[PMC free article] [PubMed] [Google Scholar] 19. The presence of anti\RBD antibodies was recognized using Access SARS\CoV\2 IgM and IgG II antibody checks, while nAbs were measured by sVNT. The level of sensitivity and specificity of sVNT were 94.4% and 98.9%, respectively. There were strong positive correlations between the inhibition ideals of sVNT and the results of the Access SARS\CoV\2 IgM (or median and IQR and were compared using the test and the Wilcoxon rank\sum test for VU0652835 VU0652835 parametric and nonparametric data, respectively. Linear regression analysis was used to assess the relationship between each continuous variable. Rho ideals were analyzed from the Spearman rank\order correlation coefficient. A two\sided value <0.05 was considered statistically significant. All statistical analyses were carried out using R (v4.0.2; R Basis for Statistical Computing, Vienna, Austria; http://www.R-project.org/). 3.?RESULTS 3.1. Level of sensitivity and specificity of the access IgM and IgG antibody assays for COVID\19 Distributions of S/CO and AU/ml for the Access IgM and IgG II assays for COVID\19 and non\COVID\19 sera are demonstrated in Number?1A,B, respectively. In the IgM assay, the median S/CO value of the COVID\19 samples was 16.8 (IQR: 7.0C37.8), while that of the non\COVID\19 samples was 0.2 (IQR: 0.2C0.2) (p?0.001). In the IgG II assay, the median S/CO value of the COVID\19 samples was 198.7 (IQR: 137.2C427.3), while that of the non\COVID\19 samples was 0.2 (IQR: 0.1C0.5) (p?0.001). The area under the curve of the IgM assay was 0.99 and that of the IgG II assay was 0.99 (Figure?2A). The cut\off value of the IgM assay identified from VU0652835 ROC curve analysis to maximize Youden's index was S/CO?1.00 and that of the IgG II assay was 10?AU/ml, and these ideals were concordant with the manufacturer's instructions. The overall level of sensitivity was 96.3% (95% confidence interval [CI]: 87.3%C99.5%) and specificity was 100% (95% CI: 95.9%C100%) in the IgM assay and 94.4% (95% CI: 84.6%C98.8%) and 98.9% (95% CI: 93.9%C99.9%) in the IgG II assay, respectively (Table?1). Open in a separate window Number 1 (A) Distribution of IgM and (B) IgG antibody levels for receptor\binding website protein and (C) inhibition of severe acute respiratory syndrome coronavirus 2 (SARS\CoV\2) using the surrogate disease neutralization test (sVNT). Plot shows the distribution of the test results for each method. Black plots, coronavirus disease 2019 (COVID\19) instances; white plots, non\COVID\19 instances; black horizontal dashed collection, optimal cut\off value based on the test results; and blue horizontal dashed collection, cut\off value provided by the manufacturer. IgG, immunoglobulin G; IgM, immunoglobulin M Open in a separate window Physique 2 (A) Receiver operating characteristic curves of the IgM and IgG II antibody assays for receptor\binding domain name protein and of the (B) surrogate computer virus neutralization test (sVNT) for SARS\CoV\2. (A) Black collection, IgM antibody assay; reddish dashed collection, IgG antibody assay. (B) Black collection, sVNT. AUC, area under the curve; IgG, immunoglobulin G; IgM, immunoglobulin M; SARS\CoV\2, severe acute respiratory syndrome coronavirus 2 Table 1 Sensitivity, specificity, and slice\off values of the IgM and IgG II antibody assays and nAbs for COVID\19
Specificity
Sensitivity
Non\COVID\19 samples
Detected
Not detected
Specificity (95% CI)
COVID\19 samples
Detected
Not detected
Sensitivity (95% CI)
IgM antibody assayCut\off S/CO?1.089089100%5452296.3%(95.9C100)(87.3C99.5)IgG II antibody assayCut\off IgG 10?AU/ml8918898.9%5451394.4%(93.9C99.9)(84.6C98.8)sVNTCut\off inhibition 20%8968393.3%5451394.4%(85.9C97.5)(84.6C98.8)Cut\off inhibition 30%8918898.9%5451394.4%(93.9C99.9)(84.6C98.8) Open in a separate windows Abbreviations: AU, arbitrary models; CI, confidence interval; COVID\19, coronavirus disease 2019; IgG, immunoglobulin G; IgM, immunoglobulin M; nAb, neutralization antibody; S/CO, transmission for the test sample/transmission at slice\off value; sVNT, surrogate computer virus neutralization test. 3.2. Alternate cut\off point, sensitivity, and specificity for sVNT The alternative cut\off value for sVNT was decided using Rabbit Polyclonal to CDCA7 serum samples from COVID\19 patients (n?=?54) and non\COVID\19 patients (n?=?89). Median inhibition was 91.4% (IQR: 84.6%C94.8%) for COVID\19 and 5.9% (IQR: 0%C12.1%) for non\COVID\19 in sVNT (p?0.001) (Physique?1C). In the ROC curve analysis, the area under the.