TABLE 3.
Sensitivities of SARS-CoV-2 antigen LFTs according to the number of days from symptom onset and the viral load, as assessed by the CT value in RT-PCR
| Cohort and category | Sensitivity (95% CI) (%) of test | |||||
|---|---|---|---|---|---|---|
| Cohort 1 (1) | AAZ | CerTest | GenBody | Nadal | GenSure | AMP |
| Days from symptom onset | ||||||
| ≤7 | 70.0 (57.9–80.4) | 50.0 (37.8–62.2) | 47.7 (35.1–60.5) | 52.9 (40.6–64.9) | 43.5 (31.6–56.0) | 68.1 (55.8–78.8) |
| 8–11 | 42.9 (9.9–81.6) | 14.3 (0.4–57.9) | 14.3 (0.4–57.9) | 28.6 (3.4–71.0) | 14.3 (0.4–57.9) | 42.9 (9.9–81.6) |
| ≥12 | 14.3 (0.4–57.9) | 14.3 (0.4–57.9) | 14.3 (0.4–57.9) | 14.3 (0.4–57.9) | 0 (0–45.9) | 14.3 (0.4–57.9) |
| CT value | ||||||
| ≤20 | 100 (83.9–100) | 100 (83.9–100) | 100 (80.5–100) | 100 (83.9–100) | 94.7 (74.0–99.9) | 90.5 (69.6–98.8) |
| 21–25 | 93.5 (82.1–98.6) | 63.0 (47.5–76.8) | 55.6 (40–70.4) | 63.0 (47.5–76.8) | 47.8 (32.9–63.1) | 91.3 (79.2–97.6) |
| 26–30 | 39.5 (24.0–56.6) | 18.4 (7.7–34.3) | 18.9 (8.0–35.2) | 23.7 (11.4–40.2) | 13.2 (4.4–28.1) | 48.6 (31.9–65.6) |
| >30 | 6.4 (1.3–17.5) | 2.1 (0.1–11.3) | 2.2 (0.1–11.8) | 4.3 (0.5–14.5) | 0 (0–7.5) | 14.9 (6.2–28.3) |
| ≤25 | 95.5 (87.5–99.1) | 74.6 (62.5–84.5) | 67.6 (54.7–79.1) | 74.6 (62.5–84.5) | 61.5 (48.6–73.3) | 91.0 (81.5–96.6) |
| ≤30 | 75.2 (65.9–83.1) | 54.3 (44.3–64.0) | 49.5 (39.3–59.7) | 56.2 (46.2–65.9) | 43.7 (33.9–53.8) | 76.0 (66.6–83.8) |
| Any | 53.9 (45.7–62.1) | 38.2 (30.4–46.4) | 34.7 (27.0–43.1) | 40.1 (32.3–48.4) | 30.0 (22.8–38) | 57 (48.7–65) |
| Cohort 1 (2) | QuickProfile | Novel | Toda Pharma | Sofia | Wantai | |
| Days from symptom onset | ||||||
| ≤7 | 46.4 (34.3–58.8) | 68.6 (56.4–79.1) | 47.4 (35.1–59.4) | 80.0 (67–89.6) | 83.9 (71.7–92.4) | |
| 8–11 | 0 (0–41.0) | 33.3 (4.3–77.7) | 0 (0–41.0) | 28.6 (3.7–71.0) | 60.0 (14.7–94.7) | |
| ≥12 | 14.3 (0.4–57.9) | 14.3 (0.4–57.9) | 14.3 (0.4–57.9) | 20.0 (0.5–71.6) | 25.0 (0.6–80.6) | |
| CT value | ||||||
| ≤20 | 95.2 (76.2–99.9) | 95.2 (76.2 -99.9) | 100 (83.9–100) | 100 (83.2–100) | 95.0 (75.1–99.9) | |
| 21–25 | 52.2 (36.9–67.1) | 93.5 (82.1–98.6) | 50.0 (34.9–65.1 | 94.7 (82.3–99.4) | 97.3 (85.8–100) | |
| 26–30 | 13.5 (4.5–28.8) | 37.8 (22.5–55.2) | 10.8 (3.0–25.4) | 45.5 (28.1–63.6) | 89.3 (71.8–97.7) | |
| >30 | 4.3 (0.5–14.5) | 4.3 (0.5–14.8) | 2.2 (0.1–11.5) | 17.1 (7.2–32.1) | 42.4 (25.5–60.8) | |
| ≤25 | 65.7 (53.1–76.8) | 94.0 (85.4–98.3) | 65.7 (53.1–76.8) | 96.6 (88.1–99.6) | 96.5 (87.9–99.6) | |
| ≤30 | 47.1 (37.2–57.2) | 74.0 (64.5–82.1) | 46.2 (36.3–56.2) | 78.0 (68.1–86.0) | 94.1 (86.8–98.1) | |
| Any | 33.7 (26.3–42) | 52.7 (44.4–60.9) | 32.7 (25.2–40.8) | 59.1 (50.2–67.6) | 79.7 (71.3–86.5) | |
| Cohort 2 (1) | AAZ | Genomic Vision | Fasual Care | Servibio | Humasis | |
| Days from symptom onset | ||||||
| ≤7 | 62.2 (44.8–77.5) | 48.6 (31.9–65.6) | 73.0 (55.9–86.2) | 51.4 (34.4–68.1) | 86.5 (71.2–95.5) | |
| 8–11 | 30.8 (9.1–61.4) | 30.8 (9.1–61.4) | 38.5 (13.9–68.4) | 7.7 (0.2–36.0) | 38.5 (13.9–68.4) | |
| ≥12 | 40.0 (5.3–85.3) | 20.0 (0.5–71.6) | 80.0 (28.4–99.5) | 0 (0–52.2) | 40.0 (5.3–85.3) | |
| CT value | ||||||
| ≤20 | 90.5 (69.6–98.8) | 90.5 (69.6–98.8) | 90.5 (69.6–98.8) | 90.5 (69.6–98.8) | 100 (83.9–100) | |
| 21–25 | 91.3 (79.2–97.6) | 93.5 (82.1–98.6) | 91.1 (78.8–97.5) | 80.4 (66.1–90.6) | 93.5 (82.1–98.6) | |
| 26–30 | 63.2 (46–78.2) | 36.8 (21.8–54) | 71.1 (54.1–84.6) | 34.2 (19.6–51.5) | 78.9 (62.7–90.4) | |
| >30 | 24.4 (12.9–39.5) | 17.8 (8–32.1) | 55.6 (40–70.4) | 13.3 (5.1–26.8) | 48.9 (33.7–64.2) | |
| ≤25 | 91.0 (81.5–96.6) | 92.5 (83.4–97.5) | 90.9 (81.3–96.6) | 83.6 (72.5–91.5) | 95.5 (87.5–99.1) | |
| ≤30 | 81.0 (72.1–88.0) | 72.4 (62.8–80.7) | 83.7 (75.1–90.2) | 65.7 (55.8–74.7) | 89.5 (82.0–94.7) | |
| Any | 64.0 (55.8–71.7) | 56.0 (47.7–64.1) | 75.2 (67.4–81.9) | 50.0 (41.7–58.3) | 75.3 (67.6–82.0) | |
| Cohort 2 (2) | Biospeedia | R-Biopharm | Siemens | NG Biotech 2 | Medisur | |
| Days from symptom onset | ||||||
| ≤7 | 54.0 (36.9–70.5) | 67.6 (50.2–82) | 70.3 (53.0–84.1) | 40.5 (24.8–57.9) | 62.2 (44.8–77.5) | |
| 8–11 | 30.8 (9.1–61.4) | 23.1 (5.0–53.8) | 38.5 (13.9–68.4) | 15.4 (1.9–45.4) | 30.8 (9.1–61.4) | |
| ≥12 | 20.0 (0.5–71.6) | 20.0 (0.5–71.6) | 40.0 (5.3–85.3) | 0 (0–52.2) | 20.0 (0.5–71.6) | |
| CT value | ||||||
| ≤20 | 90.5 (69.6–98.8) | 90.5 (69.6–98.8) | 90.5 (69.6–98.8) | 100 (83.9–100) | 100 (83.9 -100) | |
| 21–25 | 91.3 (79.2–97.6) | 87.0 (73.7–95.11) | 95.7 (85.2–99.5) | 84.8 (71.1–93.7) | 97.8 (88.5–99.9) | |
| 26–30 | 50.0 (33.74–66.6) | 60.5 (43.4–76) | 68.4 (51.3–82.5) | 23.7 (11.4–40.2) | 60.5 (43.4–76) | |
| >30 | 22.2 (11.2–37.1) | 27.3 (14.9–42.8) | 26.7 (14.6–41.9) | 2.2 (0.1–11.8) | 13.3 (5.1–26.8) | |
| ≤25 | 91.0 (81.5–96.6) | 88.1 (77.8–94.7) | 94.0 (85.4–98.3) | 89.6 (79.7–95.7) | 98.5 (92–100) | |
| ≤30 | 76.2 (66.9–84.0) | 78.1 (69.0–85.6) | 84.8 (76.4–91.0) | 65.7 (55.8–74.7) | 84.8 (76.4–91.0) | |
| Any | 60.0 (51.7–67.9) | 63.1 (54.8–70.8) | 67.3 (59.2–74.8) | 46.7 (38.5–55) | 63.3 (55.1–71) | |
| Cohort 3 | AAZ | Tanit Care | Orgentec | |||
| Days from symptom onset | ||||||
| ≤7 | 66.0 (50.7–79.1) | 23.5 (12.8–37.5) | 46.8 (32.1–61.9) | |||
| 8–11 | 50.0 (27.2–72.8) | 0 (0–16.8) | 10.5 (1.3–33.1) | |||
| ≥12 | 40.0 (5.3–85.3) | 20.0 (0.5–71.6) | 20.0 (0.5–71.6) | |||
| CT value | ||||||
| ≤20 | 100 (83.9–100) | 90.5 (69.6–98.8) | 100 (83.9–100) | |||
| 21–25 | 100 (92.3–100) | 45.7 (30.9–61.0) | 80.4 (66.1–90.6) | |||
| 26–30 | 81.3 (63.6–92.8) | 9.4 (2.0–25.0) | 32.3 (16.7–51.4) | |||
| >30 | 21.6 (11.3–35.3) | 2.0 (0–10.4) | 3.9 (4.8–13.4) | |||
| ≤25 | 100 (94.6–100) | 59.7 (47.0–71.5) | 86.6 (76.0–93.7) | |||
| ≤30 | 93.9 (87.3–97.7) | 43.4 (33.5–53.8) | 69.4 (59.3–78.3) | |||
| Any | 69.3 (61.3–76.6) | 29.3 (22.2–37.3) | 47 (38.8–55.3) | |||