Abbott i-STAT Alinity - I-STAT ACT Controls

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 clong mes expected for moderate and
high level heparinizaon to indicate that the cartridges are funconing 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
soluon). 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) unl the expiraon date printed on the box
and vial labels. Do not use beyond the expiraon date.
Warnings and Precauons
Handle this product using the same safety precauons used when handling any potenally infecous
material. The human plasma used in the preparaon of this product has been tested by FDA-approved
test methods and found negave/non-reacve for HIV-1, HIV-2, HBsAg, and HCV. However, no known
test method can oer complete assurance that products derived from human blood will not transmit
infecous disease.
Ranges
Assigned ranges are found on i‑STAT Value Assignment Sheets (VAS) located on hps://
www.globalpointofcare.abbo/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 naonal regulaons.
Reconstuon Instrucons
Prior to tesng, 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.
Note: Vials le out a
t room temperature for more than 4 hours should be discarded.
Pour the enre contents of the diluent into the lyophilized plasma vial. See further instrucons under
Procedure for Tesng
Procedure for Tesng
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 tesng must be performed IMMEDIATELY (less than 30 seconds) AFTER
COMPLETING THE RECONSTITUTION AND MIXING STEPS.
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i-STAT Alinity — System Operaons Manual Art: 745533-01 Rev. H Rev. Date: 02-Nov-2022