The effect of therapeutic leukapheresis on early complications and outcomes in patients with acute leukemia and hyperleukocytosis: a propensity score-matched study.

BACKGROUND: Hyperleukocytosis in acute leukemia is associated with higher early mortality due to the major complications of leukostasis, tumor lysis syndrome (TLS), and disseminated intravascular coagulopathy (DIC). Leukapheresis remains an important modality for the management of patients with acute leukemia and hyperleukocytosis. However, the role of leukapheresis in early mortality is controversial. This study sought to evaluate the prognostic impact of leukapheresis and its beneficial effects on TLS and DIC. STUDY DESIGN AND METHODS: We conducted a propensity score-matched study of 166 patients with acute leukemia and hyperleukocytosis admitted between 2006 and 2016. The incidence of TLS and DIC was determined using well-defined Cairo-Bishop criteria for TLS and International Society of Thrombosis and Haemostasis criteria for DIC. RESULTS: Before matching, 27 of 91 patients (30%) with acute myeloid leukemia (AML) and 32 of 75 patients (43%) with acute lymphoblastic leukemia (ALL) underwent leukapheresis. Propensity score matching was performed to adjust for clinical disparities between the leukapheresis and without-leukapheresis groups and resulted in 22 matched pairs of patients with AML and 16 matched pairs of patients with ALL. After matching, we observed no significant difference in early mortality rates or in the incidence of TLS or DIC between the two groups of patients with AML and ALL. CONCLUSION: Although leukapheresis may rapidly reduce white blood cell counts and leukemic blasts, any positive influence of leukapheresis could not be demonstrated by an effect on survival outcome and the incidence of early complications, such as TLS and DIC. These results suggest that a routinely performed, prophylactic leukapheresis cannot be recommended.

Comparison of the QIAGEN artus HBV QS-RGQ Assay With the Roche COBAS AmpliPrep/COBAS TaqMan HBV Assay for Quantifying Viral DNA in Sera of Chronic Hepatitis B Patients.

BACKGROUND: Hepatitis B virus DNA quantification is essential for managing chronic hepatitis B (CHB). We compared the performance of artus HBV QS-RGQ (QIAGEN GmbH, Germany) and CAP/CTM v2.0 HBV assays (Roche Molecular Diagnostics, USA) in CHB patients. METHODS: A comparative evaluation between two assays was performed with 508 clinical serum samples. Precision, linearity, and the limit of detection (LOD) of QS-RGQ assay was evaluated by using the WHO standard 97/750 and clinical samples. RESULTS: Detection rates and viral loads as determined QS-RGQ assay were significantly lower than those from the CAP/CTM v2.0 assay (52.8% vs 60.6%; 3.55±1.77 IU/mL vs 4.18±1.89 IU/mL, P<0.0001). The kappa coefficient between qualitative results was 0.79 (95% confidence interval, 0.74 to 0.85). Bland-Altman plot found a mean difference of (QS-RGQ - CAP/CTM v2.0)=-0.63 log10 IU/mL (95% limit of agreement, -1.48 to 0.22). Repeatability and total imprecision (% CV) of the QS-RGQ assay were 1.0% and 1.1% at 2,000 IU/mL, and 0.7% and 1.4% at 20,000 IU/mL, respectively. Linearity of this assay ranged from 31.6 to 1.0±107 IU/mL, and the LOD was 2.95 IU/mL. CONCLUSIONS: The artus HBV QS-RGQ assay showed good performance but significantly decreased detection rate and viral load compared with CAP/CTM v2.0 assays. This assay recommends using plasma; however, we used stored serum because of the retrospective study design. Usually HBV DNA quantification is performed in plasma or serum, but sample type and clinical relevance of quantitative values should be considered when determining the clinical application of this reagent.

Evaluation of bilirubin interference and accuracy of six creatinine assays compared with isotope dilution-liquid chromatography mass spectrometry.

OBJECTIVES: The aim of this study was to estimate bilirubin interference and accuracy of six routine methods for measuring creatinine compared with isotope dilution-liquid chromatography mass spectrometry (ID-LC/MS). DESIGN AND METHODS: A total of 40 clinical serum samples from 31 patients with serum total bilirubin concentration >68.4µmol/L were collected. Serum creatinine was measured using two enzymatic reagents and four Jaffe reagents as well as ID-LC/MS. Correlations between bilirubin concentration and percent difference in creatinine compared with ID-LC/MS were analyzed to investigate bilirubin interference. Bias estimations between the six reagents and ID-LC/MS were performed. Recovery tests using National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 967a were also performed. RESULTS: Both the enzymatic methods showed no bilirubin interference. However, three of the four Jaffe methods demonstrated significant bilirubin concentration-dependent interference in samples with creatinine levels <53µmol/L, and two of them showed significant bilirubin interference in samples with creatinine levels ranging from 53.0 to 97.2µmol/L. Comparison of these methods with ID-LC/MS using patients' samples with elevated bilirubin revealed that the tested methods failed to achieve the bias goal at especially low levels of creatinine. In addition, recovery test using NIST SRM 967a showed that bias in one Jaffe method and two enzymatic methods did not achieve the bias goal at either low or high level of creatinine, indicating they had calibration bias. One enzymatic method failed to achieve all the bias goals in both comparison experiment and recovery test. CONCLUSIONS: It is important to understand that both bilirubin interference and calibration traceability to ID-LC/MS should be considered to improve the accuracy of creatinine measurement.