Department of Mechanical and Industrial Engineering, University of Toronto, Toronto, Ontario, Canada;
Urology Research Laboratory, Department of Surgery, McGill University and Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.
Clin Chem. 2016 Mar;62(3):458-65. doi: 10.1373/clinchem.2015.250282. Epub 2016 Jan 8.
More than 70 million couples worldwide are affected by infertility, with male-factor infertility accounting for about half of the cases. Semen analysis is critical for determining male fertility potential, but conventional testing is costly and complex. Here, we demonstrate a paper-based microfluidic approach to quantify male fertility potential, simultaneously measuring 3 critical semen parameters in 10 min: live and motile sperm concentrations and sperm motility.
The device measures the colorimetric change of yellow tetrazolium dye to purple formazan by the diaphorase flavoprotein enzyme present in metabolically active human sperm to quantify live and motile sperm concentration. Sperm motility was determined as the ratio of motile to live sperm. We assessed the performance of the device by use of clinical semen samples, in parallel with standard clinical approaches.
Detection limits of 8.46 and 15.18 million/mL were achieved for live and motile sperm concentrations, respectively. The live and motile sperm concentrations and motility values from our device correlated with those of the standard clinical approaches (R(2) ≥ 0.84). In all cases, our device provided 100% agreement in terms of clinical outcome. The device was also robust and could tolerate conditions of high absolute humidity (22.8 g/m(3)) up to 16 weeks when packaged with desiccant.
Our device outperforms existing commercial paper-based assays by quantitatively measuring live and motile sperm concentrations and motility, in only 10 min. This approach is applicable to current clinical practices as well as self-diagnostic applications.
全世界有超过 7000 万对夫妇受到不孕不育的影响，其中男性因素导致的不孕不育约占一半。精液分析对于确定男性生育能力至关重要，但传统的检测既昂贵又复杂。在这里，我们展示了一种基于纸张的微流控方法，用于定量男性生育能力，同时在 10 分钟内测量 3 个关键的精液参数：活精子和运动精子浓度以及精子活力。
该设备通过存在于代谢活跃的人类精子中的黄四唑染料还原酶将黄色四唑染料转化为紫色甲臜，从而测量活精子和运动精子浓度的比色变化。精子活力通过运动精子与活精子的比例来确定。我们使用临床精液样本与标准临床方法并行评估了该设备的性能。
分别实现了活精子和运动精子浓度的检测下限 846 万/mL 和 1518 万/mL。该设备的活精子和运动精子浓度以及活力值与标准临床方法高度相关（R²≥0.84）。在所有情况下，该设备在临床结果方面均达到 100%的一致性。该设备还具有鲁棒性，在与干燥剂包装在一起时，可在高达 16 周的时间内耐受高绝对湿度（22.8 g/m³）的条件。
我们的设备通过在 10 分钟内定量测量活精子和运动精子浓度以及活力，在性能上优于现有的商业基于纸张的检测方法。这种方法既适用于当前的临床实践，也适用于自我诊断应用。
