PEBBLE qcLAMP Platform
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I N S T R U C T I O N S F O R U S E
v1.1 10.08.2021
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PEBBLE qcLAMP Platform must be used only under environmental specifications as described
by BIOPIX DNA Technology (please refer to section 4. STORAGE AND HANDLING
REQUIREMENTS).
13.
TROUBLESHOOTING
13.1 FAILURE ASSESMENT
FALSE POSITIVES AND NEGATIVES RESULTS
RESULT
POTENTIAL REASON
SOLUTION
False Positive
Contamination of workspace area
Decontaminate with 10% bleach
Opening of reactions post-
amplification
Decontaminate with 10% bleach
Deviation from handbook protocol
Consult the instructions for use of the IVD
kit
Incorrect heating temperature.
Contact BIOPIX-T
Improper handling of samples
and/or positive controls
Consult the instructions for use of the IVD
kit
False Negative
Samples with lower or close to the
limit of detection
Consult the instructions for use of the IVD
kit
Incorrect heating temperature
Contact BIOPIX-T
Deviation from handbook protocol
Consult the instructions for use of the IVD
kit
Improper collection, handling,
and/or storage of samples
(including improper extraction
process)
Use the 5X Control Primer mix to verify
the RNA quality or repeat the process
Tubes are not properly placed inside
the tube holder.
Make sure that the tubes are firmly
placed in the tube holder
The presence of LAMP inhibitors or
interfering substances
Consult the instructions for use of the IVD
kit
PEBBLE qcLAMP Platform device
FAILURE MODE
POTENTIAL CAUSE
SOLUTION
Green LED does not light up
when you start the test
Failure of green LED
No action needs to be
taken. The system
remains functional.
Failure of electronics
Contact BIOPIX-T
