Clinical Performance of Two SARS-CoV-2 Serologic Assays

Tang, Mei; Hock, Karl G.; Logsdon, Nicole; Hayes, Jennifer; Gronowski, Ann M.; Anderson, Neil W.; Farnsworth, Christopher W

doi:10.1093/clinchem/hvaa120

Cited by 188 publications

(210 citation statements)

References 13 publications

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“…From our analysis of 1347 specimens, the sensitivity of IgG assay increased weekly to reach 99.6% at 4-5 weeks after symptom onset. The observed sensitivity of 93.6% at 15-21 days following symptom onset is consistent with previous studies [ 15 , 16 ], but lower than what is claimed in the manufacturer’s package insert. The difference may be attributed in part to the patient population used for this study, in which the majority was hospitalized with multiple comorbidities.…”

Section: Discussionsupporting

confidence: 91%

Longitudinal characterization of the IgM and IgG humoral response in symptomatic COVID-19 patients using the Abbott Architect

Maine

Lao

Krishnan

et al. 2020

Journal of Clinical Virology

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Highlights The Abbott IgM assay against SARS-CoV-2 is detected slightly earlier compared to IgG. Both Abbott IgM and IgG assays exhibit excellent sensitivity and specificity. Positive rate of IgM drops to 30.8% after 3 months of symptoms, in contrast to IgG which is sustained in 92.3% patients 3-6 months post symptom onset. In symptomatic patients who test negative by PCR for a SARS-CoV-2 infection, assessing IgM and IgG antibodies can aid in supporting a diagnosis of COVID-19.

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Section: Discussionsupporting

confidence: 91%

Longitudinal characterization of the IgM and IgG humoral response in symptomatic COVID-19 patients using the Abbott Architect

Maine

Lao

Krishnan

et al. 2020

Journal of Clinical Virology

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“…Manufacturers' sensitivity estimates ranged from 96·8% to 100% on samples taken at least 14 days post symptom onset or RT-PCR, and specificity estimates ranged from 98·5% to 99·8% on pre-pandemic samples ( appendix p 14 ). 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18…”

Section: Methodsmentioning

confidence: 99%

Performance characteristics of five immunoassays for SARS-CoV-2: a head-to-head benchmark comparison

Ainsworth¹,

Andersson²,

Auckland³

et al. 2020

The Lancet Infectious Diseases

347

291

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Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a global pandemic in 2020. Testing is crucial for mitigating public health and economic effects. Serology is considered key to population-level surveillance and potentially individual-level risk assessment. However, immunoassay performance has not been compared on large, identical sample sets. We aimed to investigate the performance of four high-throughput commercial SARS-CoV-2 antibody immunoassays and a novel 384-well ELISA. Methods We did a head-to-head assessment of SARS-CoV-2 IgG assay (Abbott, Chicago, IL, USA), LIAISON SARS-CoV-2 S1/S2 IgG assay (DiaSorin, Saluggia, Italy), Elecsys Anti-SARS-CoV-2 assay (Roche, Basel, Switzerland), SARS-CoV-2 Total assay (Siemens, Munich, Germany), and a novel 384-well ELISA (the Oxford immunoassay). We derived sensitivity and specificity from 976 pre-pandemic blood samples (collected between Sept 4, 2014, and Oct 4, 2016) and 536 blood samples from patients with laboratory-confirmed SARS-CoV-2 infection, collected at least 20 days post symptom onset (collected between Feb 1, 2020, and May 31, 2020). Receiver operating characteristic (ROC) curves were used to assess assay thresholds. Findings At the manufacturers' thresholds, for the Abbott assay sensitivity was 92·7% (95% CI 90·2–94·8) and specificity was 99·9% (99·4–100%); for the DiaSorin assay sensitivity was 95·0% (92·8–96·7) and specificity was 98·7% (97·7–99·3); for the Oxford immunoassay sensitivity was 99·1% (97·8–99·7) and specificity was 99·0% (98·1–99·5); for the Roche assay sensitivity was 97·2% (95·4–98·4) and specificity was 99·8% (99·3–100); and for the Siemens assay sensitivity was 98·1% (96·6–99·1) and specificity was 99·9% (99·4–100%). All assays achieved a sensitivity of at least 98% with thresholds optimised to achieve a specificity of at least 98% on samples taken 30 days or more post symptom onset. Interpretation Four commercial, widely available assays and a scalable 384-well ELISA can be used for SARS-CoV-2 serological testing to achieve sensitivity and specificity of at least 98%. The Siemens assay and Oxford immunoassay achieved these metrics without further optimisation. This benchmark study in immunoassay assessment should enable refinements of testing strategies and the best use of serological testing resource to benefit individuals and population health. Funding Public Health England and UK National Institute for Health Research.

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“…Specimens were analyzed on three commercially available immunoassays and reported previously (15,16). The Roche Elecsys Anti-SARS-CoV- and <1.4 is negative; for the EI assay, a ratio ³ 1.2 is positive 0.80-1.19 is indeterminate, and < 0.8 is negative.…”

Section: Instrumentationmentioning

confidence: 99%

“…We previously compared the clinical performance of three commercial serological assays (15,16). Here, we further assess the ability of these assays to predict the presence of neutralizing antibodies.…”

Section: Introductionmentioning

confidence: 99%

Association between SARS-CoV-2 neutralizing antibodies and commercial serological assays

Tang

Case

Franks

et al. 2020

Preprint

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AbstractIntroductionCommercially available SARS-CoV-2 serological assays based on different viral antigens have been approved for the qualitative determination of anti-SARS-CoV-2 antibodies. However, there is limited published data associating the results from commercial assays with neutralizing antibodies.Methods67 specimens from 48 patients with PCR-confirmed COVID-19 and a positive result by the Roche Elecsys SARS-CoV-2, Abbott SARS-CoV-2 IgG, or EUROIMMUN SARS-CoV-2 IgG assays and 5 control specimens were analyzed for the presence of neutralizing antibodies to SARS-CoV-2. Correlation, concordance, positive percent agreement (PPA), and negative percent agreement (NPA) were calculated at several cutoffs. Results were compared in patients categorized by clinical outcomes.ResultsThe correlation between SARS-CoV-2 neutralizing titer (EC50) and the Roche, Abbott, and EUROIMMUN assays was 0.29, 0.47, and 0.46 respectively. At an EC50 of 1:32, the concordance kappa with Roche was 0.49 (95% CI; 0.23-0.75), with Abbott was 0.52 (0.28-0.77), and with EUROIMMUN was 0.61 (0.4-0.82). At the same neutralizing titer, the PPA and NPA for the Roche was 100% (94-100) & 56% (30-80); Abbott was 96% (88-99) & 69% (44-86); and EUROIMMUN was 91% (80-96) & 81% (57-93) for distinguishing neutralizing antibodies. Patients who died, were intubated, or had a cardiac injury from COVID-19 infection had significantly higher neutralizing titers relative to those with mild symptoms.ConclusionCOVID-19 patients generate an antibody response to multiple viral proteins such that the calibrator ratios on the Roche, Abbott, and EUROIMMUN assays are all associated with SARS-CoV-2 neutralization. Nevertheless, commercial serological assays have poor NPA for SARS-CoV-2 neutralization, making them imperfect proxies for neutralization.

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Clinical Performance of Two SARS-CoV-2 Serologic Assays

Cited by 188 publications

References 13 publications

Longitudinal characterization of the IgM and IgG humoral response in symptomatic COVID-19 patients using the Abbott Architect

Longitudinal characterization of the IgM and IgG humoral response in symptomatic COVID-19 patients using the Abbott Architect

Performance characteristics of five immunoassays for SARS-CoV-2: a head-to-head benchmark comparison

Association between SARS-CoV-2 neutralizing antibodies and commercial serological assays

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