Pub Date : 2026-02-05DOI: 10.1016/j.plabm.2026.e00522
João Renato Rebello Pinho , Gabriela Rampazzo Cruz , Priscila de Meira Oliveira , Fernanda de Mello Malta , Roberta Cardoso Petroni , Roberta Miraglia , Ana Claudia Campana , Alice Friedenberg de Ulhoa Cintra , Ricardo Andreotti Siqueira , Rubia Anita Ferraz Santana , Fabiane Camargo Gomes Nunes , Marinês Dalla Valle Martino , André Mario Doi , Nair Hideko Muto , Cristóvão Luis Pitangueira Mangueira
Objective
This study aimed to evaluate the Trueprep/Truelab platform with four Truenat assays (COVID-19, Mycobacterium tuberculosis - MTB, malaria, leptospirosis), focusing on analytical performance, repeat rates, and time-to-result.
Methods
Remnant clinical specimens and commercial controls were analyzed under routine conditions. Performance metrics included accuracy, reproducibility, limit of detection (LOD), linearity, and specificity, when applicable. Each analyte was tested in replicates, and results were compared with established reference methods.
Results
The Truenat COVID-19 assay achieved 100% agreement with the reference and LOD of 500 copies/mL. Truenat MTB showed 95% concordance with the comparator, though repeat runs were occasionally required (7.3%). Malaria assays demonstrated high reproducibility and linearity (R2 = 0.9996) with an observed LOD of 3000 copies/mL. Leptospira assays yielded 100% accuracy with a LOD of 750 copies/mL. Performance generally matched manufacturer specifications, though low-burden MTB samples were less consistently detected.
Conclusion
Truenat assays showed reliable analytical performance, especially for COVID-19. While MTB detection remains more robust with Xpert Ultra in low-burden cases, Truenat provides a viable point-of-care alternative in resource-limited settings. For malaria and leptospirosis, broader clinical validation is needed before routine implementation in our service.
{"title":"Evaluation of the Truenat® chip-based real-time PCR platform for infectious disease diagnostics","authors":"João Renato Rebello Pinho , Gabriela Rampazzo Cruz , Priscila de Meira Oliveira , Fernanda de Mello Malta , Roberta Cardoso Petroni , Roberta Miraglia , Ana Claudia Campana , Alice Friedenberg de Ulhoa Cintra , Ricardo Andreotti Siqueira , Rubia Anita Ferraz Santana , Fabiane Camargo Gomes Nunes , Marinês Dalla Valle Martino , André Mario Doi , Nair Hideko Muto , Cristóvão Luis Pitangueira Mangueira","doi":"10.1016/j.plabm.2026.e00522","DOIUrl":"10.1016/j.plabm.2026.e00522","url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to evaluate the Trueprep/Truelab platform with four Truenat assays (COVID-19, <em>Mycobacterium tuberculosis</em> - MTB, malaria, leptospirosis), focusing on analytical performance, repeat rates, and time-to-result.</div></div><div><h3>Methods</h3><div>Remnant clinical specimens and commercial controls were analyzed under routine conditions. Performance metrics included accuracy, reproducibility, limit of detection (LOD), linearity, and specificity, when applicable. Each analyte was tested in replicates, and results were compared with established reference methods.</div></div><div><h3>Results</h3><div>The Truenat COVID-19 assay achieved 100% agreement with the reference and LOD of 500 copies/mL. Truenat MTB showed 95% concordance with the comparator, though repeat runs were occasionally required (7.3%). Malaria assays demonstrated high reproducibility and linearity (R<sup>2</sup> = 0.9996) with an observed LOD of 3000 copies/mL. Leptospira assays yielded 100% accuracy with a LOD of 750 copies/mL. Performance generally matched manufacturer specifications, though low-burden MTB samples were less consistently detected.</div></div><div><h3>Conclusion</h3><div>Truenat assays showed reliable analytical performance, especially for COVID-19. While MTB detection remains more robust with Xpert Ultra in low-burden cases, Truenat provides a viable point-of-care alternative in resource-limited settings. For malaria and leptospirosis, broader clinical validation is needed before routine implementation in our service.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"49 ","pages":"Article e00522"},"PeriodicalIF":1.3,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146190342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-31DOI: 10.1016/j.plabm.2026.e00521
Shoumin Li , Haiping Yang , Qian Zhang , Fu Zhao , Yong Mu , Yingjiang Chen
Objectives
This study aimed to systematically investigate the interference of lipemia on the Mindray BC-6800 hematology analyzer, elucidate the underlying mechanisms via optical signal analysis, and develop data-driven strategies for its recognition and correction.
Methods
In vitro models of moderate and severe lipemia were established using 30 healthy specimens. Complete blood count (CBC) parameters, leukocyte differentials, and optical signals were measured and compared against controls. A random forest model was constructed for interference identification, and a multiple linear regression model was developed from 600 normal samples to predict hemoglobin (HGB).
Results
Lipemia significantly increased Hb, MCH, and MCHC (P < 0.05), with severe lipemia further affecting HCT, LYMPH%, and MONO%. Optical analysis revealed increased X-axis (side scatter) and decreased Y-/Z-axis (fluorescence) signals (P < 0.001). The random forest model achieved an AUC of 0.952, and a simplified rule (“MCH >36 pg & MCHC >410 g/L″) attained 81.1% accuracy. The HGB prediction model (HGB = 6.67 + 3.14 × HCT) performed robustly across lipemia levels (R2 > 0.96).
Conclusions
Lipemia interferes with multiple parameters on the Mindray BC-6800 through alterations in cellular optical signals. The developed recognition and correction models demonstrate high clinical applicability for improving result accuracy.
{"title":"Mechanistic investigation and data-driven correction of lipemic interference in hematological parameters on the Mindray BC-6800 hematology analyzer","authors":"Shoumin Li , Haiping Yang , Qian Zhang , Fu Zhao , Yong Mu , Yingjiang Chen","doi":"10.1016/j.plabm.2026.e00521","DOIUrl":"10.1016/j.plabm.2026.e00521","url":null,"abstract":"<div><h3>Objectives</h3><div>This study aimed to systematically investigate the interference of lipemia on the Mindray BC-6800 hematology analyzer, elucidate the underlying mechanisms via optical signal analysis, and develop data-driven strategies for its recognition and correction.</div></div><div><h3>Methods</h3><div>In vitro models of moderate and severe lipemia were established using 30 healthy specimens. Complete blood count (CBC) parameters, leukocyte differentials, and optical signals were measured and compared against controls. A random forest model was constructed for interference identification, and a multiple linear regression model was developed from 600 normal samples to predict hemoglobin (HGB).</div></div><div><h3>Results</h3><div>Lipemia significantly increased Hb, MCH, and MCHC (P < 0.05), with severe lipemia further affecting HCT, LYMPH%, and MONO%. Optical analysis revealed increased X-axis (side scatter) and decreased Y-/Z-axis (fluorescence) signals (P < 0.001). The random forest model achieved an AUC of 0.952, and a simplified rule (“MCH >36 pg & MCHC >410 g/L″) attained 81.1% accuracy. The HGB prediction model (HGB = 6.67 + 3.14 × HCT) performed robustly across lipemia levels (R<sup>2</sup> > 0.96).</div></div><div><h3>Conclusions</h3><div>Lipemia interferes with multiple parameters on the Mindray BC-6800 through alterations in cellular optical signals. The developed recognition and correction models demonstrate high clinical applicability for improving result accuracy.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"49 ","pages":"Article e00521"},"PeriodicalIF":1.3,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146190341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-21DOI: 10.1016/j.plabm.2026.e00519
Frances Zhao , Carel Pretorius , Peter Mollee
{"title":"Comparative evaluation of free light chain assays in AL amyloidosis: Performance of Sebia versus Freelite and N-Latex","authors":"Frances Zhao , Carel Pretorius , Peter Mollee","doi":"10.1016/j.plabm.2026.e00519","DOIUrl":"10.1016/j.plabm.2026.e00519","url":null,"abstract":"","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"49 ","pages":"Article e00519"},"PeriodicalIF":1.3,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146043326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.plabm.2026.e00520
Yuki Fujiwara , Yuzuru Takei , Hiroto Nakazawa
Urine sediment examination is vital for detecting atypical urothelial cells but is highly operator-dependent. The UF-5000 automated urine analyzer quantifies nucleic acid-containing particles. The atypical cell (Atyp.C) parameter reflects increased nucleic acid content and detects atypical urothelial cells and intracytoplasmic inclusion-bearing (ICIB) cells linked to viral infection or inflammation. We assessed the relationship between Atyp.C, atypical cells, and ICIBs and evaluated the parameter's screening performance. Overall, 264 urine sediment samples from 203 patients were analyzed using the UF-5000. Manual microscopy was used to identify atypical and ICIB-positive cells. Atyp.C values were compared between groups using the Mann–Whitney U test. Diagnostic performance was assessed using receiver operating characteristic (ROC) analysis and sensitivity, specificity, and Cohen's κ calculation at cutoffs of 0.1, 0.3, and 0.5 cells/μL. Atyp.C values were significantly higher in atypical-cell-positive specimens (p < 0.001). Atypical cell and ICIB positivity showed moderate agreement (Cohen's κ = 0.534; 77 % agreement; p < 0.01). ROC analysis showed an area under the curve of 0.829 for atypical cells, which increased to 0.895 when ICIB-positive samples were considered positive. At a cutoff of 0.1 cells/μL, Atyp.C exhibited high sensitivity (97.8 %) with low specificity (46.5 %) for detecting atypical cells; a 0.3 cells/μL cutoff provided optimal balance (sensitivity 85.2 %, specificity 68.2 %). The UF-5000 Atyp.C parameter effectively detects cells with increased nucleic acid content, including atypical and ICIB-positive cells. Recognizing ICIBs as diagnostically relevant improves screening sensitivity, supporting Atyp.C as a valuable tool for urinalysis. Combining automated detection with manual microscopy may improve the efficiency of atypical cell detection.
{"title":"UF-5000 Atyp.C parameter for urinary screening: Impact of detecting atypical and inclusion-bearing cells","authors":"Yuki Fujiwara , Yuzuru Takei , Hiroto Nakazawa","doi":"10.1016/j.plabm.2026.e00520","DOIUrl":"10.1016/j.plabm.2026.e00520","url":null,"abstract":"<div><div>Urine sediment examination is vital for detecting atypical urothelial cells but is highly operator-dependent. The UF-5000 automated urine analyzer quantifies nucleic acid-containing particles. The atypical cell (Atyp.C) parameter reflects increased nucleic acid content and detects atypical urothelial cells and intracytoplasmic inclusion-bearing (ICIB) cells linked to viral infection or inflammation. We assessed the relationship between Atyp.C, atypical cells, and ICIBs and evaluated the parameter's screening performance. Overall, 264 urine sediment samples from 203 patients were analyzed using the UF-5000. Manual microscopy was used to identify atypical and ICIB-positive cells. Atyp.C values were compared between groups using the Mann–Whitney <em>U</em> test. Diagnostic performance was assessed using receiver operating characteristic (ROC) analysis and sensitivity, specificity, and Cohen's κ calculation at cutoffs of 0.1, 0.3, and 0.5 cells/μL. Atyp.C values were significantly higher in atypical-cell-positive specimens (<em>p <</em> 0.001). Atypical cell and ICIB positivity showed moderate agreement (Cohen's κ = 0.534; 77 % agreement; <em>p <</em> 0.01). ROC analysis showed an area under the curve of 0.829 for atypical cells, which increased to 0.895 when ICIB-positive samples were considered positive. At a cutoff of 0.1 cells/μL, Atyp.C exhibited high sensitivity (97.8 %) with low specificity (46.5 %) for detecting atypical cells; a 0.3 cells/μL cutoff provided optimal balance (sensitivity 85.2 %, specificity 68.2 %). The UF-5000 Atyp.C parameter effectively detects cells with increased nucleic acid content, including atypical and ICIB-positive cells. Recognizing ICIBs as diagnostically relevant improves screening sensitivity, supporting Atyp.C as a valuable tool for urinalysis. Combining automated detection with manual microscopy may improve the efficiency of atypical cell detection.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"48 ","pages":"Article e00520"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145939753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lead can be found everywhere in the environment and continues to be a public health concern. Lead exposure through kohl is a well-identified problem. In adults, the few reported cases show that this exposure is underestimated. The health consequences of chronic exposure are not well known.
Case report
a 63-year-old woman contacted the Department of Medical Pharmacology and Toxicology to report suffering from numerous neurological disorders. She mentioned having previously undergone toxicological assessments showing abnormally high levels of lead and mercury about three years ago. Several lead tests revealed active lead exposure but at levels considered subtoxic, 170–198 μg/L. Subsequently, several interviews with an internist and a toxicologist allowed the identification of the contamination source: kohl. After discontinuing the use of kohl, it took a year for lead concentrations to drop below 50 μg/L. Apart from neurological symptoms, neither renal function nor hematopoiesis was affected.
Discussion
This is the first case report describing the effects of chronic lead poisoning in adults over a period of more than 40 years. It is crucial to raise awareness among populations about daily using traditional kohls and to avoid these products due to their manufacturing process using galena.
{"title":"A case report of an unconventional chronic lead poisoning resulting from daily eyelid application of kohl","authors":"Charlène Aïn , Antoine Baudriller , Olivier Mathieu , Yoann Cazaubon","doi":"10.1016/j.plabm.2025.e00517","DOIUrl":"10.1016/j.plabm.2025.e00517","url":null,"abstract":"<div><h3>Introduction</h3><div>Lead can be found everywhere in the environment and continues to be a public health concern. Lead exposure through kohl is a well-identified problem. In adults, the few reported cases show that this exposure is underestimated. The health consequences of chronic exposure are not well known.</div></div><div><h3>Case report</h3><div>a 63-year-old woman contacted the Department of Medical Pharmacology and Toxicology to report suffering from numerous neurological disorders. She mentioned having previously undergone toxicological assessments showing abnormally high levels of lead and mercury about three years ago. Several lead tests revealed active lead exposure but at levels considered subtoxic, 170–198 μg/L. Subsequently, several interviews with an internist and a toxicologist allowed the identification of the contamination source: kohl. After discontinuing the use of kohl, it took a year for lead concentrations to drop below 50 μg/L. Apart from neurological symptoms, neither renal function nor hematopoiesis was affected.</div></div><div><h3>Discussion</h3><div>This is the first case report describing the effects of chronic lead poisoning in adults over a period of more than 40 years. It is crucial to raise awareness among populations about daily using traditional kohls and to avoid these products due to their manufacturing process using galena.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"48 ","pages":"Article e00517"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145939755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.plabm.2025.e00516
Sadia Almas , Rob E. Carpenter , Vaibhav K. Tamrakar , Aditya Sharma , Kamalpreet Suri , Salima Karki , Katelyn Kyser , Randy Sronce , Rahul Sharma
The rapid detection of beta-lactam antibiotic resistance is crucial for guiding effective antimicrobial therapy and controlling the spread of resistant bacterial strains. CTX-M Group 1 extended-spectrum beta-lactamases (ESBLs) are among the most prevalent resistance determinants in Gram-negative bacteria, particularly Escherichia coli and Klebsiella pneumoniae, which are major causes of urinary tract infections (UTIs). Conventional molecular diagnostic methods for detecting CTX-M genes rely on nucleic acid extraction before polymerase chain reaction (PCR) amplification. However, these processes are time-consuming, labor-intensive, and resource-intensive, limiting their accessibility in low-resource and high-throughput laboratory settings. This study evaluates Direct-to-PCR (D2P) extraction-free technology as an alternative to traditional extraction-based methods for detecting CTX-M Group 1 genes. A comparative analysis was conducted using reference microbial isolates and clinical urine samples, testing D2P alongside silica column- and magnetic bead-based extraction methods. Quantitative PCR results demonstrated that D2P achieved comparable sensitivity and specificity to traditional extraction methods while significantly reducing sample processing time and cost. Statistical analysis revealed no significant differences (p > 0.05) in cycle threshold (Ct) values between D2P and conventional extraction-based methods, supporting its feasibility as a rapid, cost-effective alternative. The findings suggest that D2P technology may enhance antibiotic resistance surveillance, clinical diagnostics, and infection control programs by enabling faster, extraction-free molecular detection of ESBL-producing pathogens. Further studies should assess its performance in diverse sample matrices and clinical settings.
{"title":"Evaluating extraction-free PCR for rapid detection of beta-lactam antibiotic resistance in urinary tract infection","authors":"Sadia Almas , Rob E. Carpenter , Vaibhav K. Tamrakar , Aditya Sharma , Kamalpreet Suri , Salima Karki , Katelyn Kyser , Randy Sronce , Rahul Sharma","doi":"10.1016/j.plabm.2025.e00516","DOIUrl":"10.1016/j.plabm.2025.e00516","url":null,"abstract":"<div><div>The rapid detection of beta-lactam antibiotic resistance is crucial for guiding effective antimicrobial therapy and controlling the spread of resistant bacterial strains. <em>CTX-M</em> Group 1 extended-spectrum beta-lactamases (ESBLs) are among the most prevalent resistance determinants in Gram-negative bacteria, particularly <em>Escherichia coli</em> and <em>Klebsiella pneumoniae</em>, which are major causes of urinary tract infections (UTIs). Conventional molecular diagnostic methods for detecting <em>CTX-M</em> genes rely on nucleic acid extraction before polymerase chain reaction (PCR) amplification. However, these processes are time-consuming, labor-intensive, and resource-intensive, limiting their accessibility in low-resource and high-throughput laboratory settings. This study evaluates Direct-to-PCR (D2P) extraction-free technology as an alternative to traditional extraction-based methods for detecting <em>CTX-M</em> Group 1 genes. A comparative analysis was conducted using reference microbial isolates and clinical urine samples, testing D2P alongside silica column- and magnetic bead-based extraction methods. Quantitative PCR results demonstrated that D2P achieved comparable sensitivity and specificity to traditional extraction methods while significantly reducing sample processing time and cost. Statistical analysis revealed no significant differences (p > 0.05) in cycle threshold (Ct) values between D2P and conventional extraction-based methods, supporting its feasibility as a rapid, cost-effective alternative. The findings suggest that D2P technology may enhance antibiotic resistance surveillance, clinical diagnostics, and infection control programs by enabling faster, extraction-free molecular detection of ESBL-producing pathogens. Further studies should assess its performance in diverse sample matrices and clinical settings.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"48 ","pages":"Article e00516"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145939752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.plabm.2025.e00518
Li'an Hou , Rui Li , Liangyu Xia , Lu Bai , Shuyi Yang , Peng Li , Ye Zhao , Guoqiang Chen , Shiqing Cheng , Yang Luo , Xiaofei Zhang , Qian Li , Yingqi Liang , Wenyan Niu , Limei Luo , Jianhua Han , Xufu Ye , Bin Yi , Luyan Zhang , Jicai Zhang , Yingchun Xu
Objective
To conduct a multi-center evaluation of the applicability of automated quality control (QC) on fully automated laboratory lines.
Methods
This study assessed the stability and out-of-control rates of both automated and manual QC for 12 biochemical parameters and 11 immunological parameters across 13 hospitals from different regions of China, between January 2021 and July 2021.
Results
Compared to manual QC, which typically requires around 30 min, automated QC significantly reduced processing time to approximately 10 min. Performance comparisons across 23 test items covering 57 testing levels showed no statistically significant difference in sigma (σ) values between automated and manual QC, with both methods achieving σ ≥ 6 in two testing levels of the HCG assay. Additionally, automated QC demonstrated lower out-of-control rates than manual QC: 2.95 % vs. 3.77 % for biochemical tests and 1.54 % vs. 3.10 % for immunoassay tests. Homogeneity analysis revealed that the absolute Bias% between automated and manual QC results within regional peer groups was consistently less than one-quarter of the total allowable error (TEa), indicating good consistency. However, the BIO-RAD peer group showed slightly higher average Bias% values (4.97 %–5.11 %) for both QC methods compared to regional peer groups.
Conclusion
Automated QC demonstrated good consistency with manual QC and met laboratory quality requirements, optimizing internal QC processes. The standardization of automated QC procedures reduced out-of-control rates. Furthermore, automated QC had significant value in promoting the homogeneity of medical test results.
{"title":"Multicenter application and evaluation of automated quality control systems on fully automated assembly lines","authors":"Li'an Hou , Rui Li , Liangyu Xia , Lu Bai , Shuyi Yang , Peng Li , Ye Zhao , Guoqiang Chen , Shiqing Cheng , Yang Luo , Xiaofei Zhang , Qian Li , Yingqi Liang , Wenyan Niu , Limei Luo , Jianhua Han , Xufu Ye , Bin Yi , Luyan Zhang , Jicai Zhang , Yingchun Xu","doi":"10.1016/j.plabm.2025.e00518","DOIUrl":"10.1016/j.plabm.2025.e00518","url":null,"abstract":"<div><h3>Objective</h3><div>To conduct a multi-center evaluation of the applicability of automated quality control (QC) on fully automated laboratory lines.</div></div><div><h3>Methods</h3><div>This study assessed the stability and out-of-control rates of both automated and manual QC for 12 biochemical parameters and 11 immunological parameters across 13 hospitals from different regions of China, between January 2021 and July 2021.</div></div><div><h3>Results</h3><div>Compared to manual QC, which typically requires around 30 min, automated QC significantly reduced processing time to approximately 10 min. Performance comparisons across 23 test items covering 57 testing levels showed no statistically significant difference in sigma (σ) values between automated and manual QC, with both methods achieving σ ≥ 6 in two testing levels of the HCG assay. Additionally, automated QC demonstrated lower out-of-control rates than manual QC: 2.95 % vs. 3.77 % for biochemical tests and 1.54 % vs. 3.10 % for immunoassay tests. Homogeneity analysis revealed that the absolute Bias% between automated and manual QC results within regional peer groups was consistently less than one-quarter of the total allowable error (TEa), indicating good consistency. However, the BIO-RAD peer group showed slightly higher average Bias% values (4.97 %–5.11 %) for both QC methods compared to regional peer groups.</div></div><div><h3>Conclusion</h3><div>Automated QC demonstrated good consistency with manual QC and met laboratory quality requirements, optimizing internal QC processes. The standardization of automated QC procedures reduced out-of-control rates. Furthermore, automated QC had significant value in promoting the homogeneity of medical test results.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"48 ","pages":"Article e00518"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145939754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-16DOI: 10.1016/j.plabm.2025.e00515
Michela Salvatici , Francesca Carreras , Monica Gaimarri , Francesca Delia Sansico , Paolo Marinoni , Chiara Masserini , Barbara Bianchi , Carmen Sommese , Lorenzo Drago
Background
Blood collection tubes can influence sample stability and analytical accuracy. We compared two different commercially available tube systems, Vacutainer® (BD) and Vacusera® (Disera), assessing stability of hematological and biochemical parameters under various preanalytical conditions.
Methods
Residual blood samples from routine laboratory testing were aliquoted into both different tubes. Parameters measured included Red blood cells (RBC), White blood cells (WBC), Hemoglobin (Hb), Potassium (K), Chloride (Cl), Sodium (Na), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Lactate dehydrogenase (LDH), along with hemolysis index. Preanalytical variables included storage temperature (ambient vs 4 °C), storage time (T0, 1h, 3h, 24h), and transport conditions (local vs remote collection sites, with/without pre-centrifugation).
Results
From January 27 to July 31, 2025, 95 samples were analyzed: 49 from the Castellanza Hospital site, located approximately 50 km from the main laboratory (26 stored at room temperature, 23 at 4 °C), and 46 from the Fantoli MultiLab Laboratory (25 samples at room temperature, 21 at 4 °C), yielding 6621 determinations. Comparative analysis demonstrated no clinically significant differences between the two tube types under all tested conditions. Minor variations in K, Na and LDH (Castellanza Hospital site), Hb and ALT (Fantoli MultiLab Laboratory) were within acceptable analytical variation. Hemolysis index remained comparable between tubes in all scenarios, including transport and delayed processing.
Conclusion
Vacutainer® (BD) and Vacusera® (Disera) tube systems showed analytical equivalence across hematology and biochemistry parameters under multiple preanalytical conditions. We conclude that the tubes are suitable for common clinical hematological use and show acceptable performance for common clinical chemistry parameters.
{"title":"Comparative evaluation of two different blood collection tubes for hematological and biochemical testing","authors":"Michela Salvatici , Francesca Carreras , Monica Gaimarri , Francesca Delia Sansico , Paolo Marinoni , Chiara Masserini , Barbara Bianchi , Carmen Sommese , Lorenzo Drago","doi":"10.1016/j.plabm.2025.e00515","DOIUrl":"10.1016/j.plabm.2025.e00515","url":null,"abstract":"<div><h3>Background</h3><div>Blood collection tubes can influence sample stability and analytical accuracy. We compared two different commercially available tube systems, Vacutainer® (BD) and Vacusera® (Disera), assessing stability of hematological and biochemical parameters under various preanalytical conditions.</div></div><div><h3>Methods</h3><div>Residual blood samples from routine laboratory testing were aliquoted into both different tubes. Parameters measured included Red blood cells (RBC), White blood cells (WBC), Hemoglobin (Hb), Potassium (K), Chloride (Cl), Sodium (Na), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Lactate dehydrogenase (LDH), along with hemolysis index. Preanalytical variables included storage temperature (ambient vs 4 °C), storage time (T<sub>0</sub>, 1h, 3h, 24h), and transport conditions (local vs remote collection sites, with/without pre-centrifugation).</div></div><div><h3>Results</h3><div>From January 27 to July 31, 2025, 95 samples were analyzed: 49 from the Castellanza Hospital site, located approximately 50 km from the main laboratory (26 stored at room temperature, 23 at 4 °C), and 46 from the Fantoli MultiLab Laboratory (25 samples at room temperature, 21 at 4 °C), yielding 6621 determinations. Comparative analysis demonstrated no clinically significant differences between the two tube types under all tested conditions. Minor variations in K, Na and LDH (Castellanza Hospital site), Hb and ALT (Fantoli MultiLab Laboratory) were within acceptable analytical variation. Hemolysis index remained comparable between tubes in all scenarios, including transport and delayed processing.</div></div><div><h3>Conclusion</h3><div>Vacutainer® (BD) and Vacusera® (Disera) tube systems showed analytical equivalence across hematology and biochemistry parameters under multiple preanalytical conditions. We conclude that the tubes are suitable for common clinical hematological use and show acceptable performance for common clinical chemistry parameters.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"48 ","pages":"Article e00515"},"PeriodicalIF":1.3,"publicationDate":"2025-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145799424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-15DOI: 10.1016/j.plabm.2025.e00514
Gabriella Iacovetti , Bradley B. Collier , Jill M. Rafalko , Mitchell Peevler , Nicolas Tokunaga , Jason Ragar , Whitney C. Brandon , Matthew R. Chappell , Russell P. Grant , Greg J. Sommer , Ulrich Y. Schaff
Background
Blood specimen transport conditions can have critical impacts on analyte stability and test result accuracy. This study evaluated the impact of multiday storage of specimens at 30 °C and 0 °C, approximating shipment under summer conditions and shipment in contact with melting ice, respectively.
Methods
Blood samples from 16 healthy subjects were processed as serum samples and as clotted whole blood (uncentrifuged) stored at 30 °C on separator gel, and as serum stored in microtainers at 0 °C, each for 24- and 72-h periods prior to analysis. Each sample was analyzed for 20 common analytes and compared to the values from a paired baseline control sample. Mean absolute and/or relative biases were calculated and compared to CLIA acceptance limits.
Results
Serum samples stored at 30 °C for 24- or 72-h met acceptance criteria for all assessed analytes, except for 72-h ALT, Total Bilirubin, Carbon Dioxide, Creatinine, and Sodium. Numerous analytes were unstable at 30 °C in uncentrifuged whole blood, with only Albumin, ALP, Total Bilirubin, Cholesterol, HDL, Total Protein, Triglycerides, Uric Acid, and hsCRP remaining stable up to 72 h. For serum samples stored at 0 °C, all 24- hour and 72-h analytes showed biases within limits.
Conclusion
Storage of serum samples at 0 °C for up to 72 h yielded valid results for all analytes studied. Storage at 30 °C for up to 72-h yielded valid results for most analytes when combined with centrifugation prior to storage. Compared to room temperature storage, ALT and Sodium in serum and whole blood showed signs of accelerated degradation at 30 °C.
{"title":"Assessment of the stability of 20 biochemical analytes in serum and whole blood samples after storage at nonstandard temperatures","authors":"Gabriella Iacovetti , Bradley B. Collier , Jill M. Rafalko , Mitchell Peevler , Nicolas Tokunaga , Jason Ragar , Whitney C. Brandon , Matthew R. Chappell , Russell P. Grant , Greg J. Sommer , Ulrich Y. Schaff","doi":"10.1016/j.plabm.2025.e00514","DOIUrl":"10.1016/j.plabm.2025.e00514","url":null,"abstract":"<div><h3>Background</h3><div>Blood specimen transport conditions can have critical impacts on analyte stability and test result accuracy. This study evaluated the impact of multiday storage of specimens at 30 °C and 0 °C, approximating shipment under summer conditions and shipment in contact with melting ice, respectively.</div></div><div><h3>Methods</h3><div>Blood samples from 16 healthy subjects were processed as serum samples and as clotted whole blood (uncentrifuged) stored at 30 °C on separator gel, and as serum stored in microtainers at 0 °C, each for 24- and 72-h periods prior to analysis. Each sample was analyzed for 20 common analytes and compared to the values from a paired baseline control sample. Mean absolute and/or relative biases were calculated and compared to CLIA acceptance limits.</div></div><div><h3>Results</h3><div>Serum samples stored at 30 °C for 24- or 72-h met acceptance criteria for all assessed analytes, except for 72-h ALT, Total Bilirubin, Carbon Dioxide, Creatinine, and Sodium. Numerous analytes were unstable at 30 °C in uncentrifuged whole blood, with only Albumin, ALP, Total Bilirubin, Cholesterol, HDL, Total Protein, Triglycerides, Uric Acid, and hsCRP remaining stable up to 72 h. For serum samples stored at 0 °C, all 24- hour and 72-h analytes showed biases within limits.</div></div><div><h3>Conclusion</h3><div>Storage of serum samples at 0 °C for up to 72 h yielded valid results for all analytes studied. Storage at 30 °C for up to 72-h yielded valid results for most analytes when combined with centrifugation prior to storage. Compared to room temperature storage, ALT and Sodium in serum and whole blood showed signs of accelerated degradation at 30 °C.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"48 ","pages":"Article e00514"},"PeriodicalIF":1.3,"publicationDate":"2025-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145760774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01DOI: 10.1016/j.plabm.2025.e00512
Sixtus Aguree , Arthur Owora , Patricia Silveyra
Background
Iron deficiency (ID) and iron deficiency anemia (IDA) are common in women of reproductive age, but the influence of menstrual cycle phase on iron biomarkers is not well defined and is often overlooked in clinical and public health assessments.
Aim
To assess phase-specific variation in iron biomarkers and the prevalence of ID and IDA in non-pregnant women aged 18–44 years using 2003–2006 NHANES data.
Methods
We analyzed 1484 women with complete reproductive and iron status data. Menstrual cycle phase was categorized as menstruation (day 1–5), follicular phase (6−15), early/mid luteal phase (16–23), and late luteal phase (24–35). Eight biomarkers were analyzed: serum iron (SI), transferrin saturation (%TS), soluble transferrin receptor (sTfR), ferritin, erythrocyte protoporphyrin (EPP), hemoglobin (Hb), mean corpuscular volume (MCV) and body iron index (BII). ID and IDA were defined using ferritin-, MCV- and BII-based diagnostic models. All statistical models accounted for the complex design of the NHANES survey.
Results
SI and %TS were lowest during menstruation and increased across the cycle, peaking in the early/mid-luteal phase (SI: p = 0.001; %TS: p = 0.003). sTfR was highest during menstruation (p < 0.05) compared to other phases, consistent with increased iron requirements. Ferritin, EPP, Hb and MCV remained stable across phases. The prevalence of ID varied by model (10.5 %–22.0 %) but showed no consistent phase differences. In contrast, the prevalence of IDA decreased after menstruation, with composite IDA estimates dropping from 7.5 % during menstruation to 3.7 % in the late luteal phase (p = 0.033).
Conclusions
Iron biomarkers and IDA prevalence vary systematically across the menstrual cycle, with iron status being lowest during menstruation and recovering in the luteal phase. Consideration of menstrual phase may improve diagnostic accuracy and interpretation of iron biomarkers in women of reproductive age.
背景：铁缺乏症（ID）和缺铁性贫血（IDA）在育龄妇女中很常见，但月经周期对铁生物标志物的影响尚未明确，在临床和公共卫生评估中经常被忽视。目的利用2003-2006年NHANES数据，评估18-44岁非妊娠女性铁生物标志物的阶段性变化以及ID和IDA的患病率。方法对1484例女性进行完整的生殖和铁元素状况分析。月经周期阶段分为月经期（1-5天）、卵泡期（6 - 15天）、早/中黄体期（16-23天）和晚黄体期（24-35天）。分析8项生物指标：血清铁（SI）、转铁蛋白饱和度（%TS）、可溶性转铁蛋白受体（sTfR）、铁蛋白、红细胞原卟啉（EPP）、血红蛋白（Hb）、平均红细胞体积（MCV）和体铁指数（BII）。使用基于铁蛋白、MCV和bii的诊断模型来定义ID和IDA。所有统计模型都解释了NHANES调查的复杂设计。结果SI和%TS在月经期间最低，在月经周期中升高，在黄体前期/中期达到峰值（SI: p = 0.001; %TS: p = 0.003）。与其他时期相比，月经期间sTfR最高（p < 0.05），与铁需求量增加一致。铁蛋白、EPP、Hb和MCV各期均保持稳定。不同模型的ID患病率不同（10.5% - 22.0%），但没有一致的相位差异。相比之下，月经后IDA的患病率下降，综合IDA估计值从月经期间的7.5%下降到黄体晚期的3.7% （p = 0.033）。结论铁生物标志物和IDA患病率在月经周期中存在系统性变化，月经期铁水平最低，在黄体期恢复。考虑月经期可以提高诊断的准确性和对育龄妇女铁生物标志物的解释。
{"title":"Cyclical fluctuations of iron biomarkers in women: Diagnostic implications for iron deficiency","authors":"Sixtus Aguree , Arthur Owora , Patricia Silveyra","doi":"10.1016/j.plabm.2025.e00512","DOIUrl":"10.1016/j.plabm.2025.e00512","url":null,"abstract":"<div><h3>Background</h3><div>Iron deficiency (ID) and iron deficiency anemia (IDA) are common in women of reproductive age, but the influence of menstrual cycle phase on iron biomarkers is not well defined and is often overlooked in clinical and public health assessments.</div></div><div><h3>Aim</h3><div>To assess phase-specific variation in iron biomarkers and the prevalence of ID and IDA in non-pregnant women aged 18–44 years using 2003–2006 NHANES data.</div></div><div><h3>Methods</h3><div>We analyzed 1484 women with complete reproductive and iron status data. Menstrual cycle phase was categorized as menstruation (day 1–5), follicular phase (6−15), early/mid luteal phase (16–23), and late luteal phase (24–35). Eight biomarkers were analyzed: serum iron (SI), transferrin saturation (%TS), soluble transferrin receptor (sTfR), ferritin, erythrocyte protoporphyrin (EPP), hemoglobin (Hb), mean corpuscular volume (MCV) and body iron index (BII). ID and IDA were defined using ferritin-, MCV- and BII-based diagnostic models. All statistical models accounted for the complex design of the NHANES survey.</div></div><div><h3>Results</h3><div>SI and %TS were lowest during menstruation and increased across the cycle, peaking in the early/mid-luteal phase (SI: p = 0.001; %TS: p = 0.003). sTfR was highest during menstruation (p < 0.05) compared to other phases, consistent with increased iron requirements. Ferritin, EPP, Hb and MCV remained stable across phases. The prevalence of ID varied by model (10.5 %–22.0 %) but showed no consistent phase differences. In contrast, the prevalence of IDA decreased after menstruation, with composite IDA estimates dropping from 7.5 % during menstruation to 3.7 % in the late luteal phase (p = 0.033).</div></div><div><h3>Conclusions</h3><div>Iron biomarkers and IDA prevalence vary systematically across the menstrual cycle, with iron status being lowest during menstruation and recovering in the luteal phase. Consideration of menstrual phase may improve diagnostic accuracy and interpretation of iron biomarkers in women of reproductive age.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"47 ","pages":"Article e00512"},"PeriodicalIF":1.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145614219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号