Performance evaluation of two SARS-CoV-2 IgG/IgM rapid tests (Covid-Presto and NG-Test) and one IgG automated immunoassay (Abbott)

doi:10.1016/j.jcv.2020.104618

. 2020 Nov:132:104618.

doi: 10.1016/j.jcv.2020.104618. Epub 2020 Sep 3.

Performance evaluation of two SARS-CoV-2 IgG/IgM rapid tests (Covid-Presto and NG-Test) and one IgG automated immunoassay (Abbott)

Affiliations

¹ Université de Paris, INSERM UMR 1137 IAME, Laboratoire de Virologie, AP-HP, Hôpital Bichat-Claude Bernard, F-75018, Paris, France. Electronic address: charlotte.charpentier@aphp.fr.
² Université de Paris, INSERM UMR 1137 IAME, Laboratoire de Virologie, AP-HP, Hôpital Bichat-Claude Bernard, F-75018, Paris, France.
³ Service de Maladies Infectieuses et Tropicales, Hôpital Bichat-Claude Bernard, F-75018, Paris, France.
⁴ Université de Paris, INSERM UMR 944, Département des Agents Infectieux, Service de Virologie, Hôpital Saint-Louis, Paris, France.

PMID: 32919222
PMCID: PMC7470702
DOI: 10.1016/j.jcv.2020.104618

Performance evaluation of two SARS-CoV-2 IgG/IgM rapid tests (Covid-Presto and NG-Test) and one IgG automated immunoassay (Abbott)

Charlotte Charpentier et al. J Clin Virol. 2020 Nov.

. 2020 Nov:132:104618.

doi: 10.1016/j.jcv.2020.104618. Epub 2020 Sep 3.

Affiliations

¹ Université de Paris, INSERM UMR 1137 IAME, Laboratoire de Virologie, AP-HP, Hôpital Bichat-Claude Bernard, F-75018, Paris, France. Electronic address: charlotte.charpentier@aphp.fr.
² Université de Paris, INSERM UMR 1137 IAME, Laboratoire de Virologie, AP-HP, Hôpital Bichat-Claude Bernard, F-75018, Paris, France.
³ Service de Maladies Infectieuses et Tropicales, Hôpital Bichat-Claude Bernard, F-75018, Paris, France.
⁴ Université de Paris, INSERM UMR 944, Département des Agents Infectieux, Service de Virologie, Hôpital Saint-Louis, Paris, France.

PMID: 32919222
PMCID: PMC7470702
DOI: 10.1016/j.jcv.2020.104618

Abstract

The aim of this study was to assess the analytical performances, sensitivity and specificity, of two rapid tests (Covid- Presto® test rapid Covid-19 IgG/IgM and NG-Test® IgM-IgG COVID-19) and one automated immunoassay (Abbott SARS-CoV-2 IgG) for detecting anti- SARS-CoV-2 antibodies. This study was performed with: (i) a positive panel constituted of 88 SARS-CoV-2 specimens collected from patients with a positive SARS-CoV-2 RT-PCR, and (ii) a negative panel of 120 serum samples, all collected before November 2019, including 64 samples with a cross-reactivity panel. Sensitivity of Covid-Presto® test for IgM and IgG was 78.4% and 92.0%, respectively. Sensitivity of NG-Test® for IgM and IgG was 96.6% and 94.9%, respectively. Sensitivity of Abbott IgG assay was 96.5% showing an excellent agreement with the two rapid tests (κ = 0.947 and κ = 0.936 for NGTest ® and Covid-Presto® test, respectively). An excellent agreement was also observed between the two rapid tests (κ = 0.937). Specificity for IgM was 100% and 86.5% for Covid-Presto® test and NG-Test®, respectively. Specificity for IgG was 92.0%, 94.9% and 96.5% for Covid-Presto®, NGTest ®, and Abbott, respectively. Most of the false positive results observed with NG-Test® resulted from samples containing malarial antibodies. In conclusion, performances of these 2 rapid tests are very good and comparable to those obtained with automated immunoassay, except for IgM specificity with the NG-Test®. Thus, isolated IgM should be cautiously interpreted due to the possible false-positive reactions with this test. Finally, before their large use, the rapid tests must be reliably evaluated with adequate and large panel including early seroconversion and possible cross-reactive samples.

Keywords: Cross-reactivity; Rapid test; SARS-CoV-2; Serology.

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[1] Long Q.X., Liu B.Z., Deng H.J., Wu G.C., Deng K., Chen Y.K., Liao P., Qiu J.F., Lin Y., Cai X.F., Wang D.Q., Hu Y., Ren J.H., Tang N., Xu Y.Y., Yu LH Mo Z., Gong F., Zhang X.L., Tian W.G., Hu L., Zhang X.L., Xiang J.L., Du HX Liu H.W., Lang C.H., Luo X.H., Wu S.B., Cui X.P., Zhou Z., Zhu M.M., Wang J., Xue C.J., Li X.F., Wang L., Li Z.J., Wang K., Niu C.C., Yang Q.J., Tang X.J., Zhang Y., Liu X.M., Li Z.J., Zhang D.C., Zhang F., Liu P., Yuan J., Li Q., Hu J.L., Chen J., Huang A.L. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat. Med. 2020;26:845–848. doi: 10.1038/s41591-020-0897-1. - DOI - PubMed

[2] Long Q.X., Liu B.Z., Deng H.J., Wu G.C., Deng K., Chen Y.K., Liao P., Qiu J.F., Lin Y., Cai X.F., Wang D.Q., Hu Y., Ren J.H., Tang N., Xu Y.Y., Yu LH Mo Z., Gong F., Zhang X.L., Tian W.G., Hu L., Zhang X.L., Xiang J.L., Du HX Liu H.W., Lang C.H., Luo X.H., Wu S.B., Cui X.P., Zhou Z., Zhu M.M., Wang J., Xue C.J., Li X.F., Wang L., Li Z.J., Wang K., Niu C.C., Yang Q.J., Tang X.J., Zhang Y., Liu X.M., Li Z.J., Zhang D.C., Zhang F., Liu P., Yuan J., Li Q., Hu J.L., Chen J., Huang A.L. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat. Med. 2020;26:845–848. doi: 10.1038/s41591-020-0897-1. - DOI - PubMed

[3] Yongchen Z., Shen H., Wang X., Shi X., Li Y., Yan J., Chen Y., Gu B. Different longitudinal patterns of nucleic acid and serology testing results based on disease severity of COVID-19 patients. Emerg. Microbes Infect. 2020;9:833–836. doi: 10.1080/22221751.2020.1756699. - DOI - PMC - PubMed

[4] Yongchen Z., Shen H., Wang X., Shi X., Li Y., Yan J., Chen Y., Gu B. Different longitudinal patterns of nucleic acid and serology testing results based on disease severity of COVID-19 patients. Emerg. Microbes Infect. 2020;9:833–836. doi: 10.1080/22221751.2020.1756699. - DOI - PMC - PubMed

[5] Sethuraman N., Jeremiah S.S., Ryo A. Interpreting diagnostic tests for SARS-CoV-2. JAMA. 2020;(May):6. doi: 10.1001/jama.2020.8259. - DOI - PubMed

[6] Sethuraman N., Jeremiah S.S., Ryo A. Interpreting diagnostic tests for SARS-CoV-2. JAMA. 2020;(May):6. doi: 10.1001/jama.2020.8259. - DOI - PubMed

[7] Meschi S., Colavita F., Bordi L., Matusali G., Lapa D., Amendola A., Vairo F., Ippolito G., Capobianchi M.R., Castilletti C. INMICovid-19 laboratory team, Performance evaluation of Abbott ARCHITECT SARS-CoV-2 IgG immunoassay in comparison with indirect immunofluorescence and virus microneutralization test. J. Clin. Virol. 2020;129:104539. doi: 10.1016/j.jcv.2020.104539. - DOI - PMC - PubMed

[8] Meschi S., Colavita F., Bordi L., Matusali G., Lapa D., Amendola A., Vairo F., Ippolito G., Capobianchi M.R., Castilletti C. INMICovid-19 laboratory team, Performance evaluation of Abbott ARCHITECT SARS-CoV-2 IgG immunoassay in comparison with indirect immunofluorescence and virus microneutralization test. J. Clin. Virol. 2020;129:104539. doi: 10.1016/j.jcv.2020.104539. - DOI - PMC - PubMed

[9] Nicol T., Lefeuvre C., Serri O., Pivert A., Joubaud F., Dubée V., Kouatchet A., Ducancelle A., Lunel-Fabiani F., Le Guillou-Guillemette H. Assessment of SARS-CoV-2 serological tests for the diagnosis of COVID-19 through the evaluation of three immunoassays: two automated immunoassays (Euroimmun and Abbott) and one rapid lateral flow immunoassay (NG Biotech) J. Clin. Virol. 2020;129:104511. doi: 10.1016/j.jcv.2020.104511. - DOI - PMC - PubMed

[10] Nicol T., Lefeuvre C., Serri O., Pivert A., Joubaud F., Dubée V., Kouatchet A., Ducancelle A., Lunel-Fabiani F., Le Guillou-Guillemette H. Assessment of SARS-CoV-2 serological tests for the diagnosis of COVID-19 through the evaluation of three immunoassays: two automated immunoassays (Euroimmun and Abbott) and one rapid lateral flow immunoassay (NG Biotech) J. Clin. Virol. 2020;129:104511. doi: 10.1016/j.jcv.2020.104511. - DOI - PMC - PubMed

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Performance evaluation of two SARS-CoV-2 IgG/IgM rapid tests (Covid-Presto and NG-Test) and one IgG automated immunoassay (Abbott)

Affiliations

Performance evaluation of two SARS-CoV-2 IgG/IgM rapid tests (Covid-Presto and NG-Test) and one IgG automated immunoassay (Abbott)

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