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Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Clin+Chim+Acta 2020 ; 510 (ä): 760-766 Nephropedia Template TP
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Performance of an automated chemiluminescence SARS-CoV-2 IG-G assay #MMPMID32910979
Lau CS; Oh HML; Hoo SP; Liang YL; Phua SK; Aw TC
Clin Chim Acta 2020[Nov]; 510 (ä): 760-766 PMID32910979show ga
INTRODUCTION: We describe our evaluation of the Abbott SARS-CoV-2 IgG assay on the Architect immunoassay analyser. METHODS: 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. RESULTS: 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 (45.9-55.8%), with a small decrease in specificity (98.9%). The assay throughput was 100 samples in 70 min. CONCLUSION: The Abbott SARS-CoV-2 IgG assay shows excellent performance in patients >/= 14 days POS. The difference between the COIs of HCWs and pre-pandemic samples was numerically small. A lower COI limit improves assay sensitivity with a slight decrease in specificity.