Cellular Pathology - Andrology

Andrology

The laboratory's priority is to provide a comprehensive semen analysis service for Consultants, Urologists and General Practitioners from the Birmingham and Solihull area. This includes semen analysis (Diagnostic Semen Analysis), post-operative analysis of semen following a vasectomy operation (Post Vasectomy Semen Analysis) and Retrograde analysis of urine.

The laboratory operates on a clinic based service and has a maximum capacity of 2000 appointments available per annum. This covers the annual workload of routine diagnostic semen analysis, post-vasectomy samples and retrograde ejaculation analysis. Routinely patients will be given an appointment to attend the Andrology Department for on-site sample production in a designated private clinic room, however in exceptional circumstances samples may be produced off site if then able to be delivered to the laboratory within an appropriate time interval. 

The UHB Andrology Laboratory has fully trained scientists who are highly proficient in performing quality diagnostic semen analysis in line with World Health Organisation (2021) and the 2016 Laboratory Guidelines for post vasectomy semen analysis. The laboratory regularly performs internal quality control, participates in the UK National External Quality Assurance Reproductive scheme for Andrology (UKNEQAS) and liaises with other accredited laboratories for comparison of tests not covered within the UKNEQAS scope.

A laboratory referral can be made via:

Paper copy referral forms sent to Appointment Centre via post/e-mail

Electronic Referral Service (e-RS) with an attached referral form 

A copy of the referral form can be obtained by;

Contacting the laboratory directly on 0121 424 9717 Or by downloading from here Andrology Referral Form Or by GP’s accessing the word version at: https://www.uhb.nhs.uk/gps/referrals/andrology.htm

Off-site production can be arranged by the patient by telephoning the laboratory on 0121 424 9717 or by e-mailing This email address is being protected from spambots. You need JavaScript enabled to view it. (if you e-mail you are accepting that the connection is not secure and potentially not confidential – laboratory staff will minimise data transmission but cannot guarantee security). Please note that retrograde urine production must be on-site at Good Hope Hospital.

 Turnaround Time: 7-10 days (electronic reporting may be more rapid). Paper copies sent out following result authorisation.

Anti-sperm antibodies (ASAB) are not tested at this laboratory. Agglutination is described if noted.

Please see user handbook for additional information including contact details.

Accreditation information can be found under Cellular Pathology (UKAS 10141): https://www.ukas.com/download-schedule/10141/Medical/

 Post-vasectomy Semen Analysis (PVSA)

The laboratory undertakes examination procedures in line with the following guidelines: 2016 PVSA Guidelines. This will give clinicians information regarding clearance criteria. 

 Results are available to Hospital clinicians via PICS, Clinical Portal, and ICE.

 GP’s can access patient results through their own electronic result systems.

 Key details of the service:

Operates Monday to Friday 08:00am to 16:00pm
Undertakes Diagnostic semen analysis, Post vasectomy semen analysis and Retrograde examination (urine)
Appointment based with on-site private room for sample production
7-10 day turnaround time (electronic and paper copy reporting)
Patients are booked within 7 weeks from referral, unless clinically indicated or by patient choice
The User Handbook can be accessed here: Andrology User Handbook
 

Andrology - Measurement Uncertainty

Following on from our recent UKAS assessment, we were advised that we need to demonstrate that the clinical impact of the Measurement of Uncertainty on clinical decision values has been assessed and considered in relation to patient outcome. This must include an explanation of any effects this could have to the decision limits and how they should be interpreted.

 

Application of the CV to the clinical relevance of Diagnostic Semen Analysis (DSA)

The Coefficient of Variation (CV) was calculated for each parameter for DSA and used as the measurement of uncertainty associated with each parameter. Each parameter’s CV is as follows:

Parameter	CV
Motility	7.32
Concentration	8.89
Morphology	17.02
Vitality	2.31

 The uncertainty is calculated by dividing the analysis result by 100 and multiplying by the associated CV. The range is calculated by +/- the uncertainty from the result.

 The uncertainty could influence the fertility pathway for patients who have received results close to the clinical decision values for each specific parameter. Examples include:

Motility – Uncertainty = 2.2%

This informs us that if the laboratory reports a motility result of 30% then it will have a range of 30% ± 2.2 (27.8 – 32.2%).

Concentration – Uncertainty = 1.4 x 10⁶/ml

This informs us that if the laboratory reports a concentration result of 16 x 10⁶/ml then it will have a range of 16 x 10⁶/ml ± 1.4 (14.6 – 17.4 x 10⁶/ml).

Morphology – Uncertainty = 0.7%

This informs us that if the laboratory reports a morphology result of 4% then it will have a range of 4% ± 0.7 (3.3 – 4.7%).

Vitality – Uncertainty = 1.2%

This informs us that if the laboratory reports a vitality result of 54% then it will have a range of 54% ± 1.2 (52.8 – 55.2%).

Clinical impact of measurement of uncertainty will be communicated to users with annual website updates. Internal users of the service will be emailed directly (fertility and urology).

 

 

Clinical Impact of Measurement Uncertainty

Measurement uncertainty, either for one reported parameter or as a combination of multiple reported parameters could have a clinical impact. For example, if a concentration of 15 x 10⁶/ml is reported (oligozoospermia), given a UoM of 1.4 x 10⁶/ml, this sample could have a concentration of 16 x 10⁶/ml (normozoospermia).

For some users, a diagnosis of oligozoospermia, even at the borderline level of 15 x 10⁶/ml, could lead to the recommendation of an assisted reproductive technology such as intracytoplasmic sperm injection (ICSI) to promote the chance of fertilisation, when conventional IVF, or even natural conception, might be possible. 

We inform our users of this uncertainty and emphasize that the reports can be used to guide clinicians to determine how to proceed with further investigation and management of a subfertile couple. We stress that all reported parameters should be considered holistically.

Furthermore, as per WHO 2021 guidance, we inform users that many known and unknown female factors hamper the value of using only semen examination parameters to predict the prognosis for the couple of spontaneous or assisted fertilization.

The decision limits that we provide on our reports are derived from WHO 2021 and are derived from data characterizing the semen characteristics of a reference population (men whose partners had a time to pregnancy of 12 months or less). The data uses a diverse international populations, noting that the percentiles used do not represent distinct limits between fertile and subfertile men.

We highlight that a semen analysis is never prognostic of fertility, as it is the fertility potential of the couple that defines them as fertile or subfertile.