Practical Laboratory Medicine最新文献

{"title":"Temperature stability of urinary F2-isoprostane and 8-hydroxy-2′-deoxyguanosine","authors":"Katarzyna Kordas ,&nbsp;Diala Ghazal ,&nbsp;Elena I. Queirolo ,&nbsp;James R. Olson ,&nbsp;María Inés Beledo ,&nbsp;Richard W. Browne","doi":"10.1016/j.plabm.2024.e00373","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00373","url":null,"abstract":"<div><h3>Background</h3><p>Clinical and epidemiological studies employ long-term temperature storage but the effect of temperature on the stability of oxidative stress (OS) markers is unknown. We investigated the effects of storage at −20 °C and −80 °C over 4–9 months on F₂-isoprostanes (F₂-IsoP) and 8-hydroxy-2<em>′</em>-deoxyguanosine (8-OHdG) levels in urine of children, a population group among whom the measurement of these markers is still limited.</p></div><div><h3>Methods</h3><p>Paired spot urine samples from 87 children aged 8.9–16.9 years (52.9% boys) were analyzed. Samples were preserved with 0.005% (w/v) butylated hydroxytoluene, portioned and stored within 2.5 h (median) of collection. Samples were analyzed in duplicate or triplicate using commercial ELISA kits and their correlations were evaluated.</p></div><div><h3>Results</h3><p>F₂-IsoP and 8-OHdG showed high correlations (Spearman rho of 0.90 and 0.97, respectively; P &lt; 0.0001) with storage at −20 °C and −80 °C. There was a strong agreement among categories of values for F₂-IsoP (Kappa = 0.76 ± 0.08, agreement = 83.9%, P &lt; 0.0001) and 8-OHdG: (Kappa = 0.83 ± 0.08, agreement = 88.4%, P &lt; 0.0001). The correlation between the temperatures for F₂-IsoP concentrations was also high when stored for &lt;4 (0.93), 4 (0.93), and 5 months (0.88), all P &lt; 0.0001. For 8-OHdG, Spearman correlations at &lt;8, 8, and 9 months of storage at −20 °C and −80 °C were 0.95, 0.98, and 0.96 (all P &lt; 0.0001), respectively.</p></div><div><h3>Conclusions</h3><p>Urine storage with BHT for up to nine months at a temperature of −20 °C to −80 °C yields highly comparable concentrations of F₂-IsoP and 8-OHdG.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00373"},"PeriodicalIF":1.9,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000192/pdfft?md5=1f9c3849178398128514fbaedf3434f7&pid=1-s2.0-S2352551724000192-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139935561","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}

{"title":"Establishing reference intervals for soluble urokinase plasminogen activator receptor in Northern European adults","authors":"Stine Bakkensen Bruun ,&nbsp;Jeppe Buur Madsen ,&nbsp;Claus Lohman Brasen","doi":"10.1016/j.plabm.2024.e00371","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00371","url":null,"abstract":"<div><h3>Objectives</h3><p>Soluble urokinase plasminogen activator receptor (suPAR) may have untapped potential in clinical diagnostics. Previous studies determined reference intervals using an enzyme-linked immunoassay, but there is a need for reference intervals using a faster assay if the analysis is to be used in emergency medicine. The current study aims to determine reference intervals for suPAR using a fully automated particle-enhanced turbidimetric immunoassay (PETIA) according to the Clinical and Laboratory Standards Institute guideline A28-A3c.</p></div><div><h3>Design and methods</h3><p>Blood samples were prospectively collected from Danish blood donors. Plasma suPAR was analyzed on the cobas 8000 module c502 in an open channel using a PETIA. Sex-partitioned reference intervals were determined using a parametric quantile approach.</p></div><div><h3>Results</h3><p>The study included 241 participants—123 females and 118 males. The common reference interval for suPAR was 1.56–4.11 ng/mL (95% confidence intervals (CI) for the lower and upper limits were 1.56–1.63 and 3.81–4.47, respectively). The reference interval for females was 1.59–4.65 ng/mL (95% CIs 1.48–1.70 and 4.09–5.48, respectively) and for males, 1.56–3.59 ng/mL (95% CIs 1.47–1.65 and 3.31–3.93, respectively).</p></div><div><h3>Conclusions</h3><p>Our results support using sex-partitioned reference intervals for suPAR and provide a basis for future studies using the PETIA method.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00371"},"PeriodicalIF":1.9,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000179/pdfft?md5=f335061a211165e564c72fb37dceb885&pid=1-s2.0-S2352551724000179-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139907696","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}

{"title":"Correlation between variant call accuracy and quality parameters in comprehensive cancer genomic profiling tests","authors":"Hideaki Isago,&nbsp;Kousuke Watanabe,&nbsp;Yumiko Satoh,&nbsp;Makoto Kurano","doi":"10.1016/j.plabm.2024.e00369","DOIUrl":"10.1016/j.plabm.2024.e00369","url":null,"abstract":"<div><h3>Background</h3><p>Comprehensive genomic profiling (CGP) tests have been widely utilized in clinical practice. In this test, the variant list automatically output from the data analysis pipeline often contains false-positive variants, although the correlation between the quality parameters and prevalence of false-positive variants remains unclear.</p></div><div><h3>Methods</h3><p>We analyzed 125 CGP tests performed in our laboratory. False-positive variants were manually detected via visual inspection. The quality parameters of both wet and dry processes were also analyzed.</p></div><div><h3>Results</h3><p>Among the 125 tests, 52 (41.6%) required more than one correction of the called variants, and 21 (16.8%) required multiple corrections. A significant correlation was detected between somatic false-positive variants and quality parameters in the wet (ΔΔCq, pre-capture library peak size, pre-capture library DNA amount, capture library peak size, and capture library concentration) and dry processes (total reads, mapping rates, duplication rates, mean depth, and depth coverage). Capture library concentration and mean depth were strong independent predictors of somatic false-positive variants.</p></div><div><h3>Conclusions</h3><p>We demonstrated a correlation between somatic false-positive variants and quality parameters in the CGP test. This study facilitates gaining a better understanding of CGP test quality management.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00369"},"PeriodicalIF":1.9,"publicationDate":"2024-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000155/pdfft?md5=482fb8d2769a4b2634936ad7334284a5&pid=1-s2.0-S2352551724000155-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139832288","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}

{"title":"Performance evaluation of the new Sysmex XR-Series haematology analyser","authors":"Kenichi Fujimaki ,&nbsp;Kornelia Hummel ,&nbsp;Immaculate Magonde ,&nbsp;Katharina Dammert ,&nbsp;Yoshiko Hamaguchi ,&nbsp;Konstantinos Mintzas ,&nbsp;Jarob Saker ,&nbsp;Ondrej Valina ,&nbsp;Klaus-Martin Otte","doi":"10.1016/j.plabm.2024.e00370","DOIUrl":"10.1016/j.plabm.2024.e00370","url":null,"abstract":"<div><h3>Background</h3><p>The new XR-Series haematology analyser from Sysmex provides increased throughput and automation, along with a new reagent in WDF channel for optimised WBC differential.</p></div><div><h3>Methods</h3><p>An analytical performance study for the XR analyser was conducted to evaluate the WDF channel parameters in comparison to the instrument specifications. Additionally, 7460 samples were measured on XR and XN analysers to compare selected parameters and flags, and 930 randomly selected samples were further evaluated with microscopy.</p></div><div><h3>Results</h3><p>All investigated aspects of the analytical performance study for the XR fell within the manufacturer specifications. The correlation coefficients between the two systems for the parameters tested were greater than 0.983 for the main CBC and DIFF parameters, greater than 0.909 for the Extended Inflammation Parameters, and greater than 0.932 for the parameters used in the workflow rulesets of the <em>Extended</em> IPU. Similarly high sensitivities for the detection of abnormal cells were observed for the ‘Blasts/Abn Lympho?’ flag (XN: 100%, XR: 99.0%) and WPC abnormal flags (‘Blasts?’ or ‘Abn Lympho?‘) (XN: 97.0%, XR: 96.0%). XN with WPC channel had a 26% reduction of false positive smears compared to XR with 22% reduction, a statistically non-significant difference.</p></div><div><h3>Conclusion</h3><p>The XR analyser had very good analytical performance, and highly comparable results to the predecessor XN analyser in all investigated parameters, flags and workflow aspects.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00370"},"PeriodicalIF":1.9,"publicationDate":"2024-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000167/pdfft?md5=b03d47a7f3e5f233a84c776dd83c29fb&pid=1-s2.0-S2352551724000167-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139822697","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}

{"title":"Analysis of quality metrics in comprehensive cancer genomic profiling using a dual DNA–RNA panel","authors":"Kousuke Watanabe ,&nbsp;Shinji Kohsaka ,&nbsp;Kenji Tatsuno ,&nbsp;Aya Shinozaki-Ushiku ,&nbsp;Hideaki Isago ,&nbsp;Hidenori Kage ,&nbsp;Tetsuo Ushiku ,&nbsp;Hiroyuki Aburatani ,&nbsp;Hiroyuki Mano ,&nbsp;Katsutoshi Oda","doi":"10.1016/j.plabm.2024.e00368","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00368","url":null,"abstract":"<div><h3>Background</h3><p>The nucleic acid quality from formalin-fixed paraffin-embedded (FFPE) tumor vary among samples, resulting in substantial variability in the quality of comprehensive cancer genomic profiling tests. The objective of the study is to investigate how nucleic acid quality affects sequencing quality. We also examined the variations in nucleic acid quality among different hospitals or cancer types.</p></div><div><h3>Methods</h3><p>Three nucleic acid quality metrics (ddCq, Q-value, and DV200) and five sequencing quality metrics (on-target rate, mean depth, coverage uniformity, target exon coverage, and coverage of the housekeeping gene) were examined using 585 samples from the Todai OncoPanel, a dual DNA–RNA panel.</p></div><div><h3>Results</h3><p>In the DNA panel, ddCq served as an indicator of sequencing depth and Q-value reflected the uniformity of sequencing across different regions. It was essential to have favorable values not only for ddCq but also for Q-value to obtain ideal sequencing results. For the RNA panel, DV200 proved to be a valuable metric for assessing the coverage of the housekeeping genes. Significant inter-hospital differences were observed for DNA quality (ddCq and Q-value), but not for RNA quality (DV200). Differences were also observed among cancer types, with Q-value being the lowest in lung and the highest in cervix, while DV200 was the highest in lung and the lowest in bowel.</p></div><div><h3>Conclusions</h3><p>We demonstrated distinct characteristics and high predictive performances of ddCq, Q-value, and DV200. Variations were observed in the nucleic acid quality across hospitals and cancer types. Further study is warranted on preanalytical factors in comprehensive cancer genomic profiling tests.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00368"},"PeriodicalIF":1.9,"publicationDate":"2024-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000143/pdfft?md5=0d4f364d688beec09b431ca258e9bb7d&pid=1-s2.0-S2352551724000143-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139748352","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}

{"title":"Laboratory tests for investigating anemia: From an expert system to artificial intelligence","authors":"Philippe Halfon ,&nbsp;Guillaume Penaranda ,&nbsp;Dan Ringwald ,&nbsp;Frederique Retornaz ,&nbsp;Nicolas Boissel ,&nbsp;Sylvain Bodard ,&nbsp;Jean Marc Feryn ,&nbsp;David Bensoussan ,&nbsp;Patrice Cacoub","doi":"10.1016/j.plabm.2024.e00357","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00357","url":null,"abstract":"<div><h3>Objective</h3><p>To compare the laboratory tests conducted in real-life settings for patients with anemia with the expected prescriptions derived from an optimal checkup.</p></div><div><h3>Methods</h3><p>A panel of experts formulated an “optimal laboratory test assessment\" specific to each anemia profile. A retrospective analysis was done of the laboratory tests conducted according to the type of anemia (microcytic, normocytic or macrocytic). Using an algorithmic system, the laboratory tests performed in real-life practice were compared with the recommendations suggested in the “optimal laboratory test assessment” and with seemingly “unnecessary” laboratory tests.</p></div><div><h3>Results</h3><p>In the analysis of the “optimal laboratory test assessment”, of the 1179 patients with microcytic anemia, 269 (22.8%) had had one of the three tests recommended by the expert system, and only 33 (2.8%) had all three tests. For normocytic anemia, 1054 of 2313 patients (45.6%) had one of the eleven recommended tests, and none had all eleven. Of the 384 patients with macrocytic anemia, 196 (51%) had one of the four recommended tests, and none had all four. In the analysis of “unnecessary laboratory tests\", one lab test was unnecessarily done in 727/3876 patients (18.8%), i.e. 339 of 1179 (28.8%) microcytic, 171 of 2313 (7.4%) normocytic, and 217 of 384 (56.5 %) macrocytic anemias.</p></div><div><h3>Conclusion</h3><p>Laboratory investigations of anemia remain imperfect as more than half of the cases did not receive the expected tests. Analyzing other diagnostic domains, the authors are currently developing an artificial intelligence system to assist physicians in enhancing the efficiency of their laboratory test prescriptions.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00357"},"PeriodicalIF":1.9,"publicationDate":"2024-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000039/pdfft?md5=2ffe98457e0edcdbb69e1c04318ccbe6&pid=1-s2.0-S2352551724000039-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139748353","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}

{"title":"Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation","authors":"Maria Gonçalves-Reis ,&nbsp;Daniela Proença ,&nbsp;Laura P. Frazão ,&nbsp;João L. Neto ,&nbsp;Sílvia Silva ,&nbsp;Hugo Pinto-Marques ,&nbsp;José B. Pereira-Leal ,&nbsp;Joana Cardoso","doi":"10.1016/j.plabm.2024.e00365","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00365","url":null,"abstract":"<div><h3>Objectives</h3><p>To verify the analytical performance of the HepatoPredict kit, a novel tool developed to stratify Hepatocellular Carcinoma (HCC) patients according to their risk of relapse after a Liver Transplantation (LT).</p></div><div><h3>Methods</h3><p>The HepatoPredict tool combines clinical variables and a gene expression signature in an ensemble of machine-learning algorithms to forecast the benefit of a LT in HCC patients. To ensure the accuracy and reliability of this method, extensive analytical validation was conducted to verify its specificity and robustness. The experiments were designed following the guidelines for multi-target genomic assays such as ISO201395-2019, MIQE, CLSI-MM16, CLSI-MM17, and CLSI-EP17-A. The validation process included reproducibility between operators and between RNA extractions and RT-qPCR runs, and interference of input RNA levels or varying reagent levels. A recently retrained version of the HepatoPredict algorithms was also tested.</p></div><div><h3>Results</h3><p>The validation process demonstrated that the HepatoPredict kit met the required standards for robustness (p &gt; 0.05), analytical specificity (inclusivity of 95 %), and sensitivity (LoB, LoD, linear range, and amplification efficiency between 90 and 110 %). The operator, equipment, input RNA, and reagents used had no significant effect on the HepatoPredict results. Additionally, the testing of a recently retrained version of the HepatoPredict algorithm, showed that this new version further improved the accuracy of the kit and performed better than existing clinical criteria in accurately identifying HCC patients who are more likely to benefit LT.</p></div><div><h3>Conclusions</h3><p>Even with the introduced variations in molecular and clinical variables, the HepatoPredict kit's prognostic information remains consistent. It can accurately identify HCC patients who are more likely to benefit from a LT. Its robust performance also confirms that it can be easily integrated into standard diagnostic laboratories.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00365"},"PeriodicalIF":1.9,"publicationDate":"2024-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000118/pdfft?md5=95ebd2e890d2b47d236002b5f3c43a33&pid=1-s2.0-S2352551724000118-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139715009","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}

{"title":"Double trouble: Unmasking two hook effects on Siemens Atellica® - Total PSA and total hCG assays","authors":"Meryem Benamour ,&nbsp;Pauline Brouwers ,&nbsp;Arnaud Nevraumont,&nbsp;Tatiana Roy,&nbsp;Jean-Louis Bayart","doi":"10.1016/j.plabm.2024.e00366","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00366","url":null,"abstract":"<div><p>The “hook effect” or “prozone phenomenon” occurs when the concentration of a particular analyte saturates the antibodies used in the test, resulting in falsely low or negative results despite the presence of high analyte concentrations. We report two recent cases of hook effect encountered with a widely used immunoassay analyzer, the Siemens Atellica® IM1600. The first case involves a patient with advanced metastatic prostate cancer whose total PSA (tPSA) concentration dropped dramatically from his last biological control. The second case concerns a pregnant woman whose total HCG (ThCG) levels were also subject to the hook effect and who was found to have a molar pregnancy. In both cases, a dilution step enabled to overcome this analytical concern and to obtain a correct result. In addition, a comparison of the sensitivity of different immunoassay analyzers to this phenomenon was carried out. To avoid this analytical error, an additional dilution step should automatically be performed when there is a clinical suspicion of elevated levels of tumor or hormone markers. Finally, the most affected manufacturers should adapt their assays, accordingly.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00366"},"PeriodicalIF":1.9,"publicationDate":"2024-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S235255172400012X/pdfft?md5=6861192cd5f0bc2bd10e0891cdb63103&pid=1-s2.0-S235255172400012X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139675727","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}

{"title":"Assessment of novel POCT to evaluate liver function","authors":"Carmen Minea ,&nbsp;Damien Gruson","doi":"10.1016/j.plabm.2024.e00367","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00367","url":null,"abstract":"<div><h3>Objectives</h3><p>Point of care testing (POCT) offers the possibility of near bedside patient testing with a reduction of the turn-around time of analysis. The aim of our study was to determine the analytical performances and usability of a recently developed POCT device for the measurement of tests related to liver function. We evaluated the performance of a liver tests panel performed on the LINX EVO® POCT device.</p></div><div><h3>Design and methods</h3><p>The imprecision was determined with the Bio-Rad Liquichek Unassayed Chemistry Control. Method comparison was performed with a Cobas® 8000 analyzer. Samples from twenty healthy volunteers were used to verify the reference intervals. Furthermore, practicality was assessed by the healthcare staff handling the POCT device through a dedicated questionnaire.</p></div><div><h3>Results</h3><p>The imprecision observed was matching the criteria for the in-lab assay with only one exception, globulin, with an observed imprecision of 6.3 % and a criteria of 5.7 %. With the exception of total and direct bilirubin, the POCT method showed good agreement with the in-lab methods. The verification of reference intervals showed that more than 90 % of the healthy volunteer values were included into the reference interval claimed by the manufacturer except for glucose and globulin. The POCT practicality questionnaire was satisfying overall for users.</p></div><div><h3>Conclusions</h3><p>Our study showed very good analytical performances overall for the liver test panel performed on the LINX EVO® POCT instrument.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00367"},"PeriodicalIF":1.9,"publicationDate":"2024-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000131/pdfft?md5=fa54cc037eeb88fae3c1cac455bea5c4&pid=1-s2.0-S2352551724000131-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139675228","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}

{"title":"Evaluation and experience from routine use of chemiluminescence assays for serological screening of blood and plasma donations on the Alinity s system and the Alinity i system, two new fully-automated immunoassay systems in Poland","authors":"Aneta Kopacz ,&nbsp;Dorota Kubicka-Russel ,&nbsp;Grzegorz Liszewski ,&nbsp;Alicja Bukowska ,&nbsp;Sylwia Samek ,&nbsp;Dorota Malka ,&nbsp;Magdalena Łętowska ,&nbsp;Piotr Grabarczyk","doi":"10.1016/j.plabm.2024.e00364","DOIUrl":"10.1016/j.plabm.2024.e00364","url":null,"abstract":"<div><p>In Poland, independent evaluations under the auspices of the Institute of Hematology and Transfusion Medicine (IHTM) are mandated for any new device, assay, systems for screening samples from whole blood and plasma donors prior to implementation by Blood Transfusion Center (BTC). In last 5 years, two new systems were introduced to the market by Abbott GmbH, namely the Alinity s and the Alinity i. The evaluations performed for these two systems included the assessment of sensitivity, specificity and precision for each of the four mandatory serological screening markers in Poland: Hepatitis B Surface Antigen (HBsAg), Hepatitis C virus antibodies (Anti-HCV), HIV antibodies (anti-HIV) and Syphilis antibodies (anti-<em>Treponema pallidum,</em> anti-TP). Sensitivity was assessed by testing seroconversion panels, HBsAg international reference standard, well characterized local samples, and dilution panels. Specificity was assessed by testing routine donor samples. The results from Alinity i assays were compared to the results from Abbott ARCHITECT i2000SR and Ortho VITROS 3600 assays, while the results from Alinity s assays were compared to the results of ARCHITECT i2000SR assays. The evaluation of the Alinity s and Alinity i assays for sensitivity (100 %), specificity (99,92–100 %) and precision generated results that were as good as or better than generated by routinely used systems, were within acceptance criteria, and met all requirements for screening blood donor samples in accordance with Polish regulations. The specificity of the assays in routine use by BTCs, analyzed after approximately 150,000 donations on both systems, was comparable to the specificity observed during the evaluations at IHTM.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00364"},"PeriodicalIF":1.9,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000106/pdfft?md5=2084406dcb4697eab73ce30be4c33222&pid=1-s2.0-S2352551724000106-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139639358","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}