IVD SYSTEMS & AUTOMATED CLINICAL DIAGNOSTIC ANALYSERS
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Enzyme-Linked Immunosorbent Assays (ELISAs) are the most widely used type of assay.
They have high sensitivity and specificity.
ELISAs are designed specifically for screening large numbers of specimens at a time, making them suitable for use in surveillance and centralized blood transfusion services.
As ELISAs require sophisticated equipment and skilled technicians to perform the tests, their use is limited to certain circumstances.
ELISAs are highly sensitive and specific, and are able to detect more variants. They require sophisticated equipment that must be regularly maintained, a constant electricity supply and skilled technicians. They are really not suitable for small laboratories, but for testing large numbers of samples per day, as well as in blood banks or for surveillance studies. Rapid tests are better for emergency testing, and in smaller laboratories with low numbers of tests per day or for testing on site.
Adaltis, as per internal policy and in agreement with the regulation in force, publishes the Instructions for Use (IFU) directly on the website where are available for the downloading.
This procedure is in compliance with 98/79/CE IVD Directive and the MEDDEV.2.14/3 issued by the European Commission and we are able to be more efficient in providing our updated information instantly to you.
This worldly wisdom can actively contribute to less consumption of paper and a better environmental care.
Each IFU located at the specific reagent page.
All the Certificate of Analysis are available for the downloading directly from the web site.
IFU’s are only downloadable after registration to our website (for the direct link to registration click on the link: http://www.adaltis.net/account/register/).
Choose “Products” and then “IVD Reagents”
Once you are in “IVD Reagents” page, if you scroll down the page, you will see that there are 4 columns visualised:
Immunoassays – IMMUNOgen
MicroELISA – EIAgen
Chemiluminescence – CLIAgen
Clinical Chemistry – Pchem Reagents
If you need to download the package inserts of EIAgen reagents you select “MicroELISA – EIAgen”.
The assays are divided by different categories like; Fertility/Pregnancy, Diabetes, Anemia, Thyroid, Retrovirus etc…
If you are looking for the IFU of HBsAg, select assay group “Hepatitis”, and once you are in this new page, you navigate to the bottom of the page you will see the list of products that belong to Hepatitis group.
Find the line related to the kit you are looking for and click on “Go to Product”.
In this new page, you will notice that, besides the description, the code and the package information, there are also the IFU and the MSDS.
Click on IFU / MSDS download icon.
