Evidence map›Paper›PMID 42197541›Full record

ArticleMicroorganisms2026

Validation of a Mucosal IgA Assay for SARS-CoV-2.

Mingzhu Zhu, Edmond Massuda, Shane Cloney-Clark, Urvashi Patel, Anand Parekh, Andrew Gorinson, Andrew Klindworth, Ali Ahmadi, Miranda R Cai, Chijioke Bennett and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Microorganisms, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Mingzhu ZhuClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.ORCID 0009-0005-1628-7442
Edmond MassudaClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Shane Cloney-ClarkClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Urvashi PatelClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.ORCID 0000-0003-2995-1515
Anand ParekhClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Andrew GorinsonClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Andrew KlindworthClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Ali AhmadiClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Miranda R CaiBiostatistics, Novavax, Gaithersburg, MD 20878, USA.
Chijioke BennettClinical Development, Novavax, Gaithersburg, MD 20878, USA.
Raj KalkeriClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Joyce S PlestedClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.

Funding

Novavax (United States) N/A
6 · The paper itself

Abstract

Mucosal immunity, including antibodies like immunoglobulin A (IgA), function as the body's first line of defense in the respiratory tract, particularly against viruses. An anti-rS protein IgA enzyme-linked immunosorbent assay (ELISA) was developed using the Omicron XBB.1.5 subvariant of SARS-CoV-2 and was validated to demonstrate the suitability of the method for testing saliva from SARS-CoV-2 vaccine clinical trials. This assay successfully met acceptance criteria for inter-/intra-assay precision, specificity, selectivity, linearity, lower/upper limits of quantitation, and assay robustness. The IgA in saliva was stable for up to 7 freeze/thaw cycles, for up to 48 h at 24 °C, up to 7 days at 4 °C, up to 3 weeks at -20 °C, and up to 1 year at -80 °C. After validation using Omicron XBB.1.5 rS protein, cross-reactivity was demonstrated with the SARS-CoV-2 variant JN.1. This validated IgA assay can be a valuable tool to assess mucosal IgA levels in SARS-CoV-2 clinical trials.

Indexed as

assay validationcorrelate of protectionCOVID-19immunogenicityOmicron XBB.1.5SARS-CoV-2

Identifiers

PMID42197541
PMCPMC13209381

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Registered trials

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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.