Evidence map›Paper›PMID 33594297›Full record

ArticleBiochemia medica2021

Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays.

Andrea Tešija Kuna, Milena Hanžek, Ines Vukasović, Nora Nikolac Gabaj, Valentina Vidranski, Ivana Ćelap, Marijana Miler, Nevenka Stančin, Brankica Šimac, Marcela Živković and 8 more

Open access · diamondAbstract read
In one paragraph

Article in Biochemia medica, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 24% 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

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Hypogammaglobulinemia is associated with reduced antibody response after anti-SARS-CoV-2 vaccination in MS patients treated with antiCD20 therapies.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
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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

18 authors at 3 institutions in 2 countries.

Andrea Tešija KunaDepartment of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Milena HanžekDepartment of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Ines VukasovićDepartment of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Nora Nikolac GabajDepartment of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Valentina VidranskiDepartment of Oncology and Nuclear Medicine, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Ivana ĆelapDepartment of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Marijana MilerDepartment of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Nevenka StančinClinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
Brankica ŠimacClinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
Marcela ŽivkovićClinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
Marko ŽarakClinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
Marta KmetClinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
Marijana JovanovićClinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
Sanja TadinacDepartment of Oncology and Nuclear Medicine, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Sandra Šupraha GoretaDepartment of Biochemistry and Molecular Biology, Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia.
Josipa PerišaDepartment of Oncology and Nuclear Medicine, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Ivan ŠamijaDepartment of Oncology and Nuclear Medicine, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Mario ŠtefanovićDepartment of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
University Hospital Dubrava · HRUniversity Hospital Centre Zagreb · HRUniversity of Zagreb · HR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests have been suggested as an additional diagnostic tool in highly suspected cases with a negative molecular test and determination of seroprevalence in population. We compared the diagnostic performance of eight commercial serological assays for IgA, IgM, and IgG antibodies to the SARS-CoV-2 virus. MATERIALS AND

methodsThe comparison study was performed on a total of 76 serum samples: 30 SARS-CoV-2 polymerase chain reaction (PCR)-negative and 46 SARS-CoV-2 PCR-positive patients with asymptomatic to severe disease and symptoms duration from 3-30 days. The study included: three rapid lateral flow immunochromatographic assays (LFIC), two enzyme-linked immunosorbent assays (ELISA), and three chemiluminescence immunoassays (CLIA).

resultsAgreement between IgM assays were minimal to moderate (kappa 0.26 to 0.63) and for IgG moderate to excellent (kappa 0.72 to 0.92). Sensitivities improved with > 10 days of symptoms and were: 30% to 89% for IgM; 89% to 100% for IgG; 96% for IgA; 100% for IgA/IgM combination; 96% for total antibodies. Overall specificities were: 90% to 100% for IgM; 85% to 100% for IgG; 90% for IgA; 70% for IgA/IgM combination; 100% for total antibodies. Diagnostic accuracy for IgG ELISA and CIA assays were excellent (AUC ≥ 0.90), without significant difference. IgA showed significantly better diagnostic accuracy than IgM (P < 0.001).

conclusionThere is high variability between IgM assays independently of the assay format, while IgG assays showed moderate to perfect agreement. The appropriate time for testing is crucial for the proper immunity investigation.

Indexed as

COVID-19COVID-19 TestingHumansSARS-CoV-2Sensitivity and SpecificitySerologic TestsSARS-CoV-2sensitivityserological testspecificity

Identifiers

PMID33594297
PMCPMC7852303
OpenAlexW3129018545

What OpenQuestion holds

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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.