Audit Microcontrols K719M-5 - MicroCV Tumor Marker Linear Set 5Lvl Asy 5x1mL Lyophilized 5/Pk **REFRIGERATED**
Tumor Markers Linearity is assayed quality control material consisting of five levels of human serum.
Features
Five distinct levels that demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.
Storage
7 days (2 days for Free PSA) when stored at 2-8C.
Analytes
- Alpha-Fetoprotein (AFP)
- CA 125
- CA 15-3
- CEA
- PSA, Free
- PSA, Total
INTENDED USE
Linearity FD Tumor Markers is assayed quality control material consisting of five levels of human serum. Each level contains the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), CA 125, CA 15-3, Free Prostate specific antigen (Free PSA), and Total prostate specific antigen (Total PSA). These five levels demonstrate a linear relationship to each other for their respective analytes1 . It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), CA 125, CA 15-3, Free Prostate specific antigen (Free PSA), and Total prostate specific antigen (Total PSA).
This product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. Linearity FD Tumor Markers should not be used for calibration or standardization of the Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), CA 125, CA 15-3, Free Prostate specific antigen (Free PSA), and Total prostate specific antigen (Total PSA) assays. Linearity FD Tumor Markers is for In Vitro Diagnostic use only.
INSTRUCTIONS FOR USE
- Remove a vial from the package and reconstitute with 1 mL of deionized water.
- Allow the vial to sit at room temperature for 5 minutes.
- Occasionally swirl for 15 minutes, or until all visible material is dissolved. Do not shake. Donot mix mechanically. Avoid getting any undissolved material on the sides of the vial or thestopper.
- When all visible solid material is dissolved, invert several times to dissolve any material onthe stopper.
- Swirl occasionally for at least 5 minutes.
- Use immediately or return to 2-8C.
- The vial should remain stored at 2-8C at all times. If additional sampling is necessary, thetime outside of 2-8C storage should be minimized.
