Jase: What does the Prima Celiac Test look for?

Kimmi: IgA and IgG antibodies to deamidated gliadin peptides in a small blood sample.

Jase: Does a positive line confirm coeliac disease?

Kimmi: No. It’s a screening result that needs confirmation by a healthcare professional.

Prima Celiac Test is a single-use blood self-test for anti-DGP antibodies. It does not diagnose coeliac disease or general “gluten sensitivity.” A negative result cannot rule out coeliac disease, particularly because the supplied sensitivity is below 100%. Do not change diet or treatment solely on the result; seek clinical advice if the result is positive or symptoms continue.

The supplied technical specifications state a cut-off close to 20 U/mL, specificity of 94.1%, sensitivity of 81.25% and accuracy of 90.0%. These figures do not guarantee an individual result.

Contents:

• 1 test cassette
• 1 vial with dropper containing the diluent
• 2 sterile lancets
• 1 pipette for blood sampling
• 1 cleanser gauze
• Instructions for use

Directions

USE PROCEDURE

1. Draw a blood sample by using the sterile lancet provided;
   
2. Collect the sample indicated with the black line by using the capillary pipette provided;
   
3. Deposit the collected specimen into the vial, previously opened, then screw it;
   
4. Add 3 drops of the obtained liquid into the sample well (S) indicated on the test cassette and wait 10 minutes before reading the result.
   

RESULTS INTERPRETATION 

Negative: No anti-DGP antibodies have been detected in the sample or their concentration is below the cut-off of 20 U/mL. 

Positive: Anti-DGP antibodies have been detected in the sample, thus a possible celiac disease. It is necessary to check with a specialist. 

F.A.Q.

What happens if the results reading time is not met?
 

The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.
 

How to prove that the test worked correctly?
 

A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.
 

How to interpret the test if the control and test lines have different intensities?
 

The color and intensity of the lines do not affect the interpretation of the result. The test is to be considered positive regardless of the color intensity of the test line (T).