{"title":"Application of Sigma Metrics for Assessing Analytical Performance of Drug Assay in Patient Care.","authors":"Seema Patel, Preeti Chauhan, Ritu Singh","doi":"10.7754/Clin.Lab.2025.241044","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.241044","url":null,"abstract":"<p><strong>Background: </strong>Clinical laboratories are indispensable in-patient care, particularly for conditions like epilepsy, where precise monitoring is vital. Phenytoin and valproate are commonly used antiepileptics. Sigma metrics may be utilized to monitor overall performance of diagnostic laboratories, ensuring accurate and reliable results. In this regard, our study aimed to evaluate the performance of Indiko Drug analyzer by using Sigma metrics based on different total allowable error (TEa) sources and to determine the consequences of these variations in Sigma metric evaluation.</p><p><strong>Methods: </strong>TEas of 25% and 15% requirements were selected from different industry standards to calculate Sigma metrics of drugs phenytoin and valproate. Coefficient of variation (CV) and bias records were taken from internal quality control (IQC) and external quality assessment scheme (EQAS), respectively.</p><p><strong>Results: </strong>According to TEa based on different international bodies` database specifications of Sigma calculation, TEa 25% showed an average Sigma of both drugs greater than 6 (world class), compared to greater than 3 (marginally acceptable) for TEa 15%.</p><p><strong>Conclusions: </strong>The study emphasizes the importance of thorough analysis and documentation in handling analytes with poor Sigma scores to mitigate laboratory errors and ensure reliability. It recommends root cause analysis and corrective action plans to achieve world-class Sigma goals. However, challenges remain in selecting the appropriate method for calculating Sigma metrics and TEa before harmonizing Sigma metrics across laboratories to minimize confusion.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"71 8","pages":""},"PeriodicalIF":0.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ning Ding, Yuan-Yuan Tan, Tingting Zhang, Meng-Meng Zhang, Zhi-Bin Xie, Jia-Jia Li
{"title":"The Expression and Clinical Significance of SARM1 in Newly Diagnosed Acute Myeloid Leukemia.","authors":"Ning Ding, Yuan-Yuan Tan, Tingting Zhang, Meng-Meng Zhang, Zhi-Bin Xie, Jia-Jia Li","doi":"10.7754/Clin.Lab.2025.250123","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.250123","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to evaluate the expression level of SARM1 in the bone marrow of patients with newly diagnosed acute myeloid leukemia (AML) and assess its clinical and prognostic significance.</p><p><strong>Methods: </strong>Bone marrow specimens were collected from 60 patients with newly diagnosed AML (observation group) and 20 healthy individuals (control group). Clinical and pathological characteristics of AML patients were recorded. Real-time quantitative PCR (qRT-PCR) was used to measure SARM1 expression in both groups. The relationship between SARM1 expression and clinicopathological features and prognosis in AML patients was analyzed. Kaplan-Meier curves were generated to assess the impact of SARM1 on overall survival (OS), and Cox regression was performed to identify prognostic factors.</p><p><strong>Results: </strong>Univariate analysis revealed significantly elevated SARM1 expression in AML patients compared with controls (p < 0.0001). No significant differences were observed in prognostic stratification, chromosomal karyotype variations, or gene mutations between high- and low-expression groups. However, high SARM1 expression was significantly associated with older age, increased bone marrow blasts, and failure to achieve remission after initial treatment (p < 0.05). OS was markedly shorter in the high-expression group compared with the low-expression group (p < 0.0001). Multivariate analysis identified high SARM1 expression as an independent risk factor for poor prognosis in AML.</p><p><strong>Conclusions: </strong>Elevated SARM1 expression in AML patients is associated with poor prognosis and reduced survival. These findings suggest that SARM1 may serve as a prognostic biomarker and a potential therapeutic target in AML.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"71 8","pages":""},"PeriodicalIF":0.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Pseudo Elevation of CA199 Caused by Rheumatoid Factor: a Case Report and Literature Review.","authors":"Hong-Gang Sun, Ming-Feng Yang, Jian-Qing Zhang, Ying Zhang","doi":"10.7754/Clin.Lab.2025.250356","DOIUrl":"10.7754/Clin.Lab.2025.250356","url":null,"abstract":"<p><strong>Background: </strong>When CA199 is solely elevated, it may be a false increase due to interference. Rheumatoid factor (RF), an autoantibody binding to the Fc fragment of denatured IgG, can interfere with immunological tests.</p><p><strong>Methods: </strong>Chemiluminescent immunoassay was used to detect tumor markers. For this patient, to exclude false CA199 elevation, PEG precipitation, serial dilution, and platform switching were applied.</p><p><strong>Results: </strong>In the PEG precipitation test, the patient's sample formed flocs. Post-PEG treatment, CA199 dropped from 179.62 U/mL to 17.66 U/mL (9.83% recovery), suggesting interference. Serial dilution showed a non-linear CA199 relationship, further indicating interference. Platform switching revealed significant results: Abbott's platform measured CA199 at 179.62 U/mL, while Mindray's was 18.68 U/mL.</p><p><strong>Conclusions: </strong>RFis an IgG antibody and can disrupt immunological tests. When encountering high RF in reports, consider its interference on other immunological tests. Use methods like sample dilution, spiking/recovery tests, platform switching, and comparing related test results to verify interference and ensure detection accuracy.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"71 8","pages":""},"PeriodicalIF":0.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical Characteristics and Diagnosis of Chronic Myelogenous Leukemia with Rare Karyotype.","authors":"Xiaofang Zhang, Ruimin Li, Xiaoqiang Lian, Shang Li, Yiping Wu","doi":"10.7754/Clin.Lab.2025.250148","DOIUrl":"10.7754/Clin.Lab.2025.250148","url":null,"abstract":"<p><strong>Background: </strong>The aim was to investigate the clinical features and diagnostic methods of chronic myelogenous leukemia with rare karyotype.</p><p><strong>Methods: </strong>The clinical features and diagnostic methods of a case of chronic myelogenous leukemia with rare karyotype were retrospectively analyzed, including a comprehensive review of the literature.</p><p><strong>Results: </strong>The patient is a young male, 36 years old. Four years ago, he was treated for elevated white blood cell count. Bone marrow cell morphology, cytogenetics, and molecular biology confirmed the diagnosis of BCR-ABL1 fusion gene positive and t (16; 22) Translocated chronic myelogenous leukemia chronic period. Treatment with standard first-line drug imatinib was effective. Two years ago, the reexamination of routine blood routine showed elevated white blood cells. Considering the resistance to the first-generation targeting drug imatinib, a change was made to administer the second-generation targeting drug nilotinib, and the patient was discharged to recuperate. After discharge, the changes in routine blood routine were monitored and adverse reactions were observed. Recently, the patient developed loss of appetite with nausea and vomiting, intermittent fever, further treatment and admission. Leukocytes continued to increase, platelets decreased, and perioral numbness and gingiva bleeding appeared. The diagnosis was confirmed by bone marrow cell morphology, immunology, cytogenetics, and molecular biology, which was considered to be associated with BCR-ABL1 fusion gene positive and t (9; 22) accelerated period of translocation chronic myelogenous leukemia. After chemotherapy with cytarabine, leukocytes decreased significantly and platelets increased gradually. After chemotherapy, the patient had poor mental state, general fatigue and discomfort, poor appetite, intermittent headache and discomfort, and head CT showed subdural hematoma. Headache worsened and left limb weakness occurred. Reexamination of head CT indicated that subdural hematoma was larger than before, considering increased bleeding and greater risk of cerebral hernia, the patient's family requested to be transferred to a superior hospital for further treatment and asked the superior doctor to discharge him automatically.</p><p><strong>Conclusions: </strong>The BCR-ABL1 fusion gene and t (16;22) are rare in chronic myeloid leukemia, easily resistant to imatinib, and complex chromosomal translocations have great influence on the curative effect and prognosis.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"71 8","pages":""},"PeriodicalIF":0.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Muhammad S Aslam, Iqra Sohail, Nadia Dar, Iram Gull, Zaigham Abbas, Sehreen Ashraf, Zoha Khan, Zahoor Q Samra
{"title":"In Vitro Development of Human Monoclonal Antibodies Against Recombinant Staphylococcus enterotoxin B.","authors":"Muhammad S Aslam, Iqra Sohail, Nadia Dar, Iram Gull, Zaigham Abbas, Sehreen Ashraf, Zoha Khan, Zahoor Q Samra","doi":"10.7754/Clin.Lab.2025.250122","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.250122","url":null,"abstract":"<p><strong>Background: </strong>Treatment of diseases related to enterotoxin B of S. aureus (SEB) is challenging due to the emergence of antibiotic resistance in Staphylococcus aureus (S. aureus). Antibodies specific to SEB can potentially play a role in the treatment of SEB-related illnesses of humans. The aim of the present study was to produce human monoclonal antibodies against recombinant SEB (rSEB) by in vitro immunization of peripheral blood lymphocytes (PBLs). rSEB which was previously purified was used to produce monoclonal antibodies by in vitro immunization of PBLs in the presence of PWM.</p><p><strong>Methods: </strong>We established a sensitive and reproducible cell culture system where 0.3 µg/µL of rSEB was used to trigger rSEB specific antibodies by PBLs. Furthermore, cloning of cells for monoclonal antibodies was done through limiting dilution.</p><p><strong>Results: </strong>Supernatants were harvested and assayed for both human polyclonal and monoclonal anti-SEB IgGs respectively by ELISA. All the supernatants from cell culture showed presence of human polyclonal and monoclonal antibodies, whereas specifically 3 wells reported to have higher concentration of monoclonal antibodies.</p><p><strong>Conclusions: </strong>This is the first testimony on the production of human monoclonal antibodies against rSEB in Pakistan. In future, these antibodies can be used for immunodiagnostic assays as well as immunotherapy of S. aureus.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"71 8","pages":""},"PeriodicalIF":0.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mohammed Makkawi, Faisal Alhajori, Sultan Alasmari
{"title":"Platelet and Coagulation Abnormalities in Pediatric Hematological Malignancies: Potential for Hemorrhagic Events.","authors":"Mohammed Makkawi, Faisal Alhajori, Sultan Alasmari","doi":"10.7754/Clin.Lab.2025.241241","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.241241","url":null,"abstract":"<p><strong>Background: </strong>The purpose of the study was to evaluate the platelet counts and coagulation profiles in pediatric patients with the most common types of hematological malignancies (HMs) to assess the predisposition to thrombotic and hemorrhagic complications.</p><p><strong>Methods: </strong>This is a retrospective study carried out from 2016 to 2022. The research encompassed 172 children under the age of 16 diagnosed with HMs. The data were obtained from King Salman Medical City's Maternity and Children's Hospital in Madinah, Saudi Arabia.</p><p><strong>Results: </strong>Platelet count was statistically observed to be low in all prevalent types of HMs in our study, including B-cell acute lymphoblastic leukemia (B-ALL), acute myelomonocytic leukemia (AML-M4), T-cell acute lymphoblastic leukemia (T-ALL), and acute promyelocytic leukemia (AML-M3). The coagulation profile exhibited variability, with prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) significantly prolonged in AML-M3 patients, while only PT and INR were prolonged in other types.</p><p><strong>Conclusions: </strong>The study data reveals significant alterations in platelet count and coagulation profiles in pediatric patients with HMs, indicating an increased risk of hemorrhagic complications. The subtype of HMs may specifically influence clinical complications associated with thrombotic and hemorrhagic events and should be consid-ered in the evaluation of platelets and coagulation profiles.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"71 8","pages":""},"PeriodicalIF":0.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Preparation of a Heat-Elution Solution GSG for A/B/H Weak Antigen Test.","authors":"Yaozong He, Yuhua Lyu, Yanjun Lu, Houquan Zhou, Sijing Liu, Zheng Liang, Yunlong Gao, Ting Liu, Xinzhong Wu, Yan Chao","doi":"10.7754/Clin.Lab.2025.250160","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.250160","url":null,"abstract":"<p><strong>Background: </strong>Our study aimed to enhance the efficiency and sensitivity of the 56°C heat-elution test, minimize he-molysis in the eluate, and improve detection of A/B/H weak antigens. To achieve this, we developed a novel, simplified heat-elution solution: the glycine/sodium chloride/glycerin mixture (GSG).</p><p><strong>Methods: </strong>We monitored the osmotic pressure, pH changes, and bacterial growth of GSG over a 10-week period, comparing it to fresh solution and 6% calf serum. Additionally, we assessed GSG's antibody concentration, sensitivity, specificity, hemolysis degree, and antibody preservation against 6% calf serum and normal saline. The elution efficacy of GSG was also compared with that of glycine-HCl/EDTA.</p><p><strong>Results: </strong>GSG stored at 4°C for 9 weeks maintained osmotic pressure and pH values comparable to fresh preparations, demonstrating superior stability over 6% calf serum. GSG outperformed 6% calf serum and normal saline in agglutination intensity, antibody titer, sensitivity, and hemolysis degree, without yielding false positives. Agglutination strength and antibody titer remained stable 24 hours post-preparation. The sensitivity of antibodies reached 100% after 48 hours, significantly higher than that of 6% calf serum and normal saline. Moreover, GSG's elution efficacy surpassed the glycine-HCl/EDTA method.</p><p><strong>Conclusions: </strong>The GSG method is superior to 6% calf serum, normal saline and glycine-HCL /EDTA elution techniques in terms of sensitivity and other elution efficiency. This breakthrough significantly improves the detection of ABH weak antigens and sets new standards for blood grouping and transfusion protocols.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"71 8","pages":""},"PeriodicalIF":0.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Reference Intervals of Red Blood Cell Parameters in Healthy Adults of the Chinese Population in High-Altitude Areas.","authors":"Shengfang Ye, Jinlong Wang, Zhijuan Liu, Xiaoxing Liu, Zejipuchi, Liping Tian, Ling Qiu","doi":"10.7754/Clin.Lab.2024.240734","DOIUrl":"10.7754/Clin.Lab.2024.240734","url":null,"abstract":"<p><strong>Background: </strong>Typically, red blood cell (RBC)-based parameters and platelet count vary with age and gender. Moreover, these variations may happen due to geographical origin and ethnicity. Nevertheless, the reference intervals (RIs) in healthy Tibetan adult populations are limited. This study aimed to determine the RIs for RBC parameters and platelet count (PLT) in Tibetans living at various high altitudes.</p><p><strong>Methods: </strong>Initially, a total of 1,104 subjects were randomly recruited from Ali, Shigatse/Lhasa, and Nyingchi of Ti-bet. Further, RBC count, hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and PLT were measured using an automated hematocytometer (Sysmex XN-2100). Then, multiple linear regression and variance component analyses were employed to assess the effect of gender, age, and altitude on RBC parameters and PLT count. Finally, RIs were established using non-parametric methods and compared with those currently used in China.</p><p><strong>Results: </strong>The notified blood parameters (RBC, HGB, HCT, MCV, MCH, and MCHC) were significantly higher in males than in females, while PLT count was higher in females than males. Notably, some parameters, including RBC, HGB, and MCHC values, increased with increasing altitude, while MCHC and PLT parameters increased with age. The RIs for RBC parameters and PLT were finally determined according to gender and altitude in healthy Tibetan adults.</p><p><strong>Conclusions: </strong>In summary, the specific RIs for RBC parameters and PLT among Tibetans were significantly different, emphasizing the need to consider gender and geographical origin in the clinical use of IRs of hemogram parameters.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"71 8","pages":""},"PeriodicalIF":0.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mengqiao Wang, Qinwen Wen, Hang Yu, Xiudi Wu, Shuai Zhi, Han Cen
{"title":"Target Gene Polymorphisms and Clinical Response to Methotrexate in Chinese Rheumatoid Arthritis Patients.","authors":"Mengqiao Wang, Qinwen Wen, Hang Yu, Xiudi Wu, Shuai Zhi, Han Cen","doi":"10.7754/Clin.Lab.2025.241250","DOIUrl":"10.7754/Clin.Lab.2025.241250","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to evaluate the associations between genetic polymorphisms within target genes and clinical response to methotrexate (MTX) in Chinese rheumatoid arthritis (RA) patients.</p><p><strong>Methods: </strong>One hundred and fifteen RA patients treated with MTX for approximately 3 months were enrolled, and clinical response was determined by European League Against Rheumatism (EULAR) response criteria and disease activity score in 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR) low disease activity (LDA). Thirty genetic polymorphisms within DHFR, TYMS, ATIC, ADA, and AMPD1 were genotyped.</p><p><strong>Results: </strong>The major allele of ATIC rs2372536 (RR = 0.85, 95% CI = 0.72 - 0.99, p = 0.04), ATIC rs4673991 (RR = 0.85, 95% CI = 0.73 - 0.99, p = 0.04), ATIC rs4673993 (RR = 0.85, 95% CI = 0.73 - 0.99, p = 0.04), ADA rs2057638 (RR = 0.86, 95% CI = 0.76 - 0.99, p = 0.03), and ADA rs6017375 (RR = 0.86, 95% CI = 0.76 - 0.99, p = 0.03) were found to be significantly associated with EULAR response under dominant model, while the major allele of ADA rs371927 (RR = 1.23, 95% CI = 1.04 - 1.46, p = 0.02) was shown to be significantly associated with EULAR re¬sponse under recessive model. Moreover, the major allele of ADA rs1799880 (RR = 0.60, 95% CI = 0.43 - 0.84, p = 0.003) and rs6031697 (RR = 0.61, 95% CI = 0.47 - 0.78, p < 0.001) were detected to be significantly associated with DAS28-ESR LDA.</p><p><strong>Conclusions: </strong>Genetic polymorphisms within ATIC and ADA were significantly associated with clinical response to MTX in Chinese patients with RA.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"71 8","pages":""},"PeriodicalIF":0.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sultan Alasmari, Mohammed Makkawi, Ahmed Alshehri, Adel A Mansour, Ahmad Shaikh, Yasser Al Mohaya, Nashwa H Eisa, Denise Jackson
{"title":"Assessment of the Prevalence and Coagulation Profiles of Individuals with Coagulation Factor Deficiencies in the Asir Region, Saudi Arabia.","authors":"Sultan Alasmari, Mohammed Makkawi, Ahmed Alshehri, Adel A Mansour, Ahmad Shaikh, Yasser Al Mohaya, Nashwa H Eisa, Denise Jackson","doi":"10.7754/Clin.Lab.2025.241244","DOIUrl":"https://doi.org/10.7754/Clin.Lab.2025.241244","url":null,"abstract":"<p><strong>Background: </strong>Bleeding and coagulation disorders are influenced by genetic variations and environmental factors. The prevalence of coagulation factor deficiencies in Saudi Arabia, at both national and regional levels, remains largely unexamined. This study aimed to evaluate the prevalence of coagulation factor deficiencies and analyze the corresponding coagulation profiles in patients exhibiting low coagulation factor levels in the Asir region.</p><p><strong>Methods: </strong>This retrospective study assessed 228 patients exhibiting low coagulation factor levels. Data relevant to patients with coagulation factor deficiencies, including coagulation profiles and factor values, were extracted from the hospital information system. The Mann-Whitney test was employed to ascertain the significance of differences.</p><p><strong>Results: </strong>Among patients with coagulation factor deficiencies, fibrinogen was the most prevalent, occurring in 32.5% of cases, followed by factor VIII at 24.1% and factor IX at 13.6%. Factor XIII deficiency was the least prevalent, occurring at a rate of 1.3%. Prothrombin time and activated partial thromboplastin time confirmed our findings and demonstrated expected results in relation to most factors.</p><p><strong>Conclusions: </strong>The present study determined that factors I, VIII, and IX were the most prevalent among all examined deficient coagulation factors in the Asir region of Saudi Arabia. There is a lack of research on coagulation factor deficiencies in Saudi Arabia; thus, this study might establish a basis for future regional or national investigations.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"71 8","pages":""},"PeriodicalIF":0.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}