mb content guideline jan 2012

3
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Page 1: MB Content Guideline JAN 2012

Pag

EX EX Thefrais a WitTheinc Easubdetsco EX TheBioEasub

Ap

FoCO Aug

e 1 of 3 

XAMINAXAMINATION

e MB(ASCP) me. All examadministered

th CAT, whene difficulty lev

correctly. The

ch question inbtest area of ttermined by tore above the

XAMINATION

e MB(ASCP) ology: Molecuch of these sbtests for the

SU

Molecu

Molecula

Laborato

pplications o(

r a more specONTENT OUT

TE

gust 2011

ATION C MODEL

certification emination quest

using the form

n a person anvel of the queen a slightly e

n the test banthe content ohe level of dif

e pass point in

SUBTESTS

certification eular Science, Mubtests compMB examina

BTESTS

ular Science (MS)

ar Technique(MT)

ory Operation(LO)

of Molecular (AMT)

cific overviewTLINE on pag

ECHNOL

CONTEN

examination itions are multmat of compu

nswers a quesstions presenasier questio

nk is calibrateutline for a pafficulty. Theren order to suc

examination qMolecular Teprises a specition are desc

es Bo

ns

Testing

w of the four suges 2 – 3.

LOGIST

T GUIDE

s composed tiple-choice w

uter adaptive t

stion correctlynted to the exn is presente

ed for level of articular examefore, the exaccessfully pas

questions encchniques, Labfic percentag

cribed in the fo

Basic strucprinciples a

Basic principloptimize, trou

M

ContamGuidelines/R

Disease-spe

ubtest areas

T IN MOEXAMIN

ELINE

of 100 examiwith one best testing (CAT)

y, the next tesxaminee contid. In this way

difficulty and mination. Theaminee must ss the certifica

compass fourboratory Opee of the overaollowing table

DESCRIPTcture and funcand theory of M

les and selecbleshoot, and

Molecular Tech

ination, QualiRegulations,

ecific applicatTechniqu

on the MB(AS

OLECUNATION C

nation questioanswer. The).

st question hanues to increy, the test is t

is assigned ae weight (valuanswer enouation examina

r different subrations, and Aall 100-questi

e:

TION ction as relateMolecular Bio

t, prepare, ped evaluate reshniques

ity AssurancePersonnel, S

tions of Molecues

SCP) certifica

LAR BICONTENT

ons given in ae MB(ASCP) c

as a slightly hase until a qutailored to the

a content areae) given to eagh difficult quation.

btests within thApplications oion certificatio

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IOLOGYT GUIDEL

© American So

a 2 hour 30 mcertification e

igher level ofuestion is anse individual’s a

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he area of Moof Molecular Ton examinatio

EXAM PERCE

25-30

20-30

15-25

25-30

ation, please r

Y, MB(ALINE & O

ociety for Clinic

minute time xamination

f difficulty. swered ability level.

es with the is

chieve a

olecular Testing. on. The

ENTAGES

0%

0%

5%

0%

refer to the

ASCP)OUTLINE

cal Pathology

Page 2: MB Content Guideline JAN 2012

Page 2 of 3 

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

Page 3: MB Content Guideline JAN 2012

Page 3 of 3 

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. HerceptinR,

warfarin, PlavixR, 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