Diagnostics Global… Analytical studies …

Analytical studies

Besides the clinical studies listed on the homepage, antigen rapid diagnostic tests (Ag-RDTs) are also evaluated in specific laboratory settings. In addition to sensitivity and specificity, such analytical studies analyze the lowest virus concentration an Ag-RDT is able to detect (Limit of Detection, LOD) and whether it incorrectly recognizes any pathogens other than SARS-CoV-2 (cross reactivity). In the following, we would like to give an overview of the results of analytical studies evaluating Ag-RDTs.

Manufacturer,
Test
Study
location
Sensitivity
(CI 95%)
Specificity
(CI 95%)
Cross reactivity LOD [log10
copies/swab]
LOD 50%
by viral load
(CI 95%) *
LOD 95%
by viral load
(CI 95%) *
Source
Abbott, Panbio Germany n/a 100,00%
(n/a)
- RSV-A 6,551 5,61
(5,27-5,95)
7,45
(6,79-8,20)
Corman, V.M., et al.
Germany n/a n/a n/a 6,07 n/a n/a Haage, V., et al.
Abbott, BinaxNOW Germany n/a n/a n/a 4,6 - 4,92 n/a n/a Perchetti. G.A., et al.
BIONOTE, NowCheck Germany n/a n/a n/a 6,0 n/a n/a Haage, V., et al.
Boditech Med,
ichroma
Germany n/a n/a n/a 5,91 n/a n/a Haage, V., et al.
Coris BioConcept,
Respi-Strip
Germany n/a 100,00%
(n/a)
none detected 7,461 7,60
(7,37-7,82)
8,36
(8,00-8,76)
Corman, V.M., et al.
Germany n/a n/a n/a 7,90 n/a n/a Haage, V., et al.
Edinburgh Genetics,
ActivXpress
Germany n/a n/a n/a 6,15 n/a n/a Haage, V., et al.
GMCS Genedia,
COVID-19 Ag
Germany n/a n/a n/a 7,66 n/a n/a Haage, V., et al.
Healgen, Rapid Test Germany n/a 91,42%
(n/a)
  • Adenovirus
  • Entero / Rhinovirus
  • Influenzavirus A H1
  • Influenzavirus A H3
  • Parainfluenzavirus 1
  • Parainfluenzavirus 2
  • Parainfluenzavirus 3
6,371 4,48
(3,41-5,32)
7,27
(6,27-8,40)
Corman, V.M., et al.
JOYSBIO (Tianin),
COVID-19 Ag-RTK
Germany n/a n/a n/a 6,15 n/a n/a Haage, V., et al.
NAL von minden,
NADAL
Germany n/a 97,12%
(n/a)
none detected 6,971 7,19
(6,97-7,43)
7,87
(7,52-8,23)
Corman, V.M., et al.
RapiGEN, Biocredit Germany n/a 100,00%
(n/a)
none detected 10,21 9,51
(8,84-12,26)
11,10
(9,71-17,01)
Corman, V.M., et al.
R-Biopharm,
RIDA QUICK
Germany n/a 82,86%
(n/a)
- Influenzavirus A H1
- Influenzavirus A H3
6,321 5,40
(4,99-5,77)
7,22
(6,57-7,96)
Corman, V.M., et al.
SD Biosensor / Roche, Standard Q Germany n/a 97,12%
(n/a)
- Parainfluenzavirus 3 6,781 5,64
(5,23-6,00)
7,68
(6,96-8,50)
Corman, V.M., et al.
Germany n/a n/a n/a 6,0 n/a n/a Haage, V., et al.
Shenzen Bioeasy, FIA Germany n/a n/a n/a 6,85 n/a n/a Haage, V., et al.
Siemens Healthineers, CLINITEST Germany n/a n/a n/a 6,04 n/a n/a Haage, V., et al.

* The values “LOD 50% and 95% by viral load” were only determined in study [37]. However, their sample preparation included a step of dilution that was not taken into account for the “LOD 50% and 95% by viral load” values. Thus, these values are eight-fold lower. Still, they can be usefull to estimate the confidence interval and as a rough guide on how far the viral load can decrease to still be detected in 50% of the samples. All values are shown in log10 SARS-CoV-2 RNA copies per swab.

1 At the given LOD, the authors accepted a 5% false-negative rate. Thus, the true LOD could vary slightly.

2 The authors allowed no false-negatives. Only a LOD-range could be provided as the estimation of virus concentration of the test specimen was done using two different PCR methods. The true value lies in between.