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Cited by 2Sperm and Testicular FunctionClinical Laboratory Practices and Quality ControlMale Reproductive Health Studies

Good practice in laboratory diagnostic andrology: Association of Reproductive and Clinical Scientists guidelines 2024

Open access
Gallagher, Meurig T., Roxburgh, Emily, Bennett, Gwen, Parker, Susan, Kirkman-Brown, Jackson C., Association of Reproductive and Clinical Scientists·2024·Reproductive BioMedicine Online
DOI 10.1016/j.rbmo.2024.104373
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Abstract

These guidelines update and clarify items relating to diagnostic andrology in the 2012 Association of Biomedical Andrologists Laboratory Andrology Guidelines for Good Practice Version 3. The main change separates diagnostic and therapeutic andrology into individual documents; post-vasectomy semen analysis still references the 2016 guideline. These guidelines seek to incorporate and clarify internationally agreed methodology following the World Health Organization Laboratory Manual for the Examination and Processing of Human Semen 6th edition and publication of ISO 23162:2021. Significant updates include: requiring four-category grading for motility (A, rapidly progressive; B, slowly progressive; C, non-progressive; D, immotile); a four-part morphology assessment (head, midpiece, tail, cytoplasmic droplets) as essential for quality assurance (even if only the percentage of 'normal' is reported); and specifying sperm toxicity testing procedures for diagnostic andrology. These guidelines include a section on haematospermia, an observation requiring rapid onward referral. An Association of Reproductive and Clinical Scientists (ARCS) working group wrote these guidelines, with review by ARCS members. The aim is to guide good practice in laboratories but they are not intended as a tool to judge the practice of centres within the UK or beyond.

AI snapshot

Written from the paper’s full text.

TL;DR

These 2024 Association of Reproductive and Clinical Scientists (ARCS) guidelines update the diagnostic andrology sections of the 2012 Association of Biomedical Andrologists guidelines, separating diagnostic from therapeutic andrology and aligning practice with the WHO 2021 semen manual (6th edition) and ISO 23162:2021. They set out requirements across personnel, premises, equipment, pre-analytical, analytical, post-analytical and quality assurance processes, including a new section on haematospermia.

Key findings

  • Motility must be graded in four categories (A, rapidly progressive; B, slowly progressive; C, non-progressive; D, immotile), and morphology must be scored as a four-part assessment (head, midpiece, tail, cytoplasmic droplets) as essential for quality assurance, even if only the percentage of "normal" is reported.
  • Sperm toxicity testing must use the precise container/consumable–analyte combination (e.g. raw semen, not prepared spermatozoa), with motility compared between control and test containers at baseline and 4 h across five separate ejaculates using a paired statistical test; P > 0.05 indicates non-toxicity.
  • Vitality testing (eosin–nigrosin or hypo-osmotic swelling) is required when total motility is <40%; time-dependent measures (pH, motility, vitality, agglutination) should be completed within 60 min of sample production, and concentration dilutions made within 60 min with assessment ideally within 3 h.
  • Haematospermia always requires further investigation, with men over 40 at particularly increased risk of serious underlying cause; reports should be referred to the GP/primary care doctor within 2 working days to allow rapid referral through the 2-week suspected cancer pathway.
  • Workforce guidance suggests 1000 specimens per annum per individual may be more reasonable than the historically suggested 1.0 whole-time equivalent per 1500 specimens, with increases possible where automation is in place.

Methods

  • Guideline development: an ARCS working group wrote the guidelines, with review by ARCS members; evidence is provided where relevant and possible, otherwise a consensus and pragmatic ARCS view is given.
  • Sources: current legislation, the WHO laboratory manual for the examination and processing of human semen (6th edition, 2021), ISO 15189 and ISO 23162, experts in clinical and laboratory diagnostic andrology, and professionals in associated disciplines.
  • Scope: diagnostic andrology laboratories; post-vasectomy semen analysis continues to reference the 2016 guideline, and donor banking/cryostorage are deferred to separate documents. The paper states "No data was used for the research described in the article."

Limitations

  • Stated: the guidelines "are not intended as a tool to judge the practice of centres within the UK or beyond"; where evidence is unavailable, recommendations rest on ARCS consensus and pragmatic judgement rather than empirical evidence.
  • Stated: existing guidelines on post-vasectomy semen analysis and uncertainty measurement are maintained rather than revised here, and matters relating to donor banking and cryostorage are excluded.
  • Evident from the text: this is a normative guidance document with no primary data, no sample, and no outcome measures, so no effect sizes or comparative results are reported.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1016/j.rbmo.2024.104373

Cites

6 of 6 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

1 of 13 cited sources checked · 0 supported · 0 flagged · accuracy not yet measured

  • Premisecitation
    § Introduction

    The development of ISO 23162 gives de facto references for the basic examination of human semen, with wide international consensus.

    “The development of ISO 23162 gives de facto references for the basic examination of human semen, with wide international consensus (Björndahl et al., 2022”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites Björndahl et al., 2022 source

      The 'Appeal to the scientific society involved in Andrology and Reproductive Medicine' section (page unavailable) says that publication of ISO 23162 gives the field de facto reference methods for basic human semen examination. The Abstract (page unavailable) calls ISO 23162 and the WHO manual concordant documents, but the paper does not establish the claimed wide international consensus. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
  • Premisecitation
    § C. Equipment, information systems and materials

    Sperm progressive motility is a strong predictor of fertility outcome.

    “There is clinical evidence supporting sperm progressive motility being a strong predictor of fertility outcome (Barratt et al., 2011”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Barratt et al., 2011 source
  • Premisecitation
    § C. Equipment, information systems and materials

    Men older than 40 years with haematospermia are at particularly increased risk of a serious underlying cause.

    “men older than 40 years are at particularly increased risk of a serious underlying cause”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Haematospermia 2022

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Premisecitation
    § C. Equipment, information systems and materials

    Haematospermia always requires further investigation.

    “This condition always requires further investigation”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Haematospermia 2022

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Premisecitation
    § C. Equipment, information systems and materials

    Methods where the semen sample cannot be assessed within 60 min of ejaculation cannot be used to make accurate diagnostic presumptions allied to the WHO 2021 reference ranges.

    “ARCS highlights that methods where the semen sample cannot be assessed within 60 min of ejaculation cannot be used to make accurate diagnostic presumptions allied to the WHO 2021”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites World Health Organization, 2021

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Classified as probably not a substantial claim. 10

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § Introduction

    The HFE Act does not itself regulate diagnostic andrology.

    “noting that the HFE Act does not itself regulate diagnostic andrology.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Human Fertilisation and Embryology Act, 2008

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § Introduction

    The overarching accreditation standard for medical laboratories is ISO 15189.

    “The overarching accreditation standard for medical laboratories is ISO 15189 (International Organization for Standardization (ISO), 2022”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites International Organization for Standardization (ISO), 2022

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § C. Equipment, information systems and materials

    There is always a degree of error or uncertainty associated with any laboratory measurement of biological processes.

    “There is always a degree of error or uncertainty associated with any laboratory measurement of biological processes; see the best practice guideline on uncertainty (Sanders et al., 2017”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Sanders et al., 2017 source

  • Classified as probably not a substantial claim.

    Premisecitation
    § Introduction

    Toxicity testing must involve exposure to the relevant analyte (e.g., raw semen) and not a different material (e.g., prepared spermatozoa) where a different reaction and response could be observed.

    “toxicity testing must involve exposure to the relevant analyte (e.g. raw semen) and not a different material (e.g. prepared spermatozoa) where a different reaction and response could be observed”
    • Also stated in: § C. Equipment, information systems and materials · plain
      “It is essential that any toxicity testing involves the precise combination of container/consumable and analyte. For example, sperm collection containers must be tested with raw semen and not prepared spermatozoa, where the media could alter or buffer any observed effects”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites World Health Organization, 2021

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § C. Equipment, information systems and materials

    The WHO 2021 manual does not suggest anti-sperm antibody testing or identification of leukocytes as part of a basic semen analysis.

    “does not suggest anti-sperm antibody testing or identification of leukocytes as part of a basic semen analysis.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites World Health Organization, 2021

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S4 (based).

    Interpretationnone given
    § C. Equipment, information systems and materials

    Taking information that will not be included on the report form confounds clinical interpretation.

    “Centres should never take information that they are not going to include on the report form as this confounds clinical interpretation”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

    Interpretationnone given
    § Introduction

    Failure to comply with these methodologies risks undermining the accuracy and relevance of any result for patient diagnosis.

    “Failure to comply with these methodologies risks undermining the accuracy and relevance of any result for patient diagnosis.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Interpretationreasoning
    § C. Equipment, information systems and materials

    Failure to not communicate motility or morphology results that fall beneath the normal reference range alongside WHO 2021 ranges when diagnostic laboratories cannot assess samples within 1 h may result in clinical misinterpretation of evidence.

    “Failure to do this may result in clinical misinterpretation of evidence.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisenone given
    § Introduction

    All laboratories are obliged to comply with other legislation such as the Health and Safety at Work Act 1974, COSHH Regulations 2022, and the HFE Act 2008.

    “All laboratories are obliged to comply with other legislation such as the following: the Health and Safety at Work Act 1974”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites Health and Safety at Work Act 1974

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites Control of Substances Hazardous to Health (COSHH) regulations, 2002

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites Human Fertilisation and Embryology Act, 2008

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationnone given
    § Introduction

    Basic semen analysis may find other observations that are critical to patient care beyond a question of fertility.

    “basic semen analysis may find other observations that are critical to patient care beyond a question of fertility, as for example in the new section on haematospermia”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Haematospermia is an observation requiring rapid onward referral.
10 of 10

  • The paper relies on this without support.

    Haematospermia is an observation requiring rapid onward referral.

    “These guidelines include a section on haematospermia, an observation requiring rapid onward referral.”

  • The paper relies on this without support.

    CE marking of low-risk products does not indicate that sperm toxicity testing has been carried out.

    “Centres should be aware of the limitations of CE marking of low-risk products, as this does not indicate that sperm toxicity testing has been carried out.”

  • The paper relies on this without support.

    Four-category sperm morphology scoring minimizes inter-operator variability in the laboratory and is essential for correct quality assurance.

    “This ensures minimization of inter-operator variability in the laboratory and is essential for correct quality assurance.”

  • The paper relies on this without support.

    Sperm preparation methods are not necessary for basic semen analysis.

    “While sperm preparation methods are not necessary for basic semen analysis, there are specific diagnostic tests that may benefit from preparation.”

  • The paper relies on this without support.

    Specific diagnostic tests may benefit from sperm preparation.

    “While sperm preparation methods are not necessary for basic semen analysis, there are specific diagnostic tests that may benefit from preparation.”

  • The paper relies on this without support.

    Most centres issue several report types.

    “Most centres issue several report types.”

  • The paper relies on this without support.

    Expert fertility clinicians may require a low level of comment, summary and interpretation of the report, yet a much higher level may be required by others.

    “Expert fertility clinicians may require a low level of comment, summary and interpretation of the report, yet a much higher level may be required by others (e.g. a general practitioner, an oncologist, a urologist or a subject).”

  • The paper relies on this without support.

    Statistically discerning between 3% and 5% typical forms in a morphology analysis requires approximately 1500 spermatozoa to be assessed.

    “statistically discerning between results of 3% and 5% typical forms in a morphology analysis requires approximately 1500 spermatozoa to be assessed”
8 of 8

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • COSHH regulation year differs from the cited reference

    Minor

    The text calls these the 2022 COSHH Regulations, but its cited reference identifies the regulations as 2002.

  • Vitality testing points to the morphology section

    Minor

    E1.1 directs readers to E1.10 for vitality testing, but E1.10 concerns sperm morphology. Vitality testing is described in E1.9.

2 of 2

Cites

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Related

Authors
Gallagher, M. T., Roxburgh, E., Bennett, G., Parker, S., Kirkman-Brown, J. C., & Association of Reproductive and Clinical Scientists
Affiliations
  • University of Birmingham (GB)
  • Betsi Cadwaladr University Health Board (GB)
  • Pilgrim Hospital (GB)
ORCID
Venue
Reproductive BioMedicine Online
Publisher
Elsevier BV
Published
2024-12
Volume
49
Issue
6
Pages
104373
ISSN
1472-6483 (ISSN-L)
DOI
10.1016/j.rbmo.2024.104373
OpenAlex
W4400618379
Cited by
2
References
6
Citations by year
2026: 1 · 2025: 1
FWCI
0.66
Type
journal article
Language
en
Open access
Licence
Locations
  • Reproductive BioMedicine Online (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • University of Birmingham Research Portal (University of Birmingham) (publishedVersion, cc-by)
Topics
  • Health Sciences › Medicine › Reproductive Medicine › Sperm and Testicular Function
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Health Professions › General Health Professions › Male Reproductive Health Studies
Keywords
semen analysis, sperm morphology assessment, post-vasectomy semen analysis, hematospermia, quality assurance
MeSH terms
Humans, Male, Andrology, Semen Analysis

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Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-26.

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