graded A+
1. What is the of mol- ecular testing for transplant pa-
focus of tients?
molecular di-
agnostics?
2. What are the
main applica-
tions of
molecu- lar
testing?
3. What are the
two types of
molecu- lar
testing?
4. Why is
quantita- tive
testing criti-
cal in
molecular
diagnostics?
5. In which infec-
tious diseases
is molecular
test- ing
widely used?
6. What is the
sig- nificance
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39
,Exam 6 DGS 4234 questions well answered to pass
graded A+
Molecular diagnostics focus on
nucleic acid-based testing (DNA Qualitative Testing (determines if a pathogen is present) and Quantitative
or RNA) for diagnosing, Testing (measures the concentration of a pathogen).
prognosis, disease risk
assessment, monitoring,
It is essential for monitoring disease progression and treatment eflcacy
screening, and pre- dicting
therapy response.
Applications span genetics,
infectious diseases,
pharmacogenetics, and Molecular testing is used in HIV, HCV, HBV, BK virus, EBV, and CMV.
oncology.
It helps monitor viral reactivation and disease progression.
7. What are FDA-Ap- Commercially manufactured tests validated by the FDA, requiring less
ettort for
proved clinical labs.
Tests
(IVDs)?
2/
39
,Exam 6 DGS 4234 questions well answered to pass
graded A+
8. What are Lab-De- Internally designed and validated tests that have been subject to legal
debates
veloped Tests trans- plant patients?
(LDTs)?
13. How is BK virus monitored in pa- tients?
9. What recent
le- gal 14. What is the ben- efit of transition- ing B
decision was virus test-
made
regarding
LDTs?
10. What are the
advantages of
molecular
test- ing
compared to
traditional
meth- ods?
11. What is the
role of
quantitative
testing in
chronic viral
infections?
12. What is BK
virus, and why
is it sig-
nificant in
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39
,Exam 6 DGS 4234 questions well answered to pass
graded A+
regarding FDA oversight.
A federal court ruled that the FDAThrough quantitative PCR testing in urine and plasma.
does not have the authority to
regulate LDTs.
It improves standardization and reliability.
Faster results, higher
sensitivity, ability to detect
non-viable pathogens, and
flex- ibility in testing
methods.
t involves creating calibration
curves to measure pathogen
concentrations and establish
reliable results.
BK virus is a polyomavirus that can
reactivate in kidney transplant
patients due to
immunosuppression, leading to
potential kidney transplant loss.
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