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OnSite Rapid Test Procedure Training

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Presentation on theme: "OnSite Rapid Test Procedure Training"— Presentation transcript:

1 OnSite Rapid Test Procedure Training
Part 1 CTK-MK-PPT-R0001 (1)

2 Disclaimer This is a general training presentation based on the OnSite Rapid Test procedure. Trainees should take precautions when performing a specific assay, and should strictly follow the procedure provided by the test kit.

3 Training Purpose Tests are performed correctly
Results are accurate & reliable Errors are found & corrected

4 Training Contents Introduction Perform Assay Before, During, After 1
2 Perform Assay Before, During, After 3 Assaying with Accuracy 4 Troubleshooting 5 Product Evaluation Additional Information Storage Temperature & Shelf Life 6

5 Infection Induced Immune Response
Detectable Level Antigen Indicates active infection , and can be used as early infection marker (such as HIV p24 Ag) IgM Current or active infection IgM +IgG Current infection IgG Recovering or past infection

6 Immunoassay An immunoassay is a biochemical test that measures the presence or concentration of an analyte (antibody or antigen) in a solution through the use of antibodies or antigens Antigen Antibody Detect antigen by antibody Detect antibody by antigen

7 Explanation of Test Principle
Lateral flow chromatographic immunoassay

8 Products Manufacturing Process
Conjugation pad (conjugate Abs or Ags with colloid gold) C and T band (coat with Abs or Ags on NC membrane) Sample pad Absorbent pad Vinyl matte adhesive

9 Intended Use Be used as a screening test and aid in the diagnosis of a large range of diseases, such as: Blood Borne Tropical/Parasitic Hepatitis Respiratory Hormone/Neonatal Sexually Transmitted Biomarkers Gastrointestinal

10 Assay Samples and Targets
Samples Type Targets Examples Serum, plasma, whole blood Ag HBsAg, Dengue, Malaria, etc Abs (IgG/IgM/IgA) HIV, H. pylori, HAV, etc Biomarkers Troponin I, PSA, etc Fecal Cholera, Rotavirus/Adenovisurs, etc FOB Urine Hormone hCG

11 Kit Formats Cassette in Pouch Strip in Pouch Strip in Canister

12 Kit Main Components (as Applicable)
Package Insert Test Devices (Cassette or Strip) Sample Diluent or Buffer Extraction Tubes

13 Other Accessories (as Applicable)
Droppers Swabs Alcohol Swabs Lancets Band-aids

14 Read result within defined time line
Key Benefits Feature Benefit 2-3 step procedure Simple, easy to perform Result in minutes Fast, easy to read Minimal training, no equipment Can be used anywhere Accurate and reliable Suitable as screening test Competitive price Cost effective Room temperature storage (2-30℃) Flexible format Meets different demands Add specimen Add Sample Diluent (as applicable) Read result within defined time line


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