Flashcards in Diagnostic molecular methods by Dr. Raymond (Roche) Deck (12)
List 3 advantages of molecular diagnostics over traditional methods.
1. extremely sensitive- low levels detected, previously uncultured agents identified, and small changes monitored.
2. highly accurate- based on identifying a pathogen by its DNA or RNA sequence, differentiate genotypic variants.
3. fast results for timely clinical decisions
medical devices that analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease.
In vitro diagnostics (IVD)
IVD stands for
In vitro diagnostic kit
RUOs stands for
Research use only kits
IUOs stands for
investigational use only
ASR stands for
Analyte specific reagents
Intended for use in diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.
When provided with the number of molecules generated and the number of PCR cycles performed, calculate how many molecules were in the original samples.
Example: 4 cycles = 96 so starting would be 6
Purifies nucleic acids from 1 to 32 samples in 90 minutes. And allows automated assembly of PCR reactions in 96 well plates, PCR tubes, light cycler capillaries and A rings for cobas amplicor analyzer.
MagNA pure LC instrument
This instrument is FDA cleared for use only with the Factor V leiden kit and the Factor II kit. User must validate any other use themselves.
The MagNA Pure LC
Name the most commonly inherited coagulation disorder that is associated with venous thrombosis.
DVT- deep vein thrombosis - Factor V leiden mutation