World First

COVID-19 COVID-19
Point-of-care
Molecular diagnostic kit
 Wiz COVID-19 CrystalMix PCR Kit
WorldFirst

COVID-19 COVID-19
Point-of-care
Molecular diagnostickit

Description
Wiz COVID-19 CrystalMix PCR Kit provides a range of testing options for the real-time detection of
2019-Novel Coronavirus by ultra-fast real-time PCR. The Kit is a lyophilized real-time
PCR mix containing a specific primer and probe for the amplification of the 2019-Novel
coronavirus.
Kit Contents
Kit Storage and Stability
• Store at 4 ~ 25°C, Do not freeze. Component Amount Cap Color
• Do not use once the cone-shape mix shrinks as dot-form. COVID-19 (RdRP) CrystalMix 48 tube
It damaged by re-hydration.
COVID-19 (E) CrystalMix 48 tube
COVID-19 Positive control * 1 vial
RNase-Fee water * 1 vial
Reagent and Equipment to be supplied by the user PCR Chip 15 chip
• WizDx™ F-150 Real-Time PCR System
• Micropipette & sterile pipette tips * Before using the positive control, add 200µl of RNase-free water and
• Disposable gloves dissolve sufficiently before use.
* Positive control & RNase-Free water are shipped at room temperature.
After receipt, please store in refrigerated or frozen.
 Wiz COVID-19 CrystalMix PCR Kit
WorldFirst

COVID-19 COVID-19
Point-of-care
Molecular diagnostickit

High-fast ( > 1 hr ) Anyone do it test COVID-19 anywhere

Lyophilized ready-to-use PCR kit molecular diagnosis within 45 min.

Room temperature storage

No need PCR preparation step

Minimize human error & contamination

5 min. 1 min. 40 min.
Point-of-care test available
 Wiz COVID-19 CrystalMix PCR Kit
WorldFirst

COVID-19 COVID-19
Point-of-care
Molecular diagnostickit

Quick Protocol

wait 2~3 min.

(RdRP) (E)
Collect sample RNA extraction Add 10µl of RNA sample Transfer 10µl of Seal the tape Insert the PCRchip
(Swab) to each CrystalMix tube CrystalMix to to F-150
PCR chip

START/STOP

Open WizDx Check the ‘Device connet’ Select ‘Load Protocol’ Select P01: PCR START Results analysis
Recorder program
 WorldFirst

COVID-19 COVID-19
Point-of-care
Molecular diagnostickit Wiz COVID-19 CrystalMix PCR Kit
System Configuration
PCR Kit Real-time PCR system

PCR chip COVID-19 CrystalMix WizDx™ F-150

Lyophilized PCR Kit PCR Chip

WizCOVID-19 CrystalMix PCR kit is freeze-dried type, it Wiz COVID-19 CrystalMix PCR kit reacts using a
contained all compo-nents for COVID-19 real-time RT-PCR, specialized PCR chip. The PCR chip allows the
such as RT and PCR enzyme, COVID-19 specific primers and COVID-19 to be diagnosed in 35 minutes by
probe.So, it can use directly without any PCR mixture prepa- controlling the temperature at a high rate of
ration step, therefore, easy-to-use, less contamination, less 8ºC/second.
human error and, higher reproducibility.
 WorldFirst

COVID-19 COVID-19
Point-of-care
Molecular diagnostickit Wiz COVID-19 CrystalMix PCR Kit

Test Process
STEP 2 STEP 3 STEP 4
STEP 1 Prepare sample (5 min.) Prepare reaction (1 min.) Run and Analysis (40 min.)
Collect sample

A B B

Put in the swab sampel to Buffer A Transfer 10ul of Buffer B to the Insert the PCR chip to the F-150.
Collect the upper respiratory After 5 minutes add 75ul of PCR kit and load 10ul of PCR Select the program and runPCR
swab sample Buffer A to Buffer B mixto the PCRchip Analysis of the results.
 Wiz COVID-19 CrystalMix PCR Kit
WorldFirst

COVID-19 COVID-19
Point-of-care
Molecular diagnostickit

Example of Test Results

Intuitive results using ‘WizDx Recorder’software

RdRP
 COVID-19
WorldFirst
COVID-19
Point-of-care
Molecular diagnostickit
Wiz COVID-19 CrystalMix PCR Kit
Features of WizDx Molecular Diagnostic Kit
Carryover Protection Technology applied to prevent cross-contamination
Two-stage hot-start technology applied to minimize non-specific reactions and increase specificity
Special drying method and Ultra-Stability Technology applied to long-term storage for 1 year at room temperature
Mechanical dispense maximizes reproducibility and minimizes experimental errors
As a dried type, it is convenient to store and ready-to-use, minimizing the experimental process.

Kit component

Competitor WizDx™
1. qRT-PCR mix 1. COVID-19 CrystalMix
2. Primer/Probe mix

VS
2. Positive control
3. Positive control 3. RNase-Free water
4. Distilled water 4. PCR chip
 WorldFirst

COVID-19 COVID-19
Point-of-care
Molecular diagnostickit Wiz COVID-19 CrystalMix PCRKit
Protocol
RNA purification PCR preparation PCR reacton
Competitor

• Complication step 1. Thawing the kit • PCR running time : > 2 hours
• RNA extraction takes more than 20minutes. 2. Prepare a microtube • Need PCR laboratory
• Sample transfer to a dedicatedlaboratory 3. Mix RT-PCR reagent and Primer/Probe • Expensive Real-time PCR instrument
• Need electrical instruments (centrifuge, etc.) 4. Dispense RT-PCR reagent to PCRtube • Heavy and large size
5. Add RNA sample and mix well
6. Spin down
7. PCRready
•If the sample quantity increases, the
preparation time increases proportionally.
Wiz

Collect sample Mix to buffer

• Simple step 1. Add RNA sample to CrystalMix tube • PCR running time : 40 minutes
• 5 minutes (just waiting time) 2. Transfer to PCRchip • No need spcical laboratory
• Anywhere, immediately use 3. Sealing tape • Cheap Real-time PCR instrument
• No need an electrical instrument 4. PCR ready • Samll size and light weight
 WorldFirst

COVID-19 COVID-19
Point-of-care
Molecular diagnostickit Wiz COVID-19 CrystalMix PCRKit
Comparison With Other Molecular Diagnostic Kits
Principle Competitor’s COVID-19 Real-time PCR kit Wiz COVID-19 CrystalMix PCR Kit
Principle Real-time PCR Real-time PCR
Accuracy Depends on the manufacturer 100% specificity, LOD (RdRP :10 copy/ul, E : 10 copy/ul)
Kit type Solution type (Prepare PCR mixture by mixing with Dried (lyophillized) type, No need PCR mix step.
PCR enzymes, primers and probes)
Storage/Shipping Freezing / Dry ice Room temperature / Room temperature
Specimen Throat, nasopharyngeal, sputum Throat, nasopharyngeal swab
Test time Over 3 hours 40 minutes
User Skilled & trained Non-professional
RNA preparation time 30 minutes 5 minutes
RNA prepartion step Complicate Easy
Target gene RdRP, E, (or N gene) RdR, E
Advantages / Long test time, Complicate protocol, Laboratory use only, Short test time, Easy protocol, No PCR mix preparation ste
Disadvantages Need cold chain, Feezing/thawing problem, Less contamination, Point-of-care test available,
Cross-contamination risk, Human error risk, Low human error, Competitive instrument
Very expensive instrument
 Wiz COVID-19 CrystalMix PCRKit
WorldFirst

COVID-19 COVID-19
Point-of-care
Molecular diagnostickit

DiagnosticAccuracy
Parameter RdRP gene E gene
Limit of detection 10 copy/ul 10 copy/ul
Specificty 100%, no cross-reactivity to other respiratory virus 100%, no cross-reactivity to other respiratory virus
Detection COVID-19 specific Beta coronavirus (SARS-related coronavirus)

Limit of detection of RdRP gene : 10 copy/µl Limit of detection of E gene : 10 copy/µl

270 RdRPgene 270 Egene

240 240
210 210
Signal Intensity

Signal Intensity
180 180
150 150
120 120
90 90
60 60
106 105 104 103 102 101 100 106 105 104 103 102 101 100
30 30
NTC NTC
0 0
0 5 10 15 20 25 30 35 40 0 5 10 15 20 25 30 35 40

Cycles Cycles
 WorldFirst

COVID-19 COVID-19
Point-of-care
Molecular diagnostickit Wiz COVID-19 CrystalMix PCRKit
Example of Test Results Software Information
Target Amp Signal
150
Positive
Signal Intensity

100

50

Invalid, try again PCR

0 Negative
0 10 20 30 40
Cycles

Troubleshooting
Guide Problem Possible Cause Solution and Explanation

Positive signal is detected Carry-over contamination • Exchange all critical solutions.

for negative controls • Repeat the analysis of all tests with fresh aliquots of all reagents.
• Take measures to detect and eliminate the source of contamination

No signal is detected Incorrect programming of the Real-time PCR • The PCR should be repeated after check for programming of
for positive control instrument. instruments, storage conditions, and the expiration date.

The kit reagents have expired. • Do not use once the cone-shape mixshrinks as dot-form.
The storage conditions for kit components have It damaged by re-hydration.
not complied with manufacturer instruction.
 COVID-19
WorldFirst
COVID-19
Point-of-care
Molecular diagnostickit
Wiz COVID-19 CrystalMix PCRKit

Ordering Information

Product Description Cat No. Package

Wiz COVID-19 CrystalMix PCR Kit Detection of Coronavirus 2019 (COVID-19) DX1202A 48 tests
Wiz F-150 Real-time PCR System Ultra-fast Real-time PCR machine W1150 1 system
WizPrep Viral DNA/RNA Mini Kit (V2) Viral DNA/RNA extraction by spin column W73052-100 100 prep
1-Step™ Solution Direct-to PCR buffer for swab sample W5105 24 prep
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