INTENDED USE

The Procalcitonin Semi-Quantitative Rapid Test is used for semi-quantitative determination and monitoring of PCT concentrations in whole blood/serum/plasma specimens.

SUMMARY

The Procalcitonin (PCT) is a peptide hormone mainly produced by the C cells of the thyroid and certain endocrine cells of the lung. Under normal expression conditions, procalcitonin is immediately cleaved into three specific fragments, an N terminal residue, calcitonin and katacalcin, Levels of unprocessed procalcitonin rise significantly after bacterial infection, trauma or shock.
The Procalcitonin Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that semi-qualitatively detects the presence of Procalcitonin in whole blood, plasma or serum specimens at the sensitivity of 0.5ng/mL, 2ng/mL and 10ng/mL. The test utilizes a combination of monoclonal antibodies to selectively detect elevated levels of Procalcitonin in whole blood, plasma or serum. At the level of claimed sensitivity, the Procalcitonin Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma) shows no cross-reactivity interference from the structurally related CRP or others at high physiological levels.

PRINCIPLE

The Procalcitonin Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma) detects Procalcitonin through visual interpretation of color development on the internal strip. Anti-PCT antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-PCT antibodies conjugated to colored particles and precoated on the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If Test band 3 (T3) appears, it indicates that the PCT level in the specimen is between 0.5-2.0ng/ml. If the Test band 3 and 2 (T3 and T2) appear, it indicates that the PCT level in the specimen is between 2.0-10.0 ng/ml. If all the Test bands (T1, T2, T3), it indicates that the PCT level is above 10.0 ng/ml. The appearance of control line serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.