Hologic Aptima Controls Kit Operating instructions

Brand
Hologic
Model
Aptima Controls Kit
Type
Operating instructions

Hologic Aptima Controls Kit

The Hologic Aptima Controls Kit is a collection of quality control reagents intended for use with the Aptima Assays for the detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC). These controls are designed to establish run validity by ensuring that the Aptima Assays are performing as expected.

Key Features

  • Non-infectious CT and GC nucleic acids in a buffered solution
  • Estimated rRNA equivalent of 1 CT IFU (5 fg/assay*) and 50 GC cells (250 fg/assay*)
  • Can be used with Aptima Assays for the detection of CT and/or GC
  • Store at 2°C to 8°C; stable until the date indicated on the vials

Hologic Aptima Controls Kit

The Hologic Aptima Controls Kit is a collection of quality control reagents intended for use with the Aptima Assays for the detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC). These controls are designed to establish run validity by ensuring that the Aptima Assays are performing as expected.

Key Features

  • Non-infectious CT and GC nucleic acids in a buffered solution
  • Estimated rRNA equivalent of 1 CT IFU (5 fg/assay*) and 50 GC cells (250 fg/assay*)
  • Can be used with Aptima Assays for the detection of CT and/or GC
  • Store at 2°C to 8°C; stable until the date indicated on the vials
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
Hologic,Inc.
10210GeneticCenterDrive
SanDiego,CA92121USA
Forcountry-specificTechnicalSupportandCustomerServiceemailaddressandtelephonenumber,visitwww.hologic.com/support.
ThisproductmaybecoveredbyoneormoreU.S.patentsidentifiedatwww.hologic.com/patents.
©2003-2021Hologic,Inc.Allrightsreserved.
IN0114-01Rev.005
2021-05
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Hologic Aptima Controls Kit Operating instructions

Brand
Hologic
Model
Aptima Controls Kit
Type
Operating instructions

Hologic Aptima Controls Kit

The Hologic Aptima Controls Kit is a collection of quality control reagents intended for use with the Aptima Assays for the detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC). These controls are designed to establish run validity by ensuring that the Aptima Assays are performing as expected.

Key Features

  • Non-infectious CT and GC nucleic acids in a buffered solution
  • Estimated rRNA equivalent of 1 CT IFU (5 fg/assay*) and 50 GC cells (250 fg/assay*)
  • Can be used with Aptima Assays for the detection of CT and/or GC
  • Store at 2°C to 8°C; stable until the date indicated on the vials
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