1drop Inc.

Global Mobile Healthcare Leader, 1drop

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㎕

Inquiry

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