1. Manufacturing Process and Principle of Radioimmunoassay Kit
ShinJin Medics
S.A. Diagnostic Development Lab

2. Content Ⅰ. Design Process Ⅱ. Manufacturing Process
Ⅲ. Quality Control Process

3. I. Design Process

4. Basic concept of Radioimmunoassay
Tracer
Capture

5. Development of Raw materials
                                                             
Monoclonal Antibody development
Polyclonal Antibody development

7. Development of Radioimmunoassay
                                                        
Matching
Test
Performance
Test
Stability
Test
Evaluation
Step
Tracer iodination
Capure coating
Matching Test
Basic clinical Test
Sensitivity Test
Specificity Test
Precision Test
Recovery Test
Linearity Test
Hook effect Test
Tracer stability Test
Tube stability Test
Standard stability Test
External
Evaluation
Internal

8. II. Manufacturing Process

9. Immunotube Manufacturing Methods
1. Coating
2. Blocking
3. Fixing

10. Coating Instrument

11. Blocking / Fixing Instrument

12. Iodination Methods
Iodination of antibodies and antigens is a straighforward and effective method of labeling
I125 is normally used for most immunochemical analyses
The decay of I125 yields low-energy gamma and X-ray radiation , easy to detect.
The 60-day half-life of I125 is convenient compromise between effective shelf life and waste disposal.

13. Iodination Methods

14. Bolton-Hunter reagent
3-(4-Hydroxyphenyl)propionic acid N-hydroxysuccinimide ester 
React with I125
React with protein, petide

15. Target material of Iodination
Protein
Small molecule
1. Steroid
2. Thyroid

16. Process of Protein Iodination
1. Iodine 125 Tagging
I125 + =
I125

17. Purification of Protein-I125

18. Steroids Iodination Structure of Steroids Kinds of Steroids
1. Estradiol (E2)
2. Estriol (E3)
3. Progesterone
4. Testosterone
5. Cortisol

19. Process of Steroids Iodination
Materials
1. Steroid
2. Histamine
3. I125

20. Method 1. Steroid activation 2. Histamine activation
3. Conjugation of Steroid
and Histamine-I125
4. Purification of Steroid and Histamine-I125
by TLC (Thin layer Chromatography) method

21. III. Quality Control Process

22. QC Process Raw Materials QC Tube QC Tracer QC Semi-Assembled QC
Coating Raw
Materials QC
Tracer Raw
Standard Raw Materials QC
Coating Buffer
Blocking Buffer
Fixing Buffer QC
QC of coated Tube (sensitivity, specifity)
QC of Iodinated Tracer (sensitivity, specifity)
Before Assembled,
All components tested
(Tube and Tracer and Standard etc)
After Assembled,
kits tested

23. LLHL Effect (Low Lower, High Lower)
Tube QC
Background
LLHL Effect (Low Lower, High Lower)
Con.
Cpm
Con.
Cpm
After Damage

24. LHHL Effect (Low Higher, High Lower)
Tracer QC
Background
LHHL Effect (Low Higher, High Lower)
Con.
Cpm
Con.
Cpm
After Damage
Hinge point

25. Example of damaged Tracer
Hinge point

26. Conclusion
Capture and tracer selected and developed through monoclonal Ab and polyclonal Ab
The immunotube is manufactured through coating, blocking, fixing phase.
Tracer is manufactured through I125 coupling by oxidation method.

27. Thank You !