Comparative Clinical Evaluation of the Roche Elecsys and Abbott Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Serology Assays for Coronavirus Disease 2019 (COVID-19)

Abstract

Context: The use of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests detect antibodies in the host, contributing to the identification of individuals who have been exposed to Coronavirus Disease 2019 (COVID-19). Objective: To critically evaluate two commercially available SARS-CoV-2 serology tests. Design: A total of 333 unique, non-duplicated serum samples obtained from COVID-19 patients (n=170) and negative controls (n=163) obtained pre-December 2019 were used in the study. Samples were tested on the Roche E411 and Abbott Architect i4000SR platforms and results were correlated to reverse transcription polymerase chain reaction (PCR) results and clinical symptoms. Results: There was a strong level of agreement in the qualitative results between both assays with a Cohen's kappa value of 0.840, P<.001. The specificity for both Roche and Abbott were excellent at 100%. Roche exhibited marginally better performance in the ≥21 days group with a sensitivity of 90.6% (95% CI 75.8–96.8%) versus Abbott's sensitivity 84.4% (95% CI 68.3 – 93.1%) as well as the 14–20 days group with a sensitivity of 85.7% (95% CI 65.4 – 95.0%) versus Abbott sensitivity 81.0% (95% CI 60.0 – 92.3%). Less than 14 days of symptoms groups exhibited poor sensitivity at <50% for both assays. The area under curve (AUC ± standard error) for Roche (0.894 ± 0.025, P< .001) and Abbott (0.884 ± 0.026, P <.001) were very similar. Potential confounders for negative serological results include antiretroviral medication use and pauci-symptomatic patients. Conclusions: Specificities for high throughput Roche and Abbott immunoassays are excellent but users need to be cautious to interpret serological test results after 14 days of symptoms to avoid false negatives

Performance Evaluation: Four Chemiluminescent SARS-Cov-2 Immunoassays and Rapid-Card Test in Mild Disease and Seroprevalence of SARS CoV-2 in Frontline Healthcare Workers

“…Tan SS et al in their study reported that Roche exhibited marginally better performance in the 21 days or more group, with a sensitivity of 90.6% versus an Abbott sensitivity of 84.4%, as well as in the 14-to 20day group with a sensitivity of 85.7% versus an Abbott sensitivity of 81.0%. They reported that less than 14 days of symptoms group exhibited poor sensitivity at less than 50% for both assays [11]. Similar to our findings, Chua KYL et.…”

Head-to-head evaluation on diagnostic accuracies of six SARS-CoV-2 serological assays

“…This is supported by our previous work and current AUC results, which suggest that serological testing should generally be considered only 14 days after onset of symptoms. 15,16 If testing is performed prior to this, users should consider the high possibility of false negative results. In this study, the best performer in terms of sensitivity across all days and also at >14 days of symptoms was OCD followed closely by cPass.…”

Immunoglobin G/total antibody testing for SARS-CoV-2: A prospective cohort study of ambulatory patients and health care workers in two Belgian oncology units comparing three commercial tests

“…Understanding both the rate of asymptomatic infection and pre-existing immunity is key to assess potential impact of pandemic spread of this virus in a cancer patient community [ 8 ]. Important insights can be gained from serology studies to get data on the proportion of (asymptomatic) infected high-risk patients in a population [ 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 ]. In addition, patients and health care workers may be identified that are potentially protected from reinfection by neutralizing antibodies, although currently it is not certain if and how long immunity would be present [ 9 ].…”