Performance of an automated chemiluminescence SARS-COV-2 IG-G Assay

Clinica Chimica Acta; International Journal of Clinical Chemistry
C S LauT C Aw

Abstract

We describe our evaluation of the Abbott SARS-CoV-2 IgG assay on the Architect immunoassay analyser. We assessed assay precision, sensitivity, specificity, positive/negative predictive values (PPV/NPV), cross-reactivity (influenza/dengue/hepatitis B and C/rheumatoid factor/anti-nuclear/double-stranded DNA/syphilis) and sample throughput in samples from real-time polymerase chain reaction (RT-PCR) positive patients/healthcare workers (HCWs)/pre-pandemic samples. We compared the cut-off indexes (COIs) between all control samples (HCWs and pre-pandemic) to generate an optimised COI limit for reactivity. The assay specificity was 99.8% (n=980) and sensitivity was 45.9-96.7% (n=279). When tested ≥14 days post-positive RT-PCR (POS), the PPV/NPV was 96.4%/99.8%. The difference between the COIs of HCWs/pre-pandemic samples was small (0.01, p<0.0001). There was minimal cross-reactivity with other antibodies. A lower COI limit for reactivity (≥0.55, using the 99th percentile COI of our controls and ROC analysis) improved diagnostic sensitivity, especially at 0-6 days POS (45.9% to 55.8%), with a small decrease in specificity (98.9%). The assay throughput was 100 samples in 70 min. The Abbott SARS-CoV-2 IgG assay shows excellent performan...Continue Reading

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Citations

Mar 28, 2021·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Peter van DamMarc Peeters

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Methods Mentioned

BETA
PCR
antibody assay

Software Mentioned

MedCalc
Architect
Stata

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