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Reliability of the sperm chromatin dispersion assay to evaluate sperm deoxyribonucleic acid damage in men with infertility
Fertility and Sterility ( IF 6.7 ) Pub Date : 2021-09-20 , DOI: 10.1016/j.fertnstert.2021.08.045
Sandro C Esteves 1 , Carmen López-Fernández 2 , Mercedes González Martínez 3 , Ellen A Silva 4 , Jaime Gosálvez 2
Affiliation  

Objective

To investigate the intraindividual agreement of the sperm chromatin dispersion (SCD) assay results to assess sperm DNA fragmentation (SDF) in men with infertility.

Design

Diagnostic test reliability study.

Setting

Andrology laboratories.

Patient(s)

A total of 219 men with infertility.

Intervention(s)

Sperm DNA fragmentation assessment in two ejaculates of the same subjects within a 3-month interval, using the SCD assay performed and analyzed by the same observers under similar testing conditions.

Main Outcome Measure(s)

Cohen’s κ statistics to assess the degree of agreement between the pairs of results after converting the nominal SCD values into categorical data, that is, normal (<20%), intermediate (21%–29%), and high (≥30%) SDF rates. We also assessed the pairs of results using reliability measures for numerical variables (intraclass correlation coefficient for consistency using the two-way mixed-effects model and Bland–Altman plots).

Result(s)

The degree of agreement in classifying patients according to normal and pathological SDF classes was overall substantial (κ = 0.632; 95% confidence interval [CI], 0.546–0.718).

A total of 76.7% of individuals were classified under the same class using paired ejaculates. The agreement rate was highest (approximately 80%) in ejaculates initially classified as either normal or high and lowest (approximately 60%) among those with intermediate SDF levels. The frequency of intermediate SDF ejaculates downgraded to normal or upgrade to high SDF classes in the second test was similar (approximately 20%). The intraclass correlation coefficient was 0.856 (95% CI, 0.812–0.887), and the mean difference between the pairs of observations was 0.80% (95% CI, −0.72 to 2.23), indicating no systematic difference between paired observations.

Conclusion(s)

Our study indicates a substantial intraindividual agreement of paired SCD assay results to classify men with infertility into three SDF categories: normal, intermediate, and high. The reliability of the SCD assay was adequate and exceeded 0.80 using two ejaculates analyzed within a 3-month interval under similar conditions. Although this evidence overall supports a single SCD test for patient classification using predefined SDF thresholds, particularly when the first test shows normal or high SDF levels, one in four men will have discordant values in paired ejaculates. Clinicians should be judicious when using SDF test results in decision-making.



中文翻译:

精子染色质分散试验评估男性不育症精子脱氧核糖核酸损伤的可靠性

客观的

研究精子染色质分散 (SCD) 测定结果的个体内一致性,以评估男性不育症的精子 DNA 片段化 (SDF)。

设计

诊断测试可靠性研究。

环境

男科实验室。

耐心)

共有219名男性不育。

干预措施

使用由相同观察者在相似测试条件下进行和分析的 SCD 分析,在 3 个月的间隔内对相同受试者的两次射精进行精子 DNA 片段化评估。

主要观察指标)

Cohen 的 κ 统计量用于评估将标称 SCD 值转换为分类数据后结果对之间的一致性程度,即正常 (<20%)、中间 (21%–29%) 和高 (≥30%) SDF 费率。我们还使用数值变量的可靠性度量(使用双向混合效应模型和 Bland-Altman 图的一致性的组内相关系数)评估了结果对。

结果)

根据正常和病理 SDF 等级对患者进行分类的一致性程度总体上相当大(κ = 0.632;95% 置信区间 [CI],0.546-0.718)。

使用配对射精,共有 76.7% 的个体被归为同一类。在最初归类为正常或高水平的射精中,一致性率最高(约 80%),而在中等 SDF 水平的射精中一致性率最低(约 60%)。在第二次测试中,中等 SDF 射精降级至正常或升级至高 SDF 等级的频率相似(约 20%)。组内相关系数为 0.856(95% CI,0.812-0.887),成对观察之间的平均差异为 0.80%(95% CI,-0.72 至 2.23),表明成对观察之间没有系统差异。

结论

我们的研究表明,配对的 SCD 检测结果在个体内有很大的一致性,将不育男性分为三个 SDF 类别:正常、中度和高度。SCD 测定的可靠性是足够的,并且在类似条件下使用 3 个月间隔内分析的两次射精超过 0.80。尽管该证据总体支持使用预定义的 SDF 阈值对患者分类进行单一 SCD 测试,特别是当第一次测试显示正常或高 SDF 水平时,四分之一的男性在配对射精中会有不一致的值。临床医生在决策中使用 SDF 测试结果时应谨慎。

更新日期:2021-09-20
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