The Pregnancy-Skreen product line of controls is manufactured using a human based urine matrix that has been stabilized to insure that the product will be viable until the date of expiration. The positive control is spiked with hCG in a target range from 200-400 mIU/mL of urine matrix. The negative control is prepared from a urine pool that tested negative for hCG. The standard material used for spiking was obtained from human pregnancy urine lyophilized and found negative by ELISA to HIV-1, antibody for HCV and for HBSAG. The initial assay of the lyophilized material used for spiking was performed by radioimmunoassay. Subsequent testing of the control material is performed qualitatively to ascertain that positive controls tested positive and the negative controls tested negative for the claimed life of the product.
Each bottle contains stabilized human based urine in a convenient liquid form. Positive control urines have been spiked with known quantities of purified Human Chorionic Gonadotropin (hCG). Negative control urine is certified negative for the constituents listed in this insert.
STORAGE & STABILITY
This product is not meant to be used as a standard or calibrator.
The positive Pregnancy-Skreen control must test positive and the negative Pregnancy-Skreen control must test negative.
LIMITATIONS OF PROCEDURE
This control is meant to be used to validate the performance of qualitative urine hCG methods that screen urine for hCG levels consistent with pregnancy.
Consult test manufacturers instructions when using this product; changes in reagents, sample requirement, or methodology may effect test results.