Intended use

The Euro Diagnostica CCPoint^® test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human capillary whole blood, plasma or serum. The results of the test are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by healthcare professionals. For in vitro diagnostic use.

Background

The CCPoint^® test is a colloidal gold based lateral flow immunoassay. Reactive cyclic citrullinated peptides are immobilised as a discrete line on a porous membrane located in the test zone.

The detection reagent, consisting of colloidal gold particles conjugated to anti-human IgG, is deposited within the device onto the conjugate pad.

In the assay procedure, a sample of blood is added to the sample port. A blood cell separation membrane transfers the sample fluid onto the porous membrane. After a short incubation, running buffer is added to the buffer port. This buffer mobilizes the colloidal gold particles from the conjugate pad. The gold particles and the sample move by capillary force across the membrane.

If the sample contains anti-CCP antibodies they will bind to the peptide-antigens and a red line will appear in the test zone (marked T). If the sample does not contain any anti-CCP antibodies no line will appear. With any sample a red control line should appear in the control zone (marked C). The control ensures that the coated colloidal gold is still active.

Kit components

Contents of CCPoint^® test kit:

• 20 Foil pouches containing the CCPoint^® test device
• 22 Disposable pipettes (20 µL)
• 2 Droplet bottles, each containing 3 mL of running buffer.
• 1 CCPoint^® Instructions for Use
• 1 Quick Reference Instruction