OnSite Rapid Test Procedure Training
Part 1
CTK-MK-PPT-R0001 (1)
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.
Training Purpose
Tests are performed correctly
Results are accurate & reliable
Errors are found & corrected
Training Contents
1
•Introduction
2
•Perform Assay Before, During, After
3
•Assaying with Accuracy
4
•Troubleshooting
5• Product Evaluation
• Additional Information Storage Temperature & Shelf Life6
Infection Induced Immune Response
Antigen Indicates active infection , and can be used as early infection marker (such as HIV p24 Ag)
IgM Current or active infectionIgM +IgG Current infectionIgG Recovering or past infection
DetectableLevel
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
Antibody
Detect antibody by antigen Detect antigen by antibody
Antigen
• Lateral flow chromatographic immunoassay
Explanation of Test Principle
Products Manufacturing Process
C and T band(coat with Abs or Ags on NC membrane)Sample pad Absorbent pad
Conjugation pad(conjugate Abs or Ags with colloid gold)
Vinyl matte adhesive
Intended Use
Be used as a screening test and aid in the diagnosis of a large range of diseases, such as:
Hormone/Neonatal
Sexually Transmitted
Biomarkers
GastrointestinalBlood Borne
Tropical/Parasitic
Hepatitis
Respiratory
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 Ag Cholera, Rotavirus/Adenovisurs, etc
Biomarkers FOB
Urine Hormone hCG
Cassette in Pouch Strip in Pouch Strip in Canister
Kit Formats
Kit Main Components (as Applicable)
Package Insert Test Devices (Cassette or Strip)
Sample Diluent or Buffer Extraction Tubes
Other Accessories (as Applicable)
Droppers Swabs
Band-aidsLancetsAlcohol Swabs
Key Benefits
Add specimen Read result within defined time line
Add Sample Diluent(as applicable)
Feature Benefit2-3 step procedure Simple, easy to performResult in 10-20 minutes Fast, easy to readMinimal training, no equipment Can be used anywhereAccurate and reliable Suitable as screening test Competitive price Cost effectiveRoom temperature storage (2-30 ) ℃ Can be used anywhere Flexible format Meets different demands