Practical Laboratory Medicine最新文献

{"title":"A novel case of Hb Bart's hydrops fetalis following prenatal diagnosis: Case report from Huizhou, China","authors":"Zeyan Zhong ,&nbsp;Dina Chen ,&nbsp;Zhiyang Guan ,&nbsp;Guoxing Zhong ,&nbsp;Zhiyong Wu ,&nbsp;Jianmin Chen ,&nbsp;Jianhong Chen","doi":"10.1016/j.plabm.2024.e00438","DOIUrl":"10.1016/j.plabm.2024.e00438","url":null,"abstract":"<div><h3>Objective</h3><div>Presentation of a novel case of a patient with Hb Bart's hydrops fetalis, which was accurately identified by SMRT sequencing leading to expand the mutation spectrum of α-thalassemia.</div></div><div><h3>Case report</h3><div>A 26-year-old pregnant woman and her husband underwent molecular analysis of thalassemia due to abnormal hematological results. The molecular analysis showed that the pregnant woman carried -α^3.7/--^SEA, while her husband exhibited a negative result. Accordingly, the pregnant woman continued the pregnancy until the 19-week gestational age. She was subsequently referred to our department for genetic counseling due to abnormal ultrasound findings in the fetus. A novel deletional α-thal mutation was detected for the husband by MLPA, and the precise location of the mutation was determined through SMRT sequencing, which revealed a 45.2 kb deletion. Later, an interventional umbilical cord blood puncture was offered for the pregnant woman. The cord blood was subjected to capillary electrophoresis, which revealed apparent Hb Bart's and Hb Portland peaks associated with Hb Bart's hydrops fetalis syndrome.</div></div><div><h3>Conclusion</h3><div>It is imperative that Hb Bart's hydrops fetalis syndrome be diagnosed with the utmost expediency. If results of molecular analysis are not consistent with the clinical hematological findings, the presence of a novel thalassemia could be suspected. To identify the novel genotype, the SMRT sequencing represents an effective method for achieving an accurate diagnosis.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00438"},"PeriodicalIF":1.7,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142533310","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":"Comparison of qPCR and chromogenic culture methods for rapid detection of group B streptococcus colonization in Vietnamese pregnant women","authors":"Manh-Tuan Ha ,&nbsp;Huyen Tran-Thi-Bich ,&nbsp;Thao Bui-Thi-Kim ,&nbsp;My-Linh Nguyen-Thi ,&nbsp;Thanh Vu-Tri ,&nbsp;Thuy-Duong Ho-Huynh ,&nbsp;Tuan-Anh Nguyen","doi":"10.1016/j.plabm.2024.e00435","DOIUrl":"10.1016/j.plabm.2024.e00435","url":null,"abstract":"<div><h3>Introduction</h3><div>Neonatal infections can rapidly become severe, with delays in treatment often proving fatal. <em>Streptococcus agalactiae</em> (Group B <em>Streptococcus</em>, GBS) is a common cause, typically transmitted from colonized pregnant women to neonates during childbirth. In Vietnam, routine prenatal care lacks standardized GBS screening protocols. This study aims to compare enhanced qPCR methods with the culture method, evaluate the diagnostic accuracy of these qPCR procedures, and assess the frequency of GBS infection in pregnant Vietnamese women during their final trimester.</div></div><div><h3>Materials and methods</h3><div>Pregnant women aged 35 weeks gestation or more were recruited. Rectovaginal swabs were collected and analyzed for GBS using chromogenic culture, a commercial real-time PCR kit, and in-house real-time PCR assays targeting the <em>cfb</em> and <em>sip</em> genes. Clinical diagnostic values were calculated, and GBS prevalence was determined.</div></div><div><h3>Results</h3><div>The study included 259 pregnant women with a mean age of 30.2 ± 5.0 years. Of these, 96.6 % had gestational ages of 37 weeks or more at delivery. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the <em>cfb</em>-based and sip-based qPCR assays were 94.1/92.7, 99.0/99.5, 97.1/98.5, 97.8/97.3, and 97.6 %, respectively. The Kappa values were excellent (0.940 and 0.939), with results available in under 2 h. GBS prevalence was 24.7 % and 25.5 % by <em>cfb</em>-based and <em>sip</em>-based qPCR assays, aligning with the culture method (25.5 %).</div></div><div><h3>Conclusions</h3><div>Both direct real-time PCR assays demonstrated high accuracy and were comparable to chromogenic culture in diagnosing GBS. A significant prevalence of GBS colonization was found among Vietnamese pregnant women in their final trimester.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00435"},"PeriodicalIF":1.7,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142445068","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":"The interference and elimination of nitrite on determination of total urinary protein by Pyrogallol Red–Molybdate method","authors":"Shijian Fan ,&nbsp;Jiaqing Liu ,&nbsp;Yu Wei ,&nbsp;Jie Yao ,&nbsp;Juan Cheng ,&nbsp;Yang Tong ,&nbsp;Qiang Zhou ,&nbsp;Yuanhong Xu","doi":"10.1016/j.plabm.2024.e00436","DOIUrl":"10.1016/j.plabm.2024.e00436","url":null,"abstract":"<div><h3>Background</h3><div>Some urine samples showed negative values of total urinary protein by Pyrogallol red–molybdate (PRM) method. Interestingly, these samples showed notably high levels of nitrite in the urine dipstick test.</div></div><div><h3>Methods</h3><div>A total of 120 urine samples were collected and categorized into four groups (0 - &lt; 100, 100-&lt;500, 500-&lt;1000, ≥1000 mg/L) based on total urinary protein concentration. Various concentrations of nitrite (2, 10, 50, 100, and 200 mg/L) were added to urine samples to investigate potential interference of nitrite in total urinary protein measurement by the PRM method. Additionally, different concentrations of L-ascorbic acid (100, 500, 1000, and 2000 mg/L) were added to urine-nitrite mixtures to explore the possibility of reversing the interference effects.</div></div><div><h3>Results</h3><div>2 mg/L nitrite had no impact on the test results.10 mg/L nitrite only showed significant effects on the detection results among the groups with 0 - &lt; 100 and 100-&lt;500 mg/L (P &lt; 0.05). 200 mg/L nitrite caused a noticeable decrease in the urinary protein detection results of the four groups (0 - &lt; 100, 100-&lt;500, 500-&lt;1000, ≥1000 mg/L), and the concentrations were reduced to 2.7 %, 26.85 %, 75.22 %, and 89.33 % of their original levels, respectively. 500 mg/L L-ascorbic acid effectively eliminated the interference from 200 mg/L nitrite and almost had no effect on detection.</div></div><div><h3>Conclusions</h3><div>Nitrite had negative effect on the detection of total urinary protein by PRM method and L-ascorbic acid was effective in counteracting the interference caused by nitrite.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00436"},"PeriodicalIF":1.7,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142442029","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":"Validation of a LC-MS/MS assay for citric acid, cysteine and oxalic acid determination and its application to explore pre-analytical sample storage","authors":"Ying Shen ,&nbsp;Xia Luo ,&nbsp;Qing Guan ,&nbsp;Wenjie Lou ,&nbsp;Liming Cheng","doi":"10.1016/j.plabm.2024.e00433","DOIUrl":"10.1016/j.plabm.2024.e00433","url":null,"abstract":"<div><h3>Objectives</h3><div>Citrate, oxalate and cystine in 24-h urine are considered to be associated with the incidence and recurrence risk of urinary stone disease (USD). An evaluation of the LC-MS/MS kit for simultaneous quantification of the three analytes was undertaken.</div></div><div><h3>Design</h3><div>&amp; Methods: The analytical performance of the kit was investigated based on FDA, EMA and CLSI guidelines. To promote the standardization of sample storage, this kit has been applied to perform systematic pre-analytical stability study of these analytes in urine.</div></div><div><h3>Results</h3><div>This method was validated with good linearity with accuracy of 93.1%–104 %. Intra-day and inter-day imprecision were ≤5.55 % and 5.34 %, respectively. Recoveries of citrate, oxalate and cystine added to clinical samples were in the range of 92.0–103 %, 94.8–100 % and 99.0–107 % with CV ≤ 5.52 %. It was recommended that urine preserved with hydrochloric acid could be preferable in consideration of both reliable test results and neglected sample heterogeneity.</div></div><div><h3>Conclusions</h3><div>This kit is suitable for measurement of citrate, oxalate and cystine for understanding the etiology of urinary stones, and the proper storage of urine samples is crucial for the correctness of the test results.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00433"},"PeriodicalIF":1.7,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142424977","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 Eu3+-based CRP/SAA and PCT/IL-6 lateral flow immunoassay kits and their diagnostic value in respiratory tract infections","authors":"Mingxin Lin ,&nbsp;Jing Zhang ,&nbsp;Jianxing Cai ,&nbsp;Jumei Liu ,&nbsp;Min Zhu ,&nbsp;Ke Li ,&nbsp;Miaoyun Hu ,&nbsp;Chenxi Li ,&nbsp;Huiming Ye","doi":"10.1016/j.plabm.2024.e00432","DOIUrl":"10.1016/j.plabm.2024.e00432","url":null,"abstract":"<div><h3>Objectives</h3><div>Respiratory infections are among the most common infectious diseases, resulting in significant morbidity and mortality. C-reactive protein (CRP), serum amyloid A (SAA), procalcitonin (PCT), and interleukin-6 (IL-6) are advantageous for diagnosing respiratory tract infections. This study assessed the analytical performance and accuracy of new kits for Eu3⁺-based CRP/SAA and PCT/IL-6 lateral flow immunoassay and its diagnostic value in respiratory tract infections.</div></div><div><h3>Methods</h3><div>This study evaluated the detection performance of a test kit using guidelines from the Center for Medical Device Evaluation (CMDE) and the Clinical and Laboratory Standards Institute (CLSI). The test results were compared to those of the commercial kits (CRP: Mindray; SAA: Norman; PCT: Shanghai Upper; IL-6: Wantai BioPharm). A total of 156 patients with respiratory tract infections (53 with bacterial infections (Bac group); 50 with viral infections (Vir group); and 53 with co-infections (Bac + Vir group)) were enrolled, along with 50 healthy controls (HC group). Venous blood samples were collected to measure levels of SAA, PCT, CRP, and IL-6 using both the test and commercial kits. The diagnostic value of these biomarkers was assessed using receiver operating characteristic (ROC) curves.</div></div><div><h3>Results</h3><div>Correlation analysis demonstrated a strong concordance between the test kits and commercial kits (CRP: r = 0.9396, P &lt; 0.0001; SAA: r = 0.8986, P &lt; 0.0001; PCT: r = 0.9594, P &lt; 0.0001; IL-6: r = 0.9009, P &lt; 0.0001). The diagnostic performance of the test kits in identifying bacterial, viral, and co-infections was highly consistent with that of the commercial kit.</div></div><div><h3>Conclusions</h3><div>The Eu3⁺-based CRP/SAA and PCT/IL-6 lateral flow immunoassay test kits demonstrated high levels of consistency with commercial kits in terms of quantitative outcomes and diagnostic performance for respiratory tract infections.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00432"},"PeriodicalIF":1.7,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142357188","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":"The potential relationship between EasyNAT system Tt values and Cobas z480 Ct values in the detection of SARS-Cov-2","authors":"Lu-Qing Zheng,&nbsp;Qing-Yong Wang","doi":"10.1016/j.plabm.2024.e00431","DOIUrl":"10.1016/j.plabm.2024.e00431","url":null,"abstract":"<div><h3>Objectives</h3><div>This study aimed to evaluate the potential relationship between the time threshold (Tt) values of a commercial EasyNAT system, which is based on cross priming amplification (CPA) technology, and the cycle threshold (Ct) values of the Cobas z480 analyzer, which is based on a real-time fluorescence polymerase chain reaction (PCR) method, in the detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) from oropharyngeal swabs. Design and Methods: Data were retrospectively collected from a clinical laboratory between December 4, 2022 and July 1, 2024.</div></div><div><h3>Results</h3><div>A total of 277 EasyNAT-positive samples (Tt values from 3.83 to 29.5) were simultaneously investigated using the Cobas z480 analyzer (Ct values from 10.74 to 38.78). The concordance rate between the two systems was 100 %. Among the positive samples, the mean and maximum PCR Ct values of O and N genes increased in line with increasing Tt values of the left and right amplification areas of the EasyNAT system. The maximum Ct values of the O or N gene determined by the Cobas z480 analyzer were no more than 29.52 when the Tt values of the left or right amplification areas of the UC0116 analyzer were no more than 6.</div></div><div><h3>Conclusions</h3><div>The safe, simple, fast, accurate, and automatic EasyNAT system used in conjunction with a PCR system might be a better choice for the detection of SARS-CoV-2 in hospitals, especially in settings without sophisticated PCR facilities. The Tt value (≤6) of the EasyNAT system can be a reference index for estimating the maximum Ct value (29.52) in SARS-CoV-2-positive samples.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00431"},"PeriodicalIF":1.7,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142425000","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 considerations in the assessment of 25-hydroxyvitamin D in pregnant women by automated immunoassays","authors":"Darya Ayad Khalid ,&nbsp;Bijan Nouri ,&nbsp;Shakhawan Abdulrahman Mustafa ,&nbsp;Mohammad Abdi","doi":"10.1016/j.plabm.2024.e00430","DOIUrl":"10.1016/j.plabm.2024.e00430","url":null,"abstract":"<div><h3>Background</h3><div>Because of the pathophysiological role of vitamin D in health, there is an increased interest to check the clinical status of this vitamin. Immunochemical assays are commonly employed to determine 25-hydroxyvitamin D (25 (OH) D) in clinical laboratories and its testing could be influenced by pre-analytic and analytic issues. The aim of this study was to compare the 25(OH)D results obtained from three commonly used immunoassays in pregnant women to check a possible discrepancy between tests.</div></div><div><h3>Material and methods</h3><div>A group of 50 pregnant women who were in their third trimester were included in this study. The quantification of serum vitamin D was performed utilizing three immunochemistry-based assays including Elecsys, VIDAS and Alegria. We also involved 21 non-pregnant volunteers to clinically assess the vitamin D status in this group of people.</div></div><div><h3>Results</h3><div>Our findings revealed a significant inconsistency between the obtained results from three assays for serum 25(OH)D. The 25(OH)D showed higher values when measured by the Elecsys assay while the VIDAS assay had lower values compared to the other immunoassays. More notably, the 25(OH)D testing in non-pregnant subjects showed consistent results in all three immunoassays.</div></div><div><h3>Conclusions</h3><div>The results of the 25(OH)D measurements in pregnant women should be interpreted carefully due to a great inaccuracy in immunoassay testing. There is no such disagreement in non-pregnant people. Standardization of vitamin D testing in various settings is a crucial matter for clinical laboratories.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00430"},"PeriodicalIF":1.7,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142357189","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":"Biochemical indices of patients with enteric fever and pancreatitis: A comparative cross-sectional study","authors":"Nathaniel Ebo Aidoo ,&nbsp;Emmanuel Kwaku Ofori ,&nbsp;Vincent Boima ,&nbsp;Eric Nana Yaw Nyarko ,&nbsp;John Cletus Osei ,&nbsp;Clement G. Darkwah ,&nbsp;Morris O. Gayflor ,&nbsp;Seth K. Amponsah ,&nbsp;Henry Asare-Anane","doi":"10.1016/j.plabm.2024.e00429","DOIUrl":"10.1016/j.plabm.2024.e00429","url":null,"abstract":"<div><h3>Objective</h3><div>Enteric fever (EF), a potentially fatal febrile illness, is prevalent in developing countries. Elevated levels of lipase and amylase in serum, typically associated with acute pancreatitis (AP), have been observed in patients with EF. The elevated enzymes in both conditions may lead to diagnostic confusion and care delays. This study aimed to determine biochemical indices that are peculiar to EF and AP.</div></div><div><h3>Methods</h3><div>A cross-sectional comparative study was conducted at the Korle-Bu Teaching Hospital, Ghana. Volunteers were categorized into three groups: EF (n = 32), AP (n = 30) and healthy controls (n = 31). A standard questionnaire was used to collect socio-demographic and clinical information from the participants. Blood and stool samples were obtained, followed by biochemical analysis: total amylase, lipase, pancreatic amylase, serum elastase 1, hepatic enzymes, calcium, magnesium, phosphate, stool colour, stool pH, and stool fat presence.</div></div><div><h3>Results</h3><div>The AP group displayed higher total amylase, lipase, elastase-1, alkaline phosphatase, aspartate aminotransferase, and gamma-glutamyl transferase levels compared to the EF and control groups (<em>p</em> &lt; 0.05 respectively). Elastase 1 levels were found to be high in all AP participants, whereas no elevations were observed in the EF group. Positive associations were observed in the AP and EF groups for lipase vs total amylase (ρ = .543, <em>p</em> = 0.001; ρ = .543, <em>p</em> = 0.001 for both).</div></div><div><h3>Conclusions</h3><div>Elevated levels of total/pancreatic amylase and lipase were found to be indicative of a patient with AP and EF. Further, elastase-1 was found to be a good biomarker to distinguish between AP and EF.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00429"},"PeriodicalIF":1.7,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142320182","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":"Exploring free pregnancy associated plasma protein a (fPAPP-A) as a biomarker in early pregnancy","authors":"Jesper Friis Petersen ,&nbsp;Vilma Tiittanen ,&nbsp;Saara Wittfooth ,&nbsp;Ellen Løkkegaard ,&nbsp;Lennart Jan Friis-Hansen","doi":"10.1016/j.plabm.2024.e00428","DOIUrl":"10.1016/j.plabm.2024.e00428","url":null,"abstract":"<div><h3>Objectives</h3><div>In combined first trimester screening for Down syndrome, Pregnancy-Associated Plasma Protein A (PAPP-A) is pivotal. PAPP-A tests evaluate total PAPP-A, consisting of the biologically active free PAPP-A (fPAPP-A) and PAPP-A complexed with eosinophil major basic protein's proform (proMBP). While PAPP-A is well-researched, limited understanding persists regarding fPAPP-A's first trimester concentrations and diagnostic utility.</div></div><div><h3>Design</h3><div>and methods: PAPP-A and fPAPP-A levels were gauged in 602 serum samples at 2-week intervals (gestational weeks 4–14) from 159 women with delivery of a healthy neonate and 80 samples from 37 miscarriages. The final sample at the time of diagnosis from women who miscarried was included in analyses.</div></div><div><h3>Results</h3><div>During the first trimester, PAPP-A and fPAPP-A levels displayed significant and strong correlation (r = 0.94), with median values doubling weekly. Free PAPP-A constituted only 3.0 % of PAPP-A over gestational weeks. Low fPAPP-A linked to miscarriage (p &lt; 0.001), maternal weight (p &lt; 0.001), and smoking (p = 0.02). For miscarriage prediction fPAPP-A was equal to PAPP-A (area under the receiver operating characteristics curve 0.79 vs. 0.81, p = 0.44).</div></div><div><h3>Conclusions</h3><div>Investigating fPAPP-A presence and concentration directly in first trimester serum has not been done previously. This study report lower fPAPP-A values than anticipated from prior enzymatic studies of fPAPP-A. fPAPP-A was not superior to PAPP-A as a first trimester biomarker in this dataset.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00428"},"PeriodicalIF":1.7,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142424976","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 performance evaluation of a new integrated clinical chemistry and immunoassay analyzer","authors":"Ulla Ruffing,&nbsp;Sabrina Mickeler,&nbsp;Michaela Kraft,&nbsp;Peter Findeisen","doi":"10.1016/j.plabm.2024.e00427","DOIUrl":"10.1016/j.plabm.2024.e00427","url":null,"abstract":"<div><h3>Background</h3><p>Clinical laboratories perform a wide range of tests that are used by healthcare professionals to guide medical decision making. Use of automated analyzers in the clinical laboratory can improve patient care by not only reducing the turn-around-time (TAT) of results but also improving accuracy of the reported results by reducing human error. The aim of this study was to evaluate the performance characteristics of a new automated laboratory instrument, the Atellica® CI Analyzer, Model 1900, over a 3-month period in a European laboratory setting.</p></div><div><h3>Methods</h3><p>Analytical performance of 17 analytes (13 chemistry and four immunochemistry) was assessed by evaluating repeatability and within-laboratory precision using anonymized remnant serum samples. Method comparison studies were performed on the Atellica CI Analyzer and the Roche cobas® 6000.</p></div><div><h3>Results</h3><p>Excellent precision was observed with coefficients of variation (CVs) less than 2 % for repeatability and less than 3 % within-laboratory imprecision for most analytes. Comparison of select assays with the cobas 6000 system resulted in correlation coefficients ranging from 0.980 to 1.000.</p></div><div><h3>Conclusion</h3><p>This is the first reported evaluation of the Atellica CI Analyzer in a clinical laboratory setting. The strong analytical performance of the Atellica CI Analyzer demonstrates that this instrument is suitable for routine clinical use.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"41 ","pages":"Article e00427"},"PeriodicalIF":1.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000738/pdfft?md5=7ddf564e23e32bba0c10890fee87712a&pid=1-s2.0-S2352551724000738-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142163636","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}