Table 2

Summary of performance of COVID-19 serological assays following laboratory evaluation by PHE15

Company
(total number of samples used for PHE validation)
Roche Elecsys Anti-SARS-CoV-2
(93 convalescent, 472 negative samples)
Ortho Clinical Diagnostics VITROS Immunodiagnostic
(93 convalescent, 490 negative samples)
Ortho Clinical Diagnostics VITROS Immunodiagnostic
(100 convalescent, 491 negative samples)
Beckman Coulter Access
(100 convalescent, 499 negative samples)
Siemens Atellica-IM
(100 convalescent, 499 negative serum samples)
Assay target (type of assay)Total antibody (electrochemiluminescent)IgG
(chemiluminescent)
Total serology
(chemiluminescent)
IgG
(chemiluminescent)
Total antibody
(chemiluminescent)
Specificity (manufacturer)99.8
(99.7 to 99.9)
100
(99.1 to 100.0)
100
(99.1 to 100.0)
99.8
(99.4 to 99.9)
99.82
(91.59 to 99.98)
Sensitivity (manufacturer)100
(88.1 to 100.0)
(samples taken ≥14 post-PCR confirmation)
90.0
(76.3 to 97.2)
(samples taken >15 days after symptom onset)
100
(92.7 to 100.0)
(samples taken >8 days after symptom onset)
100
(93.8 to 100.0)
(samples taken >18 days from positive PCR test)
100
(91.59 to 100.0)
(samples taken ≥14 post PCR confirmation)
Specificity (PHE)100
(99.1 to 100.0)
99.7
(98.6 to 100.0)
99.5
(98.2 to 99.9)
99.3
(97.8 to 99.8)
100
(99.1 to 100.0)
Sensitivity ≥14 days after symptom onset (PHE)86.1
(76.5 to 92.8)
79.7
(69.2 to 88.0)
91.8
(83.3 to 96.6)
76.5
(66.0 to 85.0)
89.4
(80.8 to 95.0)
Sensitivity of the assay at ≥21 days after symptom onset
(PHE)
86.7
(76.8 to 93.4)
81.3
(70.7 to 89.4)
93.5
(85.5 to 97.9)
79.2
(93.8 to 100.0)
92.4
(84.2 to 97.2)
Company
(total number of samples used for PHE validation)
Euroimmun Medizinische Labordiagnostika AG
(93 convalescent,499 negative samples)
Abbott
(96 convalescent, 760 negative samples)
DiaSorin LIAISON
(100 serum, 472 negative samples)
 Assay target (type of assay)IgG
(ELISA)
IgG
(chemiluminescent)
S1/S2 IgG
(chemiluminescent)
Specificity (manufacturer)99.6
(No CI)
99.6
(99.1 to 99.9)
98.5
(97.6 to 99.1)
Sensitivity (manufacturer)94.4
(no CI)
(≥10 days after symptom onset)
100
(95.9 to 100.0)
(≥14 days after symptom onset)
97.4
(86.8 to 99.5)
Specificity (PHE)99.0
(97.5 to 99.7)
100
(99.1 to 100.0)
97.7
(95.8 to 99.0)
Sensitivity of ≥14 days after symptom onset (PHE)73.4
(62.3 to 82.7)
93.9
(86.3 to 98.0)
69.4
(58.5 to 79.0)
Sensitivity of the assay at ≥21 days after symptom onset
(PHE)
74.7
(63.3 to 84.0)
93.5
(85.5 to 97.9)
71.4
(60.0 to 81.2)
  • Sensitivity and specificity are presented as percentages and confidence intervals in brackets.

  • CI, confidence intervals; PHE, Public Health England; S, spike protein.