The Exact® test’s function is to measure the level of DNA fragmentation in a sperm sample. It measures both single strand DNA breaks (ssDB) and double strand DNA breaks (dsDB). The Exact® test establishes if the level of DNA fragmentation in sperm cells suggests infertility in a male patient. In addition, the test can be used to predict In Vitro Fertilisation (IVF) outcome by solely evaluating the male contribution and can establish if a male patient’s DNA fragmentation profile matches the DNA fragmentation profile of other males known to have past idiopathic miscarriages.
The Extend® test is similar to the Exact® in that it measures the level of DNA fragmentation in a sperm sample. However, unlike our Exact® test, which measures both single strand DNA breaks (ssDB) and double strand DNA breaks (dsDB), Extend® exclusively measures dsDB. dsDB in sperm cell DNA are more challenging to repair and often indicate deeper issues with spermatogenesis.
The Extend® test is recommended:
With unrivalled accuracy (AUC 0.932), Extend® offers valuable insights into dsDB damage to help clinicians and their patients make more informed decisions about their fertility journey options.
Semen analysis helps detect some of the male issues that prevent couples conceiving naturally and is the first step taken by men checking their fertility.
Semen is the fluid released during ejaculation that contains sperm along with proteins, sugars, vitamins, and minerals that nourish sperm on their journey to reach the egg. By evaluating semen, we measure the number of sperm (sperm count), sperm motility and sperm morphology – all of which influence fertility.
A summary of the tests and test bundles is provided below:
| Exact® Test | Extend® Test | Semen Analysis | |
|---|---|---|---|
| Special Precautions-Abstinence period | Abstain from ejaculating for a minimum of 48 hours and for a maximum of 7 days (unless explicitly advised otherwise by your clinician) | Abstain from ejaculating for a minimum of 48 hours and for a maximum of 7 days (unless explicitly advised otherwise by your clinician) | Abstain from ejaculating for a minimum of 48 hours and for a maximum of 7 days |
| Turnaround Times | 10 working days from receipt of the sample and a completed TRF at Examen’s laboratory | 10 working days from receipt of the sample and a completed TRF at Examen’s laboratory | 10 working days from receipt of the sample and a completed TRF at Examen’s laboratory |
| Biological Reference Intervals | Fertile Population Average DNA Fragmentation: ≤25.35% | Fertile Population Average Double Strand DNA Fragmentation: ≤4.30% | WHO 6th edition, 2021 (Lower Reference Value): Sperm concentration: ≥16M/mL, Progressive Motility: ≥30%, Morphology (Normal forms): ≥ 4%, Seminal Volume: ≥1.4, Total Sperm count: ≥39M, Total Motility: ≥42%, pH: ≥7.2 |
| Clinical Decision Values | Typical Fertile man: ≤31% Men who have experienced successful Live Birth following IVF: ≤29% Men whose partner has experienced Sporadic/Recurrent miscarriage: ≥29% | Typical Fertile man: ≤6% | NA |
| Sample acceptance criteria | We require a fully completed and signed TRF per test – without this the sample cannot be tested and will be rejected. A sample will be rejected if; the volume is too low (less than 100μl); it has been compromised during transport; it was improperly collected e.g. not all the sample was collected; it is from an unacceptable source/type. | We require a fully completed and signed TRF per test – without this the sample cannot be tested and will be rejected. A sample will be rejected if; the volume is too low (less than 100μl); it has been compromised during transport; it was improperly collected e.g. not all the sample was collected; it is from an unacceptable source/type. | We require a fully completed and signed TRF per test – without this the sample cannot be tested and will be rejected. A sample will be rejected if; the volume is too low (less than 100μl); it has been compromised during transport; it was improperly collected e.g. not all the sample was collected; it is from an unacceptable source/type. Samples requiring both Semen Analysis and Exact/Extend tests must be dropped off within 30 minutes of production to afford the time to correctly process the sample. Patients can avail of Examen’s production room if their journey to our Lab will take longer than 30 minutes. |
