Transcript 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.

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
5
6
• Product Evaluation
• Additional Information
Storage Temperature & Shelf Life
Infection Induced Immune Response
Detectable
Level
Antigen
IgM
IgM +IgG
IgG
Indicates active infection , and can be used as early
infection marker (such as HIV p24 Ag)
Current or active infection
Current infection
Recovering or past infection
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
Antigen
Detect antigen by antibody Detect antibody by antigen
Explanation of Test Principle
• Lateral flow chromatographic immunoassay
Products Manufacturing Process
Conjugation pad
(conjugate Abs or Ags with colloid gold)
Sample pad
Vinyl matte adhesive
C and T band
Absorbent pad
(coat with Abs or Ags on NC membrane)
Intended Use
Be used as a screening test and aid in the diagnosis of a large
range of diseases, such as:
Blood Borne
Gastrointestinal
Tropical/Parasitic
Biomarkers
Hepatitis
Hormone/Neonatal
Respiratory
Sexually Transmitted
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
Hormone
hCG
Urine
Kit Formats
Cassette in Pouch
Strip in Pouch
Strip in Canister
Kit Main Components (as Applicable)
Package Insert
Test Devices (Cassette or Strip)
Sample Diluent or Buffer
Extraction Tubes
Other Accessories (as Applicable)
Swabs
Droppers
Alcohol Swabs
Lancets
Band-aids
Key Benefits
Feature
2-3 step procedure
Result in 10-20 minutes
Minimal training, no equipment
Accurate and reliable
Competitive price
Room temperature storage (2-30℃)
Flexible format
Add specimen
Benefit
Simple, easy to perform
Fast, easy to read
Can be used anywhere
Suitable as screening test
Cost effective
Can be used anywhere
Meets different demands
Add Sample Diluent
(as applicable)
Read result within
defined time line