Diagnostic accuracy of Augurix COVID‐19 IgG serology rapid test

Andrey, Diego O.; Cohen, Patrick; Meyer, Benjamin; Torriani, Giulia; Yerly, Sabine; Mazza, Léna; Calame, Adrien; Arm-Vernez, Isabelle; Guessous, Idris; Stringhini, Silvia; Roux‐Lombard, Pascale; Fontao, Lionel; Agoritsas, Thomas; Stirnemann, Jérôme; Reny, Jean Luc; Siegrist, Claire Anne; Eckerle, Isabella; Kaiser, Laurent; Vuilleumier, Nicolas

doi:10.1111/eci.13357

Cited by 38 publications

(51 citation statements)

References 13 publications

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“…A total of three different targets were detected in the virus genome. Secondly, the EUROIMMUN assay, which was used for comparison purposes, cannot be considered as a gold standard, as its sensitivity and specificity are different from 100% themselves [ 31 , 32 , 42–53 ]. Thirdly, the EBV-positive samples, which were included in the specificity assessment, were collected during the time period when the COVID-19 pandemic had already reached Germany.…”

Section: Discussionmentioning

confidence: 99%

“…Heat inactivation of sera was described as not relevantly interfering with the reliability of immunochromatographic test assays [ 28 ]. Time since positive PCR testing has been reported to be crucial for optimum serological POCT sensitivity, with best results at least 14 days after the positive PCR result [ 31 ]. At later post-infectious stages, serology can become negative again [ 35 ].…”

Section: Introductionmentioning

confidence: 99%

“…To provide another piece of the puzzle regarding the assessment of serological POCT assays for COVID-19, the rapid diagnostic test (RDT) COVID-19 IgM/IgG test kit (Colloidal gold, Xiamen AmonMed Biotechnology Co., Ltd., Haicang District, Xiamen, China) was assessed in direct comparison with the EUROIMMUN benchtop assay, which shows imperfect performance characteristics as well [ 31 , 32 , 42-53 ]. Tests were performed with serum samples from patients with PCR-confirmed COVID-19 disease.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)

Dörschug

Schwanbeck

Hahn³

et al. 2020

EuJMI

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IntroductionTo efficiently monitor the COVID-19 pandemic for surveillance purposes, reliable serological rapid diagnostic tests (RDTs) are desirable for settings where well-established high-throughput bench-top solutions are not available. Here, we have evaluated such an RDT.MethodsWe have assessed the Xiamen AmonMed Biotechnology COVID-19 IgM/IgG test kit (Colloidal gold) and the EUROIMMUN benchtop assay with serum samples from patients with polymerase chain reaction (PCR)-confirmed COVID-19 disease. Samples from patients with Epstein-Barr-virus (EBV) infection and blood donors were used for specificity testing.ResultsFor the colloid gold rapid test and the EUROIMMUN assay, the study indicated overall sensitivity of 15.2% and 67.4%, respectively, while specificity of 99.0% and 97.9% with the blood donor sera, as well as 100% and 96.8% with the EBV-patients, were observed, respectively. An association of the time period between positive PCR results and serum acquisition with serological test positivity could be observed for the immunologlobulin G subclass of the EUROIMMUN assay only.ConclusionsIn spite of acceptable specificity of the assessed RDT, the detected poor sensitivity leaves room for improvement. The test results remain difficult to interpret and therefore the RDT can currently not be recommended for routine diagnostic or surveillance use.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)

Dörschug

Schwanbeck

Hahn³

et al. 2020

EuJMI

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“…This ELISA also showed a potential to set a threshold indicating the presence of protective antibodies [ 143 ]. Another study indicated that Augurix IgG rapid diagnostic kit displays a relatively high accuracy for SARS-CoV-2 IgG in high COVID-19 prevalence settings [ 144 ]. Such kits can be suggested for mass serology testing [ 144 , 145 ].…”

Section: Development and Status Of Immunoglobulin-based Rapid Testmentioning

confidence: 99%

“…Another study indicated that Augurix IgG rapid diagnostic kit displays a relatively high accuracy for SARS-CoV-2 IgG in high COVID-19 prevalence settings [ 144 ]. Such kits can be suggested for mass serology testing [ 144 , 145 ]. Among the many currently available antibody-based tests, the popular ones are lateral flow immunoassays (BioMedomics quick test and Surescreen rapid test cassette), time-resolved fluorescence immunoassays (Gold site diagnostics kit), and colloidal gold immunoassays (VivaDiag COVID-19 IgG-IgM test and Assay Genie rapid POC kit).…”

Section: Development and Status Of Immunoglobulin-based Rapid Testmentioning

confidence: 99%

Rapid Antibody-Based COVID-19 Mass Surveillance: Relevance, Challenges, and Prospects in a Pandemic and Post-Pandemic World

Augustine

Das

Hasan

et al. 2020

JCM

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The aggressive outbreak of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) as COVID-19 (coronavirus disease-2019) pandemic demands rapid and simplified testing tools for its effective management. Increased mass testing and surveillance are crucial for controlling the disease spread, obtaining better pandemic statistics, and developing realistic epidemiological models. Despite the advantages of nucleic acid- and antigen-based tests such as accuracy, specificity, and non-invasive approaches of sample collection, they can only detect active infections. Antibodies (immunoglobulins) are produced by the host immune system within a few days after infection and persist in the blood for at least several weeks after infection resolution. Antibody-based tests have provided a substitute and effective method of ultra-rapid detection for multiple contagious disease outbreaks in the past, including viral diseases such as SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). Thus, although not highly suitable for early diagnosis, antibody-based methods can be utilized to detect past infections hidden in the population, including asymptomatic ones. In an active community spread scenario of a disease that can provide a bigger window for mass detections and a practical approach for continuous surveillance. These factors encouraged researchers to investigate means of improving antibody-based rapid tests and employ them as reliable, reproducible, sensitive, specific, and economic tools for COVID-19 mass testing and surveillance. The development and integration of such immunoglobulin-based tests can transform the pandemic diagnosis by moving the same out of the clinics and laboratories into community testing sites and homes. This review discusses the principle, technology, and strategies being used in antibody-based testing at present. It also underlines the immense prospect of immunoglobulin-based testing and the efficacy of repeated planned deployment in pandemic management and post-pandemic sustainable screenings globally.

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Antibody tests for identification of current and past infection with SARS-CoV-2

Fox

Geppert

Dinnes

et al. 2022

Cochrane Database of Systematic Reviews

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Background The diagnostic challenges associated with the COVID‐19 pandemic resulted in rapid development of diagnostic test methods for detecting SARS‐CoV‐2 infection. Serology tests to detect the presence of antibodies to SARS‐CoV‐2 enable detection of past infection and may detect cases of SARS‐CoV‐2 infection that were missed by earlier diagnostic tests. Understanding the diagnostic accuracy of serology tests for SARS‐CoV‐2 infection may enable development of effective diagnostic and management pathways, inform public health management decisions and understanding of SARS‐CoV‐2 epidemiology. Objectives To assess the accuracy of antibody tests, firstly, to determine if a person presenting in the community, or in primary or secondary care has current SARS‐CoV‐2 infection according to time after onset of infection and, secondly, to determine if a person has previously been infected with SARS‐CoV‐2. Sources of heterogeneity investigated included: timing of test, test method, SARS‐CoV‐2 antigen used, test brand, and reference standard for non‐SARS‐CoV‐2 cases. Search methods The COVID‐19 Open Access Project living evidence database from the University of Bern (which includes daily updates from PubMed and Embase and preprints from medRxiv and bioRxiv) was searched on 30 September 2020. We included additional publications from the Evidence for Policy and Practice Information and Co‐ordinating Centre (EPPI‐Centre) ‘COVID‐19: Living map of the evidence’ and the Norwegian Institute of Public Health ’NIPH systematic and living map on COVID‐19 evidence’. We did not apply language restrictions. Selection criteria We included test accuracy studies of any design that evaluated commercially produced serology tests, targeting IgG, IgM, IgA alone, or in combination. Studies must have provided data for sensitivity, that could be allocated to a predefined time period after onset of symptoms, or after a positive RT‐PCR test. Small studies with fewer than 25 SARS‐CoV‐2 infection cases were excluded. We included any reference standard to define the presence or absence of SARS‐CoV‐2 (including reverse transcription polymerase chain reaction tests (RT‐PCR), clinical diagnostic criteria, and pre‐pandemic samples). Data collection and analysis We use standard screening procedures with three reviewers. Quality assessment (using the QUADAS‐2 tool) and numeric study results were extracted independently by two people. Other study characteristics were extracted by one reviewer and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test and, for meta‐analysis, we fitted univariate random‐effects logistic regression models for sensitivity by eligible time period and for specificity by reference standard group. Heterogeneity was investigated by including indicator variables in the random‐effects logistic regression models. We tabulated result...

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Diagnostic accuracy of Augurix COVID‐19 IgG serology rapid test

Cited by 38 publications

References 13 publications

Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)

Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)

Rapid Antibody-Based COVID-19 Mass Surveillance: Relevance, Challenges, and Prospects in a Pandemic and Post-Pandemic World

Antibody tests for identification of current and past infection with SARS-CoV-2

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