Prima Home Test Celiac Test

Overview

Prima Home Test Celiac Test
Self-test for the detection of anti deamidated gliadin (anti-DGP) antibodies, IgA and IgG, in blood, for celiac disease screening
CELIAC DISEASE & ANTI-DGP ANTIBODIES:
Celiac disease is a chronic autoimmune disorder that involves the inflammation of the small intestine due to gliadin intake: the protein portion of gluten found in various cereals (oats, wheat, barley, kamut, spelled, rye, spelled and triticale).
Gliadin is a water-soluble peptide that acts as “glue”, helping to maintain the shape of food, and able to pass through the intestinal epithelium. Recent studies have shown that people who suffer from celiac disease produce specific antibodies against gliadin deamidated peptides (anti-DGP), IgA and IgG, as a result of transglutaminase, which shows high specificity and sensitivity for celiac disease, thus allowing high accuracy in disease screening.
WHO IS THIS TEST FOR?
CELIAC TEST is useful for anyone who wants to check for any gluten sensitivity, which must then be confirmed by a specialist.
In particular, it is addressed to all those who have symptoms related to celiac disease, such as abdominal pain and swelling, chronic diarrhea, constipation, vomiting, weight loss and irritability, or for those who are genetically familiar with the disease. Even in the absence of the symptoms listed above, it is useful in case of iron, vitamin B or folate deficiency, which could indicate an incorrect intake of essential nutrients.
TECH SPECS:
CELIAC TEST is a lateral flow immunochromatographic device for the detection of IgA and IgG anti-DGP antibodies in whole blood. If antibodies are present in the sample, they will react with the deamidated gliadin. A positive result indicates that the antibody concentration is close to the cut-off of 20 U/mL.
Specificity     94.1%
Sensitivity     81.25%
Accuracy     90.0%
CONTENT:
1 test cassette
1 vial with dropper containing the diluent
2 sterile lancets
1 pipette for blood sampling
1 cleanser gauze
instructions for use
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” secrion 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).