Rodríguez Domínguez Maria Carla, Montes-de-Oca-Jiménez Roberto, Vázquez Chagoyan Juan Carlos, Pliego Alberto Barbabosa, Varela Guerrero Jorge Antonio, Coroas González Laura Ileana, Bernabé Salvador Lagunas
Viral and Bacterial Vaccines Producer Enterprise, LABIOFAM, Havana, Cuba.
Faculty of Veterinary Medicine and Zootechnics, Autonomy University of the State of Mexico, Toluca, Mexico.
J Equine Vet Sci. 2021 Mar;98:103372. doi: 10.1016/j.jevs.2021.103372. Epub 2021 Jan 6.
Equine infectious anemia is a worldwide distributed disease that affects the Equide family. Commercial effective vaccine is not available, for that reason control of the disease depends on diagnostic tools. To improve the efficiency of the diagnostic program in Cuba, LABIOFAM Group, developed an indirect enzyme-linked immunosorbent assay (ELISA), ELISA kit, to complement the diagnostic system that currently uses the agar gel immunodiffusion (AGID) kit. The ELISA AIE-LAB Kit was evaluated in a Mexican context, compared with the gold standard test Agar gel immunodiffusion, AGID AIE-LABIOFAM, and commercial AGID kit. The analytical sensitivity was determined using serial dilutions twofold of the positive control serum to establish the range of detected antibodies in relation to the cutoff value of the plate (OD 0.300). A precision study was carried out to evaluate repeatability, intermediate precision, and reproducibility by estimating the standard deviation and coefficient of variation. The precision results were satisfactory and the values of the coefficient of variation were considered adequate to guarantee an excellent consistency of the ELISA AIE-LAB. The diagnostic performance of the ELISA AIE-LAB involved the evaluation of specificity, sensitivity, and concordance in comparison with both AGID tests. The diagnostic sensitivity was 100% and the specificity 97.6%, with a very good degree of concordance (Kappa = 0.9). The results suggest that the ELISA AIE-LAB test could be used in Mexico as a diagnostic system for the detection of specific antibodies against the equine infectious anemia virus, as per current international norms.
马传染性贫血是一种在全球范围内传播的疾病，影响马科动物。目前尚无有效的商业疫苗，因此该疾病的控制依赖于诊断工具。为提高古巴诊断计划的效率，LABIOFAM集团开发了一种间接酶联免疫吸附测定（ELISA）试剂盒，以补充目前使用琼脂凝胶免疫扩散（AGID）试剂盒的诊断系统。在墨西哥的背景下，对ELISA AIE-LAB试剂盒进行了评估，并与金标准检测方法——琼脂凝胶免疫扩散（AGID AIE-LABIOFAM）和商业AGID试剂盒进行了比较。通过对阳性对照血清进行两倍系列稀释来确定分析灵敏度，以建立相对于酶标板临界值（OD 0.300）的检测抗体范围。通过估计标准差和变异系数进行了精密度研究，以评估重复性、中间精密度和再现性。精密度结果令人满意，变异系数值被认为足以保证ELISA AIE-LAB具有出色的一致性。ELISA AIE-LAB的诊断性能涉及与两种AGID检测方法相比，评估特异性、灵敏度和一致性。诊断灵敏度为100%，特异性为97.6%，一致性程度非常好（Kappa = 0.9）。结果表明，根据当前国际规范，ELISA AIE-LAB检测可在墨西哥用作检测抗马传染性贫血病毒特异性抗体的诊断系统。
