COVID-19 Human IgM IgG ELISAキット(Spike Protein)

マニュアル

​フライヤー

​製品の主な仕様

測定方法:　　　間接 ELISA 法

測定波長:　　　450 nm

測定試料:　　　血清

交差性:　　　　Human

保管温度:　　　HRP 標識抗ヒト IgM 抗体及び HRP 標識抗ヒト IgG 抗体　-20°C保管

​　　　　　　　 上記以外の試薬及び固相化プレート 4°C保管

品質保証期限:   本品の有効期限は製造後 5 カ月です。

プレートへの固相化抗原:　SARS-CoV-2 スパイクタンパク（S1 + S2ドメイン, 哺乳類細胞発現系）

1. SARS-CoV-2 スパイクタンパク固相化プレート

2. HRP 標識抗ヒト IgM 抗体

3. HRP 標識抗ヒト IgG 抗体

4. 洗浄液(10× PBST)

5. スキムミルク(ブロッキングバッファー用)

6. Diluent 用バッファー (10×)

7. R-1:発色基質(TMB)

8. R-2:反応停止液(1 mol/L 塩酸)

9. マイクロプレートシール

×2

4 μL×1

4 μL×1

50 mL×2

×1

50 mL×1

10 mL×2

10 mL×2

×2

測定原理

1. 固相化プレート上の リコンビナント SARS-CoV-2 スパイクタンパク と、これを認識する試料中の抗体(以後、抗スパイクタンパク抗体と略称)を反応させる。

2.  反応後、試料を洗浄操作により除去する。

3.  固相化プレート上の 抗スパイクタンパク抗体と、HRP (Horseradish peroxidase) 標識抗ヒト IgM / IgG 抗体を反応させる。

4. 余剰の HRP 標識抗ヒト IgM / IgG 抗体を洗浄操作により除去する。発色基質を加え、吸光度を測定する。

測定の意義

　本キットは、COVID-19 の原因ウイルスである、SARS-CoV-2 のスパイクタンパクを認識するヒトIgM 抗体とヒト IgG 抗体を検出するための研究用 ELISA キットです。 

　ウイルスの検出には、大きく分けて二種類のアプローチ法があり、PCR 法などのウイルス自体を検出する方法と、感染時に発現する免疫反応(IgG, IgM, IgA)を検出する方法があります。一般的 な感染症において、IgM は感染初期に生成される抗体で、症状の緩和とともに消失します。IgG は IgM に遅れて産生が始まり、治癒後も数カ月にわたって産生され続けます。これにより次に感染し た際の症状が軽くなったり、発症を防いだりすることが知られています。

本キット使用文献

• Kazuo Imai et al.
  Antibody response patterns in COVID-19 patients with different levels of disease severity-Japan

      J Med Virol. 2021 Feb 23. PubMed PMID: 33620098.

• Václav Šimánek et al.
  Five Commercial Immunoassays for SARS-CoV-2 Antibody Determination and Their Comparison and Correlation with the Virus Neutralization Test

      Diagnostics (Basel). 2021 Apr. PubMed PMID: 33806216

• Giuseppe Vetrugno et al.
  COVID-19 Seroprevalence among Healthcare Workers of a Large COVID-19 Hospital in Rome Reveals Strengths and Limits of Two Different Serological Tests

      Int J Environ Res Public Health. 2021 Mar. PubMed PMID: 33800721

• Isabelle Sermet-Gaudelus et al.
  Prior infection by seasonal coronaviruses, as assessed by serology, does not prevent SARS-CoV-2 infection and disease in children, France, April to June 2020

      Euro Surveill. 2021 Apr. PubMed PMID: 33797390

• Rebecca Elyanow et al.
  T-cell receptor sequencing identifies prior SARS-CoV-2 infection and correlates with neutralizing antibody titers and disease severity

      medRxiv. Preprint. 2021 Mar. PubMed PMID: 33791723

• Kirsten E Wiens et al.
  Seroprevalence of anti-SARS-CoV-2 IgG antibodies in Juba, South Sudan: a population-based study

      medRxiv. 2021 Mar. PubMed PMID: 33758900

• Gregorio Paolo Milani et al.
  Detection of IgM, IgG and SARS-CoV-2 RNA among the personnel of the University of Milan, March through May 2020: the UNICORN study 

      BMJ Open. 2021 Mar. PubMed PMID: 33762247

• Issaka Sagara et al.
  SARS-CoV-2 seroassay optimization and performance in a population with high background reactivity in Mali

      medRxiv. 2021 Mar. PubMed PMID: 33758883

• Anna Christine Nilsson et al.
  Comparison of six commercially available SARS-CoV-2 antibody assays-Choice of assay depends on intended use

      Int J Infect Dis. 2021 Feb. PubMed PMID: 33310021

• Robert Needle et al.
  Serological Evaluation of Human Antibodies of the Immunoglobulin Class A and G Against SARS-CoV-2 in Serum Collected in Newfoundland and Labrador

      Viral Immunol. 2021 Mar. PubMed PMID: 33739895

• Daniëlle A. T. Hanssen et al.
  Evaluation of 18 commercial serological assays for the detection of antibodies against SARS-CoV-2 in paired serum samples

      Eur J Clin Microbiol Infect Dis. 2021 Mar. PubMed PMID: 33733395

• Yi-Chun Lin et al.
  Multicenter evaluation of four immunoassays for the performance of early diagnosis of COVID-19 and assessment of antibody responses of patients with pneumonia in Taiwan​

      J Microbiol Immunol Infect. 2021 Feb. PubMed PMID: 33676864

• Louise C Rowntree et al.
  Robust correlations across six SARS‐CoV‐2 serology assays detecting distinct antibody features​

      lin Transl Immunology. 2021 Feb. PubMed PMID: 33680466

• Jesse T. Jacob et al.
  Risk Factors Associated With SARS-CoV-2 Seropositivity Among US Health Care Personnel

      JAMA Netw Open. 2021 Mar. PubMed PMID: 33688967

• Petra Emmerich et al.
  Limited specificity of commercially available SARS-CoV-2 IgG ELISAs in serum samples of African origin

      Trop Med Int Health. 2021 Mar. PubMed PMID: 33666297

• Charlotte V Hobbs et al.
  Estimated SARS-CoV-2 Seroprevalence Among Persons Aged <18 Years - Mississippi, May-September 2020​

      MMWR Morb Mortal Wkly Rep. 2021 Mar. PubMed PMID: 33661862

• Helena Cerutti et al.
  Large scale production and characterization of SARS-CoV-2 whole antigen for serological test development​

      J Clin Lab Anal. 2021 Feb. PubMed PMID: 33608968

• Francisco Belda et al.
  Available COVID-19 serial seroconversion panel for validation of SARS-CoV-2 antibody assays​

      Diagn Microbiol Infect Dis. 2021 Feb. PubMed PMID: 33596485

• David W. Eyre et al.
  Stringent thresholds in SARS-CoV-2 IgG assays lead to under-detection of mild infections​

      BMC Infect Dis. 2021 Feb. PubMed PMID: 33602152

• Jian Zhang et al.
  Spike-specific circulating T follicular helper cell and cross-neutralizing antibody responses in COVID-19-convalescent individuals

      Nat Microbiol. 2021 Jan. PubMed PMID: 33199863

• Xiao-Lin Jiang et al.
  Lasting antibody and T cell responses to SARS-CoV-2 in COVID-19 patients three months after infection

      Nat Commun. 2021 Feb. PubMed PMID: 33563974

• Andrea Tešija Kuna et al.
  Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays

      Biochem Med (Zagreb). 2021 Feb. PubMed PMID: 33594297

• Francisco Belda et al.
  Available COVID-19 serial seroconversion panel for validation of SARS-CoV-2 antibody assays

      Diagn Microbiol Infect Dis. 2021 Feb. PubMed PMID: 33596485

• Hadeel T Al-Jighefee et al.
  Evaluation of Antibody Response in Symptomatic and Asymptomatic COVID-19 Patients and Diagnostic Assessment of New IgM/IgG ELISA Kit

      Pathogens. 2021 Feb. PubMed PMID: 33546341

• Hadi M. Yassine et al.
  Performance evaluation of five ELISA kits for detecting anti-SARS-COV-2 IgG antibodies Int J Infect Dis. 2021 Jan. PubMed PMID: 33127504

      Int J Infect Dis. 2021 Jan. PubMed PMID: 33127504

• Alix T. Coste et al.
  Comparison of SARS-CoV-2 serological tests with different antigen targets

      J Clin Virol. 2021 Jan. PubMed PMID: 33253926

• Abdullah Algaissi et al.
  SARS-CoV-2 S1 and N-based serological assays reveal rapid seroconversion and induction of specific antibody response in COVID-19 patients

      Sci Rep. 2020 Oct. PubMed PMID: 33024213

• Jan Van Elslande et al.
  Antibody response against SARS-CoV-2 spike protein and nucleoprotein evaluated by four automated immunoassays and three ELISAs

      Clin Microbiol Infect. 2020 Nov. PubMed PMID: 32745595

• Anna Schaffner et al.
  Sustained SARS-CoV-2 nucleocapsid antibody levels in nonsevere COVID-19: a population-based study

      Clin Chem Lab Med. 2020 Nov. PubMed PMID: 33554502

• Martin P. Steinbuck et al.
  A lymph node–targeted Amphiphile vaccine induces potent cellular and humoral immunity to SARS-CoV-2

      Sci Adv. 2021 Feb. PubMed PMID: 33547083

• Susanne Brandstetter et al.
  Symptoms and immunoglobulin development in hospital staff exposed to a SARS‐CoV‐2 outbreak

      Pediatr Allergy Immunol. 2020 Oct. PubMed PMID: 32413201

• Lisa Müller et al.
  Sensitivity of anti-SARS-CoV-2 serological assays in a high-prevalence setting

      Eur J Clin Microbiol Infect Dis. 2021 Feb. PubMed PMID: 33534090

• Evangelos Terpos et al.
  Anti–SARS-CoV-2 Antibody Responses in Convalescent Plasma Donors Are Increased in Hospitalized Patients; Subanalyses of a Phase 2 Clinical Study

      Microorganisms. 2020 Dec. PubMed PMID: 33260775

• Susanna Scharrer et al.
  Humoral response to COVID-19 infection in immunosuppressed patients with inflammatory bowel disease

      Eur J Gastroenterol Hepatol. 2021 Jan. PubMed PMID: 33522752

• Kristin E. Mullins et al.
  Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers​

      Clin Biochem. 2021 Jan. PubMed PMID: 333472036

• Larry L. Luchsinger et al.
  Serological Assays Estimate Highly Variable SARS-CoV-2 Neutralizing Antibody Activity in Recovered COVID-19 Patients​

      J Clin Microbiol. 2020 Dec. PubMed PMID: 32917729

• Dustin D Flannery et al.
  Assessment of Maternal and Neonatal Cord Blood SARS-CoV-2 Antibodies and Placental Transfer Ratios​

      JAMA Pediatr. 2021 Jan. PubMed PMID: 33512440

• Mario Plebani et al.
  Performance of the COVID19SEROSpeed IgM/IgG Rapid Test, an Immunochromatographic Assay for the Diagnosis of SARS-CoV-2 Infection: a Multicenter European Study​

      J Clin Microbiol. 2021 Jan. PubMed PMID: 33218990

• Melanie A MacMullan et al.
  Detection of SARS-CoV-2 Antibodies in Oral Fluid Obtained Using a Rapid Collection Device​

      J Clin Microbiol. 2021 Jan. PubMed PMID: 33234589

• Melanie A. MacMullan et al.
  ELISA detection of SARS-CoV-2 antibodies in saliva​

      Sci Rep. 2020 Nov. PubMed PMID: 33257702

• Mª Isabel Galá et al.
  Hospital-Wide SARS-CoV-2 seroprevalence in health care workers in a Spanish teaching hospital​

      Enferm Infecc Microbiol Clin. 2020 Dec. PubMed PMID: 33485676

• Tim Meyer et al.
  Successful return to professional men’s football (soccer) competition after the COVID-19 shutdown: a cohort study in the German Bundesliga​

      Br J Sports Med. 2021 Jan. PubMed PMID: 32972979

• Dietrich Mack et al.
  Prevalence of SARS-CoV-2 IgG antibodies in a large prospective cohort study of elite football players in Germany (May-June 2020): implications for a testing protocol in asymptomatic individuals and estimation of the rate of undetected cases​

      Clin Microbiol Infect. 2020 Dec 5. PubMed PMID: 33285279

• N. Davidson et al.
  Comparative analysis of three laboratory based serological assays for SARS-CoV-2 in an Australian cohort

      Pathology. 2020 Dec. PubMed PMID: 33070955

• National SARS-CoV-2 Serology Assay Evaluation Group
  Performance characteristics of five immunoassays for SARS-CoV-2: a head-to-head benchmark comparison

      Lancet Infect Dis. 2020 Dec. PubMed PMID: 32979318

• Justin Manalac et al.
  Evaluation of Abbott anti-SARS-CoV-2 CMIA IgG and Euroimmun ELISA IgG/IgA assays in a clinical lab

      Clin Chim Acta. 2020 Nov. PubMed PMID: 32910980

• Ivana Lapić et al.
  The reliability of SARS-CoV-2 IgG antibody testing - a pilot study in asymptomatic health care workers in a Croatian university hospital

      Croat Med J. 2020 Dec 31. PubMed PMID: 33410294

• Nathalie Renard et al.
  Performance characteristics of the VIDAS® SARS-COV-2 IgM and IgG serological assays

      J Clin Microbiol. 2021 Jan 8. PubMed PMID: 33419947

• Anja Dörschug et al.
  Comparison of Five Serological Assays for the Detection of SARS-CoV-2 Antibodies

      Diagnostics (Basel). 2021 Jan 6. PubMed PMID: 33418886

• Ling L et al.
  Analysis of viral load in different specimen types and serum antibody levels of COVID-19 patients

      J Transl Med. 2021 Jan 7. PubMed PMID: 33413461

• Thessicar Antoine-Reid et al.
  Cross-Comparison of a Chemiluminescent Platform and a Commercial Receptor Binding Domain-Based ELISA for Detecting SARS-CoV-2 IgG

      J Appl Lab Med. 2020 Nov. PubMed PMID: 32750140

• Julien Marlet et al.
  Clinical performance of four immunoassays for antibodies to SARS-CoV-2, including a prospective analysis for the diagnosis of COVID-19 in a real-life routine care setting

      J Clin Virol. 2020 Nov. PubMed PMID: 32927357

• Barnaby Flower et al.
  Clinical and laboratory evaluation of SARS-CoV-2 lateral flow assays for use in a national COVID-19 seroprevalence survey

      Thorax. 2020 Aug. PubMed PMID: 32796119

• Adrian Shields et al.
  SARS-CoV-2 seroprevalence and asymptomatic viral carriage in healthcare workers: a cross-sectional study

      Thorax. 2020 Dec. PubMed PMID: 32917840

• Christina A Rostad et al.
  Quantitative SARS-CoV-2 Serology in Children With Multisystem Inflammatory Syndrome (MIS-C)

      Pediatrics. 2020 Dec. PubMed PMID: 32879033

• Kening Li et al.
  Dynamic changes in anti-SARS-CoV-2 antibodies during SARS-CoV-2 infection and recovery from COVID-19

      Nat Commun. 2020 Nov 27. PubMed PMID: 33247152

• Victoria Indenbaum et al.
  Testing IgG antibodies against the RBD of SARS-CoV-2 is sufficient and necessary for COVID-19 diagnosis

      PLoS One. 2020 Nov 23. PubMed PMID: 33227020

• Baweleta Isho et al.
  Persistence of serum and saliva antibody responses to SARS-CoV-2 spike antigens in COVID-19 patients

      Sci Immunol. 2020 Oct 8. PubMed PMID: 33033173​

• Anges Yadouleton et al.
  Limited Specificity of Serologic Tests for SARS-CoV-2 Antibody Detection, Benin

      Emerg Infect Dis. 2020 Dec 1. PubMed PMID: 33261717​

• Ricardo Savirón-Cornudella et al.
  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) universal screening in gravids during labor and delivery

      Eur J Obstet Gynecol Reprod Biol. 2021 Jan. PubMed PMID: 33285496

• Emily Garnett et al.
  Clinical Validation and Performance Evaluation of the Automated Vitros Total Anti-SARS-CoV-2 Antibodies Assay for Screening of Serostatus in COVID-19

      Am J Clin Pathol. 2020 Nov 4. PubMed PMID: 32864699

• Lenin Mahimainathan et al.
  Evaluation of SARS-CoV-2 Serological Testing in Patients with Multiple Myeloma and Other Hematologic Malignancies on Monoclonal Antibody Therapies

      Diagnostics (Basel). 2020 Nov 24. PubMed PMID: 33255154

• Harvey W Kaufman et al.
  Insights from Patterns of SARS-CoV-2 Immunoglobulin G Serology Test Results from a National Clinical Laboratory, United States, March-July 2020

      Popul Health Manag. 2020 Nov 19. PubMed PMID: 33216694

• Martin Risch et al.
  Temporal Course of SARS-CoV-2 Antibody Positivity in Patients with COVID-19 following the First Clinical Presentation

      Biomed Res Int. 2020. PubMed PMID: 33224987

• Ainhoa Gutiérrez-Cobos et al.
  Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies

      Eur J Clin Microbiol Infect Dis. 2020 Nov 24. PubMed PMID: 33236268

• Adrian M Shields et al.
  Serological responses to SARS-CoV-2 following non-hospitalised infection: clinical and ethnodemographic features associated with the magnitude of the antibody response

      medRxiv. Preprint. 2020 Nov 16. PubMed PMID: 33236029

• Constant Gillot et al.
  An Original ELISA-Based Multiplex Method for the Simultaneous Detection of 5 SARS-CoV-2 IgG Antibodies Directed against Different Antigens

      J Clin Med. 2020 Nov 21. PubMed PMID: 33233405

• Shamez N Ladhani et al.
  High prevalence of SARS-CoV-2 antibodies in care homes affected by COVID-19: Prospective cohort study, England

      EClinicalMedicine. 2020 Nov 6. PubMed PMID: 33173854

• Pingping Zhang et al.
  Development and evaluation of a serological test for diagnosis of COVID-19 with selected recombinant spike proteins

      Eur J Clin Microbiol Infect Dis. 2020 Nov 12. PubMed PMID: 33184753

• Melkon G DomBourian et al.
  Analysis of COVID-19 convalescent plasma for SARS-CoV-2 IgG using two commercial immunoassays

      J Immunol Methods. 2020 Nov. PubMed PMID: 32828791

• Ling Li et al.
  Characteristics and serological patterns of COVID-19 convalescent plasma donors: optimal donors and timing of donation

      Transfusion. 2020 Aug. PubMed PMID: 32627216

• Guillaume Beaudoin-Bussières et al.
  Decline of Humoral Responses against SARS-CoV-2 Spike in Convalescent Individuals

      mBio. 2020 Oct 16. PubMed PMID: 33067385

• Anita S Iyer et al.
  Persistence and decay of human antibody responses to the receptor binding domain of SARS-CoV-2 spike protein in COVID-19 patients

      Sci Immunol. 2020 Oct 8. PubMed PMID: 33033172

• Phuong Nguyen-Contant et al.
  S Protein-Reactive IgG and Memory B Cell Production after Human SARS-CoV-2 Infection Includes Broad Reactivity to the S2 Subunit

      mBio. 2020 Sep 25. PubMed PMID: 32978311

• James R. Byrnes et al.
  Competitive SARS-CoV-2 Serology Reveals Most Antibodies Targeting the Spike Receptor-Binding Domain Compete for ACE2 Binding

      mSphere. 2020 Sep 16. PubMed PMID: 32938700

• Mohammad Hosein Taziki Balajelini et al.
  Using Anti-SARS-CoV-2 IgG and IgM Antibodies to Detect Outpatient Cases with Olfactory and Taste Disorders Suspected as Mild Form of COVID-19: a Retrospective Survey

      SN Compr Clin Med. 2020 Nov 3. PubMed PMID: 33169109

• Tyler J Ripperger et al.
  Orthogonal SARS-CoV-2 Serological Assays Enable Surveillance of Low-Prevalence Communities and Reveal Durable Humoral Immunity

      Immunity. 2020 Oct 14. PubMed PMID: 33129373

• Pedro Martínez-Fleta et al.
  SARS-CoV-2 Cysteine-like Protease Antibodies Can Be Detected in Serum and Saliva of COVID-19-Seropositive Individuals

      J Immunol. 2020 Nov 4. PubMed PMID: 33148714

• Eshan U Patel et al.
  Comparative performance of five commercially available serologic assays to detect antibodies to SARS-CoV-2 and identify individuals with high neutralizing titers

      J Clin Microbiol. 2020 Nov 2. PubMed PMID: 33139419

• Zahra Rikhtegaran Tehrani et al.
  Performance of nucleocapsid and spike-based SARS-CoV-2 serologic assays

      PLoS One. 2020 Nov 2. PubMed PMID: 33137138

• Meret Huber et al.
  Postinfectious Onset of Myasthenia Gravis in a COVID-19 Patient

      Front Neurol. 2020 Oct 6. PubMed PMID: 33123081

• Ruta Kulkarni et al.
  Anti-SARS-CoV-2 IgG antibody response among Indian COVID-19 patients using β-propiolactone-inactivated, whole virus-based indirect ELISA

      J Virol Methods. 2021 Jan. PubMed PMID: 33126149

• Bernd Jahrsdörfer et al.
  Independent side-by-side validation and comparison of four serological platforms for SARS-CoV-2 antibody testing

      J Infect Dis. 2020 Oct 16. PubMed PMID: 33064789

• Manuela Pegoraro et al.
  Evaluation of three immunochromatographic tests in COVID-19 serologic diagnosis and their clinical usefulness

      Eur J Clin Microbiol Infect Dis. 2020 Oct 20. PubMed PMID: 33078222

• Xiaohui Wang et al.
  Accurate Diagnosis of COVID-19 by a Novel Immunogenic Secreted SARS-CoV-2 orf8 Protein

      mBio . 2020 Oct 20. PubMed PMID: 33082264

• Alessandra Sperotto et al.
  Screening Procedure for SARS-CoV-2 infection combining Triage, nasopharyngeal swab and serological test in allogeneic stem cell transplantation Recipients Undergoing Outpatient Post Transplant Follow-Up

      J Med Virol. 2020 Oct 8. PubMed PMID: 33030745

• Suliman A Alharbi et al.
  Enzyme-Linked Immunosorbent Assay for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgM/IgA and IgG Antibodies Among Healthcare Workers

      Cureus. 2020 Sep 6. PubMed PMID: 33047077

• Gláucia Cota et al.
  Diagnostic performance of commercially available COVID-19 serology tests in Brazil

      Int J Infect Dis. 2020 Oct 9. PubMed PMID: 33039612

• Massimo Pieri et al.
  SARS-CoV-2 infection serology validation of different methods: Usefulness of IgA in the early phase of infection

      Clin Chim Acta. 2020 Sep 28. PubMed PMID: 33002475

• Álvaro A Faccini-Martínez et al.
  Serological cross-reactivity using a SARS-CoV-2 ELISA test in acute Zika virus infection, Colombia

      Int J Infect Dis. 2020 Sep 28. PubMed PMID: 33002616

• Nguyen N Nguyen et al.
  Correlation of ELISA method with three other automated serological tests for the detection of anti-SARS-CoV-2 antibodies

      PLoS One. 2020 Oct 6. PubMed PMID: 33022019

• Massimo Guerriero et al.
  Prevalence of asymptomatic SARS-CoV-2-positive individuals in the general population of northern Italy and evaluation of a diagnostic serological ELISA test: a cross-sectional study protocol

      BMJ Open. 2020 Oct 6. PubMed PMID: 33028562

• Ekasit Kowitdamrong et al.
  Antibody responses to SARS-CoV-2 in patients with differing severities of coronavirus disease 2019

      PLoS One. 2020 Oct 9. PubMed PMID: 33035234

• Anja Dörschug et al.
  Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)

      Eur J Microbiol Immunol (Bp). 2020 Sep 25. PubMed PMID: 32979256

• Elitza S Theel et al.
  Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies against SARS-CoV-2

      J Clin Microbiol. 2020 Jul 23. PubMed PMID: 32513859

• Mei San Tang et al.
  Association between SARS-CoV-2 neutralizing antibodies and commercial serological assays

      Clin Chem. 2020 Sep 7. PubMed PMID: 32894750

• Pauline H Herroelen et al.
  Humoral Immune Response to SARS-CoV-2

      Am J Clin Pathol. 2020 Aug 18. PubMed PMID: 32808976

• Anna E Merrill et al.
  Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays

      J Appl Lab Med. 2020 Jul 27. PubMed PMID: 32717056

• Marzia Nuccetelli et al.
  Combined anti-SARS-CoV-2 IgA, IgG, and IgM Detection as a Better Strategy to Prevent Second Infection Spreading Waves

      Immunol Invest. 2020 Sep 18. PubMed PMID: 32945214

• Reuben McGregor et al.
  Collaborative networks enable the rapid establishment of serological assays for SARS-CoV-2 during nationwide lockdown in New Zealand

      PeerJ . 2020 Sep 3. PubMed PMID: 32953275

• Suzanne Pickering et al.
  Comparative assessment of multiple COVID-19 serological technologies supports continued evaluation of point-of-care lateral flow assays in hospital and community healthcare settings

      PLoS Pathog . 2020 Sep 24. PubMed PMID: 32970782

• Gang Xu et al.
  Evaluation of Orthogonal Testing Algorithm for Detection of SARS-CoV-2 IgG Antibodies

      Clin Chem. 2020 Sep 7. PubMed PMID: 32894753

• Diego O. Andrey et al.
  Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests

      J Clin Med. 2020 Aug. PubMed PMID: 32722191

• Diego O. Andrey et al.
  Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room

      Eur J Clin Invest. 2020 Jul 21. PubMed PMID: 32691863

• Zeno Bisoffi et al.
  Diagnostic accuracy of Augurix COVID‐19 IgG serology rapid test

      Diagnostics (Basel). 2020 Sep 3. PubMed PMID: 32899333

• Eshan Patel et al.
  Comparative performance of five commercially available serologic assays to detect antibodies to SARS-CoV-2 and identify individuals with high neutralizing titers

      medRxiv . 2020 Sep 2. PubMed PMID: 32908987

• Georg M. N. Behrens et al.
  Strategic Anti-SARS-CoV-2 Serology Testing in a Low Prevalence Setting: The COVID-19 Contact (CoCo) Study in Healthcare Professionals

      Infect Dis Ther. 2020 Sep 4. PubMed PMID: 32886335

• Oktavija Đaković Rode et al.
  Antibody response and the clinical presentation of patients with COVID-19 in Croatia: the importance of a two-step testing approach

      Eur J Clin Microbiol Infect Dis. 2020 Sep 4. PubMed PMID: 32886230

• Clarence W Chan et al.
  Analytical and Clinical Evaluation of the Automated Elecsys Anti–SARS-CoV-2 Antibody Assay on the Roche cobas e602 Analyzer

      Am J Clin Pathol. 2020 Aug 20. PubMed PMID: 32814955

• Fleur Wolff et al.
  Monitoring antibody response following SARS-CoV-2 infection: diagnostic efficiency of 4 automated immunoassays

      Diagn Microbiol Infect Dis. 2020 Nov. PubMed PMID: 32829098

• Niko Kohmer et al.
  Brief clinical evaluation of six high-throughput SARS-CoV-2 IgG antibody assays

      J Clin Virol. 2020 Aug. PubMed PMID: 32505777

• Christian Wechselberger et al.
  Performance evaluation of serological assays to determine the immunoglobulin status in SARS-CoV-2 infected patients

      J Clin Virol. 2020 Oct. PubMed PMID: 32810840

• Hui-Xia Gao et al.
  Detection of serum immunoglobulin M and immunoglobulin G antibodies in 2019 novel coronavirus infected patients from different stages

      Chin Med J (Engl). 2020 Jun 20. PubMed PMID: 32221133

• Sonny Elizaldi et al.
  SARS-CoV-2 infection induces robust germinal center CD4 T follicular helper cell responses in rhesus macaques

      Res Sq. 2020 Aug 14. PubMed PMID: 32818217

• Jeffrey D Whitman et al.
  Evaluation of SARS-CoV-2 serology assays reveals a range of test performance

      Nat Biotechnol. 2020 Aug 27. PubMed PMID: 32855547

• Verena Haselmann et al.
  Results of the first pilot external quality assessment (EQA) scheme for anti-SARS-CoV2-antibody testing

      Clin Chem Lab Med . 2020 Aug 27. PubMed PMID: 32853163

• Maria Infantino et al.
  Closing the Serological Gap in the Diagnostic Testing for COVID‐19: The Value of Anti‐SARS‐CoV‐2 IgA Antibodies

      J Med Virol. 2020 Aug 13. PubMed PMID: 32790181

• Verena Haselmann et al.
  Comparison of test performance of commercial anti-SARS-CoV-2 immunoassays in serum and plasma samples

      Clin Chim Acta. 2020 Nov. PubMed PMID: 32652161

• G. Caruana et al.
  Diagnostic strategies for SARS-CoV-2 infection and interpretation of microbiological results​

      Clin Microbiol Infect. 2020 Sep. PubMed PMID: 32593741

• David Peterhoff et al.
  A highly specific and sensitive serological assay detects SARS-CoV-2 antibody levels in COVID-19 patients that correlate with neutralization

      Infection. 2020 Aug 21. PubMed PMID: 32827125

• Kasopefoluwa Y Oguntuyo et al.
  Quantifying absolute neutralization titers against SARS-CoV-2 by a standardized virus neutralization assay allows for cross-cohort comparisons of COVID-19 sera

      medRxiv. 2020 Aug 15. PubMed PMID: 32817961

• Kathleen M McAndrews et al.
  Heterogeneous antibodies against SARS-CoV-2 spike receptor binding domain and nucleocapsid with implications on COVID-19 immunity

      JCI Insight. 2020 Aug 14. PubMed PMID: 32796155

• Aaron J Siegler et al.
  Protocol for a national probability survey using home specimen collection methods to assess prevalence and incidence of SARS-CoV-2 infection and antibody response

      Ann Epidemiol. 2020 Aug 10. PubMed PMID: 32791199

• Zahra Rikhtegaran Tehrani et al.
  Specificity and Performance of Nucleocapsid and Spike-based SARS-CoV-2 Serologic Assays

      medRxiv. 2020 Aug 7. PubMed PMID: 32793933

• Sebastian Hörber et al.
  Evaluation of three fully-automated SARS-CoV-2 antibody assays

      Clin Chem Lab Med. 2020 Aug 4. PubMed PMID: 32745068

• Felipe Pérez-García et al.
  Alltest rapid lateral flow immunoassays is reliable in diagnosing SARS-CoV-2 infection from 14 days after symptom onset: A prospective single-center study

      J Clin Virol. 2020 Aug. PubMed PMID: 32504945

• Anita S. Iyer et al.
  Dynamics and significance of the antibody response to SARS-CoV-2 infection

      medRxiv. Preprint. 2020 Jul 20. PubMed PMID: 32743600

• Giorgio Caturegli et al.
  Clinical Validity of Serum Antibodies to SARS-CoV-2

      Ann Intern Med. 2020 Jul 6. PubMed PMID: 32628534

• Jitendra Prasad Mathuria et al.
  Laboratory diagnosis of SARS-CoV-2 - A review of current methods 

      J Infect Public Health. 2020 Jul. PubMed PMID: 32534946

• Alexander Krüttgen et al.
  Comparison of four new commercial serologic assays for determination of SARS-CoV-2 IgG

      J Clin Virol. 2020 Jul. PubMed PMID: 32416599

• Fatima Amanat et al.

       A serological assay to detect SARS-CoV-2 seroconversion in humans

      Nat Med. 2020 Jul. PubMed PMID: 32398876

• Mayara Lisboa Bastos et al.
  Diagnostic Accuracy of Serological Tests for covid-19: Systematic Review and Meta-Analysis

      BMJ. 2020 Jul. PubMed PMID: 32611558

• Lisa Sophie Pflüger et al.
  Clinical evaluation of five different automated SARS-CoV-2 serology assays in a cohort of hospitalized COVID-19 patients

      J Clin Virol. 2020 Jul 17. PubMed PMID: 32763809

• Corine H. GeurtsvanKessel et al.
  An evaluation of COVID-19 serological assays informs future diagnostics and exposure assessment

      Nat Commun. 2020 Jul 6. PubMed PMID: 32632160

• Daniel Shyu et al.
  Laboratory Tests for COVID-19: A Review of Peer-Reviewed Publications and Implications for Clinical UIse

      Mo Med. 2020 May-Jun. PubMed PMID: 32636542

• Patrick Sean Sullivan et al.
  Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples

      JMIR Public Health Surveill. 2020 Apr-Jun. PubMed PMID: 32310815

• Thomas Nicol et al.
  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 Jun 15. PubMed PMID: 32593133

• Benjamin Meyer et al​.
  Validation of a commercially available SARS-CoV-2 serological immunoassay

      Clin Microbiol Infect. 2020 Jun 27. PubMed PMID: 3260380

• Silvia Stringhini et al.
  Seroprevalence of anti-SARS-CoV-2 IgG antibodies in Geneva, Switzerland (SEROCoV-POP): a population-based study

      Lancet. 2020 Jun 11. PubMed PMID: 32534626

• Antonio Vittorino Gaddi et al.
  The Strategic Alliance between Clinical and Molecular Science in the War against SARS-CoV-2, with the Rapid-Diagnostics Test as an Indispensable Weapon for Front Line Doctors

      Int J Mol Sci. 2020 Jun. PubMed PMID: 32580529

• Kathleen G. Beavis et al.

       Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies

      J Clin Virol. 2020 Aug. PubMed PMID: 32485620

• AJ Jääskeläinen et al.
  Performance of six SARS-CoV-2 immunoassays in comparison with microneutralization

      J Clin Virol. 2020 Aug. PubMed PMID: 32563180

• Baoqing Sun et al.
  Kinetics of SARS-CoV-2 Specific IgM and IgG Responses in COVID-19 Patients

      Emerg Microbes Infect. 2020 Dec. PubMed PMID: 32357808

• Feng-Cai Zhu et al.
  Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial

      Lancet. 2020 13-19 June. PubMed PMID: 32450106

• Andrea P Espejo et al.

       Review of Current Advances in Serologic Testing for COVID-19

      Am J Clin Pathol. 2020 Jun 25. PubMed PMID: 32583852

• Jonathan J Deeks et al.

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

      Cochrane Database Syst Rev. 2020 Jun 25. PubMed PMID: 32584464

• Ahidjo Ayouba et al.

       Multiplex detection and dynamics of IgG antibodies to SARS-CoV2 and the highly pathogenic human 

       coronaviruses SARS-CoV and MERS-CoV

       J Clin Virol. 2020 Jun 22. PubMed PMID: 32623350

• Wan Ni Chia et al.
  Serological Differentiation Between COVID-19 and SARS Infections

      Emerg Microbes Infect. 2020 Jun 12. PubMed PMID: 32529906

• Lakshmanane Premkumar et al.
  The receptor binding domain of the viral spike protein is an immunodominant and highly specific target of antibodies in SARS-CoV-2 patients

      Sci Immunol. 2020 Jun 11. PubMed PMID: 32527802

• Xin Xu et al.
  Seroprevalence of Immunoglobulin M and G Antibodies Against SARS-CoV-2 in China

      Nat Med. 2020 Jun 5. PubMed PMID: 32504052​

• Florian Krammer et al.
  Serology assays to manage COVID-19

      Science. 2020 Jun 5. PubMed PMID: 32414781​​

• Hua Li et al.
  A new and rapid approach for detecting COVID-19 based on S1 protein fragments

      Clin Transl Med . 2020 Jun 5. PubMed PMID: 32508026

• Roshan J. D'Cruz et al.
  Laboratory Testing Methods for Novel Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2)

      Front Cell Dev Biol. 2020 Jun 4. PubMed PMID: 32582718

• Huibin Lv et al.
  Cross-reactive Antibody Response between SARS-CoV-2 and SARS-CoV Infections

      Cell Rep. 2020 Jun 2. PubMed PMID: 32426212

• Chek Meng Poh et al.
  Two Linear Epitopes on the SARS-CoV-2 Spike Protein That Elicit Neutralising Antibodies in COVID-19 Patients

      Nat Commun . 2020 Jun 1. PubMed PMID: 32483236​

• Daniel Stadlbauer et al.
  SARS‐CoV‐2 Seroconversion in Humans: A Detailed Protocol for a Serological Assay, Antigen Production, and Test Setup

      Curr Protoc Microbiol. 2020 Jun. PubMed PMID: 32302069​

• Qiang Wang et al.
  A Method to Prevent SARS-CoV-2 IgM False Positives in Gold Immunochromatography and Enzyme-Linked Immunosorbent Assays

      J Clin Microbiol. 2020 Jun. PubMed PMID: 32277023

• Ying Yan et al.
  Laboratory testing of SARS‐CoV, MERS‐CoV, and SARS‐CoV‐2 (2019‐nCoV): Current status, challenges, and countermeasures

      Rev Med Virol. 2020 May. PubMed PMID: 32302058

• Huan Ma et al.
  Serum IgA, IgM, and IgG responses in COVID-19

      Cell Mol Immunol. 2020 May 28. PubMed PMID: 32467617​​

• J Van Elslande et al.
  Diagnostic Performance of Seven Rapid IgG/IgM Antibody Tests and the Euroimmun IgA/IgG ELISA in COVID-19 Patients

      Clin Microbiol Infect. 2020 May. PubMed PMID: 32473953

• Huan Ma et al.
  Serum IgA, IgM, and IgG responses in COVID-19

      Cell Mol Immunol. 2020 May 28. PubMed PMID: 32467617​​

• Nadin Younes et al.
  Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2

     Viruses. 2020 May 26. PubMed PMID: 32466458

• Wanbing Liu et al.
  Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies Against SARS-CoV-2

      J Clin Microbiol . 2020 May 26. PubMed PMID: 32229605​

• Ling Zhong et al.
  Detection of serum IgM and IgG for COVID-19 diagnosis

      Sci China Life Sci. 2020 May. PubMed PMID: 32270436

• Alba Grifoni et al.
  Targets of T Cell Responses to SARS-CoV-2 Coronavirus in Humans with COVID-19 Disease and Unexposed Individuals

      Cell. 2020 May 20. PubMed PMID: 32473127

• Trevor R F Smith et al.
  Immunogenicity of a DNA Vaccine Candidate for COVID-19
  Nat Commun. 2020 May 20. PubMed PMID: 32433465

• Marie Tré-Hardy et al.
  The role of serology for COVID-19 control: Population, kinetics and test performance do matter

     J Infect. 2020 May 15. PubMed PMID: 32417311

• Johannes Korth et al.
  SARS-CoV-2-specific antibody detection in healthcare workers in Germany with direct contact to COVID-19 patient

      J Clin Virol. 2020 Jul (Published online 2020 May 13.) PubMed PMID: 32434708​

• Fatima Amanat et al.
  A Serological Assay to Detect SARS-CoV-2 Seroconversion in Humans
  Nat Med. 2020 May 12. PubMed PMID: 32511441

• Jiajia Xie et al.
  Characteristics of patients with coronavirus disease (COVID‐19) confirmed using an IgM‐IgG antibody test
  J Med Virol. 2020 May 7. PubMed PMID: 32330303

• Anne J Jääskeläinen et al.
  Evaluation of commercial and automated SARS-CoV-2 IgG and IgA ELISAs using coronavirus disease (COVID-19) patient samples

      Euro Surveill. 2020 May 7. PubMed PMID: 32400364

• Rongqing Zhao et al.
  Early Detection of SARS-CoV-2 Antibodies in COVID-19 Patients as a Serologic Marker of Infection
  Clin Infect Dis. 2020 May. PubMed PMID: 32357209

• Hongzhou Lu et al.
  An Evolving Approach to the Laboratory Assessment of COVID-19
  J Med Virol . 2020 Apr 29. PubMed PMID: 32347966

• Quan-Xin Long et al.
  Antibody Responses to SARS-CoV-2 in Patients With COVID-19
  Nat Med. 2020 Apr 29. PubMed PMID: 32350462

• Kai Duan et al.
  Effectiveness of convalescent plasma therapy in severe COVID-19 patients

      Proc Natl Acad Sci U S A. 2020 Apr 28. PubMed PMID: 32253318

• Juanjuan Zhao et al.
  Antibody Responses to SARS-CoV-2 in Patients of Novel Coronavirus Disease 2019
  Cin Infect Dis. 2020 Mar 28. PubMed PMID: 32221519

• Bin Wang et al.
  Long-term Coexistence of SARS-CoV-2 With Antibody Response in COVID-19 Patients

      J Med Virol. 2020 Apr 28. PubMed PMID: 32343415

• Chenguang Shen et al.
  Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma

      JAMA. 2020 Apr 28. PubMed PMID: 32219428

• Ranawaka APM Perera et al.
  Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), March 2020

      Euro Surveill. 2020 Apr 23. PubMed PMID: 32347204

• Andrea Padoan et al.
  IgA-Ab Response to Spike Glycoprotein of SARS-CoV-2 in Patients With COVID-19: A Longitudinal Study

      Clin Chim Acta. 2020 Aug. PubMed PMID: 32343948​

• Nisreen M A Okba et al.

• Severe Acute Respiratory Syndrome Coronavirus 2-Specific Antibody Responses in Coronavirus Disease 2019 Patients

      Emerg Infect Dis. 2020 Apr 8. PubMed PMID: 32267220

参考文献

1.)平松　啓一, 標準微生物学, 第 11 版, 医学書院 (2012)

2.)Anu Haveri , “Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland,” January to February 2020 , Eurosurveillance.  Volume 25, Issue 11, 19, Mar 2020.

3.)Wanbing Liu, “Evaluation of Nucleocapsid and Spike Protein-based ELISAs for detecting antibodies against SARS-CoV-2”, J Clin Microbiol. 2020 Mar 30.

4.)Li Guo, “Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19)”, Clin Infect Dis. 2020 Mar 21.

5.)Juanjuan Zhao, “Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019”, Clin Infect Dis. 2020 Mar 21.