Diagnostic molecular methods by Dr. Raymond (Roche)

Question 1

List 3 advantages of molecular diagnostics over traditional methods.

Answer 1

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

Question 2

medical devices that analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease.

Answer 2

In vitro diagnostics (IVD)

Question 3

IVD stands for

Answer 3

In vitro diagnostic kit

Question 4

RUOs stands for

Answer 4

Research use only kits

Question 5

IUOs stands for

Answer 5

investigational use only

Question 6

ASR stands for

Answer 6

Analyte specific reagents

Question 7

Intended for use in diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.

Answer 7

ASR

Question 8

When provided with the number of molecules generated and the number of PCR cycles performed, calculate how many molecules were in the original samples.

Answer 8

Example: 4 cycles = 96 so starting would be 6

Question 9

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.

Answer 9

MagNA pure LC instrument

Question 10

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.

Answer 10

The MagNA Pure LC

Question 11

Name the most commonly inherited coagulation disorder that is associated with venous thrombosis.

Answer 11

DVT- deep vein thrombosis - Factor V leiden mutation

Question 12

List five environmental risk factors that predispose a person to deep vein thrombosis (DVT)

Answer 12

Prolonged bed rest, hormone replacement therapy, inactivity, childbirth, pregnancy, long airplane flights, surgery (especially knee and hip), and oral contraceptives.