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

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

1

•Introduction

2

•Perform Assay Before, During, After

3

•Assaying with Accuracy

4

•Troubleshooting

5• Product Evaluation

• Additional Information Storage Temperature & Shelf Life6

Use External Control Before Assay

Recommended, especially when:o a new operator uses the kito a new lot of test kit is usedo a new shipment of kits is usedo temperature used during storage of the kit falls outside of 2-30°Co the temperature of the test area falls outside of 15-30°Co to verify a higher than expected frequency of positive/negative

resulto 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

o All information provided with the kit o Storage temperature o Shelf lifeo Testing environment o Droppers o Swabso Specimens o Sample diluent o Read time o Result lineo Result keeping

Assaying with Accuracy

• Read all information provided with the kit

o User at first few times

o Additional information provided with the kit

Procedure change notification

Simple test procedure card

Related product information

Procedure change notification

Package insert

Assaying with Accuracy

• Storage Temperature

o Recommend at 2-30°C

o Monitor and report daily

o If the storage temperature is outside of the range:

Contact CTK technical support Verify product performance with

external control kits

Frozen ?

XOver 30°C ?

X

Temperature monitor report

Assaying with Accuracy

• Shelf Life

o Reagent in the devices can maintain its stability during the shelf life

o If the product is beyond its shelf life: Contact CTK technical support Verify product performance with

external control kits

• Testing environment

o Temperature

o NO strong air flow

Assaying with Accuracy

Below 15°C ?Slow flow rate

X

Over 30°C ?Evaporation

X

Too strong?Evaporation

X

Recommend at 15-30℃

• Droppers

o Size differences

o Use properly Do NOT switch droppers from different kit Do NOT use droppers from different supplier Practice several times if not familiar to droppers

Assaying with Accuracy

5 uL

10 uL

20 uL

35 uL

45 uL

• Swabs

o Different types

o 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

Assaying with Accuracy

Nasal and throat

Urethra

Throat

• Specimen collection, extraction and storageo Correct collectiono Extraction on time o Specimens well mixed with buffero Appropriate storage of extraction specimens

Assaying with Accuracy

Specimen collection and handling is as important as performing assay

• Loading specimen o Specified volume

Appropriate droppers Handle properly, no air bubble Do NOT overload

o Loading properly Center of sample well Vertically

Assaying with Accuracy

Too little Too much √ X X

MAX Line

√ X

• Loading sample diluent or buffer

o Correct diluent or buffer o Correct droppers

o Add immediately

o Load vertically

Assaying with Accuracy

√ XAlways keep all components

in package boxMix up

• Read time o Do NOT read result beyond the reading time, otherwise:

o false positive o false negative

Assaying with Accuracy

Read time is determined to ensure test result stable.

• Read result

Assaying with Accuracy

Broken line Half line White lineLine is shifted

Regular Negative Test Line Regular Positive Test Line

Irregular Positive Test Line Irregular Negative Test Line

• Result keeping

o Record result in form

o 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

o Take picture

Assaying with Accuracy

• Internal Controlo Contain a built-in control feature, the C line o The C line develops after adding specimen and sample diluent

o 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

Assaying with Accuracy

√

X

C line develops

C line does not develop