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Ezplex SARS-CoV-2 G Kit (FAST)

Negotiable | Min. Order

Description
The Ezplex® SARS-CoV-2 G Kit (FAST) is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test.The 2019-nCoV primer and probe set(s) is designed to detect RNA from the SARS-CoV-2 Virus in Upper Respiratory(Nasopharyngeal/Oropharyngeal) swabs and Lower Respiratory specimens(Sputum) from patients with signs and symptoms of infection who are suspected of COVID-19. Workflow Compatible DeviceCFX96 Real-time PCR InstrumentQuantStudio 6 Flex Real-time PCR Instrument Performance Evaluation 1) Analytical SensitivityUsing standard SARS-CoV-2 material, it was serially spiked in both of Upper respiratory(Nasopharyngeal) and Lower respiratory specimens(Sputum), and RNA were extracted from those prepared specimens. The test was performed 20 times on every diluted concentrations and the limit of detection is calculated as below using probit analysis of 95% positive rate. TargetCFX96QuantStudio 6 FlexUpperLowerUpperLowerRdRp1.585 copies/uL1.367 copies/uL2.587 copies/uL2.587 copies/uLN1.045 copies/uL1.259 copies/uL2.272 copies/uL1.887 copies/uL 2) Analytical Specificity2.1) Cross reactivityThe 15 species of microorganisms, which are expected of cross reactivity, are chosen for the test and the test repeated three times on every chosen species. As a result of the test, there were no cross reactivity as those were observed as all negative result.MicroorganismSARS-CoV-2 (O)SARS-CoV-2 (X)MicroorganismSARS-CoV-2 (O)SARS-CoV-2 (X)Influenza A H3PosNegCoronavirus 229EPosNegInfluenza BPosNegEnterovirus 71PosNegBordetella pertussisPosNegAdenovirusPosNegRespiratory Synncytial virus BPosNegRhinovirusPosNegParainfluenza virus 1-3PosNegBordetella parapertussisPosNegCoronavirus OC43PosNegLegionella pnermophilaPosNegCoronavirus NL63PosNeg 2.2) InterferenceThe interference materials were prepared with 3 materials of endogenous - Albumin (0.24g/mL), Hemoglobin (0.2g/mL), Bilirubin (0.05mg/mL) - those were tested three times with and without positive materials of SARS-CoV-2 diluted in low concentration. As a result of the test, there were no interference by observing the coefficient of variation(CV) value which were less than 5% in all cases.ControlsInterferenceAlbuminHemoglobinBillirubinOXOXOXSARS-CoV-2 VirusPositive(CV 5%>)PositivePositive(CV 5%>)PositivePositive(CV 5%>)PositiveNegative controlNegativeNegativeNegativeNegativeNegativeNegative 3) Analytical Precision 3.1) Analytical Precision (Reproducibility)A reference material for SARS-CoV-2 Virus(Vircell, MBC137-R) was diluted into middle concentration (100 copies/uL) and low concentration (5 copies/uL). It was tested together with negativity (D.W) using 1 Lot by 2 investigators and each investigator tested several times repeatedly. The detection results were same across the tests with CV < 5%, and it was confirmed that results did not differ between investigators. 3.2) Analytical Precision (Repeatability)A reference material for SARS-CoV-2 Virus(Vircell, MBC137-R) was diluted into middle concentration (100 copies/uL) and low concentration (5 copies/uL). It was tested together with negativity (D.W) using 2 Lots by 1 investigator and the investigator tested 10 times repeatedly, 5 times a day for 2 days. All the detection results were same with CV < 5%, and it was confirmed that results did not differ within a test, between tests and between lots. 4)Clinical EvaluationThe clinical performance was evaluated by a clinical performance testing institution in Republic of Korea using the left-over upper respiratory (nasopharyngeal and oropharyngeal) and lower respiratory (sputum) specimens that were positive and negative through the emergency use approved product (Kosen Biotech, PowerchekTM 2019-nCoV Real-time PCR kit) by Korea CDC, and the results are as follows. (1) CFX96 Real-time PCR InstrumentUpper(Nasopharyngeal/Oropharyngeal)ReferenceLower(Sputum(ReferencePositiveNegativeTotalPositiveNegativeTotalEzplex®Positive990100Ezplex®Positive990100Negative1100100Negative1100100Total100100200Total100100200Sensitivity(95% CI)99 % (94.55 ~ 99.97 %)Sensitivity(95% CI)99 % (94.55 ~ 99.97 %)Specificity(95% CI)100 % (96.38 ~ 100 %)Specificity(95% CI)100 % (96.38 ~ 100 %) (2) QuantStudio 6 Flex Real-time PCR InstumentUpper(Nasopharyngeal/Oropharyngeal)ReferenceLower(Sputum(ReferencePositiveNegativeTotalPositiveNegativeTotalEzplex®Positive30030Ezplex®Positive30030Negative03030Negative03030Total303060Total303060Sensitivity(95% CI)100 % (88.43 ~ 100 %)Sensitivity(95% CI)100 % (88.43 ~ 100 %)Specificity(95% CI)100 % (88.43 ~ 100 %)Specificity(95% CI)100 % (88.43 ~ 100 %) Kit Components * 50 tests No.Kit ComponentVolumeLid Remarks1RQ Mixture1 vial, 600uLRQ2RdRp P+P1 vial, 200uLRdRp3N P+P1 vial, 200uLN4Positive Control1 vial, 100uLPC5Negative Control1 vial, 100uLNC6Internal Control1 vial, 20uLIC * 100 tests No.Kit ComponentVolumeLid Remarks1RQ Mixture2 vials, 600uLRQ2RdRp P+P2 vials, 200uLRdRp3N P+P2 vials, 200uLN4Positive Control1 vial, 100uLPC5Negative Control1 vial, 100uLNC6Internal Control1 vial, 20uLIC
Place of Origin
South Korea
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  • 1 SML Genetree Co.,Ltd.

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    Country South Korea South Korea

    DUNS

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    PRODUCT DESCRIPTION
    COMPANY INFORMATION
    Product Information

    The Ezplex® SARS-CoV-2 G Kit (FAST) is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test.The 2019-nCoV primer and probe set(s) is designed to detect RNA from the SARS-CoV-2 Virus in Upper Respiratory(Nasopharyngeal/Oropharyngeal) swabs and Lower Respiratory specimens(Sputum) from patients with signs and symptoms of infection who are suspected of COVID-19.

     

    Workflow

     

    Compatible Device

    CFX96 Real-time PCR Instrument

    QuantStudio 6 Flex Real-time PCR Instrument

     

    Performance Evaluation

     

    1) Analytical Sensitivity

    Using standard SARS-CoV-2 material, it was serially spiked in both of Upper respiratory(Nasopharyngeal) and Lower respiratory specimens(Sputum), and RNA were extracted from those prepared specimens. The test was performed 20 times on every diluted concentrations and the limit of detection is calculated as below using probit analysis of 95% positive rate.

     

    Target

    CFX96

    QuantStudio 6 Flex

    Upper

    Lower

    Upper

    Lower

    RdRp

    1.585 copies/uL

    1.367 copies/uL

    2.587 copies/uL

    2.587 copies/uL

    N

    1.045 copies/uL

    1.259 copies/uL

    2.272 copies/uL

    1.887 copies/uL

     

    2) Analytical Specificity

    2.1) Cross reactivity

    The 15 species of microorganisms, which are expected of cross reactivity, are chosen for the test and the test repeated three times on every chosen species. As a result of the test, there were no cross reactivity as those were observed as all negative result.


    Microorganism

    SARS-

    CoV-2 (O)

    SARS-CoV-2 (X)

    Microorganism

    SARS-

    CoV-2 (O)

    SARS-

    CoV-2 (X)

    Influenza A H3

    Pos

    Neg

    Coronavirus 229E

    Pos

    Neg

    Influenza B

    Pos

    Neg

    Enterovirus 71

    Pos

    Neg

    Bordetella pertussis

    Pos

    Neg

    Adenovirus

    Pos

    Neg

    Respiratory Synncytial virus B

    Pos

    Neg

    Rhinovirus

    Pos

    Neg

    Parainfluenza virus 1-3

    Pos

    Neg

    Bordetella parapertussis

    Pos

    Neg

    Coronavirus OC43

    Pos

    Neg

    Legionella pnermophila

    Pos

    Neg

    Coronavirus NL63

    Pos

    Neg

     

     

    2.2) Interference

    The interference materials were prepared with 3 materials of endogenous - Albumin (0.24g/mL), Hemoglobin (0.2g/mL), Bilirubin (0.05mg/mL) - those were tested three times with and without positive materials of SARS-CoV-2 diluted in low concentration. As a result of the test, there were no interference by observing the coefficient of variation(CV) value which were less than 5% in all cases.


    Controls

    Interference

    Albumin

    Hemoglobin

    Billirubin

    O

    X

    O

    X

    O

    X

    SARS-CoV-2 Virus

    Positive

    (CV 5%>)

    Positive

    Positive

    (CV 5%>)

    Positive

    Positive

    (CV 5%>)

    Positive

    Negative control

    Negative

    Negative

    Negative

    Negative

    Negative

    Negative

     

    3) Analytical Precision

     

    3.1) Analytical Precision (Reproducibility)

    A reference material for SARS-CoV-2 Virus(Vircell, MBC137-R) was diluted into middle concentration (100 copies/uL) and low concentration (5 copies/uL). It was tested together with negativity (D.W) using 1 Lot by 2 investigators and each investigator tested several times repeatedly. The detection results were same across the tests with CV < 5%, and it was confirmed that results did not differ between investigators.

     

    3.2) Analytical Precision (Repeatability)

    A reference material for SARS-CoV-2 Virus(Vircell, MBC137-R) was diluted into middle concentration (100 copies/uL) and low concentration (5 copies/uL). It was tested together with negativity (D.W) using 2 Lots by 1 investigator and the investigator tested 10 times repeatedly, 5 times a day for 2 days. All the detection results were same with CV < 5%, and it was confirmed that results did not differ within a test, between tests and between lots.

     

    4)Clinical Evaluation

    The clinical performance was evaluated by a clinical performance testing institution in Republic of Korea using the left-over upper respiratory (nasopharyngeal and oropharyngeal) and lower respiratory (sputum) specimens that were positive and negative through the emergency use approved product (Kosen Biotech, PowerchekTM 2019-nCoV Real-time PCR kit) by Korea CDC, and the results are as follows.

     

    (1) CFX96 Real-time PCR Instrument


    Upper

    (Nasopharyngeal/

    Oropharyngeal)

    Reference

    Lower

    (Sputum(

    Reference

    Positive

    Negative

    Total

    Positive

    Negative

    Total

    Ezplex®

    Positive

    99

    0

    100

    Ezplex®

    Positive

    99

    0

    100

    Negative

    1

    100

    100

    Negative

    1

    100

    100

    Total

    100

    100

    200

    Total

    100

    100

    200

    Sensitivity

    (95% CI)

    99 % (94.55 ~ 99.97 %)

    Sensitivity

    (95% CI)

    99 % (94.55 ~ 99.97 %)

    Specificity

    (95% CI)

    100 % (96.38 ~ 100 %)

    Specificity

    (95% CI)

    100 % (96.38 ~ 100 %)

     

    (2) QuantStudio 6 Flex Real-time PCR Instument


    Upper

    (Nasopharyngeal/

    Oropharyngeal)

    Reference

    Lower

    (Sputum(

    Reference

    Positive

    Negative

    Total

    Positive

    Negative

    Total

    Ezplex®

    Positive

    30

    0

    30

    Ezplex®

    Positive

    30

    0

    30

    Negative

    0

    30

    30

    Negative

    0

    30

    30

    Total

    30

    30

    60

    Total

    30

    30

    60

    Sensitivity

    (95% CI)

    100 % (88.43 ~ 100 %)

    Sensitivity

    (95% CI)

    100 % (88.43 ~ 100 %)

    Specificity

    (95% CI)

    100 % (88.43 ~ 100 %)

    Specificity

    (95% CI)

    100 % (88.43 ~ 100 %)

     

    Kit Components

     

    * 50 tests

     

    No.

    Kit Component

    Volume

    Lid Remarks

    1

    RQ Mixture

    1 vial, 600uL

    RQ

    2

    RdRp P+P

    1 vial, 200uL

    RdRp

    3

    N P+P

    1 vial, 200uL

    N

    4

    Positive Control

    1 vial, 100uL

    PC

    5

    Negative Control

    1 vial, 100uL

    NC

    6

    Internal Control

    1 vial, 20uL

    IC

     

    * 100 tests

     

    No.

    Kit Component

    Volume

    Lid Remarks

    1

    RQ Mixture

    2 vials, 600uL

    RQ

    2

    RdRp P+P

    2 vials, 200uL

    RdRp

    3

    N P+P

    2 vials, 200uL

    N

    4

    Positive Control

    1 vial, 100uL

    PC

    5

    Negative Control

    1 vial, 100uL

    NC

    6

    Internal Control

    1 vial, 20uL

    IC

     

     

     

    Image
    Feature

     

    Spec

     

    Company

    SML Genetree Co.,Ltd.

    Country South Korea South Korea

    Supplier Activity

    President
    AN JI HUN
    Address
    6F Hanmaeum Bldg 225 Bauroiro, Seocho-gu, Seoul, Korea
    Product Category
    Other Monitoring & Diagnostic Equipment
    Year Established
    2015
    Company introduction

     

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