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  3. Aptima Controls Kit

Hologic Aptima Controls Kit Operating instructions

  • Hello! I've reviewed the instructions for the Hologic Control Kit 301110. This document details the purpose of the kit, which is to provide quality control reagents for Aptima Assays used to detect C. trachomatis and/or N. gonorrhoeae - including storage, handling, and expected results. I'm ready to answer any questions you might have about it.
  • What is the purpose of the Aptima Controls Kit?
    What are the storage conditions for the Aptima Controls Kit?
    Can the controls be used if they appear cloudy or contain precipitates?
Aptima Controls Kit
Aptima Controls Kit 1 IN0114-01Rev.005
Aptima®
For in vitro diagnostic use
Rxonly
Intended Use
TheAptima ControlsKit is foruse with theAptimaAssays for the detection of C. trachomatis and/or N. gonorrhoeae.These quality control reagents
aretobeusedaccordingtothe instructionsinthepackageinsertoftheappropriateAptimaAssaytoestablishrun validity.
Reagents
Note: For information on any hazard and precautionary statements that may be associated with reagents, refer to the Safety Data Sheet Library at
www.hologic.com/sds.
Materials Provided
Aptima Controls Kit (Cat.No.301110)
Warnings and Precautions
ForusewithAptimaAssaysforthedetectionofC. trachomatisand/orN. gonorrhoeae.ThePositiveControlCT (Negative ControlGC) serves asthe
negativecontrolforGCAssays/testresults.ThePositiveControlGC(NegativeControlCT)servesasthenegativecontrolforCTAssays/testresults.
Storage and Handling Requirements
ThereagentscontainedintheAptimaControlsKitaretobe storedat2°Cto 8°Candarestableuntilthe dateindicatedonthevials.
Upon warming to room temperature, some control tubes may appear cloudy orcontain precipitates. Cloudiness or precipitation associated with
controlsdoesnotaffectcontrolperformance.Thecontrolsmaybeusedwhethertheyareclearorarecloudy/precipitated.Ifclearcontrolsaredesired,
solubilizationmaybeexpeditedbyincubatingthemattheupperendoftheroomtemperaturerange(15°Cto30°C).
Aptima Assay Procedure
PleasereferencethetestproceduresectionoftheAptimaAssaypackageinsertortheinstrumentOperator'sManualforproceduralinstructions.
Aptima Assay Expected Results
*RefertotheAptimaAssaypackageinsertforspecific RLUvaluesassociatedwiththeAptimaControls.
Shouldresultsfalloutsidethese expectedresults,pleasecontact HologicTechnicalSupportforassistance.
Symbol Component Quantity Description
PCT/NGC AptimaPositiveControl,CT/
NegativeControl,GC 5 x 1.7mL Non-infectious CT nucleic acid in a buffered solution containing < 5% detergent. Each
400
L sample contains the estimated rRNA equivalent of 1 CT IFU (5 fg/assay*).
PGC/NCT AptimaPositiveControl,GC/
NegativeControl,CT 5 x 1.7mL Non-infectious GC nucleic acid in a buffered solution containing < 5% detergent. Each
400
L sample contains the estimated rRNA equivalent of 50 GC cells (250 fg/assay*).
*TherRNAequivalentswerecalculatedbasedonthegenomesizeandestimatedDNA:RNAratio/cellofeachorganism.
Control CT Result* GC Result*
PositiveControlCT/NegativeControlGC Positive Negative
PositiveControlGC/NegativeControlCT Negative Positive
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SanDiego,CA92121USA
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©2003-2021Hologic,Inc.Allrightsreserved.
IN0114-01Rev.005
2021-05
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