Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho

Abstract

22Coronavirus disease-19 (COVID19), the novel respiratory illness caused by severe acute 23 respiratory syndrome coronavirus 2 (SARS-CoV-2), is associated with severe morbidity and 24 mortality. The rollout of diagnostic testing in the United States was slow, leading to numerous 25 cases that were not tested for SARS-CoV-2 in February and March 2020, necessitating the use 26 of serological testing to determine past infections. Here, we evaluated the Abbott SARS-CoV-2 27IgG test for detection of anti-SARS-CoV-2 IgG antibodies by testing 3 distinct patient 28 populations. We tested 1,020 serum specimens collected prior to SARS-CoV-2 circulation in the 29United States and found one false positive, indicating a specificity of 99.90%. We tested 125 30 patients who tested RT-PCR positive for SARS-CoV-2 for which 689 excess serum specimens 31 were available and found sensitivity reached 100% at day 17 after symptom onset and day 13 32 after PCR positivity. Alternative index value thresholds for positivity resulted in 100% sensitivity 33 and 100% specificity in this cohort. We tested 4,856 individuals from Boise, Idaho collected over 34 one week in April 2020 as part of the Crush the Curve initiative and detected 87 positives for a 35 positivity rate of 1.79%. These data demonstrate excellent analytical performance of the Abbott 36 SARS-CoV-2 IgG test as well as the limited circulation of the virus in the western United States. 37We expect the availability of high-quality serological testing will be a key tool in the fight 38 against SARS-CoV-2. 39 40 41 on June 9, 2020 by guest

Detection of SARS-CoV-2 antibodies is insufficient for the diagnosis of active or prior COVID-19

“…At this point, serology may be the only method to track down past/cured infected patients. Here, we con rm the observations by Bryan et al, who reported no IgG detection in samples taken from patients during periods before the COVID pandemic using Architect Abbott´s SARS-CoV-2 IgG [16]. Furthermore, we show the same lack of cross-reactivity in the PanbioTM COVID-19 IgG/IgM rapid test device.…”

“…Bryan et al report 100% sensitivity in cases for which samples were taken ≥17 days from the onset of the disease. The results communicated by these authors are signi cantly higher than the ones reported in our study [16]. Here, we tested patients who attended the emergency department with acute and active clinical presentations (Cohort 1).…”

“…IgG/IgM rapid test device resulted in high agreement (98%). To the best of our knowledge, to date there is only one study that has assessed Abbott´s SARS-CoV-2 IgG assay (Architect analyser) in samples from patients admitted to the hospital [16]. The performance of the test was particularly good in samples collected ≥10 days from the onset of the disease.…”

“…The serological detection of IgG against SARS-CoV-2, mostly using inhouse procedures, has shown a sensitivity that ranges between 78% and 100% in patients requiring hospital admission [7][8][9][10][11][12][13][14][15]. Abbott´s SARS-CoV-2 IgG assay is a recent commercial chemiluminescence immunoassay (CLIA) platform approved by the FDA that allow detecting IgG in serum samples and has been validated in samples from hospitalized patients with COVID-19 [16]. On the other hand, the PanbioTM COVID-19 IgG/IgM rapid test is a point-of-care lateral ow device that may be a good alternative to CLIA-based procedures.…”

Outcomes of patients with End Stage Kidney Disease on dialysis with COVID-19. From PCR to Antibody.

“…No Paediatric patients (<18 years) developed COVID-19 disease or screened positive for the disease and patients with CKD not on renal replacement therapy, renal transplant recipients and patients with acute kidney injury requiring dialysis were excluded. (11). These and other diagnostics tests had regular and routine quality control as expected within an accredited pathology network.…”