Figure 2: Prevention of false-positive binding using LowCross-Buffer® in an ELISA against guinea-pig IgG. With the standard assay buffer (a), false positives in the specificity control (row A) and in the blank values (row H) spoiled the interpretations and evaluation. The use of LowCross-Buffer® (b) prevented all false-positive signals. Assay performed by Dr. C. Specht (PARA Bioscience GmbH (now vivo Science GmbH), Gronau, Germany)
Figure 3: Improving an RBD-based SARS-CoV-2 antibody ELISA using LowCross-Buffer. Comparison of negative samples (# 1-20; Ø is arithmetic mean of 1-20) LowCross protocol vs. the standard diluent PBS/Tween/BSA (PBS-T/BSA). Samples were analyzed either using the CANDOR solutions, including LowCross-Buffer, or a standard PBS-T/BSA protocol. The LowCross protocol allows for less average background, less sample-to-sample variation, a better signal-to-noise-ratio, and a better detection limit due to a decreased cut-off. (Samples provided by in.vent Diagnostica GmbH, Henningsdorf, Germany.)
结论
亲和力鉴别缓冲液具有处理多种不同干扰的潜力,而不需要关于其分子起源的详细信息。无需额外的处理步骤,提供了分析性能和可靠性。这些改进不仅在SARS-CoV-2免疫检测的高度关键性背景下至关重要,而且在根据欧盟体外诊断法规(IVDR)验证诊断试剂盒时,也将有助于节省时间和成本,该法规将于2022年5月全面生效。每种样品只需几美分的成本,亲和力鉴别稀释剂无论是在SARS-CoV-2流行病的背景下开发的研究,还是用于人类或兽医诊断、食品测试或生物分析的其他目的,都可以极大地促进免疫分析的改进。CANDOR保持所有产品的最高质量标准,这些产品在EN ISO 9001和EN ISO 13485认证的生产设施中“德国制造”。
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