The PREGNANCY-SKREEN™ Human Chorionic Gonadotropin (hCG) Positive and Negative controls are prepared from human based urine. These hCG controls can be used to monitor the performance of qualitative immunochromatographic hCG detection devices.
Includes: 1 Positive, 4mL dropper bottle , 1 Negative, 4mL dropper bottle
Each vial contains stabilized human based urine in a convenient liquid form. Positive control urines have been spiked with known quantities of purified hCG. Negative control urine is certified negative for the constituents listed in this insert.
Summary & Explanation
The PREGNANCY-SKREENTM hCG 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.
1. Allow controls to come to room temperature followed by gentle swirling or inversion before use. DO NOT SHAKE.
2. Add an appropriate aliquot of Pregnancy-Skreen™ control urine as required by the hCG immunochromatographic device or screening method.
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.
STORAGE & STABILITY
- Refrigerated Storage:
When stored refrigerated (2-8°C), the unopened controls are stable until the expiration date. Once opened, the controls are stable at refrigerated storage temperatures for 31 days from the date of opening or until the expiration date, whichever comes first.
- Room Temperature Storage:
If stored at room temperature (18-25°C), the controls are stable for 31 days or until the expiration date, whichever comes first, regardless of the date opened.