Product Manual
Quidel Molecular Bordetella Control Set Page 1 of 3
INTENDED USE
The Quidel Molecular Bordetella Control Set is intended to be used as full process controls in molecular
testing. This unassayed Control Set is for in vitro diagnostic use and consists of a highly purified, Bordetella
pertussis genomic DNA. The negative control is Bordetella pertussis free matrix.
INSTRUCTIONS FOR USE
The Quidel Molecular Bordetella controls should be used at the same volume as unknown samples in a
validated molecular test methodology. See table below for suggested volumes in specific Quidel Molecular
products.
Quidel Molecular Assay
Volume
AmpliVue® Bordetella
50 µL
MATERIALS PROVIDED
Cat. #M117
Control Kit (3 vials) – Store at 2°C to 8°C
#
Component
Quantity
Bordetella pertussis Positive Control Part M5100
2 vials/kit 1.0 mL per
vial
Negative Control Part M5183
1 vial/kit 2.0 mL
WARNINGS AND PRECAUTIONS
For in vitro diagnostic use.
Treat all specimens, samples and controls as potentially infectious. Follow universal precautions when
handling samples, this kit, and its contents.
Avoid contact with skin and eyes.
Use micropipettes with an aerosol barrier or positive displacement tips for all procedures.
Avoid microbial and cross contamination of the kit reagents. Follow Good Laboratory Procedures.
Controls contain 0.09% Sodium Azide. Do not empty these controls into drains.
Proper sample collection, storage, and transport are essential for correct results.
1
Store assay reagents as indicated on their individual labels.
Testing should be performed in an area with adequate ventilation.
Dispose of containers and unused contents in accordance with Federal, State and Local regulatory
requirements.
Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this kit.
Wash hands thoroughly after handling.
For additional information on hazard symbols, safety, handling and disposal of the components within this
kit, please refer to the Safety Data Sheet (SDS) located at quidel.com.