Human Erythropoietin IVD ELISA Kit - Quantikine
R&D Systems, part of Bio-Techne | Catalog # DEP00
For In Vitro Diagnostic Use
Key Product Details
Assay Length
4.5 hours (Benchtop Protocol) or 2.5 hours (Shaker Protocol)
Sample Type & Volume Required Per Well
Serum (100 µL), EDTA Plasma (100 µL)
Sensitivity
0 Not Assigned
0.6 mIU/mL (Serum, EDTA Plasma)
0.6 mIU/mL (Serum, EDTA Plasma)
Assay Range
0-0 Not Assigned
2.5-200 mIU/mL (Serum, EDTA Plasma)
2.5-200 mIU/mL (Serum, EDTA Plasma)
Product Summary for Human Erythropoietin Quantikine IVD ELISA Kit
The Quantikine® IVD Human Epo ELISA is designed to measure Epo levels in serum or plasma in less than 4.5 hours (or less than 2.5 hours using the shaker protocol) for the quantitative determination of erythropoietin (Epo) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia. For in vitro diagnostic use.
Product Specifications
Assay Type
Solid Phase Sandwich ELISA
Format
96-well strip plate
Measurement
Quantitative ELISA
Detection Method
Colorimetric - 450nm (TMB)
Conjugate
HRP
Reactivity
Human
Specificity
Natural and recombinant human Epo
Cross-reactivity
< 0.5% cross-reactivity observed with available related molecules. < 50% cross-species reactivity observed with species tested.
Interference
Interference observed with other substances.
Sample Values
Erythropoietin concentrations were obtained from 123 normal individuals from the
Minneapolis/St. Paul, Minnesota area. Using the nonparametric method for the analysis of
reference values outlined in the NCCLS publication "How to Define, Determine, and Utilize
Reference Intervals in the Clinical Laboratory" (NCCLS Document C28-P; Vol. 12, No. 2) the
following reference ranges (2.5-97.5 percentile) were established for Epo in serum and EDTA
plasma. Each testing laboratory should establish its own normal range.
Patients suffering from polycythemia rubra vera may have Epo concentrations within the normal range, whereas those suffering from secondary polycythemia may have elevated concentrations of serum Epo (17). Polycythemia rubra vera patients who undergo phlebotomy may have elevated serum Epo concentrations.
Epo Normal Ranges
| Serum | EDTA plasma |
| 3.3-16.6 mlU/mL | 3.1-14.9 mlU/mL |
Patients suffering from polycythemia rubra vera may have Epo concentrations within the normal range, whereas those suffering from secondary polycythemia may have elevated concentrations of serum Epo (17). Polycythemia rubra vera patients who undergo phlebotomy may have elevated serum Epo concentrations.
Patients suffering from most anemias will present with higher than normal concentrations of
serum Epo, whereas those suffering from anemia associated with chronic renal failure may
have serum Epo concentrations within the normal range of this assay (18). Anemic patients
who receive transfusions may exhibit lower than expected serum Epo concentrations.
Abnormally high concentrations of serum Epo may also be observed in various other
pathological states including renal neoplasms, benign tumors, polycystic kidney disease, renal
cysts and hydronephrosis (19).
The results of this assay should be used in conjunction with information available from clinical
evaluations and other diagnostic procedures.
Precision
Intra-Assay Precision (Precision within an assay) Four control pools were tested on one plate to assess intra-assay precision. Thirty assays were run using each protocol over a thirty day period with three separately manufactured lots of reagents.
Inter-Assay Precision (Precision between assays) Four control pools were tested in separate assays to assess inter-assay precision. Thirty assays were run using each protocol over a thirty day period with three separately manufactured lots of reagents.
EDTA Plasma, Serum
| Intra-Assay Precision | Inter-Assay Precision | |||||||
|---|---|---|---|---|---|---|---|---|
| Sample | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 |
| n | 30 | 30 | 30 | 30 | 30 | 30 | 30 | 30 |
| Mean (mIU/mL) | 5.82 | 16.01 | 25.18 | 79.02 | 6.45 | 16.22 | 26.35 | 84.14 |
| Standard Deviation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| CV% | 4.95 | 2.84 | 5.22 | 3.06 | 7.82 | 3.02 | 2.18 | 2.42 |
Recovery for Human Erythropoietin Quantikine IVD ELISA Kit
The recovery of human Epo spiked to levels throughout the range of the assay was evaluated in 10 serum and plasma samples.
| Specimen Type | Protocol | Amount Needed | Mean Recovery |
| Serum | Benchtop | 52.2 mlU/mL | 100% |
| Shaker | 57.5 mlU/mL | 93% | |
| Plasma (EDTA) | Benchtop | 51.8 mlU/mL | 102% |
| Shaker | 55.9 mlU/mL | 105% |
Linearity
To assess the linearity of the assay, samples spiked with high concentrations of Epo were serially diluted with Calibrator Diluent to produce samples with values within the dynamic range of the assay.
Scientific Data Images for Human Erythropoietin Quantikine IVD ELISA Kit
Human Erythropoietin ELISA/Epo ELISA Benchtop Protocol
Human Erythropoietin ELISA/Epo ELISA Shaker Protocol
Preparation and Storage
Shipping
The product is shipped at ambient temperature. Upon receipt, store it immediately at the temperature recommended below.
Stability & Storage
Store the unopened product at 2 - 8 °C. Do not use past expiration date.
Background: Erythropoietin/EPO
The over-expression of Epo may be associated with certain pathophysiological conditions (1, 2). Polycythemia exists when there is an overproduction of red blood cells (RBCs). Primary polycythemias, such as polycythemia vera, are caused by Epo-independent growth of erythrocytic progenitors from abnormal stem cells and low to normal levels of Epo are found in the serum of affected patients. On the other hand, various types of secondary polycythemias are associated with the production of higher than normal levels of Epo. The overproduction of Epo may be an adaptive response associated with conditions that produce tissue hypoxia, such as living at high altitude, chronic obstructive pulmonary disease, cyanotic heart disease, sleep apnea, high-affinity hemoglobinopathy, smoking, or localized renal hypoxia (1, 2). In other instances, excessive Epo levels are the result of production by neoplastic cells. Cases of increased Epo production and erythrocytosis have been reported for patients with renal carcinomas (3), benign renal tumors (4), Wilms' tumors, hepatomas (5), liver carcinomas (6), cerebellar hemangioblastomas (3, 7, 8), adrenal gland tumors (9), smooth muscle tumors (3, 9), and leiomyomas (10).
Deficient Epo production is found in conjunction with certain forms of anemias. These include anemia of renal failure and end-stage renal disease (1, 2, 11), anemias of chronic disorders [chronic infections (1), autoimmune diseases (1), rheumatoid arthritis (12), AIDS (13), malignancies (14)], anemia of prematurity (2), anemia of hypothyroidism (2), and anemia of malnutrition (2). Many of these conditions are associated with the generation of IL-1 and TNF-alpha, factors that have been shown to be inhibitors of Epo activity (1, 15). Other forms of anemias, on the other hand, are due to Epo-independent causes and affected individuals show elevated levels of Epo (2). These forms include aplastic anemias, iron deficiency anemias, thalassemias, megaloblastic anemias, pure red cell aplasias, and myelodysplastic syndromes.
Alternate Names
ECYT5, EPO, MVCD2
Gene Symbol
EPO
Additional Erythropoietin/EPO Products
Product Documents for Human Erythropoietin Quantikine IVD ELISA Kit
Product Specific Notices for Human Erythropoietin Quantikine IVD ELISA Kit
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⚠ WARNING: This product can expose you to chemicals including N,N-Dimethylforamide, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.