Archives of pathology & laboratory medicine (Arch Pathol Lab Med )

Publisher: College of American Pathologists; American Medical Association


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Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Context.-Nongynecologic cytology (NGC) practices are expected to expand relative to gynecologic cytology. The College of American Pathologists attempts to track practice patterns in NGC using a self-reported questionnaire. Objective.-To analyze self-reported laboratory staffing and practices from a 2010 survey relating to NGC specimens, stains, preparation, procedures, and ancillary testing. Design.-The "NGC 2010 Demographics and Supplemental Questionnaire: Current Nongynecologic Practices in Cytopathology Laboratories" was mailed to 2059 laboratories. Results.-Survey response rate was 51% (1048 of 2059), predominantly from voluntary, nonprofit hospitals, where NGC samples were reviewed in nontraining settings by pathologists without American Board of Pathology Added Qualification in Cytopathology. Cytotechnologists reviewed NGC cases in 67.4% (675 of 1002) of laboratories. The annual mean and median volumes of NGC cases were 1927 and 858, respectively. Laboratories used more than one method to process NGCs; cell-blocks were most frequently used (930 of 1029; 90.4%) and were created with centrifugation to pellet (538 of 961; 56%). Direct smears were second in preparation frequency; discrete staining was preferred to batch staining. Nongynecologic cytology was used for molecular studies in 34.9% (350 of 1002) of laboratories, most commonly for fluorescent in situ hybridization of urine specimens. Flow cytometric immunophenotyping was performed by 55.9% (554 of 991) and immunohistochemistry by 91.9% (911 of 991) of the responding laboratories. Most laboratories (911 of 993; 91.7%) report specimen completion in 2 or fewer days. Cytohistologic correlation was performed by 71.6% (722 of 1008) of the laboratories both concurrently and retrospectively. Conclusion.-The various parameters examined in the 2010 survey provide a benchmark for future efforts in quality assurance and process improvement in NGC.
    Archives of pathology & laboratory medicine 07/2014; 138(7):885-889.
  • Archives of pathology & laboratory medicine 07/2014; 138(7):871-872.
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    ABSTRACT: Eosinophilic coronary monoarteritis is an unfamiliar cause of acute myocardial ischemia. Most commonly, it presents as a left-sided chest pain or sudden death in middle-aged women with no traditional risk factors for coronary artery disease. Because the abrupt onset leaves almost no time for intervention, the symptoms readily lead to death, and most cases are diagnosed at necropsy. Dissection of the coronary artery wall with resultant occlusion of the lumen, which commonly affects the left anterior descending artery, is a consistent gross finding. An inflammatory infiltrate, which is predominantly composed of eosinophils in the tunica adventitia and tunica media and is often accompanied by a hematoma in between these 2 layers, is observed histologically. The etiology remains unclear, but an increase in the activity of eosinophils because of hormonal interactions during pregnancy has been suggested. Interplay of hormones is thought to culminate in the release of histolytic agents by the eosinophils, which initiate the dissection process. Currently, there is no specific treatment for eosinophilic coronary monoarteritis, but cyclophosphamide and prednisone have shown positive results in the treatment of spontaneous coronary artery dissection with unspecified periadventitial inflammation. Percutaneous coronary procedures have also resulted in favorable outcomes in a subset of patients. Because of the high, sudden death rate in eosinophilic coronary monoarteritis, deciphering the underlying pathophysiology of this almost invariably fatal disease remains both a challenge and a key to developing screening methods that will allow timely detection and thus treatment.
    Archives of pathology & laboratory medicine 07/2014; 138(7):979-981.
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    ABSTRACT: Context.-Monoclonal proteins can interfere with the conjugated bilirubin assay on the Beckman Coulter AU5400 and AU2700 instruments and produce spurious results. Protein depletion eliminates the interference, suggesting that monoclonal proteins cause the problem. Objectives.-To determine the interference rate with the Beckman Coulter AU5400 and AU2700 conjugated bilirubin assay and to identify the interfering substance. Design.-Beckman Coulter bilirubin results from 33 720 samples analyzed during 6 months were evaluated for interference. On a subset of samples, protein G columns were used to specifically remove immunoglobulin G (IgG) to determine the cause of the interference. Another 117 samples containing a (known) monoclonal protein were selected to determine the interference rate. Results.-From 26 different patients, 103 samples had conjugated bilirubin results greater than the total bilirubin for a false-positive rate of 0.3%. Removal of IgG from a subset of those samples with IgG monoclonal protein and increased polyclonal IgG eliminated the conjugated bilirubin interference. In separate, selected samples containing monoclonal proteins, the false-positive interference rate was 7.7% (9 of 117) and was greatest when the monoclonal protein concentration was greater than 4 g/dL. Another 11 of the 117 samples (9.4%) with monoclonal proteins exhibited assay interference by producing false-negative results. The overall interference rate, therefore, was 17.1%. Conclusion.-The false-positive interference rate for the Beckman Coulter conjugated bilirubin assay was 0.3% for routinely analyzed serum/plasma samples. In addition to monoclonal proteins, we found that polyclonal immunoglobulins can also interfere with the conjugated bilirubin assay. The overall interference rate was 17.1% for samples with a monoclonal protein.
    Archives of pathology & laboratory medicine 07/2014; 138(7):950-954.
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    ABSTRACT: Context.-The expression of membrane-bound complement regulatory proteins (mCRPs) that inhibit the complement system in normal tissues is essential for self-protection against an autologous immune reaction. However, the expression patterns of mCRPs, including CD46, CD55, and CD59, are inconsistent in different types of cancer cells. Objectives.-To determine whether CD46, CD55, and CD59 are differentially expressed in neoplastic and adjacent normal colon tissues and to assess their clinical significance. Design.-Immunohistochemistry was performed on tissue microarrays of cancerous and adjacent normal colon tissues. Results.-The expression levels of CD46, CD55, and CD59 were significantly higher in colon cancer tissues compared with the normal adjacent colon tissues. We found that the expression levels of CD55 and CD59 correlated with the grade of differentiation in colon cancers. In addition, the expression of CD55 and CD59 was greater in stage III and stage IV colon cancers than in stage I and stage II cancers according to staging by the TNM classification. Conclusions.-CD46, CD55, and CD59 are up-regulated in colon cancer. Specifically, CD55 and CD59 are of clinical relevance to differentiation and TNM staging of colon cancer. These data suggest that CD46, CD55, and CD59 have the potential to be used for molecular staging diagnoses and for colon cancer therapies.
    Archives of pathology & laboratory medicine 07/2014; 138(7):910-919.
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    ABSTRACT: Context.-Short patient wait times are critical for patient satisfaction with outpatient phlebotomy services. Although increasing phlebotomy staffing is a direct way to improve wait times, it may not be feasible or appropriate in many settings, particularly in the context of current economic pressures in health care. Objective.-To effect sustainable reductions in patient wait times, we created a simple, data-driven tool to systematically optimize staffing across our 14 phlebotomy sites with varying patient populations, scope of service, capacity, and process workflows. Design.-We used staffing levels and patient venipuncture volumes to derive the estimated capacity, a parameter that helps predict the number of patients a location can accommodate per unit of time. We then used this parameter to determine whether a particular phlebotomy site was overstaffed, adequately staffed, or understaffed. Patient wait-time and satisfaction data were collected to assess the efficacy and accuracy of the staffing tool after implementing the staffing changes. Results.-In this article, we present the applications of our approach in 1 overstaffed and 2 understaffed phlebotomy sites. After staffing changes at previously understaffed sites, the percentage of patients waiting less than 10 minutes ranged from 88% to 100%. At our previously overstaffed site, we maintained our goal of 90% of patients waiting less than 10 minutes despite staffing reductions. All staffing changes were made using existing resources. Conclusions.-Used in conjunction with patient wait-time and satisfaction data, our outpatient phlebotomy staffing tool is an accurate and flexible way to assess capacity and to improve patient wait times.
    Archives of pathology & laboratory medicine 07/2014; 138(7):929-935.
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    ABSTRACT: Solid pseudopapillary neoplasm, a lesion of uncertain cellular differentiation, is an unusual tumor of the pancreas with an indolent clinical course that typically arises in young females. We report a case of solid pseudopapillary neoplasm arising in a 17-year-old adolescent girl who presented with progressive abdominal pain. The patient underwent surgical resection of an 18 × 14 × 8-cm pancreatic mass that displayed the usual histologic features of a solid pseudopapillary neoplasm in addition to prominent nuclear atypia, increased proliferative index, and extensive necrosis. These unusual histologic findings are rare and are of particular interest owing to the dramatically decreased survival time displayed in this case. Although precise pathologic criteria suggesting a high risk for aggressive behavior of solid pseudopapillary neoplasms are uncertain, recognition of the unusual pathologic features displayed in this case may be useful in the prediction of potentially more aggressive neoplasms that portend a poorer prognosis.
    Archives of pathology & laboratory medicine 07/2014; 138(7):974-978.
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    ABSTRACT: Hepatosplenic T-cell lymphoma is a rare and aggressive peripheral T-cell malignancy that is distinctively characterized by sinusoidal infiltration of mature medium-sized T lymphocytes in the spleen and liver. The neoplastic cells are classically surface CD3(+), CD2(+), CD5(-), CD4(-), and CD8(+/-) and manifest variable expression of markers associated with natural killer (NK) cells such as CD16 and CD56. In this article, we report the first case to date of a newly diagnosed de novo surface CD3(-) hepatosplenic T-cell lymphoma with circulating blastlike neoplastic cells expressing NK-cell-associated markers. The lack of surface CD3 expression, together with the expression of NK-cell-associated markers and the leukemic presentation, leads to significant diagnostic challenges in differentiating this CD3(-) hepatosplenic T-cell lymphoma from NK-cell neoplasms, in particular aggressive NK-cell leukemia. The related literature is reviewed, and the approaches for adequate diagnosis of this novel situation are described.
    Archives of pathology & laboratory medicine 07/2014; 138(7):969-973.
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    ABSTRACT: Diagnoses most commonly associated with a unilateral parotid mass include sialadenitis, pleomorphic adenoma, Warthin tumor, and mucoepidermoid carcinoma. However, rare entities, such as intraparotid schwannoma, must be considered in the differential diagnosis. We present a brief literature review that is illustrative of the current difficulty of preoperative diagnosis of intraparotid schwannoma, which is an exceptionally rare entity, with approximately 80 cases described to date. It may mimic common neoplasms and inflammatory salivary gland conditions on fine-needle aspiration and imaging, but is more likely to be associated with the facial nerve. Depending upon the tumor's spatial relationship to the facial nerve and the extent of neurologic dysfunction, the decision may be made to observe the tumor rather than attempt resection. This potential implication for patient management is a critical consideration that highlights the need for timely, appropriate biopsy and diagnosis.
    Archives of pathology & laboratory medicine 07/2014; 138(7):982-985.
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    ABSTRACT: Context.-Little is known about the frequency of discordant diagnoses identified during research. Objective.-To describe diagnostic discordance identified during research and apply a newly designed research framework for investigating discordance. Design.-Breast biopsy cases (N = 407) from registries in Vermont and New Hampshire were independently reviewed by a breast pathology expert. The following research framework was developed to assess those cases: (1) compare the expert review and study database diagnoses, (2) determine the clinical significance of diagnostic discordance, (3) identify and correct data errors and verify the existence of true diagnostic discrepancies, (4) consider the impact of borderline cases, and (5) determine the notification approach for verified disagreements. Results.-Initial overall discordance between the original diagnosis recorded in our research database and a breast pathology expert was 32.2% (131 of 407). This was reduced to less than 10% after following the 5-step research framework. Detailed review identified 12 cases (2.9%) with data errors (2 in the underlying pathology registry, 3 with incomplete slides sent for expert review, and 7 with data abstraction errors). After excluding the cases with data errors, 38 cases (9.6%) among the remaining 395 had clinically meaningful discordant diagnoses (κ = 0.82; SE, 0.04; 95% confidence interval, 0.76-0.87). Among these 38 cases, 20 (53%) were considered borderline between 2 diagnoses by either the original pathologist or the expert. We elected to notify the pathology registries and facilities regarding discordant diagnoses. Conclusions.-Understanding the types and sources of diagnostic discordance uncovered in research studies may lead to improved scientific data and better patient care.
    Archives of pathology & laboratory medicine 07/2014; 138(7):955-961.
  • Archives of pathology & laboratory medicine 07/2014; 138(7):863-864.
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    ABSTRACT: Context.-Point-of-care glucose (POCG) testing on capillary blood specimens is central to maintaining glycemic control in patients with diabetes. Although there are known performance issues with POCG methods, especially for maintaining tight glucose control, there is little information about the accuracy of results in the critical ranges that may involve life-threatening conditions. Objectives.-To evaluate the reliability of POCG measurements in critical, high (>600 mg/dL) and low (<40 mg/dL) ranges. Design.-One-year retrospective analysis of POCG (ACCU-CHEK glucose meter, Roche Diagnostics Corporation, Indianapolis, Indiana) results for routine patient care were obtained. The frequency and accuracy of repeat testing after critical POCG results was analyzed. A convenience sample of noncritical capillary POCG measurements retested on venous blood specimens by another point-of-care device (RAPIDPoint 405 analyzer, Siemens Medical Solutions USA, Malvern, Pennsylvania) was also evaluated. Results.-Critical values were observed in 2.4 per 1000 POCG tests (256 of 105,928; 0.24%), with the highest rate (76 of 2289; 3.32%) from the emergency department. Twice as many critical high values as critical low values were seen. Nearly 80% of critical POCG tests (204 of 256) were repeated within 10 minutes. Of these 204 repeat measurements, 112 (54.9%) met accuracy criteria (±15 mg/dL of low and ±20% of high initial values). Accuracy was significantly higher when retesting was performed on the same meter or by the same operator (P ≤ .05). Comparison of capillary and venous POCG testing of noncritical results showed no significant difference (P = .95), with 89.8% (125 of 139) meeting accuracy criteria. Conclusions.-POCG measurements in the critical range are frequently erroneous, which is likely caused by preanalytic factors associated with sampling capillary blood. POCG testing practices should include retesting to confirm critical results.
    Archives of pathology & laboratory medicine 07/2014; 138(7):962-966.
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    ABSTRACT: Context.-Uroplakin II is a 15-kDa protein component of the urothelial plaques that enhance the permeability barrier and strength of the urothelium. Studies have shown uroplakin II messenger RNA to be expressed in bladder cancer tissues and peripheral blood of patients with urothelial carcinoma. Little is known about the protein expression of uroplakin II in urothelial carcinoma, possibly because of the absence of a commercially available uroplakin II antibody. Pathologists have used the uroplakin III antibody (AU1) to identify tumors of urothelial origin; however, the use of AU1 is limited because of its poor sensitivity. Objectives.-To evaluate a newly developed mouse monoclonal uroplakin II antibody (BC21) in urothelial carcinoma and to compare it with previously developed mouse monoclonal uroplakin III (BC17 and AU1). Design.-Uroplakin II and III antibodies were optimized for staining using a horseradish peroxidase-polymer detection system and were visualized with 3,3'-diaminobenzidine. Results.-BC21, BC17, and AU1 demonstrated sensitivities in urothelial carcinoma of the bladder of 79% (44 of 56), 55% (31 of 56) (P = .002), and 34% (19 of 56) (P < .001), respectively. Subsequently, the increased staining sensitivity and intensity of BC21, compared with BC17, was validated in a larger study (134 of 174; 77% and 94 of 174; 54%, respectively) (P < .001). BC21 was found to be highly specific when evaluated in various normal and neoplastic tissues, including prostatic and renal carcinomas. Conclusions.-The mouse monoclonal uroplakin II antibody (BC21) demonstrated superior sensitivity and specificity in urothelial carcinoma, compared with uroplakin III (BC17 and AU1), suggesting its advantages in the differential diagnosis of urothelial carcinoma and in the detection of tumors of unknown origin.
    Archives of pathology & laboratory medicine 07/2014; 138(7):943-949.
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    ABSTRACT: Context.-The results of studies among patients with antithrombin deficiency have suggested that the use of warfarin will increase the level of antithrombin. Objective.-To reevaluate the effect of warfarin on antithrombin levels using an automated amidolytic method in current use. Design.-Antithrombin levels were measured in patients who were receiving warfarin for atrial fibrillation and were compared with antithrombin levels in preoperative patients who had not received warfarin. Results.-Patients receiving warfarin had a mean antithrombin level of 100.40% (range, 81%-153%). Patients not receiving warfarin had a mean antithrombin level of 99.97% (range, 79%-120%). The Student t test was not significant for a difference between the mean antithrombin levels of the 2 populations. Conclusions.-The use of warfarin does not increase the level of antithrombin in patients receiving the drug.
    Archives of pathology & laboratory medicine 07/2014; 138(7):967-968.
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    ABSTRACT: Context .- Echinoderm microtubule associated proteinlike 4-anaplastic lymphoma receptor tyrosine kinase (EML4-ALK) translocation has been described in a subset of patients with non-small cell lung cancer (NSCLC) and has been shown to have oncogenic activity. Fluorescence in situ hybridization (FISH) is used to detect ALK-positive NSCLC, but it is expensive, time-consuming, and difficult for routine application. Objective .- To evaluate the potential role of immunohistochemistry (IHC) as a screening tool to identify candidate cases for FISH analysis and for ALK inhibitor therapy in NSCLC. Design .- We performed FISH and IHC for ALK and mutational analysis for epidermal growth factor receptor (EGFR) and KRAS in 523 NSCLC specimens. We conducted IHC analysis with the monoclonal antibody D5F3 (Ventana Medical Systems, Tucson, Arizona) and a highly sensitive detection system. We also performed a MassARRAY-based analysis (Sequenom, San Diego, California) in a small subset of 11 samples to detect EML4-ALK rearrangement. Results .- Of the 523 NSCLC specimens, 20 (3.8%) were positive for ALK rearrangement by FISH analysis. EGFR and KRAS mutations were identified in 70 (13.4%) and 124 (23.7%) of the 523 tumor samples, respectively. ALK rearrangement and EGFR and KRAS mutations were mutually exclusive. Of 523 tumor samples analyzed, 18 (3.4%) were ALK(+) by IHC, 18 samples (3.4%) had concordant IHC and FISH results, and 2 ALK(+) cases (0.3%) by FISH failed to show ALK protein expression. In the 2 discrepant cases, we did not detect any mass peaks for the EML4-ALK variants by MassARRAY. Conclusions .- Our results show that IHC may be a useful technique for selecting NSCLC cases to undergo ALK FISH analysis.
    Archives of pathology & laboratory medicine 06/2014;
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    ABSTRACT: Primary breast anaplastic large cell lymphoma (ALCL) is rare but is more commonly seen in patients with implants; fewer than 50 cases of breast implant-associated ALCL have been reported in the English language literature. Breast implant-associated ALCL is not a disease of the breast parenchyma, but instead is a disease of the fibrous capsule surrounding the implant. The patients usually present with an effusion around the implant and, rarely, with a solid mass. Morphologically, the neoplastic cells are large, epithelioid, and pleomorphic, with abundant cytoplasm, vesicular irregular nuclei, and frequent mitoses. Occasional "hallmark" cells may be present. The lesional cells typically show strong and diffuse immunoreactivity for CD30 and often express T-cell markers, cytotoxic-associated antigens, and epithelial membrane antigen. Almost all reported cases are negative for anaplastic lymphoma kinase. Molecular genetic analyses have demonstrated T-cell receptor gene rearrangements. The differential diagnosis essentially includes poorly differentiated carcinoma, other lymphomas, and chronic inflammation. Once a diagnosis of lymphoma is established, it is important to exclude systemic anaplastic lymphoma kinase-negative ALCL involving the breast, primary cutaneous ALCL, and other CD30(+) lymphoproliferative disorders. The patients with effusion-associated ALCL often have an indolent course and excellent prognosis, responding well to excision of the fibrous capsule around the implant (capsulectomy) and implant removal. In contrast, patients who present with a distinct mass may have a more aggressive course and poor prognosis, requiring chemotherapy and/or radiation therapy.
    Archives of pathology & laboratory medicine 06/2014; 138(6):842-846.
  • Archives of pathology & laboratory medicine 06/2014; 138(6):730.
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    ABSTRACT: Context.- Echinoderm microtubule-associated proteinlike 4 gene (EML4) and anaplastic lymphoma kinase gene (ALK) fusion was shown to be the driver of tumorigenesis in approximately 3% to 5% of patients with non-small cell lung cancer (NSCLC) and is associated with response to inhibition with crizotinib. However, no complete agreement regarding the best diagnostic test for identification of ALK rearrangements has been achieved yet. Objective.- To investigate the concordance, sensitivity, and specificity of immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and reverse transcription-polymerase chain reaction (RT-PCR) for detection of ALK rearrangements. Design.- Thirty-six prospectively tested patients with NSCLC who had adenocarcinoma and 10 ALK-positive samples were included in the study. All samples were tested by IHC (ALK1 clone, 5A4 clone, D5F3 clone), FISH (LSI ALK Break Apart and ALK FISH Probe), and multiplexed RT-PCR. Results.- Immunohistochemistry staining was successful in all samples.. Clone D5F3 showed the best sensitivity and specificity of 100%; clones ALK1 and 5A4 showed sensitivities of 91% with specificity of 100%. Both FISH probes showed concordance with sensitivity and specificity of 100%. Hybridization and RT-PCR were successful in 98% and 93.4% of samples, respectively, with sensitivity of 88% and specificity of 100%. Frequent artifacts leading to misinterpretation were observed with all 3 methodologies. Conclusions.- All 3 methodologies showed good sensitivity, specificity, and concordance, when artifacts were characterized and excluded. However, all ambiguous cases have to be confirmed as ALK rearranged by at least 2 of the 3 methods.
    Archives of pathology & laboratory medicine 06/2014; 138(6):794-802.
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    ABSTRACT: Context.- A common laboratory practice is to repeat critical values before reporting the test results to the clinical care provider. This may be an unnecessary step that delays the reporting of critical test results without adding value to the accuracy of the test result. Objectives.- To determine the proportions of repeated chemistry and hematology critical values that differ significantly from the original value as defined by the participating laboratory, to determine the threshold differences defined by the laboratory as clinically significant, and to determine the additional time required to analyze the repeat test. Design.- Participants prospectively reviewed critical test results for 4 laboratory tests: glucose, potassium, white blood cell count, and platelet count. Participants reported the following information: initial and repeated test result; time initial and repeat results were first known to laboratory staff; critical result notification time; if the repeat result was still a critical result; if the repeat result was significantly different from the initial result, as judged by the laboratory professional or policy; significant difference threshold, as defined by the laboratory; the make and model of the instrument used for primary and repeat testing. Results.- Routine, repeat analysis of critical values is a common practice. Most laboratories did not formally define a significant difference between repeat results. Repeated results were rarely considered significantly different. Median repeated times were at least 17 to 21 minutes for 10% of laboratories. Twenty percent of laboratories reported at least 1 incident in the last calendar year of delayed result reporting that clinicians indicated had adversely affected patient care. Conclusion.- Routine repeat analysis of automated chemistry and hematology critical values is unlikely to be clinically useful and may adversely affect patient care.
    Archives of pathology & laboratory medicine 06/2014; 138(6):788-793.

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