Evaluation of hemolysis, lipemia, and icterus interference with common clinical immunoassays.

OBJECTIVES: Hemolysis, icterus, and lipemia (HIL) are common sources of endogenous interference in clinical laboratory testing. Defining the threshold of interference for immunoassays enables appropriate reporting of their results when they are affected by HIL. METHODS: Pools of residual patient serum samples were spiked with a known amount of interferent to create samples with varying concentrations of hemolysate, bilirubin, and Intralipid that mimicked the effects of endogenous HIL. Samples were analysed on the Alinity i analyser (Abbott Diagnostics) for more than 25 immunoassays. The average recovery relative to the non-spiked sample was calculated for each interference level and was compared to a predefined allowable bias. RESULTS: C-peptide, estradiol, serum folate, free T4, homocysteine, insulin, and vitamin B12 were found to be affected by hemolysis, at hemoglobin concentrations between 0.3 to 20 g/L. Immunoassays for BNP, estradiol, free T3, and homocysteine were affected by icterus at conjugated bilirubin concentrations between 50 to 1,044 µmol/L. BNP, serum folate, and homocysteine were affected by Intralipid with measured triglyceride concentrations between 0.8 to 10 mmol/L. Lastly, serological immunoassays for HIV and hepatitis A, B and C were also affected by interferences. CONCLUSIONS: Immunoassays are impacted by varying degrees of HIL interference. Some measurands, in the presence of interference, are affected in a manner not previously indicated. The data presented herein provide an independent evaluation of HIL thresholds and will be of aid to resource-limited clinical laboratories that are unable to internally verify endogenous interferences when implementing the Alinity i analyser.

Pediatric reference interval verification for 17 specialized immunoassays and cancer markers on the Abbott Alinity i system in the CALIPER cohort of healthy children and adolescents.

OBJECTIVES: Clinical laboratory investigation of autoimmune, metabolic, and oncologic disorders in children and adolescents relies on appropriateness of reference intervals (RIs). The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) previously established comprehensive pediatric RIs for specialized immunoassays on the Abbott ARCHITECT system. Herein, we aim to verify performance on new Alinity i assays by evaluating sera collected from healthy children as per Clinical and Laboratory Standards Institute (CLSI) EP-28A3C guidelines. METHODS: Precision, linearity, and method comparison experiments were completed for 17 specialized Alinity immunoassays, including cancer antigens, autoimmune peptides, and hormones. Sera collected from healthy children and adolescents (birth-18 years, n=100) were evaluated. CLSI-based verification was completed using previously established CALIPER RIs for ARCHITECT assays as the reference. RESULTS: Of 17 specialized immunoassays assays, only anti-cyclic citrullinated peptides (anti-CCP) did not meet acceptable verification criterion (i.e., ≥90% of results within ARCHITECT reference CI). Anti-thyroglobulin, anti-thyroid peroxidase, and carcinoembryonic antigen did not require age-specific consideration beyond one year of age, with 63, 91, and 80% of samples equalling the limit of detection, respectively. Estimates were separated by sex for relevant assays (e.g., sex hormone binding globulin, total and free prostate specific antigen). CONCLUSIONS: Findings support transferability of pediatric RIs on ARCHITECT system to the Alinity system for 16 specialized immunoassays in the CALIPER cohort and will be a useful resource for pediatric clinical laboratories using Alinity assays. Further work is needed to establish evidence-based interpretative recommendations for anti-CCP and continue to evaluate pediatric RI acceptability for newly available assay technologies.

Pediatric reference interval verification for endocrine and fertility hormone assays on the Abbott Alinity system.

OBJECTIVES: The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has developed an extensive database of reference intervals (RIs) for several biomarkers on various analytical systems. In this study, pediatric RIs were verified for key immunoassays on the Abbott Alinity system based on the analysis of healthy children samples and comparison to comprehensive RIs previously established for Abbott ARCHITECT assays. METHODS: Analytical performance of Alinity immunoassays was first assessed. Subsequently, 100 serum samples from healthy children recruited with informed consent were analyzed for 16 Alinity immunoassays. The percentage of test results falling within published CALIPER ARCHITECT reference and confidence limits was determined. If ≥ 90% of test results fell within the confidence limits, they were considered verified based on CLSI guidelines. If <90% of test results fell within the confidence limits, additional samples were analyzed and new Alinity RIs were established. RESULTS: Of the 16 immunoassays assessed, 13 met the criteria for verification with test results from ≥ 90% of healthy serum samples falling within the published ARCHITECT confidence limits. New CALIPER RIs were established for free thyroxine and prolactin on the Alinity system. Estradiol required special considerations in early life. CONCLUSIONS: Our data demonstrate excellent concordance between ARCHITECT and Alinity immunoassays, as well as the robustness of previously established CALIPER RIs for most immunoassays, eliminating the need for de novo RI studies for most parameters. Availability of pediatric RIs for immunoassays on the Alinity system will assist clinical laboratories using this new platform and contribute to improved clinical decision-making.

Pediatric reference interval verification for common biochemical assays on the Abbott Alinity system.

OBJECTIVES: The quality of clinical laboratory service depends on quality laboratory operations and accurate test result interpretation based on reference intervals (RIs). As new analytical systems continue to be developed and improved, previously established RIs must be verified. The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has established comprehensive RIs for many biomarkers on several analytical systems. Here, published CALIPER RIs for 28 chemistry assays on the Abbott ARCHITECT were assessed for verification on the newer Alinity system. METHODS: An analytical validation was first completed to assess assay performance. CALIPER serum samples (100) were analyzed for 28 chemistry assays on the Alinity system. The percentage of results falling within published pediatric ARCHITECT reference and confidence limits was determined for each analyte. Based on Clinical and Laboratory Standards Institute (CLSI) guidelines, if ≥90% of test results fell within confidence limits of ARCHITECT assay RIs, they were considered verified. RESULTS: Of the 28 assays assessed, 26 met the criteria for verification. Reference values for calcium and magnesium did not meet the criteria for verification with 87% and 35% falling within previously established ARCHITECT confidence limits, respectively. However, both assays could be verified using pediatric RIs provided in the Abbott Alinity package insert. CONCLUSIONS: In this study, CALIPER ARCHITECT RIs were verified on the Alinity system for several chemistry assays. These data demonstrate excellent concordance for most assays between the Abbott ARCHITECT and Alinity systems and will assist in the implementation of the Alinity system in pediatric healthcare institutions.

Complete blood count and cell population data parameters from the Abbott Alinity hq analyzer are useful in differentiating myelodysplastic syndromes from other forms of cytopenia.

INTRODUCTION: Myelodysplastic syndromes (MDS) are characterized by morphologic dysplasia and cytopenia and have a propensity for acute leukemic transformation. However, dysplasia is diagnosed by morphology, thus having cell population data (CPD) that can differentiate cytopenic patients with MDS from other conditions may facilitate accurate diagnosis. We assessed the utility of complete blood count (CBC) parameters and CPD derived from an Abbott Alinity hq analyzer to discriminate MDS-related cytopenia. METHODS: The patient cohort (n = 345) included 64 samples from patients with MDS, 162 from patients with other cytopenia, and 119 from healthy controls. The hematological parameters and research use-only parameters of the Abbott Alinity hq analyzer were compared between the cytopenic groups. The effectiveness of the individual standard and research CBC parameters to differentiate MDS from other forms of cytopenia was assessed through a receiver operating characteristics (ROC) analysis. RESULTS: The percentage of MAC (Macrocytic RBCs) and hemoglobin distribution width (HDW) were higher in the MDS group than in the other cytopenia group and showed the greatest difference between both groups, with an area under the curve (AUC) of 0.766 (0.678-0.855) and 0.786 (0.702-0.870), respectively. The platelet distribution width was higher in the MDS group than in the other cytopenia group, with an AUC of 0.697 (0.623-0.770). WBC CPD extracted from histograms, especially Atyp-PMN-loc and Neu-ALL-M, showed high AUCs of 0.815 (0.750-0.879) and 0.778 (0.711-0.845), respectively. CONCLUSION: Our findings demonstrate the clinical utility of CPD and hematology parameters of the Abbott Alinity hq analyzer in the differential diagnosis of MDS.

Performance evaluation of platelet counting of Abbott Alinity hq and Sysmex XN-9000 automated hematology analyzer compared with international reference method.

INTRODUCTION: Accurate platelet counting is essential for risk assessment of bleeding and thrombosis. Abbott Alinity hq hematology analyzer was recently introduced, and its performance in platelet counting has yet to be evaluated comprehensively. In this study, we evaluated the performance of the optical platelet counting of Abbott Alinity hq (Alinity-PLT) and the impedance and fluorescent platelet counting of Sysmex XN-9000 (XN-PLT-I and XN-PLT-F) compared with the international reference method. METHODS: Blood samples were analyzed via Alinity hq and XN-9000 with PLT-F channel. Immuno-platelet (ImmnoPLT) reference method was performed with CD41/CD61 antibodies using FACSLyricTM flow cytometer (BD). Precision was determined using 10 replicates in a single run, and the platelet counts of Alinity-PLT, XN-PLT-I, XN-PLT-F, and ImmnoPLT were compared. RESULTS: At a platelet count of 13 × 109 /L, the CVs of Alinity-PLT, XN-PLT-I, and XN-PLT-F were 4.2%, 6.7%, and 4.3%, respectively, and at a platelet count of 44 × 109 /L, all showed a CV of less than 3%. For the total 210 samples, all three methods showed a very strong correlation with ImmunoPLT (r > 0.99). For platelet levels below 20 × 109 /L, XN-PLT-F showed the strongest correlation with ImmunoPLT (r = 0.975), and for platelet levels of 20-100 × 109 /L, Alinity-PLT and XN-PLT-I were comparable to ImmunoPLT. For platelet levels of 100-450 × 109 /L, XN-PLT-I was the most comparable to ImmunoPLT, and for platelet levels above 450 × 109 /L, Alinity-PLT was comparable to ImmunoPLT. CONCLUSIONS: All three methods were highly correlated with ImmunoPLT, and each method had different performance advantages according to the platelet levels.

Performance evaluation of the prototype Abbott Alinity hq hematology analyzer.

INTRODUCTION: The analytical and clinical performance as well as the workflow efficiency of the novel, prototype Alinity hq hematology analyzer was evaluated in the clinical laboratory of Universitair Ziekenhuis Brussel, Department of Hematology, Brussels, Belgium. METHODS: Within-run and within-laboratory imprecision, linearity, and carryover were assessed using clinical blood samples and commercial blood products. Four hundred and seventeen samples were selected for method comparison with Abbott CELL-DYN Sapphire, and for flagging performance analysis in comparison with smear review and manual microscopic white blood cell (WBC) differential. RESULTS: Within-run and within-laboratory imprecision verification demonstrated low %CV for complete blood count and WBC differential results within the normal ranges (0.1%-10.4%), except for basophil granulocytes. The linearity of the analytical measuring ranges was verified for WBCs, red blood cells, hemoglobin, and platelets. Alinity hq results showed strong agreement with those of CELL-DYN Sapphire. Good correlation was demonstrated with manual WBC differential results, with negative bias for neutrophil (NEU) granulocytes, and positive bias for lymphocytes and monocytes. Blasts were detected with 75% sensitivity and 96% specificity at 1% blast threshold, and 100% sensitivity at 5% blast threshold. Immature granulocyte detection was more sensitive (81% vs 76%, P = 0.086) and specific (88% vs 78%, P = 0.0002) than with CELL-DYN Sapphire. Nucleated red blood cell detection was more sensitive (89% vs 63%, P < 0.001) and just slightly less specific (96% vs 99%, P = 0.0067) than with CELL-DYN Sapphire. Re-run and reflex testing rates were lower with Alinity hq. CONCLUSION: The Alinity hq hematology analyzer is suitable for clinical use.

Performance evaluation of new Abbott Alinity hq hematology analyzer.

INTRODUCTION: Abbott Alinity hq is a next-generation automated hematology analyzer providing complete blood count (CBC) with 6-part white blood cells (WBC) differential counts. The purpose of this study was to evaluate the performance of the analyzer to verify the diagnostic and clinical utility of the Abbott Alinity hq automated system. METHODS: We evaluated specimen stability, precision, linearity, carry-over, and method comparison to assess the performance of Alinity hq. For comparison of the Alinity hq with Sysmex XN-9000, totally 314 samples from adult and pediatric patients including both normal and abnormal hematology profiles were analyzed in parallel. The Alinity hq was also compared with the manual differential counts for the same 314 samples. RESULTS: At 4°C, the Alinity hq analyzer showed no significant changes in CBC and WBC differential count up to 48 hours. When stored at room temperature (18-25°C), all parameters except the mean platelet volume (MPV) were stable up to 36 hours. The Abbott Alinity hq analyzer demonstrated excellent reproducibility and between-batch precision for all CBC and WBC differential parameters. WBC, red blood cells (RBC), hemoglobin (HGB), and platelets showed good linearity and acceptable carry-over. Comparison with a Sysmex XN-9000 analyzer and manual 400-cell differential showed excellent correlation for CBC and WBC differential count parameters (correlation coefficient = 0.815-0.999) except for mean corpuscular hemoglobin concentration (MCHC) and basophils. CONCLUSION: We performed initial validation studies and confirmed performance specifications on specimen stability, precision, linearity, carry-over, and method comparison. The Abbott Alinity hq analyzer showed good analytical performance for all standard CBC parameters.