Abbott i-STAT 1 System Manual - page 206

14-12

Art: 714376-00M 

Rev. Date: 31-Jan-12

CONTROLS FOR cTnI CARTRIDGES

i-STAT

®

 Cardiac Markers Controls are assayed human sera used to verify the 

integrityofnewlyreceivedi-STATcTnIcartridges.

Handlethisproductusingthesamesafetyprecautionsusedwhenhandlingany

potentially infectious material. The human sera used in the preparation of this 

producthavebeentestedbyFDAapprovedtestmethodsandfoundnegative/

non-reactiveforHIV-1,HIV-2,HBsAg,HCV,HTLV-1andHTLV-2.However,no

knowntestmethodcanoffercompleteassurancethatproductsderivedfrom

humanbloodwillnottransmitinfectiousdisease.

Eachvialcontains<0.1%sodiumazideasapreservative.Disposeofthisproduct

accordingtoalllocal,stateandnationalregulations.Ifdisposeddownadrain,

thesodiumazideinthisproductmayreactwithleadandcopperplumbingto

formhighlyexplosivemetalazides.Flushdrainwithlargeamountsofwater

to prevent azide build-up.

Donotuseifthecontrolsarrivethawedoruncapped.

Bacterial contamination can cause an increase in turbidity. Do not use the 

controlifthereisvisibleevidenceofmicrobialgrowthorgrosscontamination.

Storage and Stability

Store at ≤ –18

o

C (-1

 o

F)inanon-defrostingfreezer.Afterthaw,theopenedor

unopenedvialisstablefor4hourswhencappedandstoredat2-8

o

C (35-46

o

F).Donotre-freeze.

Procedure

Step

Action

1

Remove vial from freezer and thaw at room temperature (18-30°C) for 15 minutes.

2

Thoroughly mix by gently swirling the bottle. Avoid foaming of the sample.

3

Dispense a drop of sample directly from vial into the i-STAT cTnI cartridge and seal the 

cartridge. Tightly recap the bottle immediately after all sampling is complete and store 

at 2-8°C.

4

Insert cartridge into an i-STAT analyzer.

labelofthevialinuse,andthatthesoftwarerevisionabovethetablematches

thesoftwarerevisionintheanalyzer(checkthestatuspageontheanalyzer).

Note: Target values are specific to the i-STAT System; results obtained from these 

reconstitutedcontrolplasmasmaydifferifusedwithothermethods.

Warnings and 

Precautions

Control Target Values 

and Ranges

See value assignment sheet posted on the APOC website at www.

abbottpointofcare.com. The value assignment sheet displays target values and 

rangesexpectedwhencontrolsandequipmentareperformingproperly.Should

resultsfalloutsidetherange,refertotheTroubleshootingsectionthatfollows

the Procedure for Testing Controls.

Always ensure that the lot number and software revision on the value

assignmentsheetmatchesthelotnumberofthevialinuseandthesoftware

revision in the analyzer.

Targetvaluesarespecifictothei-STATSystem.Resultsmaydifferifusedwith

other methods.

Intended Use