NewScen Coast Bio-Pharmaceutical Co., Ltd

INTENDED USE
Diagnostic Kit for human procalcitonin (PCT) is a chromatographic immunoassay (CIA) for the quantitative detection of human procalcitonin in serum/plasma and whole blood with the use of NewSign Immuno Assay Reader.

PRINCIPLE
Diagnostic Kit for Human Procalcitonin (PCT) is a double antibody sandwich immunoassay kit for the quantitative testing of human procalcitonin in blood. The membrane was precoated with PCT specific antibodies on the test band region and goat anti mouse IgG on the control band region. During the test, the specimen is allowed to react with PCT specific antibodies-colloidal gold particles conjugate, which was predried on the test strip.The conjugate binds to the PCT forming an antibody-antigen complex. The complex moves forward on the membrane by the capillary action, then the complex is captured by PCT specific antibody on the test region to produces a visual pink color band. The color band is positive correlated with the concentration of PCT of the specimen. Regardless of the presence of PCT, as the mixture continues to move across the membrane to the control band region, the complex is captured by immobilized goat anti mouse antibodies to form a distinct pink colored control band. The presence of the control band indicated: 1) a normal flow is obtained, 2) antibody precoated on control line and colloidal gold conjugate are functional.

STORAGE
The kits should be stored at a cool dark place at temperature 4-30°C and, the sealed pouch for the duration of the shelf life (24 months).

ASSAY PROCEDURE
1. Bring the test to room temperature; Remove the test card from the foil pouch and place on a clean dry surface.
2. Take the fresh whole blood/serum/plasma without pretreatment; bring 2~8℃ stored speciment to room temperature for test; centrifuge the frozen sample and take the supernatant liquid for use.
3. Shake up the sample dilunet.
4. Add 10µl of serum or plasma or 20µl of whole blood into S well, after all blood completely absorbed, add 80µl of buffer into B well. Read the result with Immuno Assay Reader within 15~20 minutes. Results after 20 minutes may not be accurate.

INTERPRETATION OF RESULTS

PCT is a specific indicator of severe bacterial inflammation and fungal infection. When there is a severe infection of bacteria and fungi, a rapid increase of the concentration of PCT in serum can be observed within 2-6 hours. PCT concentrations is genenrally higher than 1.0ng/ml and remain high for a long time. As for viral infection and other non-bacterial infection, the PCT level remains the same or shows only a slight elevation. Therefore, PCT is a good indicator for the identification of bacterial, fungal infection and viral infection.
1. PCT<0.5ng/mL,indicating that it is not sepsis or septic shock, but not excluded localized infection.
2. PCT of 0.5-2.0ng/mL, indicating that infection or sepsis may exist, but not severe sepsis or septic shock.
3. PCT of 2.0-10ng/mL, indicating systemic bacteria infection exists.
4. PCT>10ng/m,indicating that severe bacteria infection exists and  and comes with systemic inflammation.
5. PCT>20ng/mL, indicating the PCT level exceeds testing range.
6. Invalid result, no control line observed, retest required.