Scopus Publications
- ASSESSING INTRA-AND INTER-ANALYSER IMPRECISION IN AUTOMATED HEMATOLOGICAL LABORATORIES
Giuseppe Lippi, Marco Tosi, Mariateresa Rizza, Gian Salvagno, Laura Pighi
Journal of Medical Biochemistry, 2026
Background: Reliable haematology results are crucial for patient diagnosis and monitoring. Maintaining low variability is particularly important for key parameters such as haemoglobin, white blood cells, and platelets, especially in automated laboratory workflows where multiple haematological analysers are connected in the same line. Methods: Two residual whole blood samples, one normal and one pathological, were analysed in ten consecutive replicates on a Sysmex XN-10 analyser (XN-1) and then on a second connected analyser (XN-2). Intra-analyser and inter-analyser imprecision were calculated as coefficients of variation (CV%). Results: Intra-analyser CVs for the normal sample ranged from 0.3% for haemoglobin to 1.5% white blood cells, while inter-analyser CVs remained below 2%. For the pathological sample, intra-analyser CVs ranged from 0.3% to 1.0%, and inter-analyser CVs reached 2.1% for hematocrit and platelets. Red blood cell count, mean corpuscular volume, and neutrophils showed CVs <1.9%. Higher variability was observed for low-abundance populations such as eosinophils and basophils (up to 20%). Conclusions: Sysmex XN-10 analysers exhibit strong intraand inter-analyser precision for most routine haematology tests, supporting their routine use in automated haematological lines. - Intra-and inter-analyzer imprecision of cell population data on Sysmex XN-10
Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine, 2026 - Analytical performance of the Roche Elecsys TnT hs Gen 6 immunoassay
Marco Tosi, Laura Pighi, Claudia Lo Cascio, Filippo Marcazzan, Mariateresa Rizza, Eveline Cremonese, Davide Negrini, Giorgio Gandini, Brandon M. Henry, Gian Luca Salvagno, Giuseppe Lippi
Clinical Chemistry and Laboratory Medicine, 2026
Objectives The acute coronary syndrome (ACS) is a leading cause of morbidity and mortality worldwide, with timely diagnosis being critical for improving outcomes. Since high-sensitivity cardiac troponin (hs-cTn) assays have become the gold standard for detecting myocardial injury, this study aimed to evaluate the analytical performance of the novel Roche Elecsys TnT hs Gen 6 (TNT6ST) immunoassay. Methods The TNT6ST immunoassay was assessed for intra- and inter-assay imprecision, linearity, limit of blank (LoB), limit of detection (LoD), functional sensitivity, and 99th percentile upper reference limit (URL). Comparisons were made with the previous Elecsys hs-cTnT immunoassay (TNTHSSTX). Hemolysis interference was evaluated in plasma samples with serially induced hemolysis. Results TNT6ST exhibited excellent precision (intra-assay CV 0.8–2.0 %, inter-assay 1.5–2.4 %), linearity (r=1.00), LoB of 0.939 ng/L, LoD of 1.201 ng/L, and functional sensitivity of 1.255 ng/L. The 99th percentile URL was 20.9 ng/L overall, 30.5 ng/L in males, and 13.7 ng/L in females. Comparison with TNTHSSTX showed strong correlation (r=0.995) but a systematic bias, with TNT6ST overestimating cTnT by around 66 %. Hemolysis decreased cTnT values in both assays, but TNT6ST remained within the allowable total error, while TNTHSSTX exceeded this threshold at higher hemolysis levels. Conclusions The novel Roche TNT6ST immunoassay demonstrates superior precision, sensitivity, and robustness to hemolysis compared with its predecessor, with excellent correlation across a wide cTnT range, supporting its reliability for introduction into routine clinical practice. - Evaluating the accuracy of ChatGPT in classifying normal and abnormal blood cell morphology
Davide Negrini, Laura Pighi, Marco Tosi, Giuseppe Lippi
Clinical Chemistry and Laboratory Medicine, 2025 - Performance assessment of ChatGPT in classification of urine particles
Laura Pighi, Davide Negrini, Marco Tosi, Giuseppe Lippi
Scandinavian Journal of Clinical and Laboratory Investigation, 2025
SirThe identification and classification of urine particles remain important in the diagnostics and monitoring of kidneys diseases, hematuria and the urinary tract infections [1]; analyzing compone... - Investigating the incremental value of urine sediment reporting in emergency medicine with a Sysmex® UN urinalysis system
Marco Tosi, Davide Negrini, Giovanni Celegon, Martina Montagnana, Giuseppe Lippi
Advances in Laboratory Medicine, 2024
Resumen Objetivos El análisis de orina es ampliamente utilizado y frecuentemente solicitado desde los servicios de urgencias para evaluar la presencia de hipovolemia, infecciones del tracto urinario, diabetes, cetoacidosis y hematuria. Nuestro objetivo era evaluar el impacto de informar el sedimento urinario en muestras enviadas desde el servicio de urgencias utilizando el analizador Sysmex® Serie-UN. Métodos Evaluamos los análisis de orina solicitados por el servicio de urgencias durante un periodo de tres meses e investigamos la interferencia del recuento de hematíes, comparamos las tiras reactivas de esterasa leucocitaria con el recuento de leucocitos citofluorimétrico y los nitritos con el recuento bacteriano citofluorimétrico. A continuación, examinamos las imágenes con el microscopio digital para identificar otros posibles elementos o patologías de interés. Resultados Recopilamos 532 casos, en 354 de los cuales solo se disponía de análisis bioquímico y citofluorimetríco, y en 178 se disponía además de análisis por microscopía digital. El recuento automatizado de eritrocitos mostró una tasa de error del 7 %, principalmente falsos positivos. La esterasa leucocitaria tuvo una sensibilidad del 88,22 % y una especificidad del 88,84 % en el límite inferior, mientras que los nitritos tuvieron una sensibilidad del 41,06 % y una especificidad del 99,38 %. Se detectaron elementos patológicos en 126 muestras mediante microscopía digital, de los cuales 70 presentaban cilindros, 36 cristales y 7 contenían células de elevado valor patológico. Conclusiones La evaluación de los sedimentos en orina por parte de especialistas capacitados puede aportar información potencialmente relevante incluso en casos urgentes, donde la fase preanalítica debe ser siempre tenida en cuenta. - Investigating the incremental value of urine sediment reporting in emergency medicine with a Sysmex UN urinalysis system
Marco Tosi, Davide Negrini, Giovanni Celegon, Martina Montagnana, Giuseppe Lippi
Advances in Laboratory Medicine, 2024
Objectives Urinalysis is widely used and is also frequently requested in emergency situations for screening hypovolemia, urinary tract infections, diabetes, ketoacidosis and hematuria. Our aim was to evaluate the impact of reporting urinary sediment in emergency department specimens with the Sysmex UN system. Methods We evaluated urinalyses requested by the emergency department over a three-month period and examined red blood cell count interference, compared leukocyte esterase dipsticks to cytofluorimetric leukocyte count and nitrites to cytofluorimetric bacterial count. We then examined digital microscopy images to identify additional elements of interest or pathology. Results We collected 532 cases, 354 with only chemical and cytofluorimetric analysis and 178 with digital microscopy. Automated erythrocyte counting showed a 7 % error rate, mainly false-positive results. Leukocyte esterase had a sensitivity of 88.22 % and specificity of 88.84 % at the lower limit, while nitrites had a sensitivity of 41.06 % and a specificity of 99.38 %. Pathological elements were detected in 126 samples by digital microscopy: 70 had casts, 36 crystals and seven cells with high pathological value. Conclusions Evaluation of urine sediments by trained specialists can provide potentially important information even in emergency situations, whereby the pre-analytical phase must always be taken into account. - Evaluation of alternative approaches to the reference method for the urine osmolality test
Biochimica Clinica, 2024 - Effect of syringe underfilling on the quality of venous blood gas analysis
Giuseppe Lippi, Laura Pighi, Marco Tosi, Marco Vettori, Giovanni Celegon, Emmanuel J. Favaloro, Gian Luca Salvagno
Diagnosis, 2024
Objectives There is limited information on the influence of collecting small amounts of blood on the quality of blood gas analysis. Therefore, the purpose of this study was to investigate the effects of different degrees of underfilling of syringes on test results of venous blood gas analysis. Methods Venous blood was collected by venipuncture from 19 healthcare workers in three 1.0 mL syringes for blood gas analysis, by manually aspirating different volumes of blood (i.e., 1.0, 0.5 and 0.25 mL). Routine blood gas analysis was then immediately performed with GEM Premier 5,000. The results of the two underfilled syringes were compared with those of the reference syringe filled with appropriate blood volume. Results The values of most assayed parameters did not differ significantly in the two underfilled syringes. Statistically significant variations were found for lactate, hematocrit and total hemoglobin, the values of which gradually increased as the fill volume diminished, as well as for sodium concentration, which decreased in both insufficiently filled blood gas syringes. The bias was clinically meaningful for lactate in syringe filled with 0.25 mL of blood, and for hematocrit, total hemoglobin and sodium in both syringes containing 0.5 and 0.25 mL of blood. Conclusions Collection of smaller volumes of venous blood than the specified filling volume in blood gas syringes may have an effect on the quality of some test results, namely lactate, hematocrit, total hemoglobin and sodium. Specific indications must be given for standardizing the volume of blood to be collected within these syringes. - Incomplete filling of spray-dried K2EDTA evacuated blood tubes: Impact on measuring routine hematological parameters on Sysmex XN-10
Giuseppe Lippi, Francesco Dima, Marco Tosi, Giovanni Carpenè, Giovanni Celegon, Emmanuel J. Favaloro, Gian Luca Salvagno
Diagnosis, 2023
Objectives Because there is little published evidence on the effects of incomplete filling of K2EDTA evacuated blood tubes on routine hematological testing, this original study aimed to provide updated information on this preanalytical aspect. Methods The study population consisted of 17 ostensibly healthy volunteers. Blood was drawn by venipuncture with a 10 mL syringe and dispensed in varying amounts (0.2, 0.5, 1.0, 2.0, and 3.0 mL) into 3.0 mL blood tubes containing spray-dried 5.4 mg K2EDTA. All tubes were gently mixed and used to perform routine hematology tests on the Sysmex XN-10. Clinically significant variations were defined when the limits of desirable specifications of bias derived from biologic variation were exceeded. Results The desirable bias was exceeded in 33 % filled tubes (1.0 mL) for hematocrit and MCV (increased values) and for MCHC (decreased values), while it was exceeded in 17 % filled tubes (0.5 mL) for hemoglobin, hematocrit and MCV (increased values), and for MCHC (decreased values). Finally, the variation of values was higher than the desirable bias for RBC, hemoglobin, hematocrit and MCV (increase), and for MCHC and MPV (decrease) in 7 % filled tubes (0.2 mL). No clinically significant variations were observed in tubes filled up to 67 % of their nominal volume (i.e., 2.0 mL). Conclusions Consideration should be given to reject spray-dried K2EDTA blood tubes that contain a blood volume <67 % of the nominal fill volume, as biased laboratory data in these samples may interfere with clinical decision making and care management.
RECENT SCHOLAR PUBLICATIONS
- Analytical performance of the Roche Elecsys TnT hs Gen 6 immunoassay
M Tosi, L Pighi, C Lo Cascio, F Marcazzan, M Rizza, E Cremonese, ...
Clinical Chemistry and Laboratory Medicine (CCLM) , 2026
2026.0 - Intra-and inter-analyzer imprecision of cell population data on Sysmex XN-10
M Tosi, L Pighi, M Rizza, GL Salvagno, G Lippi
EJIFCC 37 (1), 159 , 2026
2026.0 - Assessing Intra-and Inter-Analyzer Imprecision in Automated Hematological Laboratories
L Pighi, M Tosi, M Rizza, GL Salvagno, G Lippi
Journal of Medical Biochemistry 45 (2), 261-264 , 2026
2026.0 - Evaluating the accuracy of ChatGPT in classifying normal and abnormal blood cell morphology
D Negrini, L Pighi, M Tosi, G Lippi
Clinical Chemistry and Laboratory Medicine (CCLM) 63 (6), e143-e145 , 2025
2025.0
Citations: 4 - Performance assessment of ChatGPT in classification of urine particles
L Pighi, D Negrini, M Tosi, G Lippi
Scandinavian Journal of Clinical and Laboratory Investigation 85 (3), 223-227 , 2025
2025.0
Citations: 1 - Estudio sobre el valor incremental que supone el informe del sedimento en orina en medicina de urgencias mediante el sistema Sysmex ® Serie-UN
M Tosi, D Negrini, G Celegon, M Montagnana, G Lippi
Advances in Laboratory Medicine/Avances en Medicina de Laboratorio 5 (4 … , 2024
2024.0 - Investigating the incremental value of urine sediment reporting in emergency medicine with a Sysmex UN urinalysis system
M Tosi, D Negrini, G Celegon, M Montagnana, G Lippi
Advances in Laboratory Medicine/Avances en Medicina de Laboratorio 5 (4 … , 2024
2024.0
Citations: 1 - Evaluation of alternative approaches to the reference method for the urine osmolality test.
D Negrini, RFG Celegon, M Tosi, G Carpenè, G Lippi
Biochimica Clinica 48 (3) , 2024
2024.0 - Effect of syringe underfilling on the quality of venous blood gas analysis
G Lippi, L Pighi, M Tosi, M Vettori, G Celegon, EJ Favaloro, GL Salvagno
Diagnosis 11 (1), 91-96 , 2024
2024.0
Citations: 2 - Incomplete filling of spray-dried K 2 EDTA evacuated blood tubes: impact on measuring routine hematological parameters on Sysmex XN-10
G Lippi, F Dima, M Tosi, G Carpenè, G Celegon, EJ Favaloro, ...
Diagnosis 10 (4), 440-445 , 2023
2023.0
Citations: 8 - Screening rapporti Proteine/Creatinina ed Albumina/Creatinina urinari: quanto possiamo fidarci del dipstick?
G CELEGON, M TOSI, D NEGRINI, M MONTAGNANA, G LIPPI
MOST CITED SCHOLAR PUBLICATIONS
- Incomplete filling of spray-dried K 2 EDTA evacuated blood tubes: impact on measuring routine hematological parameters on Sysmex XN-10
G Lippi, F Dima, M Tosi, G Carpenè, G Celegon, EJ Favaloro, ...
Diagnosis 10 (4), 440-445 , 2023
2023.0
Citations: 8 - Evaluating the accuracy of ChatGPT in classifying normal and abnormal blood cell morphology
D Negrini, L Pighi, M Tosi, G Lippi
Clinical Chemistry and Laboratory Medicine (CCLM) 63 (6), e143-e145 , 2025
2025.0
Citations: 4 - Effect of syringe underfilling on the quality of venous blood gas analysis
G Lippi, L Pighi, M Tosi, M Vettori, G Celegon, EJ Favaloro, GL Salvagno
Diagnosis 11 (1), 91-96 , 2024
2024.0
Citations: 2 - Performance assessment of ChatGPT in classification of urine particles
L Pighi, D Negrini, M Tosi, G Lippi
Scandinavian Journal of Clinical and Laboratory Investigation 85 (3), 223-227 , 2025
2025.0
Citations: 1 - Investigating the incremental value of urine sediment reporting in emergency medicine with a Sysmex UN urinalysis system
M Tosi, D Negrini, G Celegon, M Montagnana, G Lippi
Advances in Laboratory Medicine/Avances en Medicina de Laboratorio 5 (4 … , 2024
2024.0
Citations: 1 - Analytical performance of the Roche Elecsys TnT hs Gen 6 immunoassay
M Tosi, L Pighi, C Lo Cascio, F Marcazzan, M Rizza, E Cremonese, ...
Clinical Chemistry and Laboratory Medicine (CCLM) , 2026
2026.0 - Intra-and inter-analyzer imprecision of cell population data on Sysmex XN-10
M Tosi, L Pighi, M Rizza, GL Salvagno, G Lippi
EJIFCC 37 (1), 159 , 2026
2026.0 - Assessing Intra-and Inter-Analyzer Imprecision in Automated Hematological Laboratories
L Pighi, M Tosi, M Rizza, GL Salvagno, G Lippi
Journal of Medical Biochemistry 45 (2), 261-264 , 2026
2026.0 - Estudio sobre el valor incremental que supone el informe del sedimento en orina en medicina de urgencias mediante el sistema Sysmex ® Serie-UN
M Tosi, D Negrini, G Celegon, M Montagnana, G Lippi
Advances in Laboratory Medicine/Avances en Medicina de Laboratorio 5 (4 … , 2024
2024.0 - Evaluation of alternative approaches to the reference method for the urine osmolality test.
D Negrini, RFG Celegon, M Tosi, G Carpenè, G Lippi
Biochimica Clinica 48 (3) , 2024
2024.0 - Screening rapporti Proteine/Creatinina ed Albumina/Creatinina urinari: quanto possiamo fidarci del dipstick?
G CELEGON, M TOSI, D NEGRINI, M MONTAGNANA, G LIPPI
