urrogate test performance for SARS-CoV-2 neutralizing antibodies (nAbs) for convalescent plasma (CCP): How useful could they be

Autor(es):Mostrar menos -

Wendel, Silvano ^[1] ; Fachini, Roberta ^[1] ; Fontao-Wendel, Rita C. L. ^[1] ; Mello, Ralyria ^[2] ; Velasquez, Carlos Vinicius ^[1] ; Guaragna Machado, Rafael Rahal ^[2] ; Brito, Mayra Altobelli ^[1] ; Amaral, Marcelo ^[1] ; Soares, Camila Pereira ^[2] ; Achkar, Ruth ^[1] ; Scuracchio, Patricia ^[1] ; Miyaji, Sandra Cristina ^[1] ; Erdens, Melina Santos ^[1] ; Durigon, Edison Luiz ^[2]

Afiliação do(s) autor(es)

^[1] Hosp Sirio Libanes, Blood Bank, Rua Adma Jafet 91, BR-01308050 Sao Paulo - Brazil

^[2] Univ Sao Paulo, Dept Microbiol, Inst Ciencias Biomed, Sao Paulo - Brazil

• Tipo de documento: Artigo Científico
• Fonte: Transfusion; v. 61, n. 12 OCT 2021.
• Citações Web of Science: 0

Resumo

Background COVID-19 high-titer CCP selection is a concern, because neutralizing antibody (nAb) testing requires sophisticated labs and methods. Surrogate tests are an alternative for measuring nAb levels in plasma bags, including those that are pathogen-reduced. Study design/methods We studied a panel consisting of 191 samples from convalescent donors tested by nAb (CPE-VNT), obtained from 180 CCP donations (collection: March 20-January 21) and 11 negative controls, with a total of 80 and 111 serum and plasma samples (71 amotosalen/UV treated), with nAb titers ranging from negative to 10,240. Samples were blindly tested for several surrogates: one anti-RBD, two anti-spike, and four anti-nucleocapsid tests, either isolated or combined to improve their positive predictive values as predictors of the presence of high-titer nAbs, defined as those with titers >= 160. Results Except for combined and anti-IgA/M tests, all isolated surrogate tests showed excellent performance for nAb detection: sensitivity (98.3%-100%), specificity (85.7%-100%), PPV (98.9%-100%), NPV (81.3%-100%), and AUC (0.93-0.96), with a variable decrease in sensitivity and considerably lower specificity when using FDA authorization and concomitant nAb titers >= 160. All surrogates had AUCs that were statistically different from CPE-VNT if nAb >= 160, including when using combined, orthogonal approaches. Conclusions Surrogate tests (isolated or in combination) have an indirect good performance in detecting the presence of nAb, with lower sensitivity and specificity when high nAb titer samples are used, possibly accepting a considerable number of donors whose nAb titers are actually low, which should be evaluated by each laboratory responsible for CCP collection. (AU)

• Processo FAPESP: 17/24769-2 - Zika vírus em puérperas e neonatos: soroepidemiologia e caracterização molecular
• Beneficiário: Rafael Rahal Guaragna Machado
• Modalidade de apoio: Bolsas no Brasil - Doutorado Direto
• Processo FAPESP: 20/06409-1 - Avaliação da resposta imune humoral e da resposta inflamatória em pacientes com diagnóstico confirmado de COVID-19 no Hospital Sírio Libanês e correlação com a severidade da doença
• Beneficiário: Edison Luiz Durigon
• Modalidade de apoio: Auxílio à Pesquisa - Regular
• Processo FAPESP: 16/20045-7 - Descoberta de antígenos e desenvolvimento de métodos de diagnóstico sorológico e estratégias vacinais contra o Vírus Zika (ZIKV)
• Beneficiário: Luis Carlos de Souza Ferreira
• Modalidade de apoio: Auxílio à Pesquisa - Temático
• Processo FAPESP: 18/23680-0 - Padronização da técnica Sherlock (Specific High-Sensitivity Enzymatic Reporter Unlocking) utilizando a proteína Cas13a para diagnóstico do vírus respiratório sincicial em pacientes pediátricos
• Beneficiário: Camila Pereira Soares
• Modalidade de apoio: Bolsas no Brasil - Mestrado