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. 2023 Dec 11;13:21913. doi: 10.1038/s41598-023-48892-x

Table 2.

a Clinical accuracy data for self-sampled Ag-RDTs. b Clinical accuracy data for self-testing Ag-RDTs.

Study Test assessed Country Type of location Study population Screening criteria Sample type Sensitivity (95% CI) Specificity (95% CI)
Harris12 Sofia USA testing site adults sympt., HRC AN 82.3% (77.5# to 86.4#) 98.8%# (97.5# to 99.5#)
Harris12 Sofia USA testing site adults asympt AN 31.6% (0.0# to 24.7#) 100% (99.8# to 100)
Lindner13 Standard Q Germany testing site adults sympt AN* 74.4% (57.9# to 87.0#) 99.2% (97.1 to 99.9#
Tinker43 BinaxNow USA testing site adults asympt AN* 20.0% (9.1# to 35.6#) 100% (99.8# to 100#)
Tanimoto44 Lumipulse Japan unclear unclear unclear saliva 61.8% (47.7# to 74.6#) 100% (94.1 to 100)
Mak45 Standard Q Hong Kong testing site unclear HRC OP/AN* 100% (15.8# to 100) 100% (90.7# to 100)
Blanchard70 Panbio nasal Canada testing site adults, children sympt AN* 78.6% (49.2# to 95.3#) 100% (98.7# to 100)
Harmon47 E25Bio USA testing site adults sympt., asympt AN 92.3% (64.0# to 99.8#) 99.6% (97.7# to 100)
Ford48 BinaxNow USA testing site children sympt., HRC, asympt AN* 71.4% (53.7 to 85.4) 100% (98.0 to 100)
Ford48 BinaxNow USA testing site adults sympt., HRC, asympt AN* 80.9% (75.9 to 85.3) 99.9% (99.5 to 100)
Klein 49 Panbio nasal Germany testing site adults sympt., HRC AN 86.4% (72.6# to 94.8#) 99.2% (97.0 to 99.9#)
Nikolai35 Standard Q Germany clinical adults sympt AN 91.2% (76.3# to 98.1#) 98.4% (91.3# to 100#)
Okoye36 BinaxNow USA testing site adults asympt AN* 53.3% (37.9# to 68.3#) 100% (99.9 to 100)
Krüger37 LumiraDx Germany testing site adults sympt., HRC AN 82.2% (75.0# to 88.0#) 99.3% (98.3 to 99.7)
Osmanodja38 Dräger Germany both adults sympt., asympt AN 88.6% (78.7 to 94.9) 99.7% (98.2 to 100)
Chiu39 Indicaid USA clinical adults, children Sympt AN 82.7% (72.2# to 90.4#) 96.4% (93.4 to 98.2#)
García-Fiñana40 Innova UK testing site adults Asympt OP/AN 40.0% (28.5 to 52.4) 99.9% (99.8 to 99.9)
Shah41 BinaxNow USA testing site adults, children sympt, HRC, asympt AN 81.4% (76.8 to 85.5) 99.6% (99.2 to 99.8)
Frediani42 BinaxNow USA unclear adults, children unclear AN 56.2%# (29.9# to 80.2#) 100% (87.7# to 100)
Tinker43 BinaxNow USA testing site adult asympt AN* 20.0 (9.1# to 35.6#) 100 (99.8# to 100#)
Tanimoto44 Lumipulse Japan unclear unclear unclear saliva 61.8 (47.7# to 74.6#) 100 (94.1 to 100)
Mak45 Standard Q Hong Kong testing site unclear HRC OP/nasal 100 (15.8# to 100) 100 (90.7# to 100)
Blanchard46 Panbio nasal Canada testing site adult, children Sympt AN* 78.6 (49.2# to 95.3#) 100 (98.7# to 100)
Harmon47 E25Bio USA testing site adult sympt., asympt AN* 92.3 (64.0# to 99.8#) 99.6 (97.7# to 100)
Ford48 BinaxNow USA testing site children sympt, HRC, asympt AN* 71.4 (53.7 to 85.4) 100 (98.0 to 100)
Ford48 BinaxNow USA testing site adult sympt, HRC, asympt AN* 80.9 (75.9 to 85.3) 99.9 (99.5 to 100)
Ahmed50 ProDetect Malaysia unclear adult, children sympt, HRC, AN 96.1# (86.5# to 99.5#) 98.0 (89.1# to 99.9#)
Cardoso51 Wondfo Brazil testing site unclear sympt AN* 73.0 (64.7# to 80.2#) 98.6 (95.2 to 99.8#)
Chen52 Labnovation China clinical adult unclear AN 70.4# (49.8# to 86.2#) 100# (29.2# to 100#)
Chen52 Labnovation China clinical adult unclear AN 81.4# (66.6# to 91.6#) 64.0# (42.5# to 82.0#)
Gagnaire53 Biospeedia France testing site adult, children sympt, HRC, asympt AN/saliva 59.4 (51.5 to 67.0) 99.8 (99.7# to 99.9)
Goodall54 Panbio Canada testing site unclear asympt AN* 64.5 (51.3# to 76.3#) 100 (99.5# to 100#)
Goodall54 Panbio Canada testing site unclear asympt TN* 64.5 (51.3# to 76.3#) 100 (99.5# to 100#)
Goodall54 Panbio Canada testing site unclear asympt AN* 68.4 (51.3# to 82.5#) 100 (99.2# to 100#)
Goodall54 Panbio Canada testing site unclear asympt TN* 81.6 (65.7# to 92.3#) 100 (99.2# to 100#)
Igloi55 Standard Q Netherlands testing site adult sympt., HRC saliva* 66.1 (52.9 to 77.6) 99.6 (98.8 to 99.9
Mane56 Coviself India testing site adult sympt., HRC OP 54.2# (39.2# to 68.6#) 96.9# (92.9# to 99.0#)
Rangaiah57 Coviself India unclear unclear unclear AN 61.5 (50.7 to 71.5) 100 (97.4 to 100)
Robinson58 BD Veritor nasal USA testing site unclear Sympt., HRC, AN - -
Savage59 Covios UK testing site adult sympt AN 90.5 (83.9 to 97.2) 99.4 (98.3 to 100)
Shin60 Standard Q Korea clinical unclear sympt., asympt AN 94.9 (87.5 to 98.6) 100 (98.3 to 100)
Sukumaran61 AG-Q India clinical unclear unclear AN 77.9 (67.7 to 86.1) 100 (94.4 to 100)
Tsao63 BinaxNow USA testing site adult sympt., asympt AN 63.0 (50.9# to 74.0#) 99.8 (99.1# to 100)
Wölfl-Duchek62 Medomics Austria clinical adult sympt., asympt AN 63.0 (47.5 to 76.8) 100 (91.0# to 100)
Study Test assessed Country Type of location Study population Screening criteria Sample type Sensitivity (95%CI) Specificity (95%CI)
Lindner11 Standard Q Germany Clinical Adults sympt AN 82.5% (67.2# to 92.7#) 100% (96.5 to 100)
Stohr22 BD Veritor Netherlands Testing site Adults sympt., asympt AN 48.9% (41.3# to 56.5#) 99.9% (99.5 to 100)
Stohr22 Standard Q Netherlands Testing site Adults sympt., asympt AN 61.5% (54.2# to 68.4#) 99.7% (99.3 to 99.9)
De Meyer25 V-Chek Belgium Testing site Adult, children unclear saliva 7.7 (0.2# to 36.0#) 100 (90.5# to 100#)
De Meyer25 Whistling Belgium Testing site Adult, children unclear saliva 9.1 (3.0# to 20.0#) 100 (92.5# to 100#)
Diawara26 PCL Morocco Unclear Adult, children unclear saliva 90.1 (80.7 to 95.9) 99.6 (97.9 to 99.9)
Diawara26 PCL Morocco Unclear Adult, children unclear AN 91.4# (82.3# to 96.8#) 100 (98.5 to 100)
Iftner27 Anbio Germany Testing site Adult asympt AN – 99.8# (98.8# to 100#)
Iftner27 Clungene Germany Testing site Adult asympt AN – 97.9# (96.2# to 99.0#)
Iftner27 Hotgen Germany Testing site Adult asympt AN – 99.8# (98.8# to 100#)
Iftner27 Mexacare Germany Testing site Adult asympt AN – 99.8# (98.8# to 100#)
Leventopoulos28 Boson Greece Testing site Adult, children sympt., asympt AN 98.2 (96.7 to 99.6) 100 (99.9 to 100)
Møller29 DNA Diagnostics Denmark Testing site Adult sympt, HRC, asympt AN 65.7 (49.2 to 79.2) 100 (99.0 to 100)
Møller29 Hangzhou Denmark Testing site Adult sympt, HRC, asympt AN 62.1 (50.1 to 72.9) 100 (98.9 to 100)
Schuit31 Flowflex Netherlands Testing site Adult sympt, HRC, asympt AN 79.0 (74.7 to 82.8) 97.2 (93.9 to 98.9)
Schuit31 MPBio Netherlands Testing site Adult sympt, HRC, asympt AN 69.9 (65.1 to 74.4) 98.8 (97.3 to 99.6)
Schuit31 Clinitest Netherlands Testing site Adult sympt, HRC, asympt AN 70.2 (65.6 to 74.5) 99.3 (97.6 to 99.9)
Schuit31 MPBio Netherlands Testing site Adult sympt, HRC, asympt OP/nasal 83.0 (78.8 to 86.7) 97.8 (94.3 to 99.4)
Schuit31 Clinitest Netherlands Testing site Adult sympt, HRC, asympt OP/nasal 77.3 (82.9 to 81.2) 97.0 (93.9 to 98.8)
Schuit30 SD Biosensor Netherlands Testing site Adult sympt, HRC, asympt NP/OP 68.9 (61.6 to 75.6) 99.5 (99.2 to 99.8)
Schuit30 Hangzhou Netherlands Testing site Adult sympt, HRC, asympt NP/OP 46.7 (39.3 to 54.2) 99.0 (98.5 to 99.4)
Tonen-Wolyec32 Biosynex France Testing site Adult sympt, HRC, asympt AN 90.9 (70.8# to 98.9#) 100 (95.7# to 100)
Venekamp33 FlowFlex Netherlands Testing site Adult sympt, HRC, asympt AN 27.5 (21.3 to 34.3) 99.8 (99.3 to 100)
Venekamp33 MPBio Netherlands Testing site Adult sympt, HRC, asympt AN 20.9 (13.9 to 29.4) 99.8 (99.2 to 100)
Venekamp33 Clinitest Netherlands Testing site Adult sympt, HRC, asympt AN 25.6 (19.1 to 33.1) 99.9 (99.5 to 100)
Zwart34 BD Veritor Netherlands Clinical Adult sympt., asympt OP/nasal 61.5 (56.6 to 66.3) 100 (99.8 to 100)
Zwart34 BD Veritor Netherlands Clinical Adult sympt., asympt AN 50.3 (43.0# to 57.6#) 99.7 (99.3 to 99.8)
Zwart34 Roche Netherlands Clinical Adult sympt., asympt OP/nasal 74.3# (66.6# to 81.1#) 99.7 (99.4# to 99.9)

sympt. symptomatic, asympt. asymptomatic without known contact, HRC High risk contact, AN Anterior nasal, OP Oropharyngeal, TN * RT-PCR sample was self-sampled. # Values have been recalculated due to missing or contradictory data.