Laboratory testing for DNA fragmentation is now quicker and easier with the introduction of the QwikCheck® DFI Kit from Medical Electronic Systems (www.mes-global.com).
Sperm carry genetic material in the form of DNA, which plays a vital role in fertilization and subsequent fetal development. DNA damage in sperm cells has been associated with infertility and miscarriages, occurring in both natural conception and conception facilitated by assisted reproduction techniques (ART). DNA damage in sperm cells is typically observed as fragmentation of the DNA strands, often termed Sperm DNA Fragmentation (SDF) in a clinical context.
The Significance of Sperm DNA Fragmentation
Disturbances in the genetic material of sperm cells are commonly associated with sperm DNA fragmentation (SDF). The types of DNA fragmentation damage identified include a mismatch of bases, loss of base, base modifications, crosslinks, pyrimidine dimers, and single or double-strand breaks. All these alterations can reduce the chance of both natural conception and the success of ART.
Furthermore, besides reducing the likelihood of implantation, there is some evidence that SDF may be associated with miscarriage and recurrent pregnancy loss.
The presence of SDF has been shown to be higher in infertile men. In these cases, SDF may be triggered by extrinsic factors, such as smoking, heat exposure, environmental pollutants, or intrinsic factors, including oxidative stress and defective germ cell maturation. These factors may lead to defective processes during spermatogenesis.
With ART procedures like IVF and ICSI making pregnancy possible with even a small quantity of sperm, selecting healthy sperm could help improve outcomes for couples undergoing fertility treatment.
Identifying the presence of SDF as part of a comprehensive semen analysis may alert clinicians and providers to the possibility of a significant underlying pathology or an environmental factor. Addressing these laboratory findings can lead to clinical intervention that supports conception and increases the likelihood of healthy embryonic development.
The World Health Organization’s 6th Edition Manual for Semen Analysis emphasizes that investigating SDF could “represent an important addition in the work-up of male infertility, becoming one of the most promising biomarkers in basic and clinical andrology.”
Testing for DNA Fragmentation
DNA fragmentation, and its potential impact on fertility, can be assessed by evaluating how susceptible sperm DNA is to denaturation. Using a sperm chromatin dispersion (SCD) method, intact sperm chromatin will form dispersion Halos after exposure to a denaturant and then to a lysing solution.
The conventional methodology focuses on whether a Halo is present once the SCD method has been completed. The appearance of a medium/large Halo corresponds to relaxed, long, undamaged DNA loops, which are released once nuclear proteins are removed. Conversely, DNA breaks or fragmentation leaves the genetic material susceptible to denaturation, preventing dispersion and leading to a small or absent Halo.
Modern Classification of Halos
Recently, Halo classification has become more detailed. Current SCD methodology still seeks to identify the presence of a Halo but also assesses the Halo size and overall staining of the sperm cell core.
The World Health Organization’s 6th Edition Manual for Semen Analysis classifies sperm Halos based on the criteria produced by Fernandez et al.
- Large Halo – the Halo width is similar to, or larger than, the small diameter of the sperm cell core.
- Medium Halo – the Halo size is between those with large or small Halos.
- Small Halo – the Halo width is similar to, or smaller than, one-third of the minor diameter of the sperm cell core.
- Without Halo – no Halo can be seen.
- Without Halo-degraded – no Halo is seen, and the sperm cell core is stained irregularly or weakly. This indicates severe damage to the DNA and protein compounds.
Once the SCD process is complete, evaluating the Halos of at least 200 sperm is required to generate a DNA Fragmentation Index (DFI). DFI looks at the percentage of sperm in the sample with fragmented DNA to ascertain whether SDF levels are elevated across the semen sample. It is calculated by dividing the total number of small Halos, no Halo, and absent Halo-degraded sperm by the total number of cells counted, then multiplying by 100.
Elevated and severely elevated levels of DNA fragmentation (15-29.9% and ≥30% of sperm, respectively) indicate that fertility potential may be impacted. In these cases, treatment with ICSI may be recommended or required.
Medical Electronic Systems DFI Kit
Medical Electronic Systems, the worldwide leader in automated semen analysis for over 20 years, is pleased to introduce the new QwikCheck® DFI Kit. The kit uses the SCD method to ascertain DFI based on the traditional Halo vs. No-Halo classification or the new WHO 6th Edition 5-category standards.
The QwikCheck® DFI Kit makes it easier to quickly assess sperm fragmentation without compromising accuracy. It has been developed to simplify the slide preparation processes so that any laboratory can accurately report DFI to its providers and patients.
Each QwikCheck® DFI kit includes the necessary reagents to complete ten tests. Compared to traditional DFI analysis, which may take more than 50 minutes, results can be obtained in under 30 minutes using the QwikCheck® DFI kit. The test is both CE-registered and FDA Cleared.
Combining the Medical Electronic Systems SQA-Vision with QwikCheck® DFI Kit
Using the SQA-Vision Sperm Quality Analyzer combined with the QwikCheck® DFI kit makes the test more accurate, easier, and faster than alternative methods. The SQA-Vision system includes a DFI Counter that reports the five Halo categories defined in the WHO 6th Edition and provides a final DFI Score as part of a comprehensive semen analysis report.
Images and videos of the analysis can be saved, shared, and attached to the semen analysis report as needed. Test results will transfer automatically to most LIS and EMR systems, and both products are backed by Medical Electronic Systems’ world-class service and support.
DNA fragmentation is associated with infertility and possibly poorer outcomes in pregnancy. Assessing sperm DNA using the sperm chromatin dispersion method and then calculating the DNA Fragmentation Index can assist with clinical reporting and fertility treatment decisions.
The introduction of the QwikCheck® DFI Kit from Medical Electronic Systems makes it easier for laboratory technicians to assess DFI in line with WHO 6th Edition guidelines. With slide preparation simplified, DNA fragmentation results can quickly be generated using the SQA-Vision Automated Sperm Quality Analyzer or by traditional analysis under a microscope.
- The QwikCheck® DFI Kit uses the SCD method to ascertain DFI based on the traditional Halo vs. No-Halo classification or the new WHO 6th Edition 5-category classifications.
- Each QwikCheck® DFI kit includes the necessary reagents to complete ten tests and is priced competitively below competing products.
- The QwikCheck® DFI Kit makes it easier to quickly assess sperm fragmentation without compromising accuracy.
- Compared to traditional analysis, which may take more than 50 minutes, results can be obtained in 25 minutes using the QwikCheck® DFI kit.
- The Medical Electronic Systems SQA-Vision includes a semi-automated testing mode for rapid and accurate assessment of DNA Fragmentation.
- Using the SQA-Vision Sperm Quality Analyzer in combination with the QwikCheck® DFI kit makes the test more accurate, easier, and faster than alternative methods.
- Images and videos of the analysis can be saved, shared, and attached to the report.
- DFI results will automatically transfer from the SQA-Vision to most LIS and EMR systems.
- Addressing DNA fragmentation findings can lead to clinical intervention that supports conception and increases the likelihood of healthy embryonic development.