Background
Methods
Study design and population
Inclusion procedure
Specimen collection and testing
Outcomes and statistical analyses
Sample size calculation
Results
Test | BD-Veritor | SD-Biosensor | PanBio | |
---|---|---|---|---|
Method of sampling | Routinely used: OP-N | Routinely used: NP | Less invasive: OP-N | Routinely used: NP |
Inclusion period | 12–30 Apr 2021 | 14–20 Apr 2021 | 3–17 May 2021 | 12–22 Apr 2021 |
Sample size | N = 1441 | N = 1769 | N = 1689 | N = 2056 |
Age [years], mean (SD)a | 41.1 (16.3) | 39.5 (15.5) | 37.5 (14.8) | 37.6 (14.8) |
Sex, female n (%)b | 798 (55.6) | 894 (50.7) | 856 (50.8) | 1075 (52.4) |
Testing indication, n (%)c | ||||
Symptomatic | 501 (34.8) | 952 (53.8) | 759 (44.9) | 1273 (61.9) |
Pre-/asymptomatic close contact of confirmed SARS-CoV-2-infected individual | 800 (55.6) | 688 (38.9) | 752 (43.9) | 594 (28.9) |
Others | 73 (5.1) | 92 (5.2) | 93 (5.5) | 91 (4.4) |
Unknown | 67 (4.6) | 37 (2.1) | 85 (5.0) | 98 (4.8) |
Vaccinated with at least one dose, n (%)d | 152 (10.5) | 96 (5.4) | 224 (13.3) | 167 (8.1) |
Type of vaccine, n (%)e | ||||
Astra Zeneca | 77 (50.7) | 48 (50.0) | 67 (29.9) | 113 (67.7) |
Janssen | 7 (3.1) | |||
Moderna | 7 (4.6) | 5 (5.2) | 19 (8.5) | 9 (5.4) |
Pfizer | 63 (41.4) | 36 (37.5) | 121 (54.0) | 43 (25.7) |
Unknown | 5 (3.3) | 7 (7.3) | 10 (4.5) | 2 (1.2) |
Number of vaccinations received, n (%)e | ||||
1 | 107 (70.4) | 75 (78.1) | 169 (75.4) | 136 (81.4) |
2 | 31 (20.4) | 11 (11.5) | 33 (14.7) | 20 (12.0) |
Unknown | 14 (9.2) | 10 (10.4) | 22 (9.8) | 11 (6.6) |
At least one prior SARS-CoV-2 infection, n (%)f | 102 (7.1) | 187 (10.6) | 196 (11.6) | 134 (6.5) |
Symptoms at time of sampling, n (%) | 662 (47.2) | 1091 (62.4) | 900 (55.0) | 1470 (74.2) |
Symptom onset, n (%)g | ||||
At day of sampling | 19 (2.9) | 91 (8.3) | 70 (7.8) | 240 (16.3) |
A day before sampling | 189 (28.5) | 482 (44.2) | 374 (41.6) | 610 (41.5) |
Two days before sampling | 218 (32.9) | 282 (25.8) | 209 (23.2) | 332 (22.6) |
Three or more days before sampling | 252 (38.1) | 250 (22.9) | 247 (27.4) | 286 (19.5) |
Unknown | 15 (2.3) | 15 (1.4) | 19 (2.1) | 20 (1.4) |
Type of symptoms (self-reported), n (%)g,h | ||||
Common cold | 570 (86.1) | 948 (86.9) | 768 (85.3) | 1349 (91.8) |
Shortness of breath | 113 (17.1) | 137 (12.6) | 121 (13.4) | 197 (13.4) |
Fever | 72 (10.9) | 146 (13.4) | 126 (14.0) | 157 (10.7) |
Coughing | 308 (46.5) | 450 (41.2) | 342 (38.0) | 584 (39.7) |
Loss of taste or smell | 24 (3.6) | 43 (3.9) | 41 (4.6) | 55 (3.7) |
Muscle ache | 88 (13.3) | 137 (12.6) | 100 (11.1) | 143 (9.7) |
Other symptoms | 37 (5.6) | 18 (1.6) | 54 (6.0) | 74 (5.0) |
Analysis | Sampling method | No. | Prevalencea (%) | Sensitivity | Specificity | PPV | NPV |
---|---|---|---|---|---|---|---|
BD-Veritor System (Beckton Dickinson) | |||||||
Primary analysis | OP-N | 1441 | 13.0 | 68.6 (61.5 to 75.2) | 99.8 (99.4 to 100.0) | 98.5 (94.6 to 99.8) | 95.5 (94.2 to 96.6) |
Secondary (stratified) analysis | |||||||
Viral load above the cut-offc | OP-N | 1441 | 10.1 | 85.6 (78.9 to 90.9) | 99.5 (99.0 to 99.8) | 95.4 (90.3 to 98.3) | 98.4 (97.6 to 99.0) |
Symptoms present at samplingb | |||||||
Yes | OP-N | 662 | 18.1 | 75.8 (67.2 to 83.2) | 99.8 (99.0 to 100.0) | 98.9 (94.1 to 100.0) | 94.9 (92.8 to 96.6) |
No | OP-N | 742 | 8.0 | 55.9 (42.4 to 68.8) | 99.9 (99.2 to 100.0) | 97.1 (84.7 to 99.9) | 96.3 (94.7 to 97.6) |
SD-Biosensor (Roche Diagnostics) | |||||||
Primary analysis | NP | 1769 | 12.2 | 74.4 (68.0 to 80.1) | 99.8 (99.4 to 100.0) | 98.2 (94.7 to 99.6) | 96.6 (95.6 to 97.4) |
OP-N | 1689 | 9.7 | 75.0 (67.7 to 81.4) | 99.8 (99.4 to 100.0) | 97.6 (93.2 to 99.5) | 97.4 (96.5 to 98.1) | |
Secondary (stratified) analysis | |||||||
Viral load above the cut-offc | NP | 1769 | 10.3 | 87.9 (82.3 to 92.3) | 99.8 (99.4 to 100.0) | 98.2 (94.7 to 99.6) | 98.6 (97.9 to 99.1) |
OP-N | 1689 | 8.3 | 83.7 (76.5 to 89.4) | 99.5 (99.0 to 99.8) | 93.7 (87.9 to 97.2) | 98.5 (97.8 to 99.1) | |
Symptoms present at samplingb | |||||||
Yes | NP | 1091 | 13.8 | 83.4 (76.5 to 89.0) | 99.8 (99.2 to 100.0) | 98.4 (94.5 to 99.8) | 97.4 (96.2 to 98.3) |
OP-N | 900 | 12.7 | 78.9 (70.3 to 86.0) | 99.7 (99.1 to 100.0) | 97.8 (92.4 to 99.7) | 97.0 (95.6 to 98.1) | |
No | NP | 658 | 9.6 | 54.0 (40.9 to 66.6) | 99.8 (99.1 to 100.0) | 97.1 (85.1 to 99.9) | 95.3 (93.4 to 96.9) |
OP-N | 735 | 6.3 | 63.0 (47.5 to 76.8) | 100.0 (99.5 to 100.0) | 100.0 (88.1 to 100.0) | 97.6 (96.2 to 98.6) | |
PanBio (Abbott) | |||||||
Primary analysis | NP | 2056 | 8.4 | 68.8 (61.3 to 75.6) | 99.9 (99.7 to 100.0) | 99.2 (95.4 to 100.0) | 97.2 (96.4 to 97.9) |
Secondary (stratified) analysis: | |||||||
Viral load above the cut-offcd | NP | 2039 | 5.9 | 89.3 (82.3 to 94.2) | 99.9 (99.6 to 100.0) | 98.2 (93.6 to 99.8) | 99.3 (98.9 to 99.6) |
Symptoms present at samplingb | |||||||
Yes | NP | 1470 | 9.0 | 72.2 (63.7 to 79.6) | 99.9 (99.6 to 100.0) | 99.0 (94.4 to 100.0) | 97.3 (96.3 to 98.1) |
No | NP | 511 | 6.7 | 55.9 (37.9 to 72.8) | 100.0 (99.2 to 100.0) | 100.0 (82.4 to 100.0) | 97.0 (95.0 to 98.3) |
Routinely used Ag-RDT sampling method
Less invasive OP-N sampling method combined with SD-Biosensor
Follow-up to identify missed infections
Phase 1 (Ag-RDT result communicated) | Phase 2 (molecular test result communicated) | |
---|---|---|
Initial test result negative, n | 4847 | 2461 |
Initial test result false negative, n (%) | 168 (3.5) | n/aa |
Initial test result true negative, n (%) | 4697 (96.5) | n/aa |
At least one subsequent SARS-CoV-2 test registered within 14 daysb, n (%) | 887 (18.3) | 284 (11.5) |
Initial test result false negative, n (%) | 103 (61.3) | n/aa |
Initial test result true negative, n (%) | 784 (16.8) | n/aa |
SARS-CoV-2-positive test within 14 days, n (%) | 213 (4.4) | 28 (1.1) |
Initial test result false negative, n (%) | 93 (55.4) | n/aa |
Initial test result true negative, n (%) | 120 (2.6) | n/aa |
Stratified analysis according to symptomology at time of initial testing | ||
Initial test result negative, n | 4715c | 2392d |
Symptomatic, n (%) | 2893 (61.4) | 1427 (59.7) |
Asymptomatic, n (%) | 1822 (38.6) | 965 (40.3) |
Initial test result false negative, n | 161 | n/aa |
Symptomatic, n (%) | 91 (56.5) | n/aa |
Asymptomatic, n (%) | 70 (43.5) | n/aa |
Initial test result true negative, n | 4554 | n/aa |
Symptomatic, n (%) | 2802 (61.5) | n/aa |
Asymptomatic, n (%) | 1752 (38.5) | n/aa |
SARS-CoV-2-positive test within 14 days | ||
Initial test result negative | - | - |
Symptomatic, n (%) | 87 (3.0) | 12 (0.8) * |
Asymptomatic, n (%) | 114 (6.3) | 16 (1.7) * |
Initial test result false negative | - | |
Symptomatic, n (%) | 42 (46.2)** | n/aa |
Asymptomatic, n (%) | 44 (62.9)** | n/aa |
Initial test result true negative | - | |
Symptomatic, n (%) | 45 (1.6)*** | n/aa |
Asymptomatic, n (%) | 70 (4.0)*** | n/aa |