The 1copy™️ qPCR Covid-19 Multi Test Kit is a PCR technology that amplifies the target nucleic acids (DNA, RNA) into the detectable level and allows the kits to detect the virus and detect whether there is COVID-19 virus present, in the sample or not. The 1copy™️ qPCR Covid-19 Multi Test Kit allows the qualitative detection of genes (E gene and RdRp gene) of COVID-19 with real-time qPCR (including reverse-transcription reaction) via RNA extracted from a specimen of a respiratory infectious disease patient.
The 1copy™️ kit is manufactured by 1drop.inc who are a global leader in the healthcare sector that develop world class technology including clinical chemistry, molecular diagnostics and immunoassays. PPE Asia Pacific are mandated to distribute the 1copy™️ across the Middle East North African region.
Notably, the 1copy™️ (RT qPCR offering) is superior to the conventional RT PCR and it promises more sensitive and consistent results. In analytical LoD, 1copy kit can detect 4 copies/reaction, whereas a conventional RT-PCR can require up to ~100 copies/reaction. Thus, the 1copy™ BCR-ABL qPCR Kit allows for fast and convenient use by detecting multiple mRNA targets in a single step
1copy™️ provides IPC (Internal Positive Control, Endogenous Human GAPDH mRNA) which is present in each clinical specimen and is sampled with target SARS-CoV-2 virus. Therefore 1copy™️ IPC can be used as a control in all processes including sampling, extraction and amplification. Competing products have been unable to support IPC used as a control in all processes.
Each Kit Contains:
One box of 1copy™ package contains 100 Tests
Features:
Detection Rate
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100% Detection rate of RdRp and E Gene (8 copies +)
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78% RdRp gene and 64% E gene from just 1 copy
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Detects multiple mRNA targets in a single step
Origin of Manufacture
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South Korea
Short Measurement Times for 1copy™️ kit
1copy™️ provides a simple workflow in 1 step that saves test time.
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In hands-on time, just 20 minutes is needed whereas conventional RT-PCR takes 1 hour
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In turn-around time, just 110mins is needed whereas conventional RT-PCR takes about 3 ½ hours
Single virus level Limit of detection
1copy™ COVID-19 qPCR Multi Kit can reduce the risk of asymptomatic and latent infection of COVID-19 by a single virus level limit of detection.
Specification
Experimental step Single step
Limit of detection 4copies/reaction
Target RdRp Gene, E gene
Time 1hour 50 minutes (hands on time 20 mins)
Specimen(Collection Specimen) Total RNA (pharyngeal swap)
Measurable disease COVID-19
Catalog number M22MD100M
Overview 1copy™ COVID-19 Multi Kit - Click Here >>>
Minimum Order Quantities:
250 boxes (1 box = 100 Tests)
Pricing:
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Available upon request.
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Pricing is Ex works South Korea.
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Payment terms are 50% payable on Purchase Order and balance payable on dispatch of goods from factory.
Shipping
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One Box of 1copy™️ package contains 100 kits.
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1copy™️COVID-19 qPCR Multi kits need to have a cold chain movement and storage maintained at -20˚C.
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Shipping, customs clearance and local transportation must be arranged by the customer.
Compliance and Certifications
1copy™️ is a validated in-vitro diagnostic medical device which has various certifications globally including Korea, US, CE-IVD, Poland, Canada, Saudi Arabia, Columbia and Sri Lanka.
Global Compliance and Certifications 1copy™ COVID-19 Multi Kit - Click Here >>>
Distribution across Australia:
PPE Asia Pacific can provide 1copy™️ qPCR Laboratory Tests worldwide. Compliance regulations and conditions for distribution vary country by country. Clients must ensure they are distributing in compliance with regulations, standards and legal requirements of their distribution markets.
For Australia, PPE Asia Pacific can supply COVID-19 qPCR laboratory tests in Australia under the Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020. In practice this emergency exemption allows COVID-19 diagnostic tests to be immediately supplied to accredited pathology laboratories approved under the Health Insurance Act 1973, while the TGA continues to expedite the regulatory assessment process for these medical devices. Please note that this product can ONLY be provided to Accredited Pathology Laboratories across Australia and is only available upon registration. Further information can be provided for accredited pathology laboratories upon request.
