GenomeCoV19 Detection Kit

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G628.v2100 Rxns
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Customize GenomeCoV19 Detection Kit
1 x COVID-19 Primers/Probes   + $0.00
1 x 2X RT-qPCR MasterMix   + $0.00
1 x Positive Control Template   + $0.00
1 x Negative Extraction Control   + $0.00
1 x qRT-PCR Enzyme Mix   + $0.00
1 x Nuclease-Free H2O   + $0.00

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GenomeCoV19 Detection Kit
GenomeCoV19 Detection Kit

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Summary
    Specifications


    Description

    The most affordable qPCR Detection Kit for SARS-CoV-2 on the market.

    abm’s GenomeCoV19 Detection Kit is a real-time reverse transcription-polymerase chain reaction (RT-qPCR) test intended for the qualitative detection of RNA from SARS-CoV-2 in human nasopharyngeal and oropharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. Our GenomeCoV19 Detection Kit is the most affordable qPCR detection kit on the market at only $1.77 USD/test (limited time pricing for US customers only).

    This kit is widely used in Europe under the CE-IVD certification and is listed by U.S. Food and Drug Administration (FDA) for distribution in the USA, under Section IV.C.

    GenomeCoV19 Detection Kit Features

    SKUG628.v2
    Applications

    An ideal tool to detect COVID-19/SARS-CoV-2 by the RT-qPCR method. 

    Product Features• Most affordable COVID-19 qPCR test kit on the market at $1.77 USD/test (limited time pricing for US customers only)
    • We have FDA permission to distribute in the US under Section IV.C
    • Already widely used in Europe under the CE-IVD certification
    Protocol OverviewTarget genes:
    • N and S genes of SARS-CoV-2 as recommended by CDC and WHO

    Advantages:
    • Results in 1 hour
    • Includes MasterMix, Primers/Probes, Internal Positive Control and Negative Extraction Control
    • 100 Reactions/Kit
    • Highly sensitive with an LoD of 5 cp/rxn

    Kit components:
    • Mastermix
    • Primers/Probes
    • Positive Control
    • Negative Extraction Control

    Equipment:
    • Compatible with standard RT-qPCR machines (Bio-Rad CFX96, Flex 7TM QuantStudio, ABI7500 Fast etc.)

    Specimen types:
    • Naso/Oropharyngeal swabs

    For more information, please review our Datasheet and Clinical Sample Data in the Documents section. A video walk-through of the protocol is also available below.

    GenomeCoV19 Detection Kit Protocol Walkthrough

    Note

    This product is CE-IVD certified and listed on the U.S. Food and Drug Administration (FDA) website, under Section IV.C. For professional use only.

    Storage Condition

    -25 to -15°C

    Unit quantity100 Rxns
    QC

    Limit of Detection (LoD):

    Our LoD study established the lowest concentration of SARS-CoV-2 RNA, as genome copies (cp) per reaction, which can be detected by the GenomeCoV19 Detection Kit at least 95% of the time. This was established by testing serial dilutions of SARS-CoV-2 genomic RNA (source: ATCC-VR1986D) into nasopharyngeal clinical matrix, verified to be COVID-19 negative, at the following concentrations: 100 cp/µl, 50 cp/µl, 5 cp/µl, 4 cp/µl, 3 cp/µl, 2 cp/µl, 1 cp/µl and 0.5 cp/µl. RNA extraction was performed with the Qiagen QIAamp DSP Viral RNA Mini Kit and tests were run on the Bio-Rad CFX96 qPCR instrument. The LoD was determined to be 5 cp/reaction and results are shown in the table below.

    Cp/ReactionSamples TestedN-gene (FAM)Average Ct (FAM)S-gene (HEX)Average Ct (HEX)% Match
    500 4 4 27.29 4 27.75 100%
    250 4 4 28.35 4 28.84 100%
    25 4 4 31.65 4 32.19 100%
    20 4 4 31.33 4 31.10 100%
    15 4 4 31.72 4 31.25 100%
    10 4 4 32.64 4 32.24 100%
    5 24 24 32.99 24 33.36 100%
    2.5 4 3 37.15 4 36.12 75%

    Clinical Performance (Contrived Samples):

    A contrived clinical study was conducted with a total of 30 negative and 30 contrived positive samples. Positive samples were prepared by spiking ATCC-VR1986D SARS-CoV-2 reference genome RNA into nasopharyngeal matrix mixed with lysis buffer from QIAamp DSP Viral RNA Mini Kit at 1X, 10X, and 100X LoD. Tests were run on the Bio-Rad CFX96 qPCR instrument and results showed 100% Positive Percent Agreement (30/30 positive results) and 100% Negative Percent Agreement (30/30 negative results).

    Clinical Performance (Remnant Samples):

    A blinded clinical study was conducted using a SARS-CoV-2 Validation Panel with 60 nasopharyngeal/oropharyngeal/nasal swab remnant clinical specimens. These 30 SARS-CoV-2 positive and 30 SARS-CoV-2 negative remnant specimens were verified using a FDA EUA-authorized COVID-19 detection kit. RNA extraction was performed with the Qiagen QIAamp DSP Viral RNA Mini Kit and tests were run on the Bio-Rad CFX96 qPCR instrument. GenomeCoV19 Detection Kit test results showed 100% Positive Percent Agreement (30/30 positive results) and 100% Negative Percent Agreement (30/30 negative results).

    Inclusivity (Analytical Sensitivity):

    The primers and probes sequences were blasted against SARS-CoV-2 genomes publicly available as of June 29th, 2020. Results showed the sequences had 100% homology to all SARS-CoV-2 isolates analyzed, with two exceptions of MT451113.1 and MT534319.1 (homology of 95.2% in both cases). Both exceptions occur at the 5'end of the primer, and thus are unlikely to cause the failure of qPCR, and would not affect the test performance under specified annealing temperature.

    Cross-Reactivity:

    Cross-reactivity studies using a panel of organisms were conducted by both in silico analysis and wet-testing of whole organisms or purified nucleic acids. The GenomeCoV19 Detection Kit primers and probes were first analyzed in silico against each of the organisms listed in the table below using BLASTn. No cross-reactivity with >80% homology was found for any of the primer and probe sets. Additionally, the bacteria, viruses and pooled human wash described in the table below were included for wet-testing. Concentrations of 106CFU/mL (for bacteria) and 105pfu/mL (for viruses) were used to purify the nucleic acids using the Qiagen QIAamp DSP Viral RNA Mini Kit. There was no cross-reactivity observed for any of the organisms tested using the GenomeCoV19 Detection Kit on Bio-Rad’s CFX96 qPCR instrument. Cross-reactivity was defined as Ct < 40.

    Organism NameN geneS geneSource
    Human Coronavirus-229E ND ND ATCC VR-740
    Human Coronavirus-OC43 ND ND Zeptometrix NATCOV(OC43)-ST
    Human Coronavirus-HKU1 ND ND ATCC VR-3262SD
    Human Coronavirus-NL63 ND ND ATCC VR-3263SD
    SARS-coronavirus ND ND BEI NR-3882
    MERS-coronavirus ND ND ATCC VR-3248SD
    Adenovirus ND ND abm 000047A
    Human Metapneumovirus ND ND ATCC VR-3250SD
    Parainfluenza virus 1 ND ND ATCC VR-94D; C35
    Parainfluenza virus 2 ND ND ATCC VR-92D; Greer
    Parainfluenza virus 3 ND ND ATCC VR-1782; ATCC-2011-5
    Parainfluenza virus 4 ND ND ATCC VR-1377; CH 19503
    Influenza A ND ND ATCC VR-1679D; H3N2, A/Hong Kong/8/68
    Influenza B ND ND ATCC VR-1735D; B/Taiwan/2/62
    Enterovirus ND ND ATCC VR-1377; CH 19503
    Respiratory syncytial virus ND ND ATCC VR-1580; 18537
    Rhinovirus ND ND ATCC VR-1171; 6669-CV39
    Chlamydia pneumoniae ND ND ATCC 53592D; AR-39
    Haemophilus influenzae ND ND ATCC 51907D
    Legionella pneumophila ND ND ATCC 33152D-5; Philadelphia-1
    Mycobacterium tuberculosis ND ND ATCC 25177; H37Ra
    Pneumocystis jirovecii ND ND Zeptometrix- 0801698DNA-1UG
    Streptococcus pneumoniae ND ND ATCC 33400D-5
    Streptococcus pyogenes ND ND ATCC 12344D-5; T1
    Streptococcus salivarius ND ND Zeptometrix - 0801896
    Mycoplasma pneumoniae ND ND ATCC 15531D; FH of Eaton Agent
    Pooled human nasal wash - representing diverse microbial flora in the human respiratory tract ND ND -
    Candida albicans ND ND ATCC 10231
    Bordetella pertussis ND ND Zeptometrix 0801459
    Pseudomonas aeruginosa ND ND ATCC 9027
    Staphylococcus epidermis ND ND ATCC 12228

    *ND = Not Detected

    Precision: CV < 5% (Between and within batches).

    Disclaimer

    Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. This product is not licensed for sale in Canada.

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