Systematic review and meta-analysis of within-subject and between-subject biological variation data of coagulation and fibrinolytic measurands
The diagnosis and monitoring of bleeding and thrombotic disorders depend on correct haemostatic measurements. The availability of high-quality biological variation (BV) data is important in this context. Many studies have reported BV data for these measurands, but results are varied. The present stu...
Gespeichert in:
| Veröffentlicht in: | Clinical chemistry and laboratory medicine Jg. 61; H. 8; S. 1470 |
|---|---|
| Hauptverfasser: | , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
| Veröffentlicht: |
Germany
26.07.2023
|
| Schlagworte: | |
| ISSN: | 1437-4331, 1437-4331 |
| Online-Zugang: | Weitere Angaben |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| Abstract | The diagnosis and monitoring of bleeding and thrombotic disorders depend on correct haemostatic measurements. The availability of high-quality biological variation (BV) data is important in this context. Many studies have reported BV data for these measurands, but results are varied. The present study aims to deliver global within-subject (CV
) and between-subject (CV
) BV estimates for haemostasis measurands by meta-analyses of eligible studies, by assessment with the Biological Variation Data Critical Appraisal Checklist (BIVAC).
Relevant BV studies were graded by the BIVAC. Weighted estimates for CV
and CV
were obtained via meta-analysis of the BV data derived from BIVAC-compliant studies (graded A-C; whereby A represents optimal study design) performed in healthy adults.
In 26 studies BV data were reported for 35 haemostasis measurands. For 9 measurands, only one eligible publication was identified and meta-analysis could not be performed. 74% of the publications were graded as BIVAC C. The CV
and CV
varied extensively between the haemostasis measurands. The highest estimates were observed for PAI-1 antigen (CV
48.6%; CV
59.8%) and activity (CV
34.9%; CV
90.2%), while the lowest were observed for activated protein C resistance ratio (CV
1.5%; CV
4.5%).
This study provides updated BV estimates of CV
and CV
with 95% confidence intervals for a wide range of haemostasis measurands. These estimates can be used to form the basis for analytical performance specifications for haemostasis tests used in the diagnostic work-up required in bleeding- and thrombosis events and for risk assessment. |
|---|---|
| AbstractList | The diagnosis and monitoring of bleeding and thrombotic disorders depend on correct haemostatic measurements. The availability of high-quality biological variation (BV) data is important in this context. Many studies have reported BV data for these measurands, but results are varied. The present study aims to deliver global within-subject (CVI) and between-subject (CVG) BV estimates for haemostasis measurands by meta-analyses of eligible studies, by assessment with the Biological Variation Data Critical Appraisal Checklist (BIVAC).OBJECTIVESThe diagnosis and monitoring of bleeding and thrombotic disorders depend on correct haemostatic measurements. The availability of high-quality biological variation (BV) data is important in this context. Many studies have reported BV data for these measurands, but results are varied. The present study aims to deliver global within-subject (CVI) and between-subject (CVG) BV estimates for haemostasis measurands by meta-analyses of eligible studies, by assessment with the Biological Variation Data Critical Appraisal Checklist (BIVAC).Relevant BV studies were graded by the BIVAC. Weighted estimates for CVI and CVG were obtained via meta-analysis of the BV data derived from BIVAC-compliant studies (graded A-C; whereby A represents optimal study design) performed in healthy adults.METHODSRelevant BV studies were graded by the BIVAC. Weighted estimates for CVI and CVG were obtained via meta-analysis of the BV data derived from BIVAC-compliant studies (graded A-C; whereby A represents optimal study design) performed in healthy adults.In 26 studies BV data were reported for 35 haemostasis measurands. For 9 measurands, only one eligible publication was identified and meta-analysis could not be performed. 74% of the publications were graded as BIVAC C. The CVI and CVG varied extensively between the haemostasis measurands. The highest estimates were observed for PAI-1 antigen (CVI 48.6%; CVG 59.8%) and activity (CVI 34.9%; CVG 90.2%), while the lowest were observed for activated protein C resistance ratio (CVI 1.5%; CVG 4.5%).RESULTSIn 26 studies BV data were reported for 35 haemostasis measurands. For 9 measurands, only one eligible publication was identified and meta-analysis could not be performed. 74% of the publications were graded as BIVAC C. The CVI and CVG varied extensively between the haemostasis measurands. The highest estimates were observed for PAI-1 antigen (CVI 48.6%; CVG 59.8%) and activity (CVI 34.9%; CVG 90.2%), while the lowest were observed for activated protein C resistance ratio (CVI 1.5%; CVG 4.5%).This study provides updated BV estimates of CVI and CVG with 95% confidence intervals for a wide range of haemostasis measurands. These estimates can be used to form the basis for analytical performance specifications for haemostasis tests used in the diagnostic work-up required in bleeding- and thrombosis events and for risk assessment.CONCLUSIONSThis study provides updated BV estimates of CVI and CVG with 95% confidence intervals for a wide range of haemostasis measurands. These estimates can be used to form the basis for analytical performance specifications for haemostasis tests used in the diagnostic work-up required in bleeding- and thrombosis events and for risk assessment. The diagnosis and monitoring of bleeding and thrombotic disorders depend on correct haemostatic measurements. The availability of high-quality biological variation (BV) data is important in this context. Many studies have reported BV data for these measurands, but results are varied. The present study aims to deliver global within-subject (CV ) and between-subject (CV ) BV estimates for haemostasis measurands by meta-analyses of eligible studies, by assessment with the Biological Variation Data Critical Appraisal Checklist (BIVAC). Relevant BV studies were graded by the BIVAC. Weighted estimates for CV and CV were obtained via meta-analysis of the BV data derived from BIVAC-compliant studies (graded A-C; whereby A represents optimal study design) performed in healthy adults. In 26 studies BV data were reported for 35 haemostasis measurands. For 9 measurands, only one eligible publication was identified and meta-analysis could not be performed. 74% of the publications were graded as BIVAC C. The CV and CV varied extensively between the haemostasis measurands. The highest estimates were observed for PAI-1 antigen (CV 48.6%; CV 59.8%) and activity (CV 34.9%; CV 90.2%), while the lowest were observed for activated protein C resistance ratio (CV 1.5%; CV 4.5%). This study provides updated BV estimates of CV and CV with 95% confidence intervals for a wide range of haemostasis measurands. These estimates can be used to form the basis for analytical performance specifications for haemostasis tests used in the diagnostic work-up required in bleeding- and thrombosis events and for risk assessment. |
| Author | Idema, René N Hollestelle, Martine J Kristoffersen, Ann Helen Aarsand, Aasne K de Maat, Moniek P M Meijer, Piet Sandberg, Sverre |
| Author_xml | – sequence: 1 givenname: Martine J orcidid: 0000-0001-5672-3775 surname: Hollestelle fullname: Hollestelle, Martine J organization: ECAT Foundation (External Quality Control for Assays and Tests), Voorschoten, The Netherlands – sequence: 2 givenname: Ann Helen surname: Kristoffersen fullname: Kristoffersen, Ann Helen organization: Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway – sequence: 3 givenname: René N surname: Idema fullname: Idema, René N organization: Result Laboratory, Amphia Hospital, Breda, The Netherlands – sequence: 4 givenname: Piet surname: Meijer fullname: Meijer, Piet organization: ECAT Foundation (External Quality Control for Assays and Tests), Voorschoten, The Netherlands – sequence: 5 givenname: Sverre surname: Sandberg fullname: Sandberg, Sverre organization: European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group on Biological Variation and Task Group for the Biological Variation Database, Milan, Italy – sequence: 6 givenname: Moniek P M orcidid: 0000-0001-7749-334X surname: de Maat fullname: de Maat, Moniek P M organization: Department of Hematology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands – sequence: 7 givenname: Aasne K surname: Aarsand fullname: Aarsand, Aasne K organization: European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group on Biological Variation and Task Group for the Biological Variation Database, Milan, Italy |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/36810291$$D View this record in MEDLINE/PubMed |
| BookMark | eNpNkMtOwzAQRS1URB-wZYmyZBOIX3GzRBUvqRILYB2NHymunLjETqv8BN9MSotgNaOje89IM0WjxjcGoUuc3WCO-a1Srk5JRkiKSSZO0AQzKlJGKR7928doGsI6yzDnTJyhMc3nOCMFnqCv1z5EU0O0KmnN1ppdAo1OahMhhQZcH2xIfJXsbPywTRo6uTYq_mSkiTtj_pi03vmVVeCSLbR2UPom0RBh31ceVp07sH25srK1jXf9_nBtIHTtgMM5Oq3ABXNxnDP0_nD_tnhKly-Pz4u7ZaoYFjHFmgHogjLI55QJZhgrKFaF0KziZJ7nQssCMqKEmnOpc5zxqgCsuBa5pFyRGbo-eDet_-xMiGVtgzLOQWN8F0oixGDPC8KH6NUx2sna6HLT2hravvz9IfkGmB94qQ |
| CitedBy_id | crossref_primary_10_1515_cclm_2024_1479 crossref_primary_10_1016_j_cca_2023_117565 crossref_primary_10_1016_j_cca_2024_119950 crossref_primary_10_1093_jalm_jfae116 crossref_primary_10_1016_j_rpth_2025_102993 crossref_primary_10_1016_j_jtha_2025_05_030 |
| ContentType | Journal Article |
| Copyright | 2023 the author(s), published by De Gruyter, Berlin/Boston. |
| Copyright_xml | – notice: 2023 the author(s), published by De Gruyter, Berlin/Boston. |
| DBID | NPM 7X8 |
| DOI | 10.1515/cclm-2022-1207 |
| DatabaseName | PubMed MEDLINE - Academic |
| DatabaseTitle | PubMed MEDLINE - Academic |
| DatabaseTitleList | MEDLINE - Academic PubMed |
| Database_xml | – sequence: 1 dbid: NPM name: PubMed url: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed sourceTypes: Index Database – sequence: 2 dbid: 7X8 name: MEDLINE - Academic url: https://search.proquest.com/medline sourceTypes: Aggregation Database |
| DeliveryMethod | no_fulltext_linktorsrc |
| Discipline | Medicine Chemistry |
| EISSN | 1437-4331 |
| ExternalDocumentID | 36810291 |
| Genre | Journal Article |
| GroupedDBID | --- 0R~ 0~D 29B 354 36B 4.4 53G 5GY 5RE AAAEU AABBZ AAFPC AAGVJ AAILP AALGR AAOQK AAOWA AAPJK AAQCX AARRE AASQH AAXCG ABAOT ABAQN ABDRH ABFKT ABFQV ABIQR ABJNI ABLJU ABMIY ABPLS ABRDF ABUVI ABWLS ABXMZ ABYBW ACDEB ACEFL ACGFS ACIWK ACPMA ACPRK ACUND ACYCL ACZBO ADDWE ADEQT ADGQD ADGYE ADOZN AECWL AEDGQ AEGVQ AEICA AEJTT AENEX AEQDQ AERZL AEXIE AFBAA AFBDD AFBQV AFCXV AFGDO AFQUK AFRAH AFYRI AGBEV AHOVO AHVWV AHXUK AIERV AIWOI AJATJ AJHHK AKXKS ALMA_UNASSIGNED_HOLDINGS ALUKF ALYBR ASYPN BAKPI BBCWN BCIFA CGQUA CS3 DU5 EBS EMOBN F5P HZ~ IY9 KDIRW N9A NPM O9- OBC OBS OEB OES OHH P2P PQQKQ QD8 RDG SA. SLJYH TEORI UK5 WTRAM 7X8 AAWFC ADNPR DSRVY |
| ID | FETCH-LOGICAL-c417t-1d4aad934a683474e44931c97d4f528667db9a02c7c85bd6105f9a1c5d76b35c2 |
| IEDL.DBID | 7X8 |
| ISICitedReferencesCount | 6 |
| ISICitedReferencesURI | http://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=Summon&SrcAuth=ProQuest&DestLinkType=CitingArticles&DestApp=WOS_CPL&KeyUT=000936984600001&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| ISSN | 1437-4331 |
| IngestDate | Thu Sep 04 14:45:21 EDT 2025 Mon Jul 21 05:54:49 EDT 2025 |
| IsDoiOpenAccess | false |
| IsOpenAccess | true |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 8 |
| Keywords | meta-analysis haemostasis measurands analytical performance specifications biological variation |
| Language | English |
| License | 2023 the author(s), published by De Gruyter, Berlin/Boston. |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c417t-1d4aad934a683474e44931c97d4f528667db9a02c7c85bd6105f9a1c5d76b35c2 |
| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 |
| ORCID | 0000-0001-7749-334X 0000-0001-5672-3775 |
| OpenAccessLink | https://www.degruyter.com/doi/10.1515/cclm-2022-1207 |
| PMID | 36810291 |
| PQID | 2779346925 |
| PQPubID | 23479 |
| ParticipantIDs | proquest_miscellaneous_2779346925 pubmed_primary_36810291 |
| PublicationCentury | 2000 |
| PublicationDate | 2023-07-26 |
| PublicationDateYYYYMMDD | 2023-07-26 |
| PublicationDate_xml | – month: 07 year: 2023 text: 2023-07-26 day: 26 |
| PublicationDecade | 2020 |
| PublicationPlace | Germany |
| PublicationPlace_xml | – name: Germany |
| PublicationTitle | Clinical chemistry and laboratory medicine |
| PublicationTitleAlternate | Clin Chem Lab Med |
| PublicationYear | 2023 |
| SSID | ssj0015547 |
| Score | 2.4187458 |
| Snippet | The diagnosis and monitoring of bleeding and thrombotic disorders depend on correct haemostatic measurements. The availability of high-quality biological... |
| SourceID | proquest pubmed |
| SourceType | Aggregation Database Index Database |
| StartPage | 1470 |
| Title | Systematic review and meta-analysis of within-subject and between-subject biological variation data of coagulation and fibrinolytic measurands |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/36810291 https://www.proquest.com/docview/2779346925 |
| Volume | 61 |
| WOSCitedRecordID | wos000936984600001&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| hasFullText | |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| link | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwpV1JSwMxFA5qRb24L3Ujgtdgs01mTiJi8WBLQYXeSpLJiNDOVLuAf8LfbF4m1ZMgeJnDMG-W5Jvk5b2870PoUhjqaCG1B6-2RIiWJcaklqSJM5kxJrMukLg-qG437fezXgy4TeK2ysWYGAbqvLIQI79iyiPJr-WYvB6_EVCNguxqlNBYRg3uXRlAter_ZBH8VBnEVQRXoTIokjb6KfzK2uHII4SBskdL_e5ehmmmvfXfF9xGm9HBxDc1InbQkit30frtQtdtF611Yjp9D30-fvM447qGBesyxyM31URHthJcFRiCta8lmcwMRG3CNXF_1_e5mswJehzP_fI79DeG7adgbyv9EmXCgnEBdQZlNfyAB49ClBIqjvfRc_vu6faeRIEGYgVVU0JzoXXuv1onKRdKOCEyTm2mclFIliaJyk2mW8wqm0qTe09NFpmmVuYqMVxadoBWyqp0RwizxGjDKXWM-5t48MjUUW-nJbNOFUkTXSxafeDbC7IaunTVbDL4afcmOqy7bjCumToGHNjWWEaP_2B9gjZASh7itiw5RY3C__7uDK3a-fR18n4ekOWP3V7nC1sB3N4 |
| linkProvider | ProQuest |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Systematic+review+and+meta-analysis+of+within-subject+and+between-subject+biological+variation+data+of+coagulation+and+fibrinolytic+measurands&rft.jtitle=Clinical+chemistry+and+laboratory+medicine&rft.au=Hollestelle%2C+Martine+J&rft.au=Kristoffersen%2C+Ann+Helen&rft.au=Idema%2C+Ren%C3%A9+N&rft.au=Meijer%2C+Piet&rft.date=2023-07-26&rft.eissn=1437-4331&rft.volume=61&rft.issue=8&rft.spage=1470&rft_id=info:doi/10.1515%2Fcclm-2022-1207&rft_id=info%3Apmid%2F36810291&rft_id=info%3Apmid%2F36810291&rft.externalDocID=36810291 |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=1437-4331&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=1437-4331&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=1437-4331&client=summon |