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
1copyâ„¢ 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
1copyâ„¢ 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.
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Short measurement time
1copyâ„¢ COVID-19 qPCR Multi Kit has a short measurement time that less than 2 hours.
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Single Molecule RNA Detection, Real-time RT-PCR
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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
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· ISO 13485: 2016
· ISO 14971: 2012
U-TOPâ„¢ COVID 19 Detection Kit
U-TOPâ„¢ 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
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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
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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
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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
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Sensitivity:
98.6%
Specificity:
88.7%
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
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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
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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