Hotgen Anti-Cyclic-Citrullinated Peptide Test ( Anti - CCP )Elisa Kit 96 Test

INTENDED USE This kit is used for semi-quantitative measurement of human anti-cyclic citrullinated peptide antibody (Anti-CCP) in serum and plasma employing colloidal gold immunochromatography as an aiding tool for diagnosis of rheumatoidarthritis(RA). PRINCIPLE OF THE ASSAY The kit employs colloidal gold immunochromatography. When specimen is added to the sample cavity, capillary effect causes the fluid to flow to the other end of the NC membrane of the test cassette, Anti-CCP (if present) in the specimen first binds to a colloidal gold CCP conjugate. As the mixture moves along the NC membrane to the test region (T line) it binds to a mouse anti human antibody that is immobilized on the membrane resulting in the formation of a red line. The mixture continues to move to the control area (C line) where it forms a red colored band, indicating that the test results are valid. The color intensity of the red T line is proportional to the Anti-CCP concentration in the specimen, which is assessed after comparison with the referencecardprovidedwiththekit. The result is reported in four concentration intervals: less than 25RU/mL, between 25 and 100RU/mL, between 100 and 400RU/mL, and more than 400RU/mL. SPECIMEN COLLECTION AND STORAGE

1. Use plasma or serum sample. Separate plasma or serum within 24 hours after blood collection and samples may be stored refrigerated (2-8°C) foraslongasoneweekorat-20°Corbelowforlongertime.
2. Donotfreezeandthawsamplemorethanonce.
3. Highly lipemic and haemolysed samples are not suitable for this assay andshouldnotbeused.

STORAGE AND STABILITY The unopened kit should be stored under 4-30℃ and under this condition the kit can be used until the expiry date labeled on the kit which normally lasts for18monthsfromdateofmanufacture. Thesampledilutecanbestoredat4-30℃for30daysafteropening