Positive agreement (PA), positive predictive value (PPV), and negative predictive value (NPV) performance for serological assays.
| . | Assays . | % Positive Agreement (95% CI) Positive/n . | 5% Infection Rate (95% CI) . | 10% Infection Rate (95% CI) . | |||||
|---|---|---|---|---|---|---|---|---|---|
| Day 3–6 . | Day 7–10 . | Day 11–13 . | Day 14+ . | PPV, % . | NPV, % . | PPV, % . | NPV, % . | ||
| Positive = Positive results | Abbott IgG | 30.0 (1.6–58.4) 3/10 | 52.9 (29.2–76.7) 9/17 | 65.6 (49.2–82.1) 21/32 | 79.2 (62.9–95.4) 19/24 | 85.7 (65.7–95.0) | 98.9 (97.7–99.5) | 92.7 (80.1–97.6) | 97.7 (95.2–98.9) |
| Beckman IgG | 30.0 (1.6–58.4) 3/10 | 47.1 (23.3–70.8) 8/17 | 62.5 (45.7–79.2) 20/32 | 58.3 (38.6–78.1) 14/24 | 92.9 (64.2–99.0) | 97.9 (96.6–98.7) | 96.5 (79.1–99.5) | 95.6 (93.1–97.2) | |
| DiaSorin IgG | 40.0 (9.6–70.4) 4/10 | 35.3 (12.6–58.0) 6/17 | 62.5 (45.7–79.2) 20/32 | 54.2 (34.2–74.1) 13/24 | 63.8 (43.6–80.0) | 97.9 (96.6–98.7) | 78.8 (62.0–89.4) | 95.1 (92.6–96.8) | |
| Roche Total | 40.0 (9.6–70.4) 4/10 | 58.8 (35.4–82.2) 10/17 | 75.0 (60.0–90.0) 24/32 | 79.2 (62.9–95.4) 19/24 | 94.8 (71.6–99.2) | 98.9 (97.7–99.5) | 97.4 (84.2–99.6) | 97.7 (95.2–99.0) | |
| Bio-Rad Total | 40.0 (9.6–70.4) 4/10 | 64.7 (42.0–87.4) 11/17 | 78.1 (63.8–92.4) 25/32 | 83.3 (68.4–98.2) 20/24 | 86.4 (66.9–95.2) | 99.1 (97.9–99.6) | 93.0 (81.0–97.7) | 98.2 (95.6–99.2) | |
| EU IgG | 30.0 (1.6–58.4) 3/10 | 35.3 (12.6–58.0) 6/17 | 65.6 (49.2–82.1) 21/32 | 50.0 (30.0–70.0) 12/24 | 61.9 (41.3–78.9) | 97.4 (96.2–98.2) | 77.4 (59.8–88.8) | 94.7 (92.2–96.4) | |
| EU IgA | 40.0 (9.6–70.4) 4/10 | 52.9 (29.2–76.7) 9/17 | 75.0 (60.0–90.0) 24/32 | 70.8 (52.6–89.0) 17/24 | 15.5 (11.8–20.1) | 98.1 (96.5–99.0) | 27.9 (22.0–34.7) | 96.1 (92.9–97.9) | |
| Positive= Postitive and Equivocal results | Bio-Rad Total | 50.0 (19.0–81.0) 5/10 | 76.5 (56.3–96.6) 13/17 | 78.1 (63.8–92.4) 25/32 | 83.3 (68.4–98.2) 20/24 | ||||
| EU IgG | 30.0 (1.6–58.4) 3/10 | 41.2 (17.8–64.6) 7/17 | 71.9 (56.3–87.5) 23/32 | 54.2 (34.2–74.1) 13/24 | |||||
| EU IgA | 40.0 (9.6–70.4) 4/10 | 52.9 (29.2–76.7) 9/17 | 78.1 (63.8–92.4) 25/32 | 75.0 (57.7–92.3) 18/24 | |||||
| . | Assays . | % Positive Agreement (95% CI) Positive/n . | 5% Infection Rate (95% CI) . | 10% Infection Rate (95% CI) . | |||||
|---|---|---|---|---|---|---|---|---|---|
| Day 3–6 . | Day 7–10 . | Day 11–13 . | Day 14+ . | PPV, % . | NPV, % . | PPV, % . | NPV, % . | ||
| Positive = Positive results | Abbott IgG | 30.0 (1.6–58.4) 3/10 | 52.9 (29.2–76.7) 9/17 | 65.6 (49.2–82.1) 21/32 | 79.2 (62.9–95.4) 19/24 | 85.7 (65.7–95.0) | 98.9 (97.7–99.5) | 92.7 (80.1–97.6) | 97.7 (95.2–98.9) |
| Beckman IgG | 30.0 (1.6–58.4) 3/10 | 47.1 (23.3–70.8) 8/17 | 62.5 (45.7–79.2) 20/32 | 58.3 (38.6–78.1) 14/24 | 92.9 (64.2–99.0) | 97.9 (96.6–98.7) | 96.5 (79.1–99.5) | 95.6 (93.1–97.2) | |
| DiaSorin IgG | 40.0 (9.6–70.4) 4/10 | 35.3 (12.6–58.0) 6/17 | 62.5 (45.7–79.2) 20/32 | 54.2 (34.2–74.1) 13/24 | 63.8 (43.6–80.0) | 97.9 (96.6–98.7) | 78.8 (62.0–89.4) | 95.1 (92.6–96.8) | |
| Roche Total | 40.0 (9.6–70.4) 4/10 | 58.8 (35.4–82.2) 10/17 | 75.0 (60.0–90.0) 24/32 | 79.2 (62.9–95.4) 19/24 | 94.8 (71.6–99.2) | 98.9 (97.7–99.5) | 97.4 (84.2–99.6) | 97.7 (95.2–99.0) | |
| Bio-Rad Total | 40.0 (9.6–70.4) 4/10 | 64.7 (42.0–87.4) 11/17 | 78.1 (63.8–92.4) 25/32 | 83.3 (68.4–98.2) 20/24 | 86.4 (66.9–95.2) | 99.1 (97.9–99.6) | 93.0 (81.0–97.7) | 98.2 (95.6–99.2) | |
| EU IgG | 30.0 (1.6–58.4) 3/10 | 35.3 (12.6–58.0) 6/17 | 65.6 (49.2–82.1) 21/32 | 50.0 (30.0–70.0) 12/24 | 61.9 (41.3–78.9) | 97.4 (96.2–98.2) | 77.4 (59.8–88.8) | 94.7 (92.2–96.4) | |
| EU IgA | 40.0 (9.6–70.4) 4/10 | 52.9 (29.2–76.7) 9/17 | 75.0 (60.0–90.0) 24/32 | 70.8 (52.6–89.0) 17/24 | 15.5 (11.8–20.1) | 98.1 (96.5–99.0) | 27.9 (22.0–34.7) | 96.1 (92.9–97.9) | |
| Positive= Postitive and Equivocal results | Bio-Rad Total | 50.0 (19.0–81.0) 5/10 | 76.5 (56.3–96.6) 13/17 | 78.1 (63.8–92.4) 25/32 | 83.3 (68.4–98.2) 20/24 | ||||
| EU IgG | 30.0 (1.6–58.4) 3/10 | 41.2 (17.8–64.6) 7/17 | 71.9 (56.3–87.5) 23/32 | 54.2 (34.2–74.1) 13/24 | |||||
| EU IgA | 40.0 (9.6–70.4) 4/10 | 52.9 (29.2–76.7) 9/17 | 78.1 (63.8–92.4) 25/32 | 75.0 (57.7–92.3) 18/24 | |||||
EU, EUUROIMMUN; n, sample size; CI, confidence interval.
Bolded data represents the %PA that changed if equivocal results were considered positive.
Predictive values were calculated using the overall %NA including positive and equivocal results as false positives.
Positive agreement (PA), positive predictive value (PPV), and negative predictive value (NPV) performance for serological assays.
| . | Assays . | % Positive Agreement (95% CI) Positive/n . | 5% Infection Rate (95% CI) . | 10% Infection Rate (95% CI) . | |||||
|---|---|---|---|---|---|---|---|---|---|
| Day 3–6 . | Day 7–10 . | Day 11–13 . | Day 14+ . | PPV, % . | NPV, % . | PPV, % . | NPV, % . | ||
| Positive = Positive results | Abbott IgG | 30.0 (1.6–58.4) 3/10 | 52.9 (29.2–76.7) 9/17 | 65.6 (49.2–82.1) 21/32 | 79.2 (62.9–95.4) 19/24 | 85.7 (65.7–95.0) | 98.9 (97.7–99.5) | 92.7 (80.1–97.6) | 97.7 (95.2–98.9) |
| Beckman IgG | 30.0 (1.6–58.4) 3/10 | 47.1 (23.3–70.8) 8/17 | 62.5 (45.7–79.2) 20/32 | 58.3 (38.6–78.1) 14/24 | 92.9 (64.2–99.0) | 97.9 (96.6–98.7) | 96.5 (79.1–99.5) | 95.6 (93.1–97.2) | |
| DiaSorin IgG | 40.0 (9.6–70.4) 4/10 | 35.3 (12.6–58.0) 6/17 | 62.5 (45.7–79.2) 20/32 | 54.2 (34.2–74.1) 13/24 | 63.8 (43.6–80.0) | 97.9 (96.6–98.7) | 78.8 (62.0–89.4) | 95.1 (92.6–96.8) | |
| Roche Total | 40.0 (9.6–70.4) 4/10 | 58.8 (35.4–82.2) 10/17 | 75.0 (60.0–90.0) 24/32 | 79.2 (62.9–95.4) 19/24 | 94.8 (71.6–99.2) | 98.9 (97.7–99.5) | 97.4 (84.2–99.6) | 97.7 (95.2–99.0) | |
| Bio-Rad Total | 40.0 (9.6–70.4) 4/10 | 64.7 (42.0–87.4) 11/17 | 78.1 (63.8–92.4) 25/32 | 83.3 (68.4–98.2) 20/24 | 86.4 (66.9–95.2) | 99.1 (97.9–99.6) | 93.0 (81.0–97.7) | 98.2 (95.6–99.2) | |
| EU IgG | 30.0 (1.6–58.4) 3/10 | 35.3 (12.6–58.0) 6/17 | 65.6 (49.2–82.1) 21/32 | 50.0 (30.0–70.0) 12/24 | 61.9 (41.3–78.9) | 97.4 (96.2–98.2) | 77.4 (59.8–88.8) | 94.7 (92.2–96.4) | |
| EU IgA | 40.0 (9.6–70.4) 4/10 | 52.9 (29.2–76.7) 9/17 | 75.0 (60.0–90.0) 24/32 | 70.8 (52.6–89.0) 17/24 | 15.5 (11.8–20.1) | 98.1 (96.5–99.0) | 27.9 (22.0–34.7) | 96.1 (92.9–97.9) | |
| Positive= Postitive and Equivocal results | Bio-Rad Total | 50.0 (19.0–81.0) 5/10 | 76.5 (56.3–96.6) 13/17 | 78.1 (63.8–92.4) 25/32 | 83.3 (68.4–98.2) 20/24 | ||||
| EU IgG | 30.0 (1.6–58.4) 3/10 | 41.2 (17.8–64.6) 7/17 | 71.9 (56.3–87.5) 23/32 | 54.2 (34.2–74.1) 13/24 | |||||
| EU IgA | 40.0 (9.6–70.4) 4/10 | 52.9 (29.2–76.7) 9/17 | 78.1 (63.8–92.4) 25/32 | 75.0 (57.7–92.3) 18/24 | |||||
| . | Assays . | % Positive Agreement (95% CI) Positive/n . | 5% Infection Rate (95% CI) . | 10% Infection Rate (95% CI) . | |||||
|---|---|---|---|---|---|---|---|---|---|
| Day 3–6 . | Day 7–10 . | Day 11–13 . | Day 14+ . | PPV, % . | NPV, % . | PPV, % . | NPV, % . | ||
| Positive = Positive results | Abbott IgG | 30.0 (1.6–58.4) 3/10 | 52.9 (29.2–76.7) 9/17 | 65.6 (49.2–82.1) 21/32 | 79.2 (62.9–95.4) 19/24 | 85.7 (65.7–95.0) | 98.9 (97.7–99.5) | 92.7 (80.1–97.6) | 97.7 (95.2–98.9) |
| Beckman IgG | 30.0 (1.6–58.4) 3/10 | 47.1 (23.3–70.8) 8/17 | 62.5 (45.7–79.2) 20/32 | 58.3 (38.6–78.1) 14/24 | 92.9 (64.2–99.0) | 97.9 (96.6–98.7) | 96.5 (79.1–99.5) | 95.6 (93.1–97.2) | |
| DiaSorin IgG | 40.0 (9.6–70.4) 4/10 | 35.3 (12.6–58.0) 6/17 | 62.5 (45.7–79.2) 20/32 | 54.2 (34.2–74.1) 13/24 | 63.8 (43.6–80.0) | 97.9 (96.6–98.7) | 78.8 (62.0–89.4) | 95.1 (92.6–96.8) | |
| Roche Total | 40.0 (9.6–70.4) 4/10 | 58.8 (35.4–82.2) 10/17 | 75.0 (60.0–90.0) 24/32 | 79.2 (62.9–95.4) 19/24 | 94.8 (71.6–99.2) | 98.9 (97.7–99.5) | 97.4 (84.2–99.6) | 97.7 (95.2–99.0) | |
| Bio-Rad Total | 40.0 (9.6–70.4) 4/10 | 64.7 (42.0–87.4) 11/17 | 78.1 (63.8–92.4) 25/32 | 83.3 (68.4–98.2) 20/24 | 86.4 (66.9–95.2) | 99.1 (97.9–99.6) | 93.0 (81.0–97.7) | 98.2 (95.6–99.2) | |
| EU IgG | 30.0 (1.6–58.4) 3/10 | 35.3 (12.6–58.0) 6/17 | 65.6 (49.2–82.1) 21/32 | 50.0 (30.0–70.0) 12/24 | 61.9 (41.3–78.9) | 97.4 (96.2–98.2) | 77.4 (59.8–88.8) | 94.7 (92.2–96.4) | |
| EU IgA | 40.0 (9.6–70.4) 4/10 | 52.9 (29.2–76.7) 9/17 | 75.0 (60.0–90.0) 24/32 | 70.8 (52.6–89.0) 17/24 | 15.5 (11.8–20.1) | 98.1 (96.5–99.0) | 27.9 (22.0–34.7) | 96.1 (92.9–97.9) | |
| Positive= Postitive and Equivocal results | Bio-Rad Total | 50.0 (19.0–81.0) 5/10 | 76.5 (56.3–96.6) 13/17 | 78.1 (63.8–92.4) 25/32 | 83.3 (68.4–98.2) 20/24 | ||||
| EU IgG | 30.0 (1.6–58.4) 3/10 | 41.2 (17.8–64.6) 7/17 | 71.9 (56.3–87.5) 23/32 | 54.2 (34.2–74.1) 13/24 | |||||
| EU IgA | 40.0 (9.6–70.4) 4/10 | 52.9 (29.2–76.7) 9/17 | 78.1 (63.8–92.4) 25/32 | 75.0 (57.7–92.3) 18/24 | |||||
EU, EUUROIMMUN; n, sample size; CI, confidence interval.
Bolded data represents the %PA that changed if equivocal results were considered positive.
Predictive values were calculated using the overall %NA including positive and equivocal results as false positives.
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