14-10 Art: 714376-00M Rev. Date: 31-Jan-12
Control Target Values
and Expected Ranges
Target values (determined by testing multiple vials of each level using
multiple lots of i-STATcartridges with analyzers that have passed the
Electronic Simulator test) are printed on a value assignment sheet
posted on the APOC website at www.abbottpointofcare.com. The ranges
displayed represent the maximum deviation expected when controls
and cartridges are performing properly. Should results outside the range
be obtained, refer to the Troubleshooting portion of this section of the
i-STAT SystemManual.Alwaysbesurethatthelot numberprintedonthe
valueassignmentsheetmatchesthelotnumberonthelabelofthevialinuse,
andthatthesoftwarerevisionabovethetablematchesthesoftwarerevision
intheanalyzer(checkthestatuspageontheanalyzer).
Note: Target values are specific to the i-STAT System; results obtained from these
reconstitutedcontrolplasmasmaydifferifusedwithothermethods.
STEP ACTION
1 After45minuteroomtemperatureequilibration,removethecap
and stopper from one lyophilized human plasma control vial and
remove the cap from one vial of calcium chloride reconstituting
fluid.
2 Pour the entire contents of the calcium chloride vial into the
lyophilized human plasma control vial. Place the stopper back
inthereconstitutedcontrolvial,sealingthevialappropriatelyso
that the contents do not leak or spill out.
3 Allowthevialtositatroomtemperaturefor1minute.
4 Mix the contents of the vial by swirling gently for 1
minute, then inverting slowly for 30 seconds.
Note: Tominimizefoamingofthecontrolsample,avoidvigorous
or rapid mixing motion. Visually inspect the control vial to
ensurethatthesampleisfullyreconstituted.Ifnot,discardthe
reconstituteduidandstartoverwithfreshvials.
5 Usinga plastic transfer pipette, plastic syringe, or plastic
capillarytubewithnoanticoagulant,immediatelytransferthe
solution from the vial into the ACT cartridge
6 Immediately seal the cartridge and insert it into an analyzer.
Note:AdditionalACTcartridgesmaybetestedwiththeremaining
uidifusedwithin30secondsofcompletereconstitutionofthe
sample.
CONTROLS FOR PT/INR CARTRIDGES
Intended Use
The i-STAT
®
PTControlLevel1(normal)andPTControlLevel2(abnormal)
areusedtoverifytheintegrityofnewlyreceivedPT/INRcartridges.
Contents
Each level of control is packaged as a box of 5 vials of lyophilized human
plasma and 5 vials of calcium chloride diluent. The Level 1 control vials contain
9.5
±
1.5mmol/L calcium chloride, whilethe Level 2 controlvials contain
12
±
2.0mmol/Lcalciumchloride.
Storage
i-STAT PT controls, Levels 1 and 2, are contained in 6-mL vials. Separate
6-mL vials contain 1-3 mL of calcium chloride solution for reconstitution.
Refrigerated storage at 2 to 8ºC (35 to 46ºF) should be maintained until the
printed expiration date on the box and vial labels. Do not use beyond the
expirationdateontheboxandviallabels.
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