Ann Clin Microbiol 2021;24:31-43. Safety and Effectiveness of Cytomegalovirus Specific Antigen Induced Interferon-Gamma ELISPOT/ELISA: A Systematic Review
| Study | F/U | Peptide/Cut-off | Odds ratio/Hazard ratio | Diagnostic accuracy | Level of evidence | |||
|---|---|---|---|---|---|---|---|---|
| 95% CI | P-value | Sensitivity (95% CI) | Specificity (95% CI) | |||||
| Prediction of prognosis | ||||||||
| Lee (2017)*[17] | 12 M | IE-1 > 128 spot/2 × 105 | – | – | 0.30 (0.09 – 0.46) | 0.95 (0.89 – 1.00) | 2+ | |
| pp65 > 134 spot/2 × 105 | – | – | 0.90 (0.58 – 1.00) | 0.38 (0.29 – 0.40) | ||||
| IE-1, pp65 | – | – | 1.00 (0.70 – 1.00) | 0.34 (0.26 – 0.34) | ||||
| Schachtner (2017)†[22] | 55 M | IE-1, pp65/NR | HR 8.51 (4.53 – 15.9) | 0.00 | 0.94 (0.84 – 0.99) | 0.28 (0.17 – 0.33) | 2+ | |
| Leone (2016)*[18] | 1 M | IE-1/15 SFCs/200,000 | OR 0.33 (0.21 – 0.94) | 0.02 | 0.70 | 0.73 | 2+ | |
| pp65/40 SFCs/200,000 | OR 0.32 (0.03 – 0.77) | 0.01 | 0.83 | 0.82 | ||||
| Nesher (2016)‡[21] | NR | IE-1/50 IFN-γ spot | HR 0.21 (0.05 – 0.97) | 0.05 | 0.96 | – | 2+ | |
| pp65/100 IFN-γ spot | 0.91 | – | ||||||
| IE-1, pp65 | 0.91 | – | ||||||
| Ritta (2015)§[6] | 12 M | 20 SFU/2×105 | – | – | 0.482 | 0.818 | 2+ | |
| Costa (2014)*[13] | 3 M | 20 SFU/2×105 | – | – | 0.71 (0.62 – 0.80) | 0.60 (0.05 – 0.65) | 2+ | |
| Mattes (2008)†[20] | 12 M | IE-1, pp65/NR | OR 14.2 (2.7 – 100) | 0.02 | 2+ | |||
| Shin (2018)*[23] | NR | IE-1, pp65/NR | – | – | 0.12 | 1.00 | 2+ | |
| Banas (2017)§[11] | NR | IE-1, pp65/10 SFC/200,000 PBMC | – | – | 0.90 (0.82 – 0.95) | 0.79 (0.70 – 0.85) | 2+ | |
| Kwon (2017)§[16] | 6 M | IE-1 > 128 spot/2 × 105 | – | – | 0.30 (0.09 – 0.46) | 0.95 (0.89 – 1.00) | 2+ | |
| pp65: > 134 spot/2 × 105 | 0.90 (0.58 – 1.00) | 0.38 (0.29 – 0.40) | ||||||
| IE-1, pp65 | 1.00 (0.70 – 1.00) | 0.34 (0.26 – 0.34) | ||||||
| Yong (2017)§[24] | 12 M | IE-1, pp65/NR | – | – | 0.98 | 0.44 | 2+ | |
| Kim (2015)§[7] | 6 M | IE-1 >10 spots/2 × 105 | – | – | 0.48 (0.32 – 0.63) | 0.67 (0.56 – 0.77) | 2+ | |
| pp65 >0 spots/2 × 105 | – | – | 0.44 (0.29 – 0.58) | 0.79 (0.69 – 0.87) | ||||
| Lucia (2014)*,∥[19] | NR | IE-1/NR | – | – | 0.71 (0.62 – 0.80) | 0.60 (0.05 – 0.65) | 2+ | |
| pp65/NR | – | – | 0.71 (0.62 – 0.80) | 0.60 (0.05 – 0.65) | – | |||
| Decision of treatment | ||||||||
| Kumar (2019)§[15] | 12 M | IE-1 > 40 SFU 2.5 × 105 cells | OR 0.77 (0.67 – 0.87) | 0.00 | – | – | 2+ | |
| pp65 | OR 0.80 (0.72 – 0.87) | 0.00 | – | – | ||||
| IE-1, pp65 | OR 0.79 (0.72 – 0.86) | 0.00 | – | – | ||||
| Jarque (2018)§[14] | 12 M | IE-1 25 IFN- γ spot | OR 5.55 (1.49 – 20.8) | 0.01 | 0.71 | 0.71 | 2+ | |
| pp65, 130 IFN- γ spot | OR 3.02 (0.87 – 10.6) | 0.08 | 0.57 | 0.76 | ||||
| IE-1, pp65 25/130 IFN- γ spot | OR 4.33 (1.18 – 15.88) | 0.03 | – | – | ||||
| Bestard (2013)§[12] | 6 M | 20cell/2×105 PBMC | – | – | 0.825 0.80 | 0.65 0.55 | 2+ | |
*predict viremia; †predict duplication; ‡predict reactivation; §predict infection; ∥predict disease. Abbreviations: ELISPOT, enzyme-linked immunospot; F/U, follow up; CI, confidence interval; M, month; IE, immediate-early; NR, not reported; HR, hazard ratio; OR, odds ratio; pp65, phosphoprotein 65; PBMC, peripheral blood mononuclear cell; SFC, spot-forming cells; IFN, interferon; SFU, spot forming units.