1. OnSite Rapid Test Procedure Training
Part 3
CTK-MK-PPT-R0001 (3)

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 Contents Introduction Perform Assay Before, During, After 12
Perform Assay Before, During, After 3
Assaying with Accuracy 4
Troubleshooting 5
Product Evaluation
Additional Information
Storage Temperature & Shelf Life 6

4. Use External Control Before Assay
Recommended, especially when:
a new operator uses the kit
a new lot of test kit is used
a new shipment of kits is used
temperature used during storage of the kit falls outside of 2-30°C
the temperature of the test area falls outside of 15-30°C
to verify a higher than expected frequency of positive/negative result
to investigate the cause of repeated invalid results
Run 1 Positive Control and 1 Negative Control

5. Assaying with Accuracy
Some important factors affect the assay accuracy
All information provided with the kit
Storage temperature
Shelf life
Testing environment
Droppers
Swabs
Specimens
Sample diluent
Read time
Result line
Result keeping

6. Assaying with Accuracy Procedure change notification
Read all information provided with the kit
User at first few times
Additional information provided with the kit
Procedure change notification
Simple test procedure card
Related product information
Package insert
Procedure change notification

7. Assaying with Accuracy
Frozen ? X
Over 30°C ?
Storage Temperature
Recommend at 2-30°C
Monitor and report daily
If the storage temperature is outside of the range:
Contact CTK technical support
Verify product performance with external control kits
Temperature monitor report

8. Assaying with Accuracy
Shelf Life
Reagent in the devices can maintain its stability during the shelf life
If the product is beyond its shelf life:
Contact CTK technical support
Verify product performance with external control kits

9. Assaying with Accuracy
Testing environment
Temperature
NO strong air flow
Over 30°C ?
Evaporation X
Below 15°C ?
Slow flow rate X
Recommend at 15-30℃
Too strong?
Evaporation X

10. Assaying with Accuracy
Droppers
Size differences
Use properly
Do NOT switch droppers from different kit
Do NOT use droppers from different supplier
Practice several times if not familiar to droppers
5 uL
10 uL
20 uL
35 uL
45 uL

11. Assaying with Accuracy
Swabs
Different types
Use properly
Swabs should be processed as soon as possible after collection,
or the swabs or extraction specimens should be stored in a defined manner
Do NOT switch swabs from different kit
Do NOT use swabs from different supplier
Nasal and throat
Urethra
Throat

12. Assaying with Accuracy
Specimen collection, extraction and storage
Correct collection
Extraction on time
Specimens well mixed with buffer
Appropriate storage of extraction specimens
Specimen collection and handling is as important as performing assay

13. Assaying with Accuracy
MAX Line
Loading specimen
Specified volume
Appropriate droppers
Handle properly, no air bubble
Do NOT overload
Loading properly
Center of sample well
Vertically
√ X X
Too much
Too little

14. Assaying with Accuracy Always keep all components in package box
Loading sample diluent or buffer
Correct diluent or buffer
Correct droppers
Add immediately
Load vertically
√ X
Always keep all components in package box
Mix up
√ X

15. Assaying with Accuracy
Read time
Do NOT read result beyond the reading time, otherwise:
false positive
false negative
Read time is determined to ensure test result stable.

16. Assaying with Accuracy
Read result
Regular Positive Test Line
Regular Negative Test Line
Irregular Positive Test Line
Irregular Negative Test Line
Broken line
Half line
Line is shifted
White line

17. Assaying with Accuracy
Result keeping
Record result in form
Do NOT keep the test device for later discussion
Test line intensity may change
False positive might develop
Flow back migration could lead to high background
Take picture

18. Assaying with Accuracy
Internal Control
Contain a built-in control feature, the C line
The C line develops after adding specimen and sample diluent
If the C line does not develop:
possible causes:
Incorrect procedure
Sticky specimen leads to low migration
Improper storage
Broken packaging exposes the device
and affects performance
Components disassociated with each other
review the entire procedure
repeat the test with a new device √ X
C line develops
C line does not
develop