Conventional semen analysis has limited diagnostic value for male infertility and poor predictive value for assisted reproductive technology (ART) success. Our ISO-accredited Sperm DNA Fragmentation (SDF) tests go beyond basic metrics to uncover the root cause of male infertility and failed fertility treatments.
Exact® and Extend® are powered by our SpermComet® assay, which applies a highly sensitive technique called single-cell gel electrophoresis. This method gently unwinds the tightly packed DNA within each sperm cell so that any DNA fragmentation present can be directly measured.
The Fertility Diagnostic
Exact® – when TTC is proving difficult
The Exact test is a diagnostic test measuring Total sperm DNA fragmentation damage, which includes both single- and double-strand DNA breaks (ssDB and dsDB).
With an AUC of 0.930 for fertility, our Exact test is powered by the alkaline comet assay, which provides the best discriminatory ability commercially available compared to other SDF tests. Detailed reports provide insights into total SDF damage to provide clinicians and their patients with key information for the next steps they can consider in their fertility journey.
Key Clinical Applications
- Diagnose infertility: Identify hidden sperm DNA fragmentation damage in men, especially if they have a normal semen analysis.
- Helping to “explain the unexplained“: SDF damage can help to explain why patients have been having difficulty TTC.
The Recurrent Miscarriage & IVF Prediction Specialist
Extend® – when miscarriage or ART failure is present
The Extend test is a specialised diagnostic test that exclusively measures double-strand DNA breaks (dsDB), which are associated with miscarriage and ART failure.
With an AUC of 0.876 for miscarriage and an AUC of 0.919 for fertility, Extend, powered by the neutral comet assay, provides highly accurate insights into dsDB damage. This helps clinicians and their patients make more informed decisions about their fertility and their treatment options.
Key Clinical Applications
- Recurrent miscarriage: Our published research shows high levels of dsDBs are associated with repeated pregnancy loss (RPL), highlighting the male factor contribution to RPL.
- Predicting IVF Live Birth Outcome: Our research shows that higher dsDB levels are linked to lower IVF live birth outcomes, highlighting the male factor contribution to successful IVF live birth outcomes.
Specialised Exact® and Extend® SDF Tests for special sample types
- ExactPrep / ExtendPrep: for all prepared ejaculate sperm samples, including those processed using methods such as density gradient, centrifuge, Zymot and microfluidic plates
- ExactSSR: a specialised variant for samples obtained via surgical sperm retrieval methods such as TESA, PESA, MESA, TESE, and micro-TESE
Detailed Test Specifications and Summaries
| Exact Tests (Total SDF damage) | |||
|---|---|---|---|
| Exact | ExactPrep | ExactSSR | |
| Measures | Total SDF damage (single and double strand breaks) | ||
| Used for | Sperm concentrations above 0.1M/ml | Prepared ejaculate samples (e.g. prepared for ICSI, ZyMot, DG, nMx, etc.) | Surgically retrieved sperm samples (using TESA, PESA, MESA, TESE, and micro-TESE) |
| Extend Tests (Double-Strand SDF damage) | ||
|---|---|---|
| Extend | ExtendPrep | |
| Measures | Double-strand DNA breaks (dsDB) damage | |
| Used for | Sperm concentrations above 0.1M/ml | Prepared ejaculate samples (e.g. prepared for ICSI, ZyMot, DG, nMx, etc.) |
| Test Packages (Exact® + Extend®) | ||
|---|---|---|
| Extensiv | ExtensivPrep | |
| Measures | Total SDF and dsDB damage | |
| Used for | Sperm concentrations above 0.1M/ml | Prepared ejaculate samples (e.g. prepared for ICSI, ZyMot, DG, nMx, etc.) |