Validation of High-Throughput, Semiquantitative Solid-Phase Sarscoronavirus-2 Serology Assays in Serum and Dried Blood Spot Matrices

Abstract

Aim: Serological assays for the detection of anti-SARS coronavirus-2 (SARS-CoV-2) antibodies are essential to the response to the global pandemic. A ligand binding-based serological assay was validated for the semiquantitative detection of IgG, IgM, IgA and neutralizing antibodies (nAb) against SARS-CoV-2 in serum. Results: The assay demonstrated high levels of diagnostic specificity and sensitivity (85–99% for all analytes). Serum IgG, IgM, IgA and nAb correlated positively (R2 = 0.937, R2 = 0.839, R2 = 0.939 and R2 = 0.501, p < 0.001, respectively) with those measured in dried blood spot samples collected using the hemaPEN® microsampling device (Trajan Scientific and Medical, Victoria, Australia). In vitro SARS-CoV-2 pseudotype neutralization correlated positively with the solid phase nAb signals in convalescent donors (R2 = 0.458, p < 0.05). Conclusion: The assay is applicable in efficacy studies, infection monitoring and postmarketing surveillance following vaccine rollout.

The Performance of Diagnostic Tests for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in the South African Population: A Scoping Review

“…Figure 1 shows the identification, screening, eligibility, and inclusion of the studies for the scoping review [ 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 ]. The quality assessment of the 17 articles resulted in four articles scoring 71% and the rest scoring 86% and above.…”

“…Table 1 provides an overview of the testing kits or methodology evaluated. Seven of the 17 studies included populations from Gauteng [ 17 , 19 , 21 , 22 , 24 , 29 , 30 ], four from the Western Cape [ 15 , 16 , 26 , 28 ], one from Limpopo [ 14 ], one from Eastern Cape [ 18 ], and one from the Free State [ 23 ]. Of the remaining three studies, two studies included samples from more than one province [ 20 , 27 ] and one study undertook testing on stored samples [ 25 ].…”

Guest edited collection serological study of SARS-CoV-2 antibodies in japanese cats using protein-A/G-based ELISA

“…An ELISA using protein-A/G conjugated with horseradish peroxidase was used to detect the anti-S1-protein antibody or anti-RBD-protein antibody [ 30 ]. Based on previous reports [ 16 , 22 , 40 ], 100 ng per well of recombinant S1 protein (No. S1N-C52H3, Acro Biosystems, Newark, DE, USA) and 50 ng per well of RBD protein (No.…”

Clinical sensitivity and specificity of a high-throughput microfluidic nano-immunoassay combined with capillary blood microsampling for the identification of anti-SARS-CoV-2 Spike IgG serostatus

“…For instance, direct collection of capillary blood microsamples on Neoteryx Mitra devices has been shown to provide comparable results to serum samples using the Roche Elecsys assay [ 15 ] or in combination with ELISAs [ 8 , 16 ]. Similarly, studies showed the potential of using other volumetric microsampling systems by using minivette and subsequent transfer on filter paper [ 17 ], or using devices which, like Mitra, also allow direct microsample collection of defined volume such as Hemapen [ 18 ], Capitainer [ 19 ] or HemaXis [ 20 ].…”