EVALUATION OF THE ABBOTT SARS-COV-2 IG-G ASSAY
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Abstract
Introduction
Antibodies to the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can increase as soon as 10-13 days after infection. We describe our evaluation of the Abbott SARS-CoV-2 IgG assay on the Architect immunoassay analyser.
Methods
We assessed the precision, sensitivity, and specificity of the Abbott SARS-CoV-2 IgG assay in samples from polymerase chain reaction (PCR) positive patients and healthy healthcare workers. The manufacturer cut-off index (COI) of 1.4 was adopted to identify positive results. We examined the assay cross-reactivity with other viral antibodies (influenza/dengue/hepatitis C/hepatitis B) and rheumatoid factor (RF). The sample throughput of the Abbott assay was also assessed.
Results
The Abbott assay showed excellent precision, with a CV of 3.4% for the negative control (COI = 0.06) and 1.6% for a high positive serum sample (COI = 8.6). Residual serum was available from 57 inpatients not initially suspected of having COVID-19, 29 of whom tested positive for SARS-CoV-2 IgG. The Abbott assay has a sensitivity of 90.9-100% when tested in 54 subjects ≥14 days post PCR positive, and a specificity of 100% (N = 358). There was no cross-reactivity with other viral antibodies (influenza/dengue/hepatitis C/hepatitis B) and RF. The Architect Abbott assay has a throughput of 100 samples in 70 minutes.
Conclusion
The Abbott SARS-CoV-2 IgG assay shows excellent performance that is well within FDA and CDC guidelines when testing patients ≥14 days POS with little cross-reactivity from other viral antibodies. There is some evidence that SARS-CoV-2 IgG develops early in the disease process.
IMPACT STATEMENT
With the current SARS-CoV-2 pandemic still ongoing, laboratories are hard pressed to introduce SARS-CoV-2 antibody testing to help as an indirect marker for infection to identify patients with prior infection/exposure. The Abbott SARS-CoV-2 IgG assay has excellent performance with good precision, specificity, and sensitivity ≥14 days after a positive SARS-CoV-2 PCR test, with a competitive throughput of 100 samples in 70 minutes. It shows no cross-reactivity with other viral antibodies (influenza/dengue/hepatitis B/hepatitis C) and rheumatoid factor. We have also found evidence of early antibody development in some patients before they tested positive on the SARS-CoV-2 PCR test.
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SciScore for 10.1101/2020.06.28.20132498: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: As this work was part of routine evaluation of new diagnostic assays, it was deemed exempt by our institutional review board. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources The Abbott SARS-CoV-2 IgG assay is a qualitative chemiluminescent microparticle immunoassay used for the detection of IgG antibodies to SARS-CoV-2 (undisclosed epitope on the viral nucleocapsid) in human serum/plasma on the ARCHITECT i2000 System. SARS-CoV-2suggested: NoneSoftware and Algorithms Sentences Resources Statistical analyses were performed using MedCalc software … SciScore for 10.1101/2020.06.28.20132498: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: As this work was part of routine evaluation of new diagnostic assays, it was deemed exempt by our institutional review board. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources The Abbott SARS-CoV-2 IgG assay is a qualitative chemiluminescent microparticle immunoassay used for the detection of IgG antibodies to SARS-CoV-2 (undisclosed epitope on the viral nucleocapsid) in human serum/plasma on the ARCHITECT i2000 System. SARS-CoV-2suggested: NoneSoftware and Algorithms Sentences Resources Statistical analyses were performed using MedCalc software v19.3.1 (MedCalc, Ostend, Belgium). MedCalcsuggested: (MedCalc, RRID:SCR_015044)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:A limitation of our study is that it is a single centre study, and we do not have the sero-prevalence of SARS-CoV-2 in our community population. In addition, we only had few samples for cases before and after 0-<7 days POS. Further studies on larger populations would be desirable.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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