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