Design of malaria diagnostic criteria for the Sysmex XE-2100 hematology analyzer.
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ABSTRACT:
SUBMITTER: Campuzano-Zuluaga G
PROVIDER: S-EPMC2829900 | biostudies-other | 2010 Mar
REPOSITORIES: biostudies-other
Publications
Design of malaria diagnostic criteria for the Sysmex XE-2100 hematology analyzer.
Campuzano-Zuluaga Germán G Alvarez-Sánchez Gonzalo G Escobar-Gallo Gloria Elcy GE Valencia-Zuluaga Luz Marina LM Ríos-Orrego Alexandra Marcela AM Pabón-Vidal Adriana A Miranda-Arboleda Andrés Felipe AF Blair-Trujillo Silvia S Campuzano-Maya Germán G
The American journal of tropical medicine and hygiene 20100301 3
Thick film, the standard diagnostic procedure for malaria, is not always ordered promptly. A failsafe diagnostic strategy using an XE-2100 analyzer is proposed, and for this strategy, malaria diagnostic models for the XE-2100 were developed and tested for accuracy. Two hundred eighty-one samples were distributed into Plasmodium vivax, P. falciparum, and acute febrile syndrome groups for model construction. Model validation was performed using 60% of malaria cases and a composite control group of ...[more]
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Project description:BackgroundAccurate and timely diagnosis of malaria is essential for disease management and surveillance. Thin and thick blood smear microscopy and malaria rapid diagnostic tests (RDTs) are standard malaria diagnostics, but both methods have limitations. The novel automated hematology analyzer XN-30 provides standard complete blood counts (CBC) as well as quantification of malaria parasitemia at the price of a CBC. This study assessed the accuracy of XN-30 for malaria detection in a controlled human malaria infection (CHMI) study and a phase 3 diagnostic accuracy study in Burkina Faso.MethodsSixteen healthy, malaria-naive CHMI participants were challenged with five Plasmodium falciparum-infected mosquitoes. Blood was sampled daily for XN-30, blood smear microscopy, and malaria qPCR. The accuracy study included patients aged > 3 months presenting with acute febrile illness. XN-30, microscopy, and rapid diagnostic tests (HRP-2/pLDH) were performed on site; qPCR was done in retrospect. The malaria reference standard was microscopy, and results were corrected for sub-microscopic cases.ResultsAll CHMI participants became parasitemic by qPCR and XN-30 with a strong correlation for parasite density (R2 = 0.91; p < .0001). The XN-30 accurately monitored treatment and allowed detection of recrudescence. Out of 908 patients in the accuracy study, 241 had microscopic malaria (density 24-491,802 parasites/μL). The sensitivity and specificity of XN-30 compared to microscopy were 98.7% and 99.4% (PPV = 98.7%, NPV = 99.4%). Results were corrected for qPCR-confirmed sub-microscopic cases. Three microscopy-confirmed cases were not detected by XN-30. However, XN-30 detected 19/134 (14.2%) qPCR-confirmed cases missed by microscopy. Among qPCR-confirmed cases, XN-30 had a higher sensitivity (70.9% versus 66.4%; p = .0009) and similar specificity (99.6% versus 100%; p = .5) as microscopy. The accuracy of XN-30 for microscopic malaria was equal to or higher than HRP-2 and pLDH RDTs, respectively.ConclusionsThe XN-30 is a novel, automated hematology analyzer that combines standard hemocytometry with rapid, objective, and robust malaria detection and quantification, ensuring prompt treatment of malaria and malaria anemia and follow-up of treatment response.Trial registrationBoth trials were registered on clinicaltrials.gov with respective identifiers NCT02836002 (CHMI trial) and NCT02669823 (diagnostic accuracy study).
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Project description:BackgroundThe Sysmex XN-V is derived from the new Sysmex XN series of human hematology analyzers. The main changes from the previously validated XT-2000iV analyzer include an optic-fluorescent analysis for platelets and nucleated RBC count.ObjectiveWe aimed to validate the Sysmex XN-V for canine blood according to American College for Veterinary Clinical Pathology and International Council for Standardization in Hematology recommendations.Materials and methodsCanine EDTA blood specimens and quality control material were analyzed on the Sysmex XN-V to evaluate imprecision, bias, linearity, a comparison with the XT-2000iV analyzer, interference effects, carry-over, and stability. We also verified previously established Sysmex XT-2000iV reference intervals (RIs).ResultsImprecision and bias were low (<5%) for most variables. Observed total error was lower than allowable total error for most measured variables except lymphocytes and monocytes. Visually determined linearity was excellent for all variables, except for lymphocytes. The correlation between the XN-V and XT-2000iV analyzers was high (>0.93) for all variables except MCHC and reticulocyte indices. Correlations between the Sysmex XN-V and manual differential counts were good for neutrophils and eosinophils, acceptable for lymphocytes, and fair for monocytes. Hemolysis, lipemia, and to a lesser extent icterus, had significant effects on measured hemoglobin concentration and associated variables. Carry-over was not visually observed for any variable. Changes in the Sysmex XN-V measurements after storage at 4℃ and 24℃ were similar to those described for the Sysmex XT-2000iV analyzer. The previously established Sysmex XT-2000iV RIs can be used to interpret results from the Sysmex XN-V analyzer for most variables except red blood cell distribution width and mean platelet volume.ConclusionsThe performance of the Sysmex XN-V analyzer was excellent and compared favorably with the Sysmex XT-2000iV analyzer.
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Project description:Morphological microscopic examinations of nucleated cells in body fluid (BF) samples are performed to screen malignancy. However, the morphological differentiation is time-consuming and labor-intensive. This study aimed to develop a new flowcytometry-based gating analysis mode "XN-BF gating algorithm" to detect malignant cells using an automated hematology analyzer, Sysmex XN-1000. XN-BF mode was equipped with WDF white blood cell (WBC) differential channel. We added two algorithms to the WDF channel: Rule 1 detects larger and clumped cell signals compared to the leukocytes, targeting the clustered malignant cells; Rule 2 detects middle sized mononuclear cells containing less granules than neutrophils with similar fluorescence signal to monocytes, targeting hematological malignant cells and solid tumor cells. BF samples that meet, at least, one rule were detected as malignant. To evaluate this novel gating algorithm, 92 various BF samples were collected. Manual microscopic differentiation with the May-Grunwald Giemsa stain and WBC count with hemocytometer were also performed. The performance of these three methods were evaluated by comparing with the cytological diagnosis. The XN-BF gating algorithm achieved sensitivity of 63.0% and specificity of 87.8% with 68.0% for positive predictive value and 85.1% for negative predictive value in detecting malignant-cell positive samples. Manual microscopic WBC differentiation and WBC count demonstrated 70.4% and 66.7% of sensitivities, and 96.9% and 92.3% of specificities, respectively. The XN-BF gating algorithm can be a feasible tool in hematology laboratories for prompt screening of malignant cells in various BF samples.
| S-EPMC5806859 | biostudies-other
Project description:IntroductionIn 2015, Sysmex launched a new series of hematology analyzers (XN-L Series) designed to fulfill the needs of niche laboratories in areas such as pediatrics, dialysis, neurology, and oncology while providing a compact solution. In this study, we evaluate the whole blood and body fluid modes of one of these analyzers, the XN-350.MethodsA total of 300 residual EDTA samples were measured on the XN-350 in whole blood mode and the XN-1000 to evaluate method comparison, flagging sensitivity, repeatability, reproducibility, linearity, carryover, and stability. In addition, 191 samples were obtained and processed in body fluid mode which included, cerebrospinal fluid (CSF), continuous ambulatory peritoneal dialysis (CAPD), ascites, synovial, and pleural fluid to perform method comparison, repeatability, reproducibility, linearity, limit of quantitation, and carryover studies.ResultsStrong agreement was shown between the XN-350 and XN-1000 for both whole blood and body fluid modes in results and flagging. Linearity results in both modes on the XN-350 showed a high R2 value (>.99). For WBC, RBC, HGB, and PLT, the carryover results were well within the predetermined criteria of ≤0.5% for whole blood and ≤0.3% for CSF. Repeatability and reproducibility were acceptable for both modes, and there were no significant deviations present in stability for whole blood. In addition, there was high agreement in all body fluid types evaluated.ConclusionThe performance of the XN-350 is comparable to the XN-1000 in both whole blood and body fluid modes, making it a reliable alternative to larger analyzers for smaller, niche laboratories.
| S-EPMC7891428 | biostudies-literature
Project description:BACKGROUND: Microarray comparative genomic hybridization (CGH) is currently one of the most powerful techniques to measure DNA copy number in large genomes. In humans, microarray CGH is widely used to assess copy number variants in healthy individuals and copy number aberrations associated with various diseases, syndromes and disease susceptibility. In model organisms such as Caenorhabditis elegans (C. elegans) the technique has been applied to detect mutations, primarily deletions, in strains of interest. Although various constraints on oligonucleotide properties have been suggested to minimize non-specific hybridization and improve the data quality, there have been few experimental validations for CGH experiments. For genomic regions where strict design filters would limit the coverage it would also be useful to quantify the expected loss in data quality associated with relaxed design criteria. RESULTS: We have quantified the effects of filtering various oligonucleotide properties by measuring the resolving power for detecting deletions in the human and C. elegans genomes using NimbleGen microarrays. Approximately twice as many oligonucleotides are typically required to be affected by a deletion in human DNA samples in order to achieve the same statistical confidence as one would observe for a deletion in C. elegans. Surprisingly, the ability to detect deletions strongly depends on the oligonucleotide 15-mer count, which is defined as the sum of the genomic frequency of all the constituent 15-mers within the oligonucleotide. A similarity level above 80% to non-target sequences over the length of the probe produces significant cross-hybridization. We recommend the use of a fairly large melting temperature window of up to 10 C, the elimination of repeat sequences, the elimination of homopolymers longer than 5 nucleotides, and a threshold of -1 kcal/mol on the oligonucleotide self-folding energy. We observed very little difference in data quality when varying the oligonucleotide length between 50 and 70, and even when using an isothermal design strategy. CONCLUSIONS: We have determined experimentally the effects of varying several key oligonucleotide microarray design criteria for detection of deletions in C. elegans and humans with NimbleGen's CGH technology. Our oligonucleotide design recommendations should be applicable for CGH analysis in most species.
2008-07-26 | GSE12208 | GEO