暂无摘要。

At present, the only reliable test for COVID-19 diagnosis is RT-qPCR. Serological assays have been widely used to increase the detection sensitivity of infected population. Hereby, we report the performance of a new pan-IgG multiplex Enzyme Immunoassay (immunodot) method for exploration of discrepant SARS-COV-2 serological results.
A retrospective study on 38 residual serum samples from recovered COVID-19 subjects with discordant serological results on Roche and Snibe platforms, were reanalyzed on a new semi-automated pan-IgG immunodot Enzyme Immunoassay, namely COVIDOT-TEST, in order to find the source of discrepancies and to evaluate the latter method. All samples were analyzed on the BlueDiver® Instrument and all strips were read by the BlueScan® Scanner using Dr DOT® Software.
Based on our data, subject samples showed specific IgG reactions on ≥  2 different antigens on immunodot strips. Of these 38 samples, 97.4 % of samples showed specific IgG reaction against S1 + S2 antigens, 89.5 % showed against RBD antigen, 86.8 % against S2 antigen reaction on the COVIDOT-TEST kit. Specific IgG-S1 antigen and IgG-N antigen reactions were detected in 73.7 % and 65.8 % of the samples, respectively.
The new semi-automated pan-IgG immunodot Enzyme Immunoassay method appeared to be a reliable assay to confirm suspicious COVID-19 serological screening results.

Case-control study for the evaluation of innovative test formats for second-tier testing for the serodiagnosis of Lyme borreliosis (LB). A head-to-head comparison was performed with the test systems ViraStripe, SeraSpot, ViraChip, and recomBead. Serum samples from 62 patients (21 erythema migrans, 33 Lyme neuroborreliosis, 8 late LB) and 91 controls (including 29 potentially cross-reacting sera) were tested. For ViraChip and recomBead, optimised interpretation criteria were developed for both IgG and IgM. The most important modification for the proposed interpretation criteria for ViraChip is the interpretation of strong (> 2.5-fold above cutoff) singular IgG reactions against VlsE as positive. This significantly improves sensitivity (32 to 85%, p < 0.0001) without significant changes in specificity (borderline reactions interpreted as negative). By application of our modified rules, specificity of ViraChip IgM is significantly increased (89 to 97%, p < 0.05; borderline results included to negatives), and sensitivities of recomBead IgG and IgM are also significantly improved (69 to 87%, p < 0.01, and 57 to 74%, p < 0.01, respectively; borderline results included to positives). Further improvement of sensitivity by the rating of strong singular IgG reactions against VlsE as positive can also be shown for recomBead. IgG/IgM result combinations must be interpreted as a function of the assumed disease stage, and the best combinations differ for the various assays. Application of our proposed interpretation criteria significantly improve the discriminatory abilities of two assays; however, this must be confirmed with other data sets. Recommendations from Scientific Societies should be updated as may be necessary.