I-Stat Act Controls - Abbott i-STAT Alinity Operation Manual

i-STAT ACT Controls

The i‑STAT ACT Control Level 1 and ACT Control Level 2 are intended for use to verify the integrity of
newly received i‑STAT ACT cartridges. The controls produce clotting times expected for moderate and
high level heparinization to indicate that the cartridges are functioning properly.
Storage
i-STAT ACT controls contain two levels, Level l and Level 2. ACT controls consist of two vials for each level
of control. One vial contains lyophilized plasma and the other vial contains the diluent (calcium chloride
solution). One box contains 5 vials of lyophilized plasma and 5 vials of diluent. Lyophilized plasma and
the diluent should be refrigerated at 2 to 8°C (35 to 46°F) until the expiration date printed on the box
and vial labels. Do not use beyond the expiration date.
Warnings and Precautions
Handle this product using the same safety precautions used when handling any potentially infectious
material. The human plasma used in the preparation of this product has been tested by FDA-approved
test methods and found negative/non-reactive for HIV-1, HIV-2, HBsAg, and HCV. However, no known
test method can offer complete assurance that products derived from human blood will not transmit
infectious disease.
Ranges
Assigned ranges are found on i‑STAT Value Assignment Sheets (VAS) located on
www.globalpointofcare.abbott/en/support/istat-brand/vas-i-stat-alinity.html. Follow facility policy
regarding control results that do not fall within assigned ranges.
Disposal
Dispose of this product as biohazardous waste according to all local, state, and national regulations.
Reconstitution Instructions
Prior to testing, i‑STAT ACT Control vials containing the lyophilized plasma and diluent should stand at
room temperature (18° to 30°C or 64° to 86°F) for a minimum of 45 minutes.
Pour the entire contents of the diluent into the lyophilized plasma vial. See further instructions under
Procedure for Testing
Procedure for Testing
Prerequisites
• Vials, cartridges, and instruments must be at the same temperature.
• i‑STAT ACT Control vials containing the lyophilized plasma and diluent should stand at room
temperature (18 to 30°С or 64 to 86°F) for a minimum of 45 minutes.
• i‑STAT ACT Control testing must be performed IMMEDIATELY (less than 30 seconds) AFTER
COMPLETING THE RECONSTITUTION AND MIXING STEPS.
i-STAT Alinity — System Operations Manual
Note: Vials left out at room temperature for more than 4 hours should be discarded.
Art: 745533-01 Rev. H
77
https://
Rev. Date: 02-Nov-2022