901) Front Public Health. 2021 Feb 18;8:620222. (PMID: 33681115) J Clin Microbiol. 2020 Jul 23;58(8):. (PMID: 32381641) Semin Thromb Hemost. 2022 Feb;48(1):72-92. (PMID: 34130340) BMJ. 2021 Mar 2;372:n423. (PMID: 33653694) J Immunol Methods. 2021 Sep;496:113096. (PMID: 34242653) Int J Infect Dis. 2021 Mar;104:159-163. (PMID: 33383223) Front Immunol. 2021 Nov 16;12:778679. (PMID: 34868051) PLoS Med. 2021 Jul 6;18(7):e1003656. (PMID: 34228725) Ann Rheum Dis. 2021 Sep;80(9):1236-1240. (PMID: 33903092) BMC Public Health. 2022 Jan 7;22(1):45. (PMID: 34996418) PLoS One. 2021 Apr 28;16(4):e0250319. (PMID: 33909646) Cochrane Database Syst Rev. 2020 Jun 25;6:CD013652. (PMID: 32584464) Euro Surveill. 2020 Jan;25(3):. (PMID: 31992387) J Clin Virol. 2022 Jan;146:105052. (PMID: 34920374) PLoS One. 2022 Apr 14;17(4):e0266923. (PMID: 35421183) Emerg Microbes Infect. 2020 Dec;9(1):2547-2549. (PMID: 33206004) Nat Med. 2020 Jun;26(6):845-848. (PMID: 32350462) J Infect Dis. 2022 Jan 18;225(2):190-198. (PMID: 34427652) J Med Virol. 2020 Nov;92(11):2312-2313. (PMID: 32383182) Clin Infect Dis. 2020 Jul 28;71(15):778-785. (PMID: 32198501) Antib Ther. 2022 Jan 15;5(1):55-62. (PMID: 35146332) Virology. 2021 Mar;555:35-43. (PMID: 33450669) J Clin Microbiol. 2021 Jan 21;59(2):. (PMID: 33208477) J Virol Methods. 2021 Apr;290:114064. (PMID: 33453299) J Clin Diagn Res. 2016 Oct;10(10):YE01-YE06. (PMID: 27891446) Thorax. 2020 Dec;75(12):1082-1088. (PMID: 32796119) J Clin Med. 2020 Jul 17;9(7):. (PMID: 32708872) Ann Clin Biochem. 2021 Jul;58(4):305-310. (PMID: 33554608) Clin Chem Lab Med. 2020 Jun 25;58(7):1081-1088. (PMID: 32301749) Lancet Infect Dis. 2020 May;20(5):565-574. (PMID: 32213337) Emerg Infect Dis. 2020 Jul;26(7):1478-1488. (PMID: 32267220) JAMA. 2020 May 12;323(18):1843-1844. (PMID: 32159775) Rev Inst Med Trop Sao Paulo. 2020 Jun 29;62:e44. (PMID: 32609256) Biometrics. 1977 Mar;33(1):159-74. (PMID: 843571) Epidemiol Infect. 2022 Apr 25;:1-20. (PMID: 35465866) Front Immunol. 2022 Apr 29;13:876037. (PMID: 35572536) Nature. 2020 May;581(7807):215-220. (PMID: 32225176) RMD Open. 2021 May;7(2):. (PMID: 33958439)
المشرفين على المادة:	0 (Antibodies, Viral) 0 (Immunoglobulin G) 0 (Immunoglobulin M)
تواريخ الأحداث:	Date Created: 20220720 Date Completed: 20220722 Latest Revision: 20220916
رمز التحديث:	20231215
مُعرف محوري في PubMed:	PMC9281580
DOI:	10.1590/S1678-9946202264049
PMID:	35858039
قاعدة البيانات:	MEDLINE

Find this article in full text from ProQuest

Full Text Finder

الوصف
تدمد:	1678-9946
DOI:	10.1590/S1678-9946202264049