1drop Inc.

Global Mobile Healthcare Leader, 1drop

4 Reactions in a Single Tube

In just a single well, you can test for SARS-CoV-2 by detecting 3 target genes, RdRp, 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 4plex 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 4plex 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

By showing a single virus-level detection limit in all three genes, it reduces the risk of COVID-19 asymptomatic and latent period infections.

50minutes Testing Time

Within 50 minutes after extraction step, the test result guaranteed with 100% sensitivity and specificity will be obtained.

Swab sample
(Positive 34, Negative 70)
Gold Standard Reference Method
Positive Negative Total
1copy™ COVID-19 qPCR 4plex Kit Positive 34 0 34
Negative 0 70 70
Total 34 70 104
Positive Agreement 100% (95% CI : 89.72% ~ 100%)
Negative Agreement 100% (95% CI : 94.87% ~ 100%)

High Compatibility

1copy™ COVID-19 qPCR 4plex 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 RdRp, N gene is the 2019-nCOV’s specific detection target.
In addition, the virus mutations which have been report to date can be also detected.

Specifications

1copy™ COVID-19 qPCR 4plex Kit 1copy™ COVID-19 qPCR Triplex Kit 1copy™ COVID-19 qPCR Multi Kit
Test step 1 step
Test/kit 100
Tube/test Single Tube(4-plex) Single Tube 2 Tubes
Target gene E gene - FAM
N gene - Texas RED
RdRp gene - VIC
E gene - FAM
N gene - Texas RED
RdRp gene - FAM
E gene - FAM
Sensitivity
(Limit of Detection)
5 copies / reaction 5 copies / reaction 4 copies / reaction
Testing time 50 min 50 min 90 min
Specimen
(Sample Specimen)
Total RNA (Nasopharyngeal swab, Oropharyngeal swab)
Sample volume 5 ㎕ 5 ㎕ 5 ㎕ x 2 reactions
Applicable PCR machines 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 M24MD100T M23MD100T M22MD100M
Certificate CE-IVD
KFDA FSC
CE-IVD
KFDA FSC
US FDA-EUA (Waiting for Approval)
Poland MOH
Indonesia MOH
India ICMR
Philippines FDA
US FDA-EUA
CE-IVD
Certificate from over 10 countries

Contents

Kit contents Cap Volume(100 Test)
Master mix Red 1,000 ㎕
Primer.Probe mix
(E gene, N gene, RdRp gene,IPC)
Brown (Amber tube) 100㎕
Control
(E gene, N gene, RdRp gene, IPC)
Yellow 100㎕
DEPC DW Clear 1,000㎕

Inquiry

Please leave an e-mail address for detailed information on our products.