Differential Performance of CoronaCHEK SARS-CoV-2 Lateral Flow Antibody Assay by Geographic Origin of Samples

• Published in: Journal of clinical microbiology Vol. 59; no. 7; p. e0083721
• Main Authors: Baker, Owen R, Grabowski, M Kate, Galiwango, Ronald M, Nalumansi, Aminah, Serwanga, Jennifer, Clarke, William, Hsieh, Yu-Hsiang, Rothman, Richard E, Fernandez, Reinaldo E, Serwadda, David, Kagaayi, Joseph, Lutalo, Tom, Reynolds, Steven J, Kaleebu, Pontiano, Quinn, Thomas C, Laeyendecker, Oliver
• Format: Journal Article
• Language: English
• Published: United States American Society for Microbiology 18.06.2021
• Subjects: Antibodies, Viral; COVID-19; Female; Humans; Immunoassays; Male; SARS-CoV-2; Sensitivity and Specificity; Uganda; Uganda; Uganda; SARS-CoV-2; assay performance; lateral flow antibody assay
• ISSN: 0095-1137; 1098-660X
• DOI: 10.1128/JCM.00837-21

We assessed the performance of the CoronaCHEK lateral flow assay on samples from Uganda and Baltimore to determine the impact of geographic origin on assay performance. Plasma samples from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) PCR-positive individuals (Uganda, 78 samples from 78 individuals, and Baltimore, 266 samples from 38 individuals) and from prepandemic individuals (Uganda, 1,077, and Baltimore, 532) were evaluated. Prevalence ratios (PR) were calculated to identify factors associated with a false-positive test. After the first positive PCR in Ugandan samples, the sensitivity was 45% (95% confidence interval [CI], 24,68) at 0 to 7 days, 79% (95% CI, 64 to 91) at 8 to 14 days, and 76% (95% CI, 50 to 93) at >15 days. In samples from Baltimore, sensitivity was 39% (95% CI, 30 to 49) at 0 to 7 days, 86% (95% CI, 79 to 92) at 8 to 14 days, and 100% (95% CI, 89 to 100) at 15 days after positive PCR. The specificity of 96.5% (95% CI, 97.5 to 95.2) in Ugandan samples was significantly lower than that in samples from Baltimore, 99.3% (95% CI, 98.1 to 99.8;  < 0.01). In Ugandan samples, individuals with a false-positive result were more likely to be male (PR, 2.04; 95% CI, 1.03,3.69) or individuals who had had a fever more than a month prior to sample acquisition (PR, 2.87; 95% CI, 1.12 to 7.35). Sensitivity of the CoronaCHEK was similar in samples from Uganda and Baltimore. The specificity was significantly lower in Ugandan samples than in Baltimore samples. False-positive results in Ugandan samples appear to correlate with a recent history of a febrile illness, potentially indicative of a cross-reactive immune response in individuals from East Africa.