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

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 Contents Introduction Perform Assay Before, During, After 1 2 Perform Assay Before, During, After 3 Assaying with Accuracy 4 Troubleshooting 5 Product Evaluation Additional Information Storage Temperature & Shelf Life 6

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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