Single Tube Reaction
In just a single well, you can test for SARS-CoV-2 by detecting 2 target genes, E and N gene, as well as IPC(GAPDH) for quality control of total process.
Total Process Validation
Unlike other PCR kits, IPC (Internal Positive Control) in 1copy™ COVID-19 qPCR Triplex Kit simultaneously extracted from human GAPDH mRNA and amplified with the target proving to be highly effective in quality control of each process : sample collection, RNA extraction, and amplification.
| Process Validation | Sample Collection | RNA Extraction | Amplification |
|---|---|---|---|
| 1copy™ COVID-19 qPCR Triplex Kit | O | O | O |
| Company A (Put Artificial IPC RNA with collected sample specimen) |
X | O | O |
| Company B (Artificial nucleic acid is already included in Master Mix) |
X | X | O |
| Process Validation | 1copy™ COVID-19 qPCR Triplex Kit | A (Put artificial IPC RNA with collected sample specimen) |
Company B (Artificial nucleic acid is already included in Master Mix) |
|---|---|---|---|
| Sample Collection | ○ | X | X |
| RNA Extractio | ○ | ○ | X |
| Amplification | ○ | ○ | ○ |
Single Virus Level Limit of Detection
1copy™ COVID-19 qPCR Triplex Kit can reduce the risk of asymptomatic and latent infection of COVID-19 by a single virus level limit of detection.
High Accuracy Rate
Evaluations conducted using clinical samples under FDA regulations ensure sensitivity and specificity to be 100%.
(N=60, Jangwon Clinical Research Center, Republic of Korea, Principal Investigator Minjeong Song, M.D., Ph.D.)
| Nasopharyngeal swab sample (positive30, negative30) Oropharyngeal swab sample (Positive30, Negative30) |
Gold Standard Reference Method | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| 1copy™ COVID-19 qPCR Triplex Kit | Positive | 60 | 0 | 60 |
| Negative | 0 | 60 | 60 | |
| Total | 60 | 60 | 120 | |
| Positive Agreement | 100% (95% CI : 92.50% ~ 100%) | |||
| Negative Agreement | 100% (95% CI : 92.50% ~ 100%) | |||
High Compatibility
1copy™ COVID-19 qPCR Triplex Kit is compatible with the following 6 PCR machines.
- Roche Light Cycler 480
- Thermo Fisher Applied Biosystems 7500 Real-Time PCR Instrument System
- Qiagen Roter-Gene Q 5plex HRM
- Bio-Rad CFX96™ Real-Time PCR Detection System
- Thermo Fisher Scientific Applied Biosystems Quantstudio5
- Analytik-Jena qTOWER3 Real-Time PCR Thermal Cycler
Detection of Target Region
E gene is the beta coronavirus detection target, and N gene is the 2019-nCOV’s specific detection target.
Specifications
| 1copy™ COVID-19 qPCR Triplex Kit | 1copy™ COVID-19 qPCR Multi Kit | |
|---|---|---|
| Test step | 1 step | 1 step |
| Test/kit | 100 | 100 |
| Tube/test | Single Tube | 2 Tubes |
| Target gene | E gene - FAM N gene - Texas RED |
RdRp gene - FAM E gene - FAM |
| Sensitivity (Limit of Detection) | 5 copies / reaction | 4 copies / reaction |
| Testing time | 50 min | 90 min |
| Specimen (Collection Specimen) | Total RNA (Nasopharyngeal swab, Oropharyngeal swab) | |
| Sample volume | 5 ㎕ | 5 ㎕ x 2 reactions |
| Applicable PCR machine | Roche LightCycler 480 Qiagen Rotor-Gene Q 5plex HRM Thermo Fisher Scientific Applied Biosystems Quantstudio5 Applied Biosystems 7500 Real-Time PCR Instrument system Bio-Rad CFX96™ Real-Time PCR Detection system Analytik-jena qTOWER3 Real-Time PCR Thermal Cycler |
|
| Measurable disease | COVID-19 | |
| Catalog number | M23MD100T | M22MD100M |
| Certificate | CE-IVD | US FDA-EUA CE-IVD form over 10 countries |
Contents
| Kit contents | Cap | Volume(100 Test) |
|---|---|---|
| Master mix |  Red |
1,000 ㎕ |
| Primer.Probe mix (E gene, N gene, IPC) |
 Brown (Amber tube) |
100㎕ |
| Control (E gene, N gene, IPC) |
 Yellow |
100㎕ |
| DEPC DW |  Clear |
1,000㎕ |
