Table 2.
Diagnostic accuracy variables for the three rapid antigen tests in participants with covid-19 symptoms in the omicron period
| Sampling method | No | RT-PCR test positivity* (%) | Sensitivity (%) (95% CI) | Specificity (%) (95% CI) | Positive predictive value (%) (95% CI) | Negative predictive value (%) (95% CI) | |
|---|---|---|---|---|---|---|---|
| Flowflex | |||||||
| Primary analysis | Nasal | 620 | 66.0 | 79.0 (74.7 to 82.8) | 97.2 (93.9 to 98.9) | 98.2 (96.1 to 99.3) | 70.4 (64.8 to 75.6) |
| Secondary (stratified) analyses: | |||||||
| Viral load cut-off† | Nasal | 620 | 58.2 | 85.6 (81.5 to 89.1) | 92.3 (88.3 to 95.2) | 93.9 (90.8 to 96.2) | 82.1 (77.2 to 86.4) |
| Vaccinated (at least once): | |||||||
| Yes | Nasal | 545 | 64.2 | 78.6 (73.9 to 82.8) | 96.9 (93.4 to 98.9) | 97.9 (95.4 to 99.2) | 71.6 (65.7 to 77.0) |
| No | Nasal | 75 | 78.7 | 81.4 (69.1 to 90.3) | 100 (79.4 to 100) | 100 (92.6 to 100) | 59.3 (38.8 to 77.6) |
| Previous SARS-CoV-2 infection: | |||||||
| Yes | Nasal | 148 | 63.5 | 67.0 (56.6 to 76.4) | 98.1 (90.1 to 100) | 98.4 (91.6 to 100) | 63.1 (51.9 to 73.4) |
| No | Nasal | 472 | 66.7 | 82.5 (77.9 to 86.6) | 96.8 (92.7 to 99.0) | 98.1 (95.7 to 99.4) | 73.4 (66.9 to 79.3) |
| Sex: | |||||||
| Female | Nasal | 357 | 63.9 | 75.0 (68.9 to 80.5) | 98.4 (94.5 to 99.8) | 98.8 (95.9 to 99.9) | 69.0 (61.8 to 75.6) |
| Male | Nasal | 260 | 68.5 | 83.7 (77.4 to 88.8) | 95.1 (88.0 to 98.7) | 97.4 (93.4 to 99.3) | 72.9 (63.4 to 81.0) |
| Age (years): | |||||||
| 16-40 | Nasal | 385 | 66.0 | 79.1 (73.6 to 84.0) | 96.2 (94.4 to 99.2) | 97.6 (94.4 to 99.2) | 70.4 (63.1 to 77.0) |
| >40 | Nasal | 235 | 66.0 | 78.7 (71.4 to 84.9) | 98.8 (93.2 to 100) | 99.2 (95.6 to 100) | 70.5 (61.2 to 78.8) |
| Reason for testing was positive self-test: | |||||||
| Yes | Nasal | 279 | 94.6 | 93.6 (89.9 to 96.2) | 80.0 (51.9 to 95.7) | 98.8 (96.5 to 99.8) | 41.4 (23.5 to 61.1) |
| No | Nasal | 341 | 42.5 | 52.4 (44.0 to 60.8) | 98.5 (95.6 to 99.7) | 96.2 (89.3 to 99.2) | 73.7 (67.9 to 78.9) |
| MPBio | |||||||
| Primary analysis | Nasal | 820 | 48.2 | 69.9 (65.1 to 74.4) | 98.8 (97.3 to 99.6) | 98.2 (95.9 to 99.4) | 77.9 (74.2 to 81.4) |
| OP-N | 543 | 67.2 | 83.0 (78.8 to 86.7) | 97.8 (94.3 to 99.4) | 98.7 (94.3 to 99.4) | 73.7 (67.6 to 79.2) | |
| Secondary (stratified) analyses: | |||||||
| Viral load cut-off† | Nasal | 819 | 41.5 | 78.5 (73.8 to 82.8) | 97.1 (95.1 to 98.4) | 95.0 (91.8 to 97.2) | 86.4 (83.2 to 89.2) |
| OP-N | 543 | 58.0 | 89.8 (86.0 to 92.9) | 89.5 (84.7 to 93.1) | 92.2 (88.6 to 94.9) | 86.4 (81.4 to 90.5) | |
| Vaccinated (at least one): | |||||||
| Yes | Nasal | 752 | 47.7 | 68.2 (63.2 to 73.0) | 99.2 (97.8 to 99.8) | 98.8 (96.5 to 99.7) | 77.4 (73.5 to 81.0) |
| OP-N | 487 | 66.9 | 82.5 (77.9 to 86.5) | 97.5 (93.8 to 99.3) | 98.5 (96.3 to 99.6) | 73.4 (66.9 to 79.2) | |
| No | Nasal | 68 | 52.9 | 86.1 (70.5 to 95.3) | 93.8 (79.2 to 99.2) | 93.9 (79.8 to 99.3) | 85.7 (69.7 to 95.2) |
| OP-N | 56 | 69.6 | 87.2 (72.6 to 95.7) | 100 (80.5 to 100) | 100 (89.7 to 100) | 77.3 (54.6 to 92.2) | |
| Previous SARS-CoV-2 infection: | |||||||
| Yes | Nasal | 185 | 35.7 | 60.6 (47.8 to 72.4) | 100 (96.9 to 100) | 100 (91.2 to 100) | 82.1 (74.8 to 87.9) |
| OP-N | 135 | 65.2 | 85.2 (76.1 to 91.9) | 97.9 (88.7 to 99.9) | 98.7 (92.9 to 100) | 78.0 (65.3 to 87.7) | |
| No | Nasal | 634 | 51.9 | 71.7 (66.5 to 76.5) | 98.4 (96.2 to 99.5) | 97.9 (95.2 to 99.3) | 76.3 (71.8 to 80.5) |
| OP-N | 408 | 67.9 | 82.3 (77.3 to 86.6) | 97.7 (93.5 to 99.5) | 98.7 (96.3 to 99.7) | 72.3 (65.1 to 78.8) | |
| Sex: | |||||||
| Female | Nasal | 524 | 45.0 | 70.3 (64.1 to 76.1) | 99.0 (97.0 to 99.8) | 98.2 (94.9 to 99.6) | 80.3 (75.8 to 84.3) |
| OP-N | 375 | 65.3 | 82.4 (77.1 to 87.0) | 97.7 (93.4 to 99.5) | 98.5 (95.8 to 99.7) | 74.7 (67.5 to 81.0) | |
| Male | Nasal | 295 | 53.9 | 69.2 (61.4 to 76.3) | 98.5 (94.8 to 99.8) | 98.2 (93.7 to 99.8) | 73.2 (66.2 to 79.5) |
| OP-N | 166 | 71.1 | 83.9 (76.0 to 80.0) | 97.9 (88.9 to 99.9) | 99.0 (94.6 to 100) | 71.2 (58.7 to 81.7) | |
| Age (years): | |||||||
| 16-40 | Nasal | 475 | 49.5 | 75.3 (69.3 to 80.7) | 99.2 (97.0 to 99.9) | 98.9 (96.0 to 99.9) | 80.4 (75.4 to 84.8) |
| OP-N | 335 | 68.4 | 82.5 (77.0 to 87.2) | 97.2 (92.0 to 99.4) | 98.4 (95.5 to 99.7) | 72.0 (63.9 to 79.2) | |
| >40 | Nasal | 345 | 46.4 | 61.9 (53.9 to 69.4) | 98.4 (95.3 to 99.7) | 97.1 (91.6 to 99.4) | 74.9 (69.0 to 80.2) |
| OP-N | 208 | 65.4 | 83.8 (76.5 to 89.6) | 98.6 (92.5 to 100) | 99.1 (95.3 to 100) | 76.3 (66.4 to 84.5) | |
| Reasons for testing was positive self-test: | |||||||
| Yes | Nasal | 239 | 94.6 | 83.6 (78.1 to 88.2) | 84.6 (54.6 to 98.1) | 99.0 (96.3 to 99.9) | 22.9 (12.0 to 37.3) |
| OP-N | 288 | 96.2 | 87.4 (82.9 to 91.0) | 90.9 (58.7 to 99.8) | 99.6 (97.7 to 100) | 22.2 (11.2 to 37.1) | |
| No | Nasal | 581 | 29.1 | 51.5 (43.7 to 59.2) | 99.3 (97.9 to 99.8) | 96.7 (90.6 to 99.3) | 83.3 (79.7 to 86.5) |
| OP-N | 255 | 34.5 | 69.3 (58.6 to 78.7) | 98.2 (94.8 to 99.6) | 95.3 (86.9 to 99.0) | 85.9 (80.1 to 90.5) | |
| Clinitest | |||||||
| Primary analysis | Nasal | 726 | 59.1 | 70.2 (65.6 to 74.5) | 99.3 (97.6 to 99.9) | 99.3 (97.6 to 99.9) | 69.7 (65.1 to 74.1) |
| OP-N | 653 | 64.6 | 77.3 (72.9 to 81.2) | 97.0 (93.9 to 98.8) | 97.9 (95.7 to 99.2) | 70.0 (64.7 to 75.0) | |
| Secondary (stratified) analyses: | |||||||
| Viral load cut-off† | Nasal | 711 | 52.0 | 77.0 (72.4 to 81.2) | 97.4 (95.0 to 98.8) | 96.9 (94.3 to 98.6) | 79.6 (75.4 to 83.4) |
| OP-N | 653 | 57.3 | 83.7 (79.5 to 87.3) | 92.8 (89.1 to 95.6) | 94.0 (90.9 to 96.3) | 80.9 (76.2 to 85.1) | |
| Vaccinated (at least one): | |||||||
| Yes | Nasal | 635 | 58.6 | 68.5 (63.6 to 73.2) | 100 (98.6 to 100) | 100 (98.6 to 100) | 69.2 (64.3 to 73.8) |
| OP-N | 586 | 64.7 | 77.0 (72.5 to 81.2) | 98.1 (95.1 to 99.5) | 98.6 (96.6 to 99.6) | 70.0 (64.4 to 75.2) | |
| No | Nasal | 90 | 63.3 | 80.7 (68.1 to 90.0) | 93.9 (79.8 to 99.3) | 95.8 (85.7 to 99.5) | 73.8 (58.0 to 86.1) |
| OP-N | 66 | 65.2 | 79.1 (64.0 to 90.0) | 91.3 (72.0 to 98.9) | 94.4 (81.3 to 99.3) | 70.0 (50.6 to 85.3) | |
| Previous SARS-CoV-2 infection: | |||||||
| Yes | Nasal | 127 | 49.6 | 60.3 (47.2 to 72.4) | 96.9 (89.2 to 99.6) | 95.0 (83.1 to 99.4) | 71.3 (60.6 to 80.5) |
| OP-N | 121 | 49.6 | 66.7 (53.3 to 78.3) | 95.1 (86.3 to 99.0) | 93.0 (80.9 to 98.5) | 74.4 (63.2 to 83.6) | |
| No | Nasal | 599 | 61.1 | 71.9 (66.9 to 76.4) | 100 (98.4 to 100) | 100 (98.6 to 100) | 69.3 (64.1 to 74.2) |
| OP-N | 532 | 68.0 | 79.0 (74.4 to 83.1) | 97.6 (94.1 to 99.4) | 98.6 (96.5 to 99.6) | 68.6 (62.3 to 74.4) | |
| Sex: | |||||||
| Female | Nasal | 449 | 57.7 | 65.3 (59.1 to 71.0) | 98.9 (96.2 to 99.9) | 98.8 (95.8 to 99.9) | 67.6 (61.8 to 73.1) |
| OP-N | 437 | 60.2 | 74.9 (69.2 to 80.0) | 96.6 (92.6 to 98.7) | 97.0 (93.7 to 98.9) | 71.8 (65.6 to 77.5) | |
| Male | Nasal | 276 | 61.2 | 77.5 (70.5 to 83.6) | 100 (96.6 to 100) | 100 (97.2 to 100) | 73.8 (65.8 to 80.7) |
| OP-N | 213 | 73.7 | 80.9 (73.9 to 86.7) | 98.2 (90.4 to 100) | 99.2 (95.7 to 100) | 64.7 (53.6 to 74.8) | |
| Age (years): | |||||||
| 16-40 | Nasal | 385 | 62.1 | 71.1 (64.9 to 76.8) | 99.3 (96.2 to 100) | 99.4 (96.8 to 100) | 67.8 (61.0 to 74.0) |
| OP-N | 339 | 64.9 | 79.1 (73.1 to 84.3) | 96.6 (91.6 to 99.1) | 97.8 (94.3 to 99.4) | 71.4 (63.8 to 78.3) | |
| >40 | Nasal | 341 | 55.7 | 68.9 (61.8 to 75.4) | 99.3 (96.4 to 100) | 99.2 (95.9 to 100) | 71.8 (65.1 to 77.8) |
| OP-N | 313 | 64.5 | 75.2 (68.7 to 81.0) | 97.3 (92.3 to 99.4) | 98.1 (94.4 to 99.6) | 68.4 (60.5 to 75.5) | |
| Tested because of positive self-test result: | |||||||
| Yes | Nasal | 257 | 95.3 | 85.7 (80.7 to 89.8) | 91.7 (61.5 to 99.8) | 99.5 (97.4 to 100) | 23.9 (12.6 to 38.8) |
| OP-N | 290 | 96.6 | 86.1 (81.5 to 89.9) | 80.0 (44.4 to 97.5) | 99.2 (97.1 to 99.9) | 17.0 (7.6 to 30.8) | |
| No | Nasal | 469 | 39.2 | 49.5 (42.0 to 56.9) | 99.6 (98.1 to 100) | 98.9 (94.1 to 100) | 75.3 (70.7 to 79.6) |
| OP-N | 363 | 39.1 | 59.9 (51.3 to 68.0) | 97.7 (94.8 to 99.3) | 94.4 (87.5 to 98.2) | 79.1 (73.8 to 83.8) | |
Flowflex=Flowflex COVID-19 Antigen Home Test (Acon Laboratories); MPBio=Rapid SARS-CoV-2 Antigen Test Card (MP Biomedicals); Clinitest=CLINITEST Rapid COVID-19 Antigen Test (Siemens-Healthineers); OP-N=combined oropharyngeal and nasal; RT-PCR=reverse transcription polymerase chain reaction.
*
SARS-CoV-2 infections based on RT-PCR test result.
†
Defined as viral load above which 95% of individuals with a positive RT-PCR test result had a positive viral culture,6 which was 5.2 log10 SARS-CoV-2 E gene copies/mL.