Biomek Workstation: Preventive maintenance and calibration performed annually by a Biomek technician.
ELISA plate reader: Autocalibration will be performed before each plate reading. In addition the linearity of detection will be tested weekly using a calibration test plate (MedTec Biolab Equipment Company).
B. Assay Solutions
Assay buffer: Stored at 4°and used before expiration date
Wash buffer: Stored at 4°and used before expiration date
Streptavidin polymer-peroxidase conjugate buffer: Purchased complete, stored at 4° and used before expiration date.
Lot numbers, date made, initials of technician, name of solution is recorded in both the solutions manual and on the solution bottle.
C. Performance of each assay:
The following information is calculated, provided to the customer with the results of each assay and recorded in our laboratory assay performance log book:
A mid-level internal control is included in each assay (12.5 to 25% of the highest standard concentration).
The inter-test %CV for the control is calculated based on an up-to-date mean of the measured internal control values.
An intra-test %CV is calculated for each dilution of standard, each sample, and the internal control.
Standard curve equation and regression coefficient (s).
Percent error of internal control based on an up-to-date mean of the measured internal control values; if the error exceeds 20%, the test is rejected and the assay is repeated.
Each assay is tested at least every 60 days to insure adequate performance.
