Table. 2.

Characteristics of commercially available CMV-specific cell-mediated immunity assays

QuantiFERON-CMV T-SPOT.CMV T-Track CMV CMV T cell immunity panel
Assay principle ELISA ELISpot ELISpot Intracellular staining and flow cytometry
Product company Qiagen Oxford Immunotec Lophius Bioscience Viracor Eurofins
Sample 3 mL of whole blood Purified PBMCs from 12 mL of whole blood Purified PBMCs from 15 mL of whole blood 10 mL of whole blood
PBMCs required No Yes Yes Yes
CMV antigen Various HLA class I restricted 21 CMV peptides pp65, IE-1 T-activated CMV-specific pp65 and IE-1 Whole viral lysate, pp65, IE-1
Measurement IFN-γ IFN-γ–specific spot-forming cells IFN-γ–specific spot-forming cells % CMV-specific CD4+ and CD8+ T-cells
Cut off for positivity CMV antigen minus Nil control ≥0.2 NA Either pp65 or IE-1
≥10 spots
CMV-specific CD4+ or CD8+ responses >0.2%
Measuring range (linearity) Up to 10 IU/mL NA 10–1,000 spots NA
Clinical sensitivity 80.5% (insert) 93.3% (insert) 89.6% (insert) 79%–82% [66]
Time to test 16–24 hours 30–40 hours 30–40 hours 3–4 business days from receipt of specimen in USA
Quality control Nil control ≤8.0
Mitogen control
Nil control <10 spots
Positive control (mitogen solution containing PHA) >20 spots
Negative control <10 spots
Positive control (SEB) >400 spots
Negative control
Positive control (SEB)
Comment CE-marked
Not FDA-approved
Not FDA-approved
Not FDA-approved
Not FDA-approved

CMV, cytomegalovirus; ELISA, enzyme-linked immunosorbent assay; ELISpot, enzyme-linked immunosorbent spot; PBMC, peripheral blood mononuclear cell; HLA, human leukocyte antigen; IFN-γ, interferon-gamma; NA, not available; PHA, phytohemagglutinin; SEB, Staphylococcus aureus enterotoxin type B; CE, Conformité Européenne; FDA, Food and Drug Administration.

Korean J Transplant 2022;36:15~28
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