Abbott i-STAT 1 System Manual page 542

i-STAT Total β-hCG Calibration Verification Kit
A. Intended Use
The i-STAT Total β-hCG Calibration Verification materials are used to verify
the calibration of the i-STAT Total β-hCG test throughout the reportable range.
B. Warnings and Precautions
Handle the products using the same safety precautions used when handling
any potentially infectious material. The human plasma used in the preparation
of these products has been tested by FDA approved test methods and found
negative/non-reactive for HBsAg, anti-HIV 1 / 2, anti-HCV, and HIV 1 Ag.
However, no known test method can offer complete assurance that products
derived from human blood will not transmit infectious disease.
Do not use if the calibration verification materials arrive uncapped.
Bacterial contamination of the calibration verification material can cause an
increase in turbidity. Do not use the calibration verification material if there is
visible evidence of microbial growth or gross contamination.
C. Storage and Stability
i-STAT Total β-hCG Calibration Verification fluids are ready-to-use liquid controls
requiring no reconstitution or frozen storage. They are stable until the expiration
date on the vial label when stored unopened at 2-8 °C (35-46 °F). Once opened,
i-STAT Total β-hCG Calibration Verification fluids are stable for 30 days when
stored tightly capped at 2-8 °C (35-46 °F).
D. Procedure
1. Access the i-STAT Cal Ver option under Quality Tests in the Administration
Menu. Enter the required information. The handheld allows 15 minutes (or the
customized timeout period) to insert the cartridge after the last data entry.
2. Immediately before use, gently mix the contents of the calibration verification
vial to ensure homogeneity. Avoid foaming of the sample.
3. Open the vial and transfer a drop of the fluid into the i-STAT Total β-hCG cartridge
using the vial dropper tip. Tightly recap the control vial and store it at 2-8 °C
(35-46 °F).
4. Seal the cartridge and immediately insert it into the handheld.
E. Target Value and Ranges
Target values (determined by testing multiple vials of each level using multiple
lots of cartridges and i-STAT 1 handhelds that pass the Electronic Simulator test)
are printed on a Value Assignment Sheet posted on the APOC website at
www.abbottpointofcare.com. The Value Assignment Sheet displays target values
and ranges expected when calibration verification fluids and equipment are
performing properly. Should results fall outside the range, refer to the Quality
Control section of the i-STAT 1 System Manual.
6
Art: 730475-01F Rev. Date: 14-Mar-16