★★★ means very important and must be mastered

★★ means important and must be understood

★ means unimportant but should be known

CA_CLIA_Foundation_Immunology_PPT
1. Immunity★★
a) Immunity Basics★: definition
b) Immune System★★: Immune organs (lymph nodes, bone marrow, thymus, spleen);
Immune cells (lymphocytes); Immune molecules (antibodies, complements)
c) Immunoassays Basics: Antigens(Ag); Antibodies(Ab); Antigen-antibody reaction
d) Antigen Characteristics★★
e) Antibody Characteristics★★
f) Application of immune principle in detection★★: Direct detection
(Immunoturbidimetry/ Immune rate scatter turbidimetry); Indirect detection
(RIA/ELISA/FIA/CLIA)

2. Luminescence★
a) Classification: Photoluminescence; Bioluminescence; Chemiluminescence

3. Chemiluminescence Immunoassay (CLIA) ★★★

a) Definition★
b) Examples★★: Direct Chemiluminescence; Electrochemical Luminescence (ECLIA);
Enzymatic Chemiluminescence
c) Common CLIA technology type★★
d) Common detection principles★★★
i. Principle (I): Double-antibody sandwich
ii. Principle (II): Double-antigen sandwich
iii. Principle (III): Competitive method --Ag Labeled / Ab Detected
iv. Principle (IV): Competitive method --Ab labeled / Ag detected
v. Principle (V): Indirect method
vi. Principle (VI): Neutral competitive method
vii. Principle (VII): Capture method
e) Example of Mindray CLIA detection process★★

4. Summary★★★
a) What is the definition of CLIA?
b) What are the detection principles for CLIA?
c) What is the basic measurement process of CLIA?
 ★★★ means very important and must be mastered
★★ means important and must be understood
★ means unimportant but should be known

CA_CLIA_Foundation_Calibration_PPT
1. Calibration principle★★★
a) Calibration: Quantitative assays; Qualitative assays★★
b) Calibration failure flag principle★★★:
i. DCF;
ii. Complete all tests for each level calibrator;
iii. DUP;
iv. MON;
v. DEV;
vi. SLO;
vii. COV;
viii. RCV;
ix. LVC

2. DUP: repeatability problem★★★

a) Possible cause
b) Solution to DUP
c) Example of DUP

3. DEV/SLO: Actual RLU or Slope out of default range★★★

a) Possible cause
b) Example of DEV/SLO

4. LVC: new vs old calibration out of range★★★

a) Solution to LVC
b) Example of LVC

5. Troubleshooting for No flag /VAM/RCV flag★★★

6. Calibration failure: summary★★★

7. Reply information★★★: Reply information; Calibration Flag; Calibration Data; Effect

check setup; Effect check results; Background results
 ★★★ means very important and must be mastered
★★ means important and must be understood
★ means unimportant but should be known

CA_CLIA_Foundation_IQC_PPT
1. Overview of internal quality control (IQC) ★★
a) Overview of IQC
b) Development history of IQC
c) Basic concepts of IQC

2. measurement error and allowable total error★★

a) Allowable total error (TEa) and its setting principle
b) Quality specifications based on biological variation

3. Element of IQC★★
a) Elements of IQC materials
b) Use and preservation of IQC materials
c) L-J chart
d) Westgard multi-rule quality control chart
e) Target value

4. Pre-analysis quality control★★★

a) Blood Collection
b) Sample status
c) Suggested pre-treatment

5. Case Studies★★
a) Case Studies 1 - Long-term cumulative QC results
b) Case Studies 2 - Reagent loading
c) Case Studies 3- Sample preparation
 ★★★ means very important and must be mastered
★★ means important and must be understood
★ means unimportant but should be known

CA_CLIA_Foundation_QC_PPT
1. Overview of internal quality control (IQC) ★★

2. Westguard multi-rule on L-J chart★★★

a) 12S
b) 22S
c) 13S
d) R4S
e) 41S
f) 10x

3. Troubleshooting guideline★★★
a) Control problem
b) Reagent problem
c) Machine problem
d) Consumable problem

4. Reply information★★★
a) Control
b) Reagent
c) Machine
d) Consumable
 ★★★ means very important and must be mastered
★★ means important and must be understood
★ means unimportant but should be known

CA_CLIA_Foundation_Influencing-factors_PPT
1. Fundamental principles of Mindray CLIA★★
a) Structure of antibody
b) Structure of antigen
c) Antigen antibody labeling
d) Fundamental principles of Mindray CLIA

2. Common factors of immune response★★★

a) Laboratory workflow
b) Common factors -Before analysis
i. Test Application
ii. Patient preparation
iii. Sample collection
iv. Sample transport
v. Sample processing

3. Case study★★★
a) Correct transportation and centrifugation
b) Factors affecting NSE test results-hemolysis
c) Correct sample tube