TABLE 3.
Analytical performance for enzyme immunoassays and lateral-flow chromatographic assays
| Assay type and name | Site | % sensitivity (CI) for samples from time point |
% specificity (CI) (n = 148 to 166) | |||||
|---|---|---|---|---|---|---|---|---|
| 0–7 days (n = 46) | 8–14 days (n = 36) | 15–34 days (n = 60) | ≥15 days (n = 94) | ≥35 days (n = 34) | All time points (n = 176) | |||
| Enzyme immunoassays | ||||||||
| DiaSorin IgG | 1 | 9 (2–21) | 56 (38–72) | 78 (66–88) | 82 (73–89) | 88 (73–97) | 57 (50–65) | 100 (98–100) |
| 5 | 9 (2–21) | 53 (35–70) | 72 (59–83) | 76 (66–84) | 82 (65–93) | 53 (46–61) | 100 (98–100) | |
| Roche total Ab | 1 | 15 (6–29) | 64 (46–79) | 75 (62–85) | 78 (68–86) | 82 (65–93) | 59 (51–66) | 100 (98–100) |
| 2 | 15 (6–29) | 64 (46–79) | 78 (66–88) | 85 (76–92) | 97 (85–100) | 63 (55–70) | 100 (98–100) | |
| Abbott IgG | 1 | 17 (8–31) | 67 (49–81) | 78 (66–88) | 83 (74–90) | 91 (76–98) | 63 (55–70) | 100 (98–100) |
| 2 | 17 (8–31) | 67 (49–81) | 78 (66–88) | 83 (74–90) | 91 (76–98) | 63 (55–70) | 100 (98–100) | |
| Beckman Coulter IgG | 1 | 15 (6–29) | 56 (38–72) | 72 (59–83) | 74 (64–83) | 79 (62–91) | 55 (47–63) | 100 (98–100) |
| 2 | 15 (6–29) | 53 (35–70) | 72 (59–83) | 74 (64–83) | 79 (62–91) | 55 (47–62) | 100 (98–100) | |
| Bio-Rad total Ab | 1 | 24 (13–39) | 81 (64–92) | 87 (75–94) | 90 (83–96) | 97 (85–100) | 71 (64–77) | 97 (92–99) |
| 2 | 26 (14–41) | 83 (67–94) | 87 (75–94) | 90 (83–96) | 97 (85–100) | 72 (65–78) | 95 (90–98) | |
| Siemens total Ab | 2 | 17 (8–31) | 56 (38–72) | 78 (66–88) | 85 (76–92) | 97 (85–100) | 61 (54–69) | 99 (96–100) |
| 3 | 15 (6–29) | 56 (38–72) | 78 (66–88) | 84 (75–91) | 94 (80–99) | 60 (53–68) | 99 (96–100) | |
| Ortho-Clinical Diagnostic IgG | 2 | 15 (6–29) | 53 (35–70) | 77 (64–87) | 84 (75–91) | 94 (80–99) | 59 (51–66) | 99 (95–100) |
| 4 | 13 (5–26) | 53 (35–70) | 78 (66–88) | 84 (75–91) | 94 (80–99) | 59 (51–66) | 98 (94–100) | |
| Ortho-Clinical Diagnostic total Ab | 2 | 20 (9–34) | 75 (58–88) | 85 (73–93) | 90 (83–96) | 100 (90–100) | 69 (61–76) | 99 (95–100) |
| 4 | 17 (8–31) | 78 (61–90) | 88 (77–95) | 93 (85–97) | 100 (90–100) | 70 (63–77) | 100 (98–100) | |
| Euro Immun IgA | 3 | 39 (25–55) | 83 (67–94) | 85 (73–93) | 89 (81–95) | 97 (85–100) | 75 (68–81) | 84 (77–89) |
| 4 | 37 (23–52) | 81 (64–92) | 85 (73–93) | 86 (78–92) | 88 (73–97) | 72 (65–79) | 77 (70–84) | |
| Euro Immun IgG | 3 | 9 (2–21) | 44 (28–62) | 72 (59–83) | 77 (67–85) | 85 (69–95) | 52 (45–60) | 94 (89–97) |
| 4 | 11 (4–24) | 44 (28–62) | 75 (62–85) | 81 (71–88) | 91 (76–98) | 55 (47–63) | 94 (89–97) | |
| Lateral-flow devices | ||||||||
| Biocan IgM and IgG | 6 | 24 (13–39) | 67 (49–81) | 83 (71–92) | 84 (75–91) | 85 (69–95) | 65 (57–72) | 99 (97–100) |
| BTNX IgM and IgG | 6 | 24 (13–39) | 78 (61–90) | 88 (77–95) | 91 (84–96) | 97 (85–100) | 71 (64–78) | 87 (81–92) |
| NADAL IgM and IgG | 6 | 35 (21–50) | 75 (58–88) | 92 (82–97) | 95 (88–98) | 100 (90–100) | 75 (68–81) | 98 (94–99) |