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V-PLEX Serology Panels and Proficiency Samples

V-PLEX Serology panels detect antibodies to antigens from SARS-CoV-2, SARS-CoV-2 variants, SARS-1, MERS, circulating Coronaviruses, and other respiratory pathogens. They are built from a large library of antigens, organized into panels. The menu includes the V-PLEX SARS-CoV-2 Panel 2, which was chosen by Operation Warp Speed (OWS) as the basis of its standard binding assays for immunogenicity assessments in all funded Phase III clinical trials of vaccines.

The V-PLEX SARS-CoV-2 Panels focus on antigens from the SARS-CoV-2 virus including the Alpha, Beta, Gamma, Delta, Lambda, Mu, and Omicron variants (click here to view the full list of variants). The V-PLEX Coronavirus Panels add circulating Coronaviruses; V-PLEX Respiratory Panels also have antigens for Influenza and RSV. The menu includes kits to measure antibodies that block binding of ACE2 to the Spike and RBD antigens of the SARS-CoV-2 virus (including variants), which is a high-throughput alternative to traditional neutralization assays.

All human serology tests are provided as complete kits and include reference standards and controls. V-PLEX Serology kits are calibrated using Reference Standard 1 or 2 against the WHO International Standard (NIBSC code: 20/136), and results from the V-PLEX Serology Panels can be reported in International Units (BAU/mL). Reference Standard 2 has been developed to generate a stronger single against newer SARS-CoV-2 variants, and is included in our newly released SARS-CoV-2 and Respiratory panels.

MSD offers COVID-19 Proficiency Samples intended for use as test samples in MSD’s V-PLEX COVID-19 Serology Kits. Samples are commercially sourced aliquots of human serum containing antibodies to antigens from SARS-CoV-2, SARS-1, MERS, circulating Coronaviruses, and other respiratory pathogens. MSD provides assigned values for the concentration of antibodies in each sample, enabling users to assess their laboratory performance for testing, training, concordance studies, validations, and troubleshooting. COVID-19 Proficiency samples are available in panels or as individual samples.

Antigen and Biomarker Assays

MSD offers two formats for direct detection of viral antigens. S-PLEX antigen assays measure the SARS-CoV-2 Spike and Nucleocapsid antigens and have ultra-sensitive detection limits (femtogram/mL). R-PLEX antibody sets for SARS-CoV-2 Spike and Nucleocapsid antigens can be used to develop singleplex and multiplex assays, including combinations with other biomarkers of interest. Our menu also offers panels of biomarkers, including inflammatory cytokines and other analytes relevant to COVID-19.

References

1. Performance and validation of an adaptable multiplex assay for detection of serologic response to SARS-CoV-2 infection or vaccination
2. Immune responses after omicron infection in triple-vaccinated health-care workers with and without previous SARS-CoV-2 infection
3. Viral Antigen and Inflammatory Biomarkers in Cerebrospinal Fluid in Patients With COVID-19 Infection and Neurologic Symptoms Compared With Control Participants Without Infection or Neurologic Symptoms
4. Sensitive Serology Measurements in the Saliva of Individuals with COVID-19 Symptoms Using a Multiplexed Immunoassay
5. SARS-CoV-2 -specific immune responses in boosted vaccine recipients with breakthrough infections during the Omicron variant surge
6. A Fourth Dose of COVID-19 Vaccine Does Not Induce Neutralization of the Omicron Variant Among Solid Organ Transplant Recipients With Suboptimal Vaccine Response
7. Quantitative serology for SARS-CoV-2 using self-collected saliva and finger-stick blood
8. Clinical Performance of Three Commercial and Two In-House Multiplex Assays for SARS-CoV-2 Antibody Detection in Dried Blood Spot Specimens
9. Age-Associated Seroprevalence of Coronavirus Antibodies: Population-Based Serosurveys in 2013 and 2020, British Columbia, Canada
10. SARS-CoV-2 Nucleocapsid Plasma Antigen for Diagnosis and Monitoring of COVID-19
11. Diagnostic accuracy of the ultrasensitive S-PLEX SARS-CoV-2 N electrochemiluminescence immunoassay
12. Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report
13. Immune Correlates Analysis of the mRNA-1273 COVID-19 Vaccine Efficacy Trial
14. A Higher Antibody Response Is Generated With a 6- to 7-Week (vs Standard) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine Dosing Interval
15. Quantitative serology for SARS-CoV-2 using self-collected saliva and finger-stick blood
16. Two doses of SARS-CoV-2 vaccination induce robust immune responses to emerging SARS-CoV-2 variants of concern
17. Immunogenicity of Ad26.COV2.S vaccine against SARS-CoV-2 variants in humans
18. Performance of Immunoglobulin G Serology on Finger Prick Capillary Dried Blood Spot Samples to Measure SARS-CoV-2 Humoral Immunogenicity
19. Targeting SARS-CoV-2 receptor-binding domain to cells expressing CD40 improves protection to infection in convalescent macaques
20. Durability of mRNA-1273-induced antibodies against SARS-CoV-2 variants
21. Coronavirus-Specific Antibody Cross Reactivity in Rhesus Macaques Following SARS-CoV-2 Vaccination and Infection
22. mRNA vaccination compared to infection elicits an IgG-predominant response with greater SARS-CoV-2 specificity and similar decrease in variant spike recognition
23. Galectin-9, a Player in Cytokine Release Syndrome and a Surrogate Diagnostic Biomarker in SARS-CoV-2 Infection
24. Infection- and vaccine-induced antibody binding and neutralization of the B.1.351 SARS-CoV-2 variant
25. Reduced binding and neutralization of infection- and vaccine-induced antibodies to the B.1.351 (South African) SARS-CoV-2 variant
26. Antibody Responses After a Single Dose of ChAdOx1 nCoV-19 Vaccine in Healthcare Workers Previously Infected with SARS-CoV-2
27. Two doses of SARS-CoV-2 vaccination induce more robust immune responses to emerging SARS-CoV-2 variants of concern than does natural infection
28. Shared B cell memory to coronaviruses and other pathogens varies in human age groups and tissues
29. SARS-CoV-2 elicits robust adaptive immune responses regardless of disease severity
30. Ultra-sensitive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection for the Diagnosis of Coronavirus Disease 2019 (COVID-19) in Upper Respiratory Samples
31. Anti-SARS-CoV-2 IgG from severely ill COVID-19 patients promotes macrophage hyper-inflammatory responses
32. Characterization and Biomarker Analyses of Post-COVID-19 Complications and Neurological Manifestations
33. Evaluation of a novel multiplexed assay for determining IgG levels and functional activity to SARS-CoV-2
34. Ultrasensitive assay for saliva-based SARS-CoV-2 antigen detection
35. Cross-sectional prevalence of SARS-CoV-2 antibodies in healthcare workers in paediatric facilities in eight countries
36. Humoral Response Dynamics Following Infection with SARS-CoV-2
37. Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates
38. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial
39. Correlation of SARS-CoV-2 nucleocapsid antigen and RNA concentrations in nasopharyngeal samples from children and adults using an ultrasensitive and quantitative antigen assay
40. Antibody reactivity to SARS-CoV-2 is common in unexposed adults and infants under 6 months
41. Multisystem inflammatory syndrome in children and COVID-19 are distinct presentations of SARS–CoV-2
42. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China
43. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology
44. Coronavirus infections and immune responses
45. Handbook of COVID-19 Prevention and Treatment

SARS-CoV-2 image courtesy of CDC/ Alissa Eckert, MS; Dan Higgins, MAMS