IVD SYSTEMS & AUTOMATED CLINICAL DIAGNOSTIC ANALYSERS
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Reagents FAQ’s

Frequently asked questions and other information about your product

Dear Customer

Search the Frequently Asked Questions.
If you cannot find answer to your question please contact us at application@adaltis.net

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ImmunoAssay Line

IMMUNOgen - ImmunoAssay Line - Eclectica Reagents

Refer to section 7 ‘Product Guide’ and check the document ‘Starting up needs to run a test’.

Or contact the Customer Care Centre via info@adaltis.net

12 or 15 months it depends on the analyte. Please contact the Customer Care Centre for the most accurate information.

It is available an excel sheet that will help you to estimate the cost per test based on the reagents/kits costs. (Download File)

The immunoassay kits (Specific Reagents) are provided with the 2 calibrators that have to be used in order to perform  the “two point verification”.

Master curve is stored into the smart card of each specific reagents and it is verified by a two points calibration procedure.

Frequency of two point verification: every 2 - 4 weeks (test dependant). 

Generally, 2 weeks the reagents and  1 week the controls ready to use. Some analytes have lyophilized calibrators which have to be reconstituted and stored in agreement with the specific IFUs.

For the analytes of your interest, you can download the Instruction for Use directly from our web site.

Each IFU located at the specific reagent page.

The immunoassay assay/kit (Specific Reagents) are provided with the 2 calibrators that have to be used in order to perform the “two points verification”, this is instead of the calibration curve.

The immunoassay assay/kit (Specific Reagents) are provided with the 2 calibrators that have to be used in order to perform the “two points verification”, this is instead of the calibration curve.

Master curve is stored into the smart card of each specific reagents and it is verified by a two points verification procedure. The ‘Master Curve’ is the calibration curve dedicated for the specific lot number and assay.

Two-point verification is mandatory in the following cases:

  • The calibration verification deadline expires (the period of validity of the calibration is analyte-dependent, ranging from 2 to 4 weeks; refer to the assay User Instructions for further information).
  • The Specific Reagent lot number changes.
  • The Common Reagent lot number changes
  • The Quality Control serum values are out of tolerance.
  • The instrument is serviced.

The calibration set is not mandatory, and have to be used only if the 2 point verification didn’t pass or if problems appear and investigation tests are necessary.