• 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

 

Axis-Shield are the global patent holders for Homocysteine immunoassays. First launched in 1995, the Axis-Shield assay is still the only EIA method available for labs without access to automated instruments.

Each kit comes complete with all required reagents and calibrators. A control pack is also available from Axis-Shield.


Axis Homocysteine EIA Reagent kit (96 Well) - FHCY100
Axis-Shield Homocysteine Control Kit (3 x 1.5mL) - FHCY200

 

Intended Use:

The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

 

Assay Principle:
The Axis-Shield Homocysteine Enzyme Immunoassay (EIA) is an enzyme immunoassay for the determination of homocysteine (Hcy) in serum or plasma. 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.

 

Measuring Range:
The calibrator range is from 2 to 50 µmol/L.

 

Assay Precision:
Precision of the Homocysteine EIA assay was evaluated according to CLSI 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   Within Run Precision   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

 

*Products may not be approved for sale in all countries. Please contact us 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.

› More about our tests

Focus on Homocysteine

As a general marker of overall health status, few tests carry greater predictive weight than Homocysteine. The amount of Homocysteine in your blood is one of the best independent indicators of how healthy you are.

 

› Axis-Shield Homocysteine assays

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Diagnostics for the laboratory & the point of care in areas of clinical need including diabetes, cardiovascular & neurodegenerative disease, rheumatoid arthritis & infectious disease.