Comparison of a Novel Thin-Walled 25-gauge Needle Push Button Blood Collection Set to a Standard 23-gauge Needle in a Cancer Patient Population.

BACKGROUND: Phlebotomy can be an uncomfortable and even painful experience that increases in likelihood in patients who require frequent blood draws, such as those with cancer. The 25-gauge BD Vacutainer® UltraTouch™ Push Button Blood Collection Set has a smaller outer bore needle size and unique bevel configuration, which in theory should reduce pain associated with phlebotomy. Smaller needles typically cause less pain, however, they have a higher incidence of compromising the specimen integrity. Innovative engineering allows this particular needle to maintain a larger inner bore size similar to a standard 23-gauge needle. This study compares pain and specimen integrity between this novel device and a standard 23-gauge needle. METHODS: Two cohorts of 190 patients each had phlebotomy performed with either needle. Pain experienced was assessed by patient surveys, rating pain from 0 (low) to 10 (high). Sample integrity was assessed by determining the hemolysis index (Abbott Architect c8000). RESULTS: No statistically significant difference in median pain scores was observed between the 2 cohorts, P-value: 0.068. The 23-gauge cohort more frequently reported 3+ pain than the 25-gauge cohort, 14/190 vs 5/190. Pain scoring 1 and 2 was more frequent in the 25-gauge cohort, 84/190 vs 54/190. Pain scores of 0 were more frequent in the 23-gauge cohort, 122/190 vs 101/190. This stratification is statistically significant, P-value: 0.003. The 25-gauge needle showed no increase in hemolysis rates, P-value: 0.5. CONCLUSIONS: Sample integrity was identical between both needles. The 25-gauge needle resulted in less 3+ pain, while pain scoring 1 and 2 was more frequent in the 25-gauge cohort.

Immunotyping Provides Equivalent Results to Immunofixation in a Population with a High Prevalence of Monoclonal Gammopathies.

BACKGROUND: Serum immunofixation (IF) is a common laboratory test used to diagnose and monitor patients with monoclonal gammopathies. Similarly, immunotyping (IT) by capillary electrophoresis can confirm the presence of a monoclonal protein (M-protein) and determine its isotype. The goal of this study was to compare the ability of IT and IF to detect M-proteins. METHODS: IT and IF results for 1000 waste clinical serum samples were obtained. All results were interpreted blindly by reviewers who were experienced in each technique. Results were compared by band. Results were also compared to patient history to determine if the original clone was present. We determined the sensitivity of IT and IF alone and in combination with additional tests. Finally, we evaluated the impact of reviewer training on the sensitivity of IT. RESULTS: IT and IF were concordant in 721/773 (93%) samples with a history of an intact M-protein and in 143/172 (83%) samples with a history of a free light chain (FLC) M-protein. IF was significantly more sensitive than IT for the detection of FLC M-proteins (P < 0.0001). However, IF was not more sensitive than IT for detection of intact M-proteins (P = 0.1272) or when each test was combined with the FLC ratio or urine immunofixation (P = 0.2812 and P = 0.6171, respectively). Finally, after training, inexperienced reviewers improved their IT sensitivity by 19%. CONCLUSION: IT provides equivalent results to IF for the detection of monoclonal proteins. Training and experience are critical to the accurate interpretation of IT.

Treatment of multiple myeloma with monoclonal antibodies and the dilemma of false positive M-spikes in peripheral blood.

OBJECTIVES: To characterize the effect of three humanized IgG κ monoclonal antibodies (daratumumab, isatuximab, and elotuzumab) on the interpretation of results generated by protein electrophoresis, immunofixation, free light chain, and heavy/light chain assays performed on human serum. METHODS: Healthy volunteer serum and serum from multiple myeloma patients were supplemented with clinically relevant concentrations of each of the three monoclonal antibodies. These specimens then underwent analysis via serum protein electrophoresis, immunofixation, serum free light chain quantification, heavy/light chain quantification, total IgG, and total protein. In addition, serum specimens from patients who had undergone treatment with elotuzumab for multiple myeloma underwent similar analysis. RESULTS: Addition of the study drugs to serum from both the healthy donor as well as multiple myeloma patients resulted in a visible and quantifiable M-protein on SPEP and a visible IgGκ band by IFE. Increases were also noted in total IgG, IgGκ, and IgGκ/IgGλ-ratios. Analysis of serum from multiple myeloma patients receiving study drug showed similar findings with an additional IgGκ band and quantifiable M-protein with similar migration patterns in specimens drawn after administration. CONCLUSION: The treatment of multiple myeloma patients with monoclonal antibodies results in a visible and quantifiable M-protein that has the potential to falsely indicate poor response to therapy.

Reducing False-Positive Pregnancy Test Results in Patients With Cancer.

OBJECTIVE: To assess whether the use of a laboratory test specific for intact human chorionic gonadotropin (hCG) would reduce the number of false-positive pregnancy test results. METHODS: From October 21, 2014, to January 20, 2015, and April 1, 2015, to June 2, 2015, all serum samples sent for pregnancy screening at a large cancer center with a value of 5 milli-international units/mL or greater total ß-hCG were frozen and stored and then retested using intact hCG reagent. We compared the accuracy of total ß-hCG and intact hCG results for the diagnosis of clinically confirmed pregnancy. A negative test was defined as 14 milli-international units/mL or less, our current institutional cutoff. We also assessed a cutoff of less than 5 milli-international units/mL, a historical cutoff to rule out pregnancy. RESULTS: We performed intact hCG testing on 64 patient samples, of which 34 had originally resulted positive when tested for total ß-hCG. These included 21 cases of clinically confirmed pregnancy and 13 false-positive cases. No women were pregnant when their intact hCG concentration was 14 milli-international units/mL or less, and all pregnancies were detected at and above this concentration. Intact hCG reduced the number of false-positive pregnancy test results from 13 to 1, a 92% reduction (95% CI 64-99%), corresponding to a reduction in the false-positive rate from 38% (95% CI 22-56%) to 3% (95% CI 1-15%). CONCLUSION: The use of intact hCG reagent in patients with cancer reduces the rate of false-positive pregnancy test results without increasing the rate of false-negative test results.

Cerebrospinal fluid from patients with hematopoietic neoplasms: the need for an integrated approach.

INTRODUCTION: Cerebrospinal fluid (CSF) evaluation plays an increasing role in the diagnosis and staging of hematopoietic neoplasms. The evaluation is based on the cytomorphologic evaluation (CE) of the specimen and flow cytometry study (FCS). The impact of the increased sensitivity of multicolor FCS and its correlation with the morphological analysis of CSF needs to be evaluated to better guide clinical management. MATERIALS AND METHODS: CSF specimens sent for CE and FCS obtained over a 9-month period were retrospectively analyzed. Cases were considered completely discordant if one method detected an abnormal hematologic population and the corresponding method was negative and partially discordant if FCS detected an abnormal hematologic population and the CE was atypical or suspicious. Root cause analysis of these discrepancies was performed. RESULTS: A total of 78 of 361 cases (22%) had discordant results; 72 cases were from patients with hematopoietic neoplasms-22 cases were completely discordant and 50 were partially discordant. FCS had a sensitivity of 95.3% and a specificity of 98.1% for detecting abnormal hematopoietic populations. CE rendered a positive diagnosis in 17.6% of cases with a specificity of 100%. CONCLUSIONS: Our series demonstrates evaluation of CSF involvement by hematopoietic malignancy with FCS is more sensitive than and equally specific as CE. Nonetheless, CE remains one of the mainstays in the evaluation of CSF specimens. Optimizing cytologic evaluation through process modifications including decreasing screening area and evaluation of multiple preparations increased the detection rate of malignant cells. As such, optimal CSF evaluation and integration FCS is critical in patient management.

D-lactic acidosis mediated neuronal encephalopathy in acute lymphoblastic leukemia patient: an under diagnosis.

BACKGROUND: D-lactic acidosis, also referred as D-lactate encephalopathy, has been reported in patients with short bowl syndrome (SBS). CASE REPORT: The neurologic symptoms include altered mental status, slurred speech, and ataxia. Onset of neurological symptoms is accompanied by metabolic acidosis and high anion gap. We present here a case of D-lactic acidosis in a patient with acute lymphoblastic leukemia (ALL) who developed severe neurological symptoms and metabolic acidosis due to vancomycin-resistant enterococci (VRE) infection, and elevated D-lactic acid.

Undifferentiated carcinoma of the renal pelvis with osteoclast-like giant cells: a report of two cases.

Undifferentiated carcinoma with osteoclast-like giant cells arising in the urothelium of the bladder or upper urinary tract is an extremely rare entity. The majority of cases found in the renal pelvis and bladder are associated with either an in situ urothelial malignancy or a conventional high-grade urothelial carcinoma. These malignancies tend to behave poorly with a grim prognosis and course. We report two additional cases of undifferentiated carcinoma with osteoclast-like giant cells of the renal pelvis in two patients disease free 42 and 18 months after surgical treatment, respectively.

Mycobacterium avium complex infection in a neck abscess: a diagnostic pitfall in fine-needle aspiration biopsy of head and neck lesions.

Fine-needle aspiration biopsy (FNAB) is a useful tool in the diagnosis of mycobacterial disease, especially Mycobacterium tuberculosis. However, nontuberculous mycobacterial infection diagnosed with FNAB material is much rarer, with Mycobacterium avium complex being the most common. In this report, we present the case of a 21-year-old HIV positive man, who presented with a unilateral, tender, enlarging cervical neck mass. FNAB had revealed acute inflammation. Mycobacterium avium complex grew in culture from the material that was aspirated and was confirmed by DNA probe. Because of the paucity of articles on this subject in the cytology literature, it is important to reiterate the value of the material aspirated at the bedside and the clinic in the diagnosis of infectious disease. When faced with antibiotic-resistant cellulitis and abscesses, the FNAB material must be sent for acid fast bacteria smears and culture.