Evidence map›Paper›PMID 34674284›Full record

ArticleTransfusion2021

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

Silvano Wendel, Roberta Fachini, Rita C L Fontão-Wendel, Ralyria Mello, Carlos Vinícius Velasquez, Rafael Rahal Guaragna Machado, Mayra Altobelli Brito, Marcelo Amaral, Camila Pereira Soares, Ruth Achkar and 4 more

Open access · bronzeAbstract read
In one paragraph

Article in Transfusion, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Silvano WendelBlood Bank, Hospital Sírio-Libanês, São Paulo, Brazil.ORCID 0000-0002-1941-7733
Roberta FachiniBlood Bank, Hospital Sírio-Libanês, São Paulo, Brazil.
Rita C L Fontão-WendelBlood Bank, Hospital Sírio-Libanês, São Paulo, Brazil.
Ralyria MelloDepartamento de Microbiologia, Instituto de Ciências Biomédicas, USP, São Paulo, Brazil.
Carlos Vinícius VelasquezBlood Bank, Hospital Sírio-Libanês, São Paulo, Brazil.
Rafael Rahal Guaragna MachadoDepartamento de Microbiologia, Instituto de Ciências Biomédicas, USP, São Paulo, Brazil.ORCID 0000-0001-6974-5092
Mayra Altobelli BritoBlood Bank, Hospital Sírio-Libanês, São Paulo, Brazil.
Marcelo AmaralBlood Bank, Hospital Sírio-Libanês, São Paulo, Brazil.
Camila Pereira SoaresDepartamento de Microbiologia, Instituto de Ciências Biomédicas, USP, São Paulo, Brazil.
Ruth AchkarBlood Bank, Hospital Sírio-Libanês, São Paulo, Brazil.
Patrícia ScuracchioBlood Bank, Hospital Sírio-Libanês, São Paulo, Brazil.
Sandra Cristina MiyajiBlood Bank, Hospital Sírio-Libanês, São Paulo, Brazil.
Melina Santos ErdensBlood Bank, Hospital Sírio-Libanês, São Paulo, Brazil.
Edison Luiz DurigonDepartamento de Microbiologia, Instituto de Ciências Biomédicas, USP, São Paulo, Brazil.
Hospital Sírio-Libanês · BR

Funding

ABGP 4097-20Fundação de Amparo à Pesquisa do Estado de São Paulo 2016/20045-7Fundação de Amparo à Pesquisa do Estado de São Paulo 2017/24769-2Fundação de Amparo à Pesquisa do Estado de São Paulo 2018/23680-0Fundação de Amparo à Pesquisa do Estado de São Paulo 2020/06409-1"Todos Pela Saúde."
6 · The paper itself

Abstract

backgroundCOVID-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/

methodsWe 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.

resultsExcept 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.

conclusionsSurrogate 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.

Indexed as

Antibodies, NeutralizingAntibodies, ViralBlood DonorsCOVID-19COVID-19 SerotherapyHumansImmunization, PassiveSARS-CoV-2Antibodies, NeutralizingAntibodies, Viralconvalescent plasma therapyCOVID-19passive immune therapy; surrogate testsSARS-CoV-2; coronavirus

Identifiers

PMID34674284
PMCPMC8661940
OpenAlexW3205879295

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.