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Evaluation of the V8 E-Class, a Novel Automated Capillary Isoelectric Focusing Instrument for Hemoglobinopathy Screening
- Source :
- American Journal of Clinical Pathology. 146:361-368
- Publication Year :
- 2016
- Publisher :
- Oxford University Press (OUP), 2016.
-
Abstract
- Objectives: We evaluated the performance of a novel capillary isoelectric focusing (CIEF) application for hemoglobinopathy screening on the recently introduced V8 E-Class platform. Methods: Analytical performance of the V8 E-Class was evaluated and included assessment of hemoglobin A2 (HbA2) imprecision; linearity for HbA2, fetal hemoglobin (HbF), and sickle hemoglobin (HbS); and carryover for HbS. Furthermore, a method comparison with the Minicap Flex Piercing (Sebia, Lisses, France), the Variant Classic (Bio-Rad Laboratories, Hercules, CA), and the G8 (Tosoh Europe, Amsterdam, the Netherlands) was done to assess analytical and clinical concordance. Results: Total HbA2 imprecision was 3.26% and 3.14% for normal and elevated HbA2 controls and 5.16% and 3.58% for a normal and a heterozygous HbS patient sample, respectively. HbA2, HbF, and HbS showed acceptable linearity, and no carryover was observed. The method comparison showed good analytical concordance ( r > 0.95) except for a homozygous HbS subset ( r = 0.532-0.704). A comparable phenomenon was seen for the clinical concordance with good agreement in samples without variants (weighted κ > 0.80) but poorer agreement in HbS samples (κ
- Subjects :
- medicine.medical_specialty
Concordance
Hemoglobin, Sickle
030204 cardiovascular system & hematology
Gastroenterology
03 medical and health sciences
0302 clinical medicine
Capillary electrophoresis
Hemoglobin A2
Internal medicine
Fetal hemoglobin
medicine
Humans
Fetal Hemoglobin
Sickle Hemoglobin
Isoelectric focusing
business.industry
Electrophoresis, Capillary
Reproducibility of Results
General Medicine
medicine.disease
Surgery
Hemoglobinopathies
Hemoglobinopathy
Hemoglobin A
030220 oncology & carcinogenesis
Isoelectric Focusing
business
Subjects
Details
- ISSN :
- 19437722 and 00029173
- Volume :
- 146
- Database :
- OpenAIRE
- Journal :
- American Journal of Clinical Pathology
- Accession number :
- edsair.doi.dedup.....a9fffd71ae8d593a9f5889ff084fc9ab