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Page2of3


EXAMINATION CONTENT OUTLINE
TECHNOLOGIST IN MOLECULAR BIOLOGY

Examination questions, which are related to the subtest areas outlined below, will be both theoretical and procedural.
Theoretical questions measure skills necessary to apply knowledge, calculate results, and correlate patient results to
disease states. Procedural questions measure skills necessary to perform laboratory techniques, evaluate laboratory
data, and follow quality assurance protocols.

I. MOLECULAR SCIENCE (25-30%)
A. Nucleic Acid Chemistry
1. Sugars
2. Bases
3. Chemical structure
4. Associated proteins
5. Mutations
B. Basic Molecular Theory
1. Replication
2. Transcription
3. Exons, introns, and splicing
4. Translation
5. Chromosome structure
6. Extrachromosomal structure (e.g., phage,
plasmid, mitochondrial)
7. Protein structure
C. Biochemical Reagents
1. Polymerase enzymes
a. DNA
b. RNA
2. Endo and exonuclease enzymes
3. Reverse transcriptase
4. DNA ligase
5. Assay development and design
D. Genetics
1. Human
2. Microbial


II. MOLECULAR TECHNIQUES (20-30%)
A. Separation and Detection
1. Electrophoresis
a. Gel (including agarose acrylamide and
pulsed field)
b. Capillary
2. Blotting and probing procedures (including
washing and stringency)
3. Probe hybridization
4. Nucleic acid purification
5. Probe structure (e.g., TaqMan, FRET,
simple, beacon, scorpion)
B. Nucleic Acid Amplification
1. Polymerase chain reaction (PCR)
2. PCR variations (e.g., real-time, nested,
multiplex, arrays, reverse transcriptase)
3. Branched DNA (bDNA) technology
4. Sequence based (NASBA)
5. Transcription-mediated technology (TMA)
6. Strand displacement amplification (SDA)
7. Loop-mediated isothermal amplification
(LAMP)
8. Other (e.g., hybrid capture, ligase chain
reaction, cleavase)
C. DNA Sequence Analysis
1. Sanger Sequencing (e.g., chain terminators)
2. Next generation sequencing
3. Automated sequence analyzer
4. Other (e.g., pyrosequencing)
D. Other Techniques
1. Denaturing HPLC
2. Melt curves analysis
3. Nucleic acid labeling
4. in-situ hybridization (ISH)
5. Restriction fragment length polymorphism
(RFLP)
6. Epigenetic modification
7. Array technology (e.g., bead, microarray)
8. Multiplex ligation-dependent probe
amplification (MLPA)
9. Mass spectrophotometry
10. Multi-locus sequence typing (MLST)


III. LABORATORY OPERATIONS (15-25%)
A. Contamination (e.g., biological, amplified
and non-amplified nucleic acid)
1. Prevention
2. Monitoring and detection
3. Elimination
B. Quality Assurance
1. Specimen collection, preparation, transport
and storage
a. Evaluate quality and quantity of
specimen
b. Evaluate quality and quantity of nucleic
acid
2. Reagent selection, preparation (including
calculations), storage, and disposal
3. Assay selection and validation
4. Result calculation, interpretation and
reporting
5. Quality control and proficiency testing
a. Assay controls
b. Proficiency testing
6. Equipment and Instrumentation principles,
calibration, maintenance, troubleshooting
and validation
C. Guidelines and Regulations
1. Test System Categories: Analyte specific
Page3of3

reagent (ASR), research use only (RUO), in-
vitro diagnostics (IVD) and lab developed
tests (LDT)
2. Regulations and Standards: CLIA, The
Joint Commission, CAP, CMS, CLSI, FDA
D. Personnel
1. Continuing education
2. Competency
E. Safety

IV. APPLICATIONS OF MOLECULAR TESTING
(25-30%)
A. Infectious Disease
1. Qualitative Analysis (e.g., MRSA, C. difficile,
respiratory pathogens, STD)
2. Quantitative Analysis (e.g., viral load)
3. Genotypic Characterization (e.g., molecular
epidemiology, viral typing, resistance
testing)
B. Oncology
1. Leukemias/Lymphomas (e.g., CML, ALL,
translocations, clonal rearrangements)
2. Solid Tumors
3. Hereditary cancer syndromes (e.g., breast,
colon, ovarian)
C. Genetics
1. Hemoglobinopathies (e.g., thalassemias,
sickle cell anemias)
2. Coagulopathies (e.g., Factor V Leiden,
prothrombin, MTHFR)
3. Trinucleotide repeat disorders (e.g., Fragile
X, Huntington, muscular dystrophy)
4. Single gene disorders (e.g., cystic fibrosis,
Gaucher, hereditary hemochromatosis)
5. Epigenetic disorders (e.g., Prader-Willi,
Angelman)
D. Other
1. Histocompatibility
2. Genetic identity (e.g., parentage, specimen
identification, forensic)
3. Engraftment
4. Pharmocogenomics (e.g. Herceptin
R
,
warfarin, Plavix
R
, carbemazepine)


Examples provided (as indicated by e.g.) are not limited
to those listed.

All Board of Certification examinations use conventional
units for results and references ranges.


END OF CONTENT GUIDELINE