1drop Inc.

Global Mobile Healthcare Leader, 1drop

Simultaneous Detection Kit

Examine 4 pathogens in 1 tube

1copy™ COVID-19/FluA/FluB/RSV qPCR Kit detects for COVID-19, Influenza A, influenza B and RSV in a single tube.
Different viral infections require specific types of treatment.
Inappropriate medical care can negatively affect a patient’s health.
Therefore, differential diagnosis is crucial in identifying the exact cause of the symptoms in order to apply the right medical treatment.

Time-saving

Improving productivity with reduced cost

1copy™ COVID-19/FluA/FluB/RSV qPCR Kit tests simultaneously in reduced running time with minimum labor required, it enables reduction of testing cost and improve test productivity.

Total Process Validation

Unlike other PCR Kits, IPC (Internal Positive Control) in 1copy™ COVID-19/FluA/FluB/RSV qPCR 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/FluA/FluB/RSV qPCR 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/FluA/FluB/RSV qPCR Kit Company A
(Put Artificial IPC RNA with collected sample specimen)
Company B
(Artificial nucleic acid is already included in Master Mix)
Sample Collection O X X
RNA Extractio O O X
Amplification O O O

Single Virus Level Limit of Detection

By showing a single virus-level detection limit in COVID-19, Influenza A, B, and RSV, 1copy™ COVID-19/FluA/FluB/RSV qPCR Kit can conduct simultaneous diagnosis including asymptomatic and latent period infections.

Limit of Detection CFX96 ABI7500 QuantStudio5
COVID-19 5 copies/rxn 5 copies/rxn 5 copies/rxn
Influenza A 10 copies/rxn 10 copies/rxn 10 copies/rxn
Influenza B 10 copies/rxn 10 copies/rxn 10 copies/rxn
RSV 10 copies/rxn 10 copies/rxn 10 copies/rxn

High Accuracy Rate

Evaluations conducted using clinical samples ensure sensitivity and specificity to be 100%.
(CRC-FWF-B20_V.1.1_20210209, Jangwon Clinical Research Center, Republic of Korea, Principal Investigator Minjeong Song, M.D., Ph.D.)

COVID-19
Swab sample
(Positive 40, Negative 10)
Gold Standard Reference Method
Positive Negative Total
1copy™ COVID-19 qPCR FluA/FluB/RSV Kit Positive 40 0 40
Negative 0 10 10
Total 40 10 50
Positive Agreement 100%
Negative Agreement 100%
RSV
Swab sample
(Positive 39, Negative 10)
Gold Standard Reference Method
Positive Negative Total
1copy™ COVID-19 qPCR FluA/FluB/RSV Kit Positive 39 0 39
Negative 0 10 10
Total 39 10 49
Positive Agreement 100%
Negative Agreement 100%
Influenza A
Swab sample
(Positive 20, Negative 10)
Gold Standard Reference Method
Positive Negative Total
1copy™ COVID-19 qPCR FluA/FluB/RSV Kit Positive 20 0 20
Negative 0 10 10
Total 20 10 30
Positive Agreement 100%
Negative Agreement 100%
Influenza B
Swab sample
(Positive 39, Negative 10)
Gold Standard Reference Method
Positive Negative Total
1copy™ COVID-19 qPCR FluA/FluB/RSV Kit Positive 20 0 20
Negative 0 10 10
Total 20 10 30
Positive Agreement 100%
Negative Agreement 100%

High Compatibility

1copy™ COVID-19/FluA/FluB/RSV qPCR Kit is compatible with the following 3 PCR machines.

  • Thermo Fisher Applied Biosystems 7500 Real-Time PCR Instrument System
  • Bio-Rad CFX96™ Real-Time PCR Detection System
  • Thermo Fisher Scientific Applied Biosystems Quantstudio5

Specifications

Test step Single Step
LoD
(Limit of Detection)
COVID-19 : 5 copies/rxn
FluA : 10 copies/rxn
FluB : 10 copies/rxn
RSV : 10 copies/rxn
Target COVID-19 (RdRp, N) FluA, FluB, RSV
Testing Time (CFX96) 50 min
IPC
(Internal Positive Control)
Control for sampling, extraction, and amplification process
Compatible PCR Machines CFX96
ABI7500
QuantStudio5
Dimensions (1kit) 73.0 x 65.0 x 40.0 mm
Weight (1kit) 27g
Storage Temperature Below -20℃
Catalogue Number M25MD100F

Contents

Kit contents Cap Color Volume(100 Tests)
Master mix Red 1,000 ㎕
Primer/Probe mix 1 Brown (Amber tube) 100㎕
Primer/Probe mix 2 Brown (Amber tube) 100㎕
Control Yellow 100㎕
DEPC DW Clear 1,000㎕

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