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Health Security

Only the 1copy COVID-19 qPCR Multi Kit is available or intended for sale within Canada.


All other COVID-19 test kits are not available or intended for sale within Canada but are available in various jurisdictions worldwide, including the US and the EU. Inquire for details regarding your jurisdiction.

 

COVID-19 Nucleic Acid Detection Kits

1copy™ COVID-19 qPCR Multi kit

This kit allows qualitative detection of genes (E gene and RdRp gene - RdRp is the 2019-nCOV’s specific detection target, and the E gene is the beta coronavirus detection target) of COVID-19 with real-time qPCR (including reverse-transcription reaction) via RNA extracted from a specimen (Nasopharyngeal swab, Oropharyngeal swab) of suspected respiratory infectious disease patient.

Manufacturer

1drop Inc.

Characteristics

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.

Short measurement time
1copy™ COVID-19 qPCR Multi Kit has a short measurement time that less than 2 hours.

  • Single Molecule RNA Detection, Real-time RT-PCR

  • Total measurement time: 1 h 50 min
    Hands-on time: 20 min 

Certifications

· FDA-EUA
· Poland MOH
· Colombia INVIMA
· CE-IVD
· Health Canada
· Saudi Arabia FDA
· NMRA Sri Lanka
· kFDA Free Sales Certification

· ISO 13485: 2016

· ISO 14971: 2012

U-TOP™ COVID 19 Detection Kit

U-TOP™ COVID-19 Detection Kit is an in-vitro diagnostic product intended for Real-time PCR based detection of new Coronavirus (COVID-19) infection via simultaneous amplification of ORF1ab and N-gene in patients with suspect COVID-19 infection. * This product is an in-vitro diagnostic medical device, please be sure to read Instruction manual first.

Manufacturer

SEASUN BIOMATERIALS (South Korea)

Characteristics

Peptide Nucleic Acid(PNA)

based Real-time RT-PCR

96 tests in 1.5 hour

Certifications

· FDA-EUA

· kFDA

· CE

· ISO 13485: 2016

· ISO 9001: 2015

PCLMDTM nCoV one step RT PCR Kit

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Manufacturer

PCL INC. (South Korea)

Characteristics

Real-Time PCR 
Easy-to-use (1-Tube)
96 tests in 45 minutes

Sensitivity:

Proven by Clinical Study
7 ~ 43 times sensitive than other products
(https://www.preprints.org/manuscript/202002.0424/v1)

 

Certifications

· kFDA

· kFSC

· CE-IVD

· ANMAT Argentina

· Colombia INVIMA

· CDSCO INDIA

· Indonesia

iLAMP Novel-Co V 19 Detection Kit

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Manufacturer

iONEBIO (South Korea)

Characteristics

Real-Time RT -LAMP PCR 
(with One step)
96 tests in 20 minutes

Sensitivity:

100%

 

Specificity:

100%
 

Certifications

· kFDA

· CE
· ISO 13485 : 2016

· ISO 9001

 

COVID-19 Antigen Detection Kits

BIOCREDIT COVID-19 Ag

Manufacturer

RapiGEN Inc. (South Korea)

Characteristics

Detection of SARS-CoV2 Antigen
5~8 mins

Sensitivity:

92%

 

Specificity:

98%

Certifications

· kFDA

· kFSC

· CE
· ISO 13485: 2016

COV05 FIA Sensitive Antigen RAPID Test

Manufacturer

PCL INC. (South Korea)

Characteristics

Detection of SARS-CoV2 Antigen
10 mins

Sensitivity:

100%

 

Specificity:

97.78%

Certifications

· kFDA

· kFSC

· CE-IVD
· CDSCO INDIA

· Greece

· Colombia INVIMA  

 

COVID-19 Antibody Detection Kits

BIOCREDIT COVID-19 IgG+IgM Duo

Manufacturer

RapiGEN Inc. (South Korea)

Characteristics

Detection of IgG&IgM SARS-CoV2 Antibodies
5~10 mins

Sensitivity:

88%

 

Specificity:

96%

Certifications

· FDA registered

· kFDA

· kFSC

· CE
· ISO 13485: 2016

COV03 COVID19 IgG/IgM Rapid Gold

Manufacturer

PCL INC. (South Korea)

Characteristics

Detection of IgG&IgM SARS-CoV2 Antibodies
10 mins

Sensitivity:

91.06%

 

Specificity:

99.37%

Certifications

· kFDA

· kFSC

· TGA Australia
· FDA registered

· CE-IVD
· Russia Federation

· CDSCO INDIA

· Philippines FDA

· Bolivia FDA

· Colombia INVIMA

Interested in purchasing test kits?
Fill the form below:

Datametrex AI Ltd.

Head Office - Toronto
4711 Yonge Street, 10th floor

Toronto, ON, Canada, M2N 6K8

©2020 Datametrex AI Ltd.

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