Validation of an Automated Urea Assay Method Using Bronchoalveolar Lavage Fluid Samples for the Therapeutic Drug Monitoring of Antimicrobials in Severe Pneumonia
Determining the concentration of an antimicrobial agent in epithelial lining fluid using therapeutic drug monitoring (TDM) may be clinically useful for optimizing drug exposure in patients with severe pneumonia. The epithelial lining fluid drug concentration can be measured in samples obtained durin...
Uloženo v:
| Vydáno v: | Therapeutic drug monitoring Ročník 47; číslo 5; s. 682 |
|---|---|
| Hlavní autoři: | , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
United States
01.10.2025
|
| Témata: | |
| ISSN: | 1536-3694, 1536-3694 |
| On-line přístup: | Zjistit podrobnosti o přístupu |
| Tagy: |
Přidat tag
Žádné tagy, Buďte první, kdo vytvoří štítek k tomuto záznamu!
|
| Abstract | Determining the concentration of an antimicrobial agent in epithelial lining fluid using therapeutic drug monitoring (TDM) may be clinically useful for optimizing drug exposure in patients with severe pneumonia. The epithelial lining fluid drug concentration can be measured in samples obtained during bronchoscopy and bronchoalveolar lavage (BAL). To account for the dilution induced by the saline instillation procedure, the concentration of the drug in BAL fluid samples is usually corrected using the serum-to-BAL fluid concentration ratio of urea. However, for this analysis to be integrated into daily TDM, a rapid, sensitive, and reproducible urea assay is required.
The authors developed and validated a urea assay method for BAL fluid samples using the Atellica Solution automated platform (Siemens Healthcare Diagnostics Inc). They analyzed the urea concentration in BAL fluid and serum samples from 40 patients with severe pneumonia who were included in a prospective cohort study. The results of the automated assay were compared with those obtained using a manual colorimetric assay kit.
The automated method was linear between 0.11 and 1.1 mmol/L urea (r 2 = 0.9928, n = 12). The within- and between-day relative errors (accuracy) and coefficients of variation (precision) for the 3 quality controls (0.25, 0.5, and 0.75 mmol/L) were all below 15%. The serum/BAL fluid urea concentration ratio of patients was not significantly different between the automated and manual assays [median (interquartile range): 29.8 (18.5-36.8) versus 26.3 (16.5-41.4), P = 0.2325, respectively], and BAL data of the 2 assays were well correlated (r 2 = 0.8679, slope of the linear regression curve: 1.06 ± 0.07). The turnaround time of the automated method was approximately 30 minutes, which was much faster than that of the manual assay, which required a dedicated technician for almost 3 hours.
These results demonstrate the feasibility of an automated urea assay that allows the measurement of drug concentration in the lungs as a routine complementary analysis to the TDM of antimicrobials in severe pneumonia. |
|---|---|
| AbstractList | Determining the concentration of an antimicrobial agent in epithelial lining fluid using therapeutic drug monitoring (TDM) may be clinically useful for optimizing drug exposure in patients with severe pneumonia. The epithelial lining fluid drug concentration can be measured in samples obtained during bronchoscopy and bronchoalveolar lavage (BAL). To account for the dilution induced by the saline instillation procedure, the concentration of the drug in BAL fluid samples is usually corrected using the serum-to-BAL fluid concentration ratio of urea. However, for this analysis to be integrated into daily TDM, a rapid, sensitive, and reproducible urea assay is required.
The authors developed and validated a urea assay method for BAL fluid samples using the Atellica Solution automated platform (Siemens Healthcare Diagnostics Inc). They analyzed the urea concentration in BAL fluid and serum samples from 40 patients with severe pneumonia who were included in a prospective cohort study. The results of the automated assay were compared with those obtained using a manual colorimetric assay kit.
The automated method was linear between 0.11 and 1.1 mmol/L urea (r 2 = 0.9928, n = 12). The within- and between-day relative errors (accuracy) and coefficients of variation (precision) for the 3 quality controls (0.25, 0.5, and 0.75 mmol/L) were all below 15%. The serum/BAL fluid urea concentration ratio of patients was not significantly different between the automated and manual assays [median (interquartile range): 29.8 (18.5-36.8) versus 26.3 (16.5-41.4), P = 0.2325, respectively], and BAL data of the 2 assays were well correlated (r 2 = 0.8679, slope of the linear regression curve: 1.06 ± 0.07). The turnaround time of the automated method was approximately 30 minutes, which was much faster than that of the manual assay, which required a dedicated technician for almost 3 hours.
These results demonstrate the feasibility of an automated urea assay that allows the measurement of drug concentration in the lungs as a routine complementary analysis to the TDM of antimicrobials in severe pneumonia. Determining the concentration of an antimicrobial agent in epithelial lining fluid using therapeutic drug monitoring (TDM) may be clinically useful for optimizing drug exposure in patients with severe pneumonia. The epithelial lining fluid drug concentration can be measured in samples obtained during bronchoscopy and bronchoalveolar lavage (BAL). To account for the dilution induced by the saline instillation procedure, the concentration of the drug in BAL fluid samples is usually corrected using the serum-to-BAL fluid concentration ratio of urea. However, for this analysis to be integrated into daily TDM, a rapid, sensitive, and reproducible urea assay is required.BACKGROUNDDetermining the concentration of an antimicrobial agent in epithelial lining fluid using therapeutic drug monitoring (TDM) may be clinically useful for optimizing drug exposure in patients with severe pneumonia. The epithelial lining fluid drug concentration can be measured in samples obtained during bronchoscopy and bronchoalveolar lavage (BAL). To account for the dilution induced by the saline instillation procedure, the concentration of the drug in BAL fluid samples is usually corrected using the serum-to-BAL fluid concentration ratio of urea. However, for this analysis to be integrated into daily TDM, a rapid, sensitive, and reproducible urea assay is required.The authors developed and validated a urea assay method for BAL fluid samples using the Atellica Solution automated platform (Siemens Healthcare Diagnostics Inc). They analyzed the urea concentration in BAL fluid and serum samples from 40 patients with severe pneumonia who were included in a prospective cohort study. The results of the automated assay were compared with those obtained using a manual colorimetric assay kit.METHODSThe authors developed and validated a urea assay method for BAL fluid samples using the Atellica Solution automated platform (Siemens Healthcare Diagnostics Inc). They analyzed the urea concentration in BAL fluid and serum samples from 40 patients with severe pneumonia who were included in a prospective cohort study. The results of the automated assay were compared with those obtained using a manual colorimetric assay kit.The automated method was linear between 0.11 and 1.1 mmol/L urea (r2 = 0.9928, n = 12). The within- and between-day relative errors (accuracy) and coefficients of variation (precision) for the 3 quality controls (0.25, 0.5, and 0.75 mmol/L) were all below 15%. The serum/BAL fluid urea concentration ratio of patients was not significantly different between the automated and manual assays [median (interquartile range): 29.8 (18.5-36.8) versus 26.3 (16.5-41.4), P = 0.2325, respectively], and BAL data of the 2 assays were well correlated (r2 = 0.8679, slope of the linear regression curve: 1.06 ± 0.07). The turnaround time of the automated method was approximately 30 minutes, which was much faster than that of the manual assay, which required a dedicated technician for almost 3 hours.RESULTSThe automated method was linear between 0.11 and 1.1 mmol/L urea (r2 = 0.9928, n = 12). The within- and between-day relative errors (accuracy) and coefficients of variation (precision) for the 3 quality controls (0.25, 0.5, and 0.75 mmol/L) were all below 15%. The serum/BAL fluid urea concentration ratio of patients was not significantly different between the automated and manual assays [median (interquartile range): 29.8 (18.5-36.8) versus 26.3 (16.5-41.4), P = 0.2325, respectively], and BAL data of the 2 assays were well correlated (r2 = 0.8679, slope of the linear regression curve: 1.06 ± 0.07). The turnaround time of the automated method was approximately 30 minutes, which was much faster than that of the manual assay, which required a dedicated technician for almost 3 hours.These results demonstrate the feasibility of an automated urea assay that allows the measurement of drug concentration in the lungs as a routine complementary analysis to the TDM of antimicrobials in severe pneumonia.CONCLUSIONSThese results demonstrate the feasibility of an automated urea assay that allows the measurement of drug concentration in the lungs as a routine complementary analysis to the TDM of antimicrobials in severe pneumonia. |
| Author | Lemaire-Hurtel, Anne-Sophie Durand-Maugard, Charlotte Preudhomme, Maite Andréjak, Claire Delomez, Julia Bodeau, Sandra Sauzay, Chloé Huriez, Elisabeth Bennis, Youssef Ghaleb, Maeva |
| Author_xml | – sequence: 1 givenname: Maeva surname: Ghaleb fullname: Ghaleb, Maeva organization: Department of Clinical Pharmacology, Amiens University Hospital, Amiens, France – sequence: 2 givenname: Julia surname: Delomez fullname: Delomez, Julia organization: Department of Pulmonology, Amiens University Hospital, Amiens, France ; and – sequence: 3 givenname: Chloé surname: Sauzay fullname: Sauzay, Chloé organization: Department of Clinical Biochemistry, Amiens University Hospital, Amiens, France – sequence: 4 givenname: Charlotte surname: Durand-Maugard fullname: Durand-Maugard, Charlotte organization: Department of Clinical Biochemistry, Amiens University Hospital, Amiens, France – sequence: 5 givenname: Sandra surname: Bodeau fullname: Bodeau, Sandra organization: Department of Clinical Pharmacology, Amiens University Hospital, Amiens, France – sequence: 6 givenname: Elisabeth surname: Huriez fullname: Huriez, Elisabeth organization: Department of Clinical Biochemistry, Amiens University Hospital, Amiens, France – sequence: 7 givenname: Maite surname: Preudhomme fullname: Preudhomme, Maite organization: Siemens Healthcare SAS, Courbevoie, France – sequence: 8 givenname: Anne-Sophie surname: Lemaire-Hurtel fullname: Lemaire-Hurtel, Anne-Sophie organization: Department of Clinical Pharmacology, Amiens University Hospital, Amiens, France – sequence: 9 givenname: Claire surname: Andréjak fullname: Andréjak, Claire organization: Department of Pulmonology, Amiens University Hospital, Amiens, France ; and – sequence: 10 givenname: Youssef orcidid: 0000-0002-0186-4797 surname: Bennis fullname: Bennis, Youssef organization: Department of Clinical Pharmacology, Amiens University Hospital, Amiens, France |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/40373235$$D View this record in MEDLINE/PubMed |
| BookMark | eNpNkFtLAzEQhYMo3v-ByDz6Uk2y2dtjvVSFFgWrr2U2O9tGdpOaZAv-HP-pKyr0vMxw5uMMnCO2a50lxs4EvxS8zK8m89tLviWRKLnDDkWaZKMkK9Xu1n7AjkJ4HxhVcL7PDhRP8kQm6SH7esPW1BiNs-AaQAvjProOI9Xw6glhHAJ-woziyg1OMHYJ195ZvXLYbsi16GGKG1wSTNre1PCC3bqlAI3zEFcE8xV5XFMfjYZb3y9h5qyJzv8EDQ_HNprOaO8qg20AY-GFNuQJni313YDiCdtrhhOd_s1j9jq5m988jKZP94834-lIy0LJEXJd6VKkOq84T-ucMmyavKQ0lWUmmqoudMplneVCccoaLaUqZE28GPBKlEIes4vf3LV3Hz2FuOhM0NS2aMn1YZFIrnIlhfpBz__QvuqoXqy96dB_Lv5rld9F7X58 |
| ContentType | Journal Article |
| Copyright | Copyright © 2025 Wolters Kluwer Health, Inc. All rights reserved. |
| Copyright_xml | – notice: Copyright © 2025 Wolters Kluwer Health, Inc. All rights reserved. |
| DBID | CGR CUY CVF ECM EIF NPM 7X8 |
| DOI | 10.1097/FTD.0000000000001342 |
| DatabaseName | Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed MEDLINE - Academic |
| DatabaseTitle | MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) MEDLINE - Academic |
| DatabaseTitleList | MEDLINE MEDLINE - Academic |
| 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 | Pharmacy, Therapeutics, & Pharmacology |
| EISSN | 1536-3694 |
| ExternalDocumentID | 40373235 |
| Genre | Validation Study Journal Article |
| GroupedDBID | --- .-D .Z2 0R~ 123 4Q1 4Q2 4Q3 5RE 5VS 71W 8L- AAAAV AAHPQ AAIQE AAMTA AARTV AASCR AAYEP ABASU ABBUW ABDIG ABJNI ABOCM ABPXF ABVCZ ABXVJ ABZAD ABZZY ACDDN ACEWG ACGFO ACGFS ACILI ACWDW ACWRI ACXJB ACXNZ ADGGA ADHPY ADKSD AE6 AENEX AFBFQ AFDTB AHMBA AHQNM AHVBC AINUH AJCLO AJIOK AJNWD AJZMW AKCTQ ALKUP ALMA_UNASSIGNED_HOLDINGS ALMTX AMJPA AMKUR AMNEI AOHHW AOQMC BQLVK C45 CGR CS3 CUY CVF DIWNM DU5 E.X EBS ECM EEVPB EIF EX3 F2K F2L F5P FCALG FL- GNXGY GQDEL H0~ HLJTE HZ~ IKREB IN~ IPNFZ JK3 JK8 K8S KD2 KMI L-C N9A NPM O9- OAG OAH OL1 OLG OLV OLZ OPC OPUJH OVD OVDNE OWV OWW OWY OWZ OXXIT P2P PQQKQ RIG RLZ S4R S4S TEORI TSPGW V2I VVN W3M WOQ WOW X3V X3W XYM YFH YOC ZFV ZY1 7X8 |
| ID | FETCH-LOGICAL-c2842-a0cbc915c7b005d7e6aff79e552961fbd8c502d67140e6fc22482de08b00b1912 |
| IEDL.DBID | 7X8 |
| ISSN | 1536-3694 |
| IngestDate | Thu Oct 02 23:34:19 EDT 2025 Wed Sep 17 02:06:55 EDT 2025 |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 5 |
| Keywords | antimicrobials pharmacokinetics epithelial lining fluid pneumonia lung penetration therapeutic drug monitoring |
| Language | English |
| License | Copyright © 2025 Wolters Kluwer Health, Inc. All rights reserved. |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c2842-a0cbc915c7b005d7e6aff79e552961fbd8c502d67140e6fc22482de08b00b1912 |
| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
| ORCID | 0000-0002-0186-4797 |
| PMID | 40373235 |
| PQID | 3204742141 |
| PQPubID | 23479 |
| ParticipantIDs | proquest_miscellaneous_3204742141 pubmed_primary_40373235 |
| PublicationCentury | 2000 |
| PublicationDate | 2025-October |
| PublicationDateYYYYMMDD | 2025-10-01 |
| PublicationDate_xml | – month: 10 year: 2025 text: 2025-October |
| PublicationDecade | 2020 |
| PublicationPlace | United States |
| PublicationPlace_xml | – name: United States |
| PublicationTitle | Therapeutic drug monitoring |
| PublicationTitleAlternate | Ther Drug Monit |
| PublicationYear | 2025 |
| SSID | ssj0014800 |
| Score | 2.4432983 |
| Snippet | Determining the concentration of an antimicrobial agent in epithelial lining fluid using therapeutic drug monitoring (TDM) may be clinically useful for... |
| SourceID | proquest pubmed |
| SourceType | Aggregation Database Index Database |
| StartPage | 682 |
| SubjectTerms | Aged Anti-Infective Agents - therapeutic use Bronchoalveolar Lavage Fluid - chemistry Drug Monitoring - methods Female Humans Male Middle Aged Pneumonia - drug therapy Pneumonia - metabolism Prospective Studies Reproducibility of Results Urea - analysis Urea - blood |
| Title | Validation of an Automated Urea Assay Method Using Bronchoalveolar Lavage Fluid Samples for the Therapeutic Drug Monitoring of Antimicrobials in Severe Pneumonia |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/40373235 https://www.proquest.com/docview/3204742141 |
| Volume | 47 |
| hasFullText | |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| link | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwpV3NT9swFLfG4MBlY2wwBkMPaeoJi8TO5wlVsIoDVJEoVW-V49goUnG6pqnUP2f_6Z6dVOUyCYkcckrkxO_Dv-f3_HuE_IpY4rGCMyr9tKBB6HGa-76mEoGcRACd5y5jOr6Ph8NkMkmzbsOt7soqNz7ROeqiknaP_IozL8Awzg_86_kfartG2exq10Jjh-xyhDK2pCuebLMIQeKOoKBRR5RHabA5OpfGV4PRbUtd2F0-t83a_wcy3WIz-PzezzwgnzqYCf1WL76QD8ockl7W8lSvL2G0PXZVX0IPsi2D9for-TtGdN42W4JKgzDQb5YVYltVwBOiTEChijU8uO7T4KoOAON5g65UzFbKRstwL1boqmAwa8oCHoUlIa4BETIg4nw9PNwummdoXYvdY7QD9s2yfCkdRRRaB5QGHhWanILMqAb_sBTfyNPg9-jmjna9HKjEBZBR4clcpn4oY2v3RawioXWcqtDmfX2dF4kMUWkiyx-oIi0RWSSsUF6Cj-cYU7Ij8tFURn0ngJrl2WxlpC0ZXpLmmmuOOEomOhAi1ifkYiOaKdqKTYAIo6qmnm6Fc0KOW_lO5y2pxzTweMwZD3-84e1Tss9sG2BX03dGdjXOhfpJ9uRqWdaLc6eEeB9mD_8AXOTncw |
| 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=Validation+of+an+Automated+Urea+Assay+Method+Using+Bronchoalveolar+Lavage+Fluid+Samples+for+the+Therapeutic+Drug+Monitoring+of+Antimicrobials+in+Severe+Pneumonia&rft.jtitle=Therapeutic+drug+monitoring&rft.au=Ghaleb%2C+Maeva&rft.au=Delomez%2C+Julia&rft.au=Sauzay%2C+Chlo%C3%A9&rft.au=Durand-Maugard%2C+Charlotte&rft.date=2025-10-01&rft.eissn=1536-3694&rft.volume=47&rft.issue=5&rft.spage=682&rft_id=info:doi/10.1097%2FFTD.0000000000001342&rft_id=info%3Apmid%2F40373235&rft_id=info%3Apmid%2F40373235&rft.externalDocID=40373235 |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=1536-3694&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=1536-3694&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=1536-3694&client=summon |