Viral Hepatitis Laboratory, Oswaldo Cruz Institute FIOCRUZ, Rio de Janeiro, Brazil.
J Oral Pathol Med. 2012 Nov;41(10):793-800. doi: 10.1111/j.1600-0714.2012.01176.x. Epub 2012 Jun 13.
Saliva samples can be used as an alternative fluid for against hepatitis C virus (anti-HCV) detection owing to the ease of collection and excellent acceptability. This study was conducted to optimize a commercial enzyme immunoassay (EIA) to detect anti-HCV in saliva samples.
Ninety-six individuals donated paired serum and saliva samples that were obtained, using a commercial device (Salivette) and spitting into a sterile container. Initially, elution buffer for the Salivette samples, sample volume, incubation time and temperature, and two different anti-HCV EIAs were evaluated. Using the optimized assay, three methods for cut-off calculation were also evaluated.
A 20-fold increase in the sample volume for both collection methods was needed. Moreover, the Radim assay was the most appropriate assay for anti-HCV detection in saliva samples, and the quality parameters were increased when a ROC curve was used to determine the cut-off value. Using this optimized assay, the sensitivities, specificities, accuracies, positive and negative predictive values were above 90% for saliva obtained using both the Salivette and spitting methods. Using this assay, discordant false-negative results were obtained for only two Salivette samples and five spitting samples. The concordance kappa was 93% for the Salivette method and 86.1% for the spitting method, demonstrating excellent performance.
Saliva samples obtained for both methods can be employed for anti-HCV detection among HCV-infected or HCV-suspected cases, but several modifications must be performed on commercial EIAs to obtain good results. Moreover, samples obtained with commercial devices are more appropriate for anti-HCV detection in saliva samples.
由于唾液样本易于采集且具有良好的可接受性，因此可以作为替代体液用于检测丙型肝炎病毒（抗-HCV）。本研究旨在优化一种商业酶免疫分析（EIA），以检测唾液样本中的抗-HCV。
96 名个体捐献了配对的血清和唾液样本，使用商业设备（Salivette）和无菌容器中的唾液采集器采集。最初，评估了 Salivette 样本的洗脱缓冲液、样本体积、孵育时间和温度以及两种不同的抗-HCV EIA。使用优化的检测方法，还评估了三种计算截止值的方法。
两种采集方法的样本体积都需要增加 20 倍。此外，Radim 检测法是检测唾液样本中抗-HCV 的最适宜检测法，使用 ROC 曲线确定截止值可提高质量参数。使用这种优化的检测方法，Salivette 和唾液采集法获得的唾液样本的灵敏度、特异性、准确性、阳性预测值和阴性预测值均超过 90%。使用该检测法，仅获得了两个 Salivette 样本和五个唾液采集样本的假阴性结果不一致。Salivette 方法的一致性kappa 值为 93%，唾液采集方法的一致性kappa 值为 86.1%，表明性能良好。
可以使用两种方法获得的唾液样本来检测 HCV 感染或疑似 HCV 病例中的抗-HCV，但必须对商业 EIA 进行多项修改才能获得良好的结果。此外，商业设备获得的样本更适合用于唾液样本中的抗-HCV 检测。
