EBV IgM

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Overview

BioPlex™ 2200 EBV IgG and IgM

EBV Infection Diagnosis

Infectious Mononucleosis (IM) diagnosis is typically based on the detection of heterophile antibodies and antibodies against specific Epstein-Barr virus antigens:

  • Viral Capsid Antigen: EBV VCA IgG and EBV VCA IgM
  • Nuclear Antigen: EBV NA-1 IgG
  • Early Antigen: EBV EA-D IgG

Combining heterophile IgM and VCA IgM detection enhances the detection of acute IM. Determining the complete patient EBV serological profile is essential to define the stage of the infection.



Adapted from: J.M. Seigneurin, Apport du laboratoire dans l’infection à virus Epstein-Barr. Laboratory diagnosis of Epstein-Barr virus infections. Immuno-analyse & Biologie Spécialisée 1 (2002) 33–39.

BioPlex™ 2200 EBV IgG and IgM

Comparison Using Serological Status

A total of 618 results were obtained using commercially available ELISA microplate and agglutination tests and the BioPlex™ 2200 EBV IgG and IgM Kits. Samples were then assigned a serological status for both methods using a generallyaccepted EBV serology interpretation table. The BioPlex 2200 EBV IgG and IgM Kits show excellent correlationwith commercially available assays for each disease status, with fewer samples categorized as inconclusive.

EBV Serological Status BioPlex 2200 EBV IgG and IgM Profile
Primary
Acute
Late
Acute
Recov-
ering
Previous
Infection
Suscep-
tible
Incon-
clusive
Total %
Serological
Agreement
95%
Confidence
Interval
Commercially
Available
Assays
Primary
Acute
30 0 0 0 0 1 31 96.8% 83.8–
99.4%
Late
Acute
5 90 1 13 0 1 110 81.8% 73.6–
87.9%
Recovering 1 0 3 0 0 0 4 75.0% 30.0–
95.4%
Previous
Infection
0 31 2 263 4 5 305 86.2% 81.9–
89.7%
Susceptible 4 0 0 0 122 1 127 96.1% 91.1–
98.3%
Inconclusive 6 10 0 7 11 7 41 17.1% 8.5–
31.3%
Overall 46 131 6 283 137 15 618 83.3% 80.2–
86.1%

EBV Serological StatusBioPlex 2200 EBV IgG and IgM Profile
Primary
Acute
Non-AcuteInconclusiveTotal%
Serological
Agreement
95%
Confidence
Interval
Commercially
Available
Assays
Acute12514214188.7%82.4–92.9%
Non-Acute36394643690.4%87.2–92.8%
Inconclusive161874117.1%8.5–31.3%
Overall1774261561885.1%82.1–87.7%
BioPlex™ 2200 EBV IgG and IgM

Reproducibility

Following CLSI EP5-A guidelines, the BioPlex™ 2200 EBV IgG and IgM Kits positive controls were run at 3 clinical sites for 3 days, 4 times a day, for a total of 36 replicates. The BioPlex 2200 EBV IgG and IgM Kits offer excellent reproducibility for both within-run and between-run calculations. Outstanding reproducibility can be attributed to: a) full automation, b) the magnetic bead, heterogenous format of the assay and c) approximately 200 measurements per analyte (up to 4 times those of other multiplex methods).

Positive Control Sample N Grand Mean AI Within-Run Between-Run
SD %CV SD %CV
EBV VCA IgG 36 2.3 0.1 2.8% 0.1 2.7%
EBV NA-1 IgG 36 2.9 0.1 1.9% 0.1 2.4%
EBV EA-D IgG 36 3.0 0.1 3.1% 0.1 2.5%

Positive Control Sample N Grand Mean AI Within-Run Between-Run
SD %CV SD %CV
EBV VCA IgM 36 2.0 0.1 5.5% 0.1 3.0%
Heterophile IgM 36 2.5 0.1 5.3% 0.0 0.0%
BioPlex™ 2200 EBV IgG and IgM

EBV IgG and IgM Assay Procedure

1. Patient sample (5 µL) automatically added to
    reaction vessel

2. Sample diluent & beads (dilution 1:60) added
    and incubated at 37°C

3. Wash step

4. Conjugate added and incubated at 37°C

5. Wash step

6. Bead resuspended in wash buffer

7. Flow-based, dual laser detection

BioPlex™ 2200 EBV IgG and IgM

Reagents, Calibrators, and Controls

EBV IgG and IgM Reagent Packs

Each contains all the necessary reagents (sample diluent, beads, and conjugate) to process 100 samples per pack and up to 3 (IgG) and 2 (IgM) results per sample.

EBV IgG and IgM Calibrator Sets

The EBV IgG and IgM kit calibrators are multiplexed and ready-to-use.

EBV IgG and IgM Control Sets

The EBV IgG and IgM kit controls are multiplexed and ready-to-use.

The BioPlex® 2200 EBV IgM kit simultaneously detects the two antibodies of highest clinical significance, including the heterophile antibody, in a multiplex format. The BioPlex heterogeneous assay format (a minimum of 150 readings per analyte) enhances precision and the system can process up to 190 results per hour (EBV IgG and EBV IgM kits combined). All reagents, calibrators, and controls are ready to use and all steps are fully automated, significantly reducing hands-on time and labor costs. Full automation from primary tube to final result minimizes the subjectivity linked to non-EIA methods and improves reproducibility. For every sample, the system also processes three internal quality controls, ensuring the integrity of results.

The system’s powerful eFlex™ software provides maximum control and flexibility. Add on new test orders from previously run samples, create custom EBV panels, and interface bidirectionally with the laboratory information system (LIS). BioPlex® 2200 EBV IgG and IgM kits provide complete information for improved diagnosis, management, and follow-up care of EBV-infected patients.

BioPlex® 2200 EBV IgM reports results for the following antibodies:

  • EBV VCA IgM
  • Heterophile IgM

 

BioPlex<sup>®</sup> 2200 EBV IgM Calibrator Set
BioPlex® 2200 EBV IgM Calibrator Set

663-1300
Multiplexed standard analytes for calibration of results of Epstein-Barr virus screening based on IgM antibodies on BioPlex® 2200 System

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BioPlex<sup>®</sup> 2200 EBV IgM Control Set
BioPlex® 2200 EBV IgM Control Set

663-1330
Set of multiplexed negative and multianalyte positive controls for Epstein-Barr virus screening based on IgM antibodies on BioPlex® 2200 System

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BioPlex<sup>®</sup> 2200 EBV IgM Reagent Pack
BioPlex® 2200 EBV IgM Reagent Pack

665-1350
Reagents for 100 tests for clinically relevant IgM antibodies to Epstein-Barr virus on BioPlex® 2200 System; aids in diagnosis of infectious mononucleosis

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Number Description Options
T-110 BioPlex EBV Brochure Click to download [ Add to Cart (Free) ]
T-136 BioPlex 2200 Panel Menu Click to download [ Add to Cart (Free) ]
T-158 BioPlex 2200 EBV IgG and IgM Brochure Click to download [ Add to Cart (Free) ]
T-167 BioPlex 2200 Infectious Disease Panels Brochure Click to download [ Add to Cart (Free) ]