OnSite Rapid Test Procedure Training Part 1 CTK-MK-PPT-R0001 (1)
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Transcript of OnSite Rapid Test Procedure Training Part 1 CTK-MK-PPT-R0001 (1)
![Page 1: OnSite Rapid Test Procedure Training Part 1 CTK-MK-PPT-R0001 (1)](https://reader038.fdocuments.us/reader038/viewer/2022110208/56649d9f5503460f94a89a96/html5/thumbnails/1.jpg)
OnSite Rapid Test Procedure Training
Part 1
CTK-MK-PPT-R0001 (1)
![Page 2: OnSite Rapid Test Procedure Training Part 1 CTK-MK-PPT-R0001 (1)](https://reader038.fdocuments.us/reader038/viewer/2022110208/56649d9f5503460f94a89a96/html5/thumbnails/2.jpg)
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.
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Training Purpose
Tests are performed correctly
Results are accurate & reliable
Errors are found & corrected
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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
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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
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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
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• Lateral flow chromatographic immunoassay
Explanation of Test Principle
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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
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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
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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
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Cassette in Pouch Strip in Pouch Strip in Canister
Kit Formats
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Kit Main Components (as Applicable)
Package Insert Test Devices (Cassette or Strip)
Sample Diluent or Buffer Extraction Tubes
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Other Accessories (as Applicable)
Droppers Swabs
Band-aidsLancetsAlcohol Swabs
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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