Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine最新文献_第3页

Highlights from the Manifesto on Early Detection and Diagnosis of Cardiovascular Disease: The Role of Laboratory Tests and Emerging Technologies. 早期发现和诊断心血管疾病宣言：实验室测试和新兴技术的作用。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2025-02-28 eCollection Date: 2025-03-01

Damien Gruson, Chiara Peranio, Aistė Štaraitė, Richard Hobbs, Knut Borch-Johnsen, Zanfina Ademi, Izabella Uchmanowicz, Neil Jonhson

引用次数: 0

Increasing the Impact and Value of Laboratory Medicine Through Effective and AI-Assisted Communication. 通过有效的人工智能辅助交流增加检验医学的影响和价值。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2025-02-28 eCollection Date: 2025-03-01

Tahir S Pillay

{"title":"Increasing the Impact and Value of Laboratory Medicine Through Effective and AI-Assisted Communication.","authors":"Tahir S Pillay","doi":"","DOIUrl":"","url":null,"abstract":"Effective communication is pivotal in maximizing the impact and value of laboratory medicine (LM) within healthcare. This review explores diverse strategies to enhance communication among healthcare providers, patients, laboratory personnel, and the general public. Key strategies include improving interdisciplinary collaboration through clear reporting, regular multidisciplinary meetings, and consultative services. Enhancing patient communication involves providing accessible test results via patient portals, developing educational materials, and fostering direct patient-provider communication. Implementing efficient information systems by integrating laboratory information systems with electronic health records and using automated alerts ensures timely data sharing and critical value notifications. Continuous education and training for healthcare providers and laboratory staff will keep them updated on advancements and improve communication skills. Fostering a culture of open communication encourages feedback and transparency, while leveraging technology such as telemedicine, mobile health applications, and artificial intelligence--(AI)-driven tools enhances real-time consultations and personalized insights. AI can be used to assist communication through providing advanced data analysis, personalized patient insights, enhanced communication, streamlined workflows, and demonstrable impact through research and analytics. These strategies collectively ensure accurate conveyance of critical information, improving patient and public insight and leading to better patient outcomes and more informed clinical decisions.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"36 1","pages":"12-25"},"PeriodicalIF":0.0,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886622/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Practices and Insights for Diabetes Mellitus Testing in Sri Lanka, Singapore and the Philippines. 斯里兰卡、新加坡和菲律宾糖尿病检测的实践和见解。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2025-02-28 eCollection Date: 2025-03-01

Indika Deepani Siriwardhana, Tan Jun Guan, Maria Ruth Pineda-Cortel, Samuel D Vasikaran, Mithu Banerjee

{"title":"Practices and Insights for Diabetes Mellitus Testing in Sri Lanka, Singapore and the Philippines.","authors":"Indika Deepani Siriwardhana, Tan Jun Guan, Maria Ruth Pineda-Cortel, Samuel D Vasikaran, Mithu Banerjee","doi":"","DOIUrl":"","url":null,"abstract":"Objectives: Considering The pivotal role of biochemical testing for the management of diabetes mellitus, we studied the current status of diabetes testing and reporting in three countries of the Asia-Pacific region.Methods: A survey of 254 practicing pathology laboratories comprising of 40, 11 and 203 laboratories from Sri Lanka, Singapore and the Philippines was conducted under the auspices of the Asia-Pacific Federation for Clinical Biochemistry and Laboratory Medicine (APFCB) Working Group for Diabetes Testing Harmonization using Survey Monkey and Google Forms.Results: The country response rate varied from 40% to 88%. A diagnostic threshold of 6.5% (48 mmol/mol) for HbA1c is reported by 51%, 22% and 90% of the participant laboratories in Sri Lanka, Singapore and the Philippines, respectively. All participants in Singapore and 86% of the laboratories in Philippines use NGSP-certified methods for HbA1c. Traceability to Certified Reference Materials for both glucose and HbA1c results was confirmed by 74% of Sri Lankan laboratories. For albuminuria testing, early morning spot urine albumin to creatinine ratio is recommended by 56%, 75% and 69% of the laboratories in Sri Lanka, Singapore and the Philippines, respectively, while 16%, 50% and 26% of the laboratories recommended 24-hour urine collection.Conclusion: There is a lack of harmonization in diabetes testing and reporting practices both across and even within the three countries surveyed. Scientific bodies or professional associations have an important role in harmonization of laboratory testing and reporting of results for the diagnosis and management of diabetes mellitus.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"36 1","pages":"50-59"},"PeriodicalIF":0.0,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886627/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Spreadsheet for Patient-Based Quality Control Analysis and Evaluation (SPAE). 基于患者的质量控制分析与评估（SPAE）电子表格。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2025-02-28 eCollection Date: 2025-03-01

Hui Qi Low, Hyun-Ki Kim, Sollip Kim, Tony Badrick, Tze Ping Loh, Chun Yee Lim

{"title":"Spreadsheet for Patient-Based Quality Control Analysis and Evaluation (SPAE).","authors":"Hui Qi Low, Hyun-Ki Kim, Sollip Kim, Tony Badrick, Tze Ping Loh, Chun Yee Lim","doi":"","DOIUrl":"","url":null,"abstract":"Introduction: Patient-based quality control (PBQC) is an alternate quality control technique to conventional (internal) quality control. It uses patient results generated for clinical care to monitor the analytical performance through statistical analysis. The use of PBQC in routine laboratory is impeded by lack of familiarity and appropriate informatics tool.Method: A Spreadsheet for PBQC Analysis and Evaluation (SPAE, based on Microsoft Excel) is developed. It incorporates IFCC recommended features for PBQC informatics tool that has been automated, including data visualization, data (Box-Cox) transformation, extreme value treatment (winsorization) and user parameter selection (block size, acceptable false positive rate, desirable bias for detection).Results: Following parameter selection and data input, the spreadsheet automatically calculates the winsorization limits, transformed values, performance verification metrics such as false positive rates and number of results affected before error detection (NPed) - a performance metric for how sensitive the PBQC model detects the predefined error (bias). The verified PBQC model can be used for routine monitoring. The performance of the spreadsheet tool was verified against an independent model based on Python. Laboratory users can download the tool at https://github.com/HuiQi96/PBQC/blob/main/PBQC_model_v2.2.zip.Discussion: The SPAE is a simple-to-use desktop tool that lowers the barrier for laboratory users to adopt PBQC in their quality control system. In addition, the spreadsheet can be used as an educational tool, such as when conducting a workshop, to help laboratory users better familiarize themselves with the PBQC concepts and used for independent verification of the output of another informatics tool.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"36 1","pages":"26-36"},"PeriodicalIF":0.0,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886628/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Rare Pure Calcite Urolithiasis Confirmed by Infrared Spectroscopy. 一罕见纯方解石型尿石症经红外光谱证实。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2025-02-28 eCollection Date: 2025-03-01

Abdelaali Belhachem, Mustapha Zendjabil, Slimane Houache, Amina Amiar, Houari Toumi

{"title":"A Rare Pure Calcite Urolithiasis Confirmed by Infrared Spectroscopy.","authors":"Abdelaali Belhachem, Mustapha Zendjabil, Slimane Houache, Amina Amiar, Houari Toumi","doi":"","DOIUrl":"","url":null,"abstract":"This case report describes a 41-year-old woman with no significant medical history and a normal body mass index (BMI), who presented with ureterohydronephrosis due to a 5.5mm x 9mm calculus composed primarily of calcite (CaCO3) at the ureterovesical junction. The kidney stone, associated with cystitis and perirenal fat infiltration, was spontaneously expelled and subsequently analyzed. Optical microscopy revealed a grey homogeneous stone with a rough surface and white crystals upon examination. Fourier-transform infrared spectroscopy (FTIR-ATR) confirmed the stone's composition as pure calcite, displaying characteristic absorption bands indicative of its crystalline structure. The patient reported long-term use of multiple vitamins and plant-based supplements, possibly contributing to stone formation. The discussion includes insights on calcite urolithiasis, highlighting factors such as alkaline urine pH and calcium metabolism that can influence stone formation, underscoring the complexity of managing kidney stone risk in supplement users.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"36 1","pages":"69-73"},"PeriodicalIF":0.0,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

International Consensus on ANA Patterns (ICAP) Classification Tree Revisited: A Single Centre Report on Four Nuclear Patterns from a Tertiary Care Centre in India. 关于ANA模式（ICAP）分类树的国际共识：印度三级保健中心的四种核模式的单中心报告。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2025-02-28 eCollection Date: 2025-03-01

Aanjik Ranjan, Shamshad Ahmad, Sushil Kumar, Pratap Kumar Patra, Avinash Kumar, Jyoti Prakash, Swetalina Pradhan, Mala Mahto

{"title":"International Consensus on ANA Patterns (ICAP) Classification Tree Revisited: A Single Centre Report on Four Nuclear Patterns from a Tertiary Care Centre in India.","authors":"Aanjik Ranjan, Shamshad Ahmad, Sushil Kumar, Pratap Kumar Patra, Avinash Kumar, Jyoti Prakash, Swetalina Pradhan, Mala Mahto","doi":"","DOIUrl":"","url":null,"abstract":"Background: ICAP describes ANA patterns from AC- 0 to AC-29. They are further marked for competent or expertise reporting depending on ease of identification. There are some debatable patterns in ICAP which share similar features with a few others yet have a distinct identity and few others which are not addressed by ICAP but are described by BCA like Quasihomogenous. This study analysed four nuclear patterns with overlapping features, namely Homogenous, speckled, Dense Fine Speckled70(DFS70) and quasi-homogenous to identify challenges posed in their identification due to overlapping features.Methods: All samples which were reported as positive for the above four nuclear patterns (n=388) by IIF using HEp-2 cell were included in the study. LIA was performed on 103 such samples to look for association between the ANA patterns and specific antibody detected by LIA.Results: DFS70 pattern is a rare pattern and existed in combination with other autoantibodies thus making its identification difficult on IIF. Homogenous pattern corresponded to AC- 29 (anti-topoisomerase, anti-Scl 70) which was probably due to wrong identification. Mixed pattern i.e speckled and homogenous was associated with Sm and U1sn RNP antibodies.Conclusions: DFS 70 is a pattern with overlapping features of both homogenous and speckled and calls for expertise reporting. More awareness is required about AC 29 pattern as it is an overlap of five different components. Its identification poses significant challenges and is rightly placed in the expert reporting by ICAP. Mixed pattern (speckled and homogenous) referred to as Quasihomogenous by BCA needs to be addressed by ICAP.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"36 1","pages":"37-49"},"PeriodicalIF":0.0,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886623/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Abnormal Urine Drug Screens in Pregnancy- Opportunity for Laboratory Stewardship. 妊娠期异常尿液药物筛查-实验室管理的机会。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2025-02-28 eCollection Date: 2025-03-01

Anil K Chokkalla, Sahil Malik, Ridwan Ibrahim, Sridevi Devaraj

{"title":"Abnormal Urine Drug Screens in Pregnancy- Opportunity for Laboratory Stewardship.","authors":"Anil K Chokkalla, Sahil Malik, Ridwan Ibrahim, Sridevi Devaraj","doi":"","DOIUrl":"","url":null,"abstract":"Background: Clinical testing for drugs of abuse typically involves initial screening followed by confirmatory testing. Due to limited evidence-based guidelines, the healthcare provider makes the decision to confirm abnormal screens based on the clinical context. This two-step approach proved to be inadequate in scenarios like maternal substance abuse and subsequent fetal/ newborn exposure. The goal of this study is to assess and improve the confirmatory testing rate of abnormal screens among pregnant patients at our women's center.Methods: A retrospective chart review was conducted to assess the confirmation rates among positively screened pregnant patients, and a lab stewardship initiative was implemented to remind ordering physicians about the importance of confirmatory drug tests. Abnormal screens were classified as expected positives based on the medication-related interference, social history and self-reported substance use from the provider notes.Results: Only 28% of pregnant patients with unexpected positive drug screens underwent confirmatory testing during the pre- intervention period, which rose significantly to 67% during the post-intervention period. Furthermore, outcome analysis revealed that 50% of patients with concordant confirmatory test results were referred to social work and psychiatry in the post-intervention period.Conclusions: This study highlights the value of laboratory stewardship in optimizing drug testing practices for pregnant patients.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"36 1","pages":"83-87"},"PeriodicalIF":0.0,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886620/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Diagnostic Accuracy of Creatinine-Based Equations for eGFR Estimation in Pakistanis: Evaluation of the European Kidney Function Consortium Equation vs the CKD-EPI Pakistan Equation. 基于肌酐的巴基斯坦人 eGFR 估算公式的诊断准确性：欧洲肾功能联盟公式与 CKD-EPI 巴基斯坦公式对比评估。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2024-12-30 eCollection Date: 2024-12-01

Sibtain Ahmed, Tushar Subash, Huzaifa Ahmed, Ayesha Sadiqa, Sonia Yaqub, Lena Jafri

{"title":"Diagnostic Accuracy of Creatinine-Based Equations for eGFR Estimation in Pakistanis: Evaluation of the European Kidney Function Consortium Equation vs the CKD-EPI Pakistan Equation.","authors":"Sibtain Ahmed, Tushar Subash, Huzaifa Ahmed, Ayesha Sadiqa, Sonia Yaqub, Lena Jafri","doi":"","DOIUrl":"","url":null,"abstract":"Introduction: Chronic Kidney Disease (CKD) is prevalent in Pakistan, necessitating accurate diagnostic methods. This study evaluates the CKD-EPI 2009, CKD-EPI 2021, CKD-EPI Pak, MDRD, and EKFC equations against creatinine clearance (CrCl) to determine their diagnostic accuracy for CKD in the Pakistani population.Methods: n a retrospective cross-sectional study, data from 2,310 participants aged 18-70 were analyzed at The Aga Khan University in Karachi. Serum creatinine (SCr) and CrCl were recorded, and eGFR was calculated using five equations. Statistical analyses compared eGFR equations with CrCl, assessing sensitivity, specificity, and predictive values.Results: EPI-Pak exhibited the highest sensitivity (95.15%) and agreement (94.85%) followed by EPI-2009 and EPI-2021 which showed the closest agreement with CrCl. Bland-Altman plots also indicated that EPI-Pak had the best agreement with CrCl.Discussion: EPI-Pak outperformed other equations in estimating eGFR for the Pakistani population, aligning with previous recommendations for South Asians. EKFC, although highly specific, was less effective overall.Conclusion: EPI-Pak is the most accurate equation for diagnosing CKD in the Pakistani population. Its clinical implementation could improve CKD diagnosis and patient outcomes. Future studies should further validate these findings with larger, diverse samples.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"35 4","pages":"285-293"},"PeriodicalIF":0.0,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11726330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Urinary findings in a 12-year-old child, a rare case of Follicular Cystitis. 一名 12 岁儿童的尿液检查结果，罕见的滤泡性膀胱炎病例。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2024-12-30 eCollection Date: 2024-12-01

Oscar D Pons-Belda, Victoria Ordoñez-Cabello, Carlos Rodríguez-Rojas, Jennifer Calviño-Molinero, Paula López-Agulló, Emilia Moreno-Noguero

{"title":"Urinary findings in a 12-year-old child, a rare case of Follicular Cystitis.","authors":"Oscar D Pons-Belda, Victoria Ordoñez-Cabello, Carlos Rodríguez-Rojas, Jennifer Calviño-Molinero, Paula López-Agulló, Emilia Moreno-Noguero","doi":"","DOIUrl":"","url":null,"abstract":"Follicular cystitis (FC) is a chronic form of cystitis with uncertain etiology, characterized by the presence of lymphoid follicles in the bladder mucosa as a result of chronic irritation. This can be caused by various factors such as prolonged catheterization, lithiasis, recurrent urinary tract infections or neoplastic bladder pathology. Although it is a rare pathology, it is mainly seen in women over 50 years of age and manifests with nonspecific urinary symptoms such as dysuria, pollakiuria, haematuria and suprapubic pain. We describe a case of a 12-year-old boy with dysuria, haematuria and hypogastric pain. Despite the absence of a history of lithiasis or trauma, and no bacteria found in urinalysis, erythrocytes and leukocytes were found, along with reactivated and degenerated urothelial cells accompanied by heterogeneous-sized cells with a high nucleus/cytoplasm ratio. Ultrasonography showed no abnormalities, but cystoscopy revealed irregularities in the trigone of the bladder and biopsy confirmed the presence of lymphoid follicles, characteristic of FC. This case underscores the relevance of considering FC in patients with persistent bladder irritation and recurrent haematuria. Cystoscopy and histologic evaluation are crucial for an accurate diagnosis, although the role of the clinical laboratory is limited, an experienced specialist can facilitate a proper diagnosis.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"35 4","pages":"294-299"},"PeriodicalIF":0.0,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11726326/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984993","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Validation of the KL6 Method on the G600II Analyser (Lumipulse) for Clinical Use in Interstitial Lung Disease. KL6方法在G600II分析仪（Lumipulse）上用于间质性肺疾病临床应用的验证

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2024-12-30 eCollection Date: 2024-12-01

Duque Alcorta Marta, González Casaús María Luisa, Serrano Olmedo María Gema

{"title":"Validation of the KL6 Method on the G600II Analyser (Lumipulse) for Clinical Use in Interstitial Lung Disease.","authors":"Duque Alcorta Marta, González Casaús María Luisa, Serrano Olmedo María Gema","doi":"","DOIUrl":"","url":null,"abstract":"The Clinical Laboratory (CL) is involved in the prevention, diagnosis and follow-up of disease, as well as in the monitoring of treatment. For this reason, the CL must have robust quality systems in place in order to provide reliable results that help to ensure correct health care. Since the entry into force of the European regulation (IVDR) on in vitro diagnostic medical devices (EU) 2017/746 has generated the loss of CE marking in some laboratory determinations. In our case, Krebs von den Lungen-6 (KL-6), a diagnostic, severity and prognostic marker, as well as a marker of response to treatment, currently has the RUO (research use only) marking and, given its importance in our healthcare environment, we have validated the method with the new reagent in order to be able to continue with the clinical care of patients. In addition, this would keep this analyte within the scope of accreditation. Following the specific CLSI protocols, we carried out a study of precision, linearity as well as the limit of blank and the limit of detection, obtaining results within the limits established by the laboratory. This positive validation of KL6 allows us to continue using this analyte for clinical use and within the scope of accreditation.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"35 4","pages":"216-222"},"PeriodicalIF":0.0,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11726327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0