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Our Vision is to improve healthcare as a global provider of innovative and reliable diagnostic tests. -
Our Mission is to identify and develop novel patentable diagnostic markers and technologies which can be commercialised to meet clinical needs, both in the laboratory and at the point of care. -
We will collaborate with partners, create branded products and identify complementary businesses which support our objective of continuing to grow as a respected and profitable healthcare company. -
Our Values include meeting all current and future regulatory, quality and environmental standards appropriate for our industry and the countries in which we operate.
Homocysteine EIA
FHCY100/FHCY200
Description:
Axis Homocysteine EIA Reagent kit (96 Well) - FHCY100
Axis Homocysteine EIA Control Kit (3 x 1.5mL) - FHCY200
Assay Principle:
Axis® Homocysteine Enzyme Immunoassay (EIA) is an enzyme immunoassay for the determination of homocysteine (Hcy) in blood. Protein-bound Hcy is reduced to free Hcy and enzymatically converted to S-adenosyl-L-homocysteine (SAH) in a separate procedure prior to the immunoassay. The enzyme is specific for the L-form of homocysteine, which is the only form present in the blood.
Measuring Range:
The calibrator range is from 2 to 50 µmol/L.
Assay Precision:
Precision of the Axis® Homocysteine EIA assay was evaluated according to NCCLS Protocol EP5. Three levels of controls were assayed for 20 days with 4 replicates per run at each level. Precision data are summarised in Table 1.
Table 1: Precision
| Samples | Average µmol/L | Hcy | Within Precision | Run | Total Precision |
| Control Low | 6.1 | 8% | 10% | ||
| Control Medium | 10.5 | 7% | 9% | ||
| Control High | 20.6 | 8% | 10% |
Limit of Quantification:
The quantification limit (CV < 20%) is 1.0 µmol/L.
Linearity of diluted plasma samples:
If the homocysteine concentration of a sample exceeds the range of the calibration curve, the sample should be diluted with Reagent A and reanalysed.
The linearity was evaluated by diluting four high patient samples with varying amounts of Reagent A as diluent.
Linear regression analysis gave:
Slope: 0.98
Intercept: -0.4µmol/L
Correlation coefficient: r2: 0.99
Method Comparison:
The Axis® Homocysteine Enzyme Immunoassay (EIA) was compared to the University of Bergen HPLC method. A comparison of 164 patient samples ranging from 3-37µmol/L homocysteine gave the linear regression shown below.
Slope: 0.94
Intercept: -0.09 µmol/L
Correlation coefficient: (r2): 0.94
| Related Papers |
| Homocysteine EIA Control Kit - All Languages (62 KB PDF) |
| Wald BMJ Paper (115 KB PDF) |
*Products may not be approved for sale in all countries. Please contact your local distributor for further details.
Axis-Shield at a Glance
A pioneering organisation focused on the development and manufacturing of important and innovative in vitro diagnostic tests for use in clinical laboratories and at the point of care.
Focus on Afinion
Axis-Shield's award winning point-of-care test system is designed for maximum simplicity coupled with laboratory accuracy and reliability for a number of key markers important for improved patient management.
