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.
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 | ○ | ○ | ○ |
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.
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%) |
1copy™ COVID-19 qPCR Triplex Kit is compatible with the following 6 PCR machines.
E gene is the beta coronavirus detection target, and N gene is the 2019-nCOV’s specific detection target.
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 |
Kit contents | Cap | Volume(100 Test) |
---|---|---|
Master mix | ![]() |
1,000 ㎕ |
Primer.Probe mix (E gene, N gene, IPC) |
![]() |
100㎕ |
Control (E gene, N gene, IPC) |
![]() |
100㎕ |
DEPC DW | ![]() |
1,000㎕ |